Friday, October 21, 2016

eflornithine topical


Generic Name: eflornithine topical (ee FLOOR nih theen)

Brand Names: Vaniqa


What is eflornithine topical?

Eflornithine interferes with a chemical in the hair follicles of the skin. This results in slower hair growth where eflornithine topical is applied.


Eflornithine topical is used to reduce unwanted facial hair in women. Eflornithine topical does not permanently remove hair or "cure" unwanted facial hair. Eflornithine topical will help you manage your condition and improve your appearance.


Eflornithine topical may also be used for purposes other than those listed in this medication guide.


What is the most important information I should know about eflornithine topical?


Eflornithine topical is for external use only.

Continue to use eflornithine topical even if you do not see immediate results. Reduction in facial hair occurs gradually. Improvement may be seen as early as 4 to 8 weeks of treatment, however it may take longer in some individuals. If no improvement is seen after 6 months of use, treatment with eflornithine topical should be discontinued. Hair growth may return to pretreatment levels approximately 8 weeks after discontinuation of treatment with eflornithine topical.


Who should not use eflornithine topical?


Do not use eflornithine topical if you have had an allergic reaction to it in the past. Eflornithine topical is in the FDA pregnancy category C. This means that it is not known whether eflornithine topical will harm an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant. It is also not known whether eflornithine passes into breast milk. Do not use eflornithine topical without first talking to your doctor if you are breast-feeding a baby. Eflornithine topical has not been approved for use by children younger than 12 years of age.

How should I use eflornithine topical?


Apply eflornithine topical exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Eflornithine topical does not permanently remove hair or "cure" unwanted facial hair. It is not a hair remover (depilatory). You will need to continue using your current hair removal techniques. Eflornithine topical will help you manage your condition and improve your appearance.


Eflornithine topical is for external use only.

Eflornithine topical is usually applied twice daily, at least eight hours apart, or as directed by your doctor.


Wash your hands before and after each application of eflornithine topical.


Remove any facial hair that is present using your current hair removal techniques. Wait at least 5 minutes after hair removal before applying eflornithine topical. Apply a thin layer of eflornithine topical to the affected areas of the face and nearby affected areas under the chin and rub it in thoroughly.


Cosmetics or sunscreen may be used after applying eflornithine topical, but you should wait a few minutes to allow the treatment to be absorbed before applying them.


Do not wash the treatment areas for at least 4 hours after application of eflornithine topical. Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wash the area with water. If eflornithine topical gets in your eyes, rinse them thoroughly with water and contact your doctor.

Eflornithine topical may cause temporary redness, rash, burning, stinging, or tingling, especially if it is applied to broken or irritated skin. If irritation develops, reduce the application of eflornithine topical to once a day. If irritation continues, stop using eflornithine topical and contact your doctor.


Continue to use eflornithine topical even if you do not see immediate results. Reduction in facial hair occurs gradually. Improvement may be seen as early as 4 to 8 weeks of treatment, however it may take longer in some individuals. If no improvement is seen after 6 months of use, treatment with eflornithine topical should be discontinued. Hair growth may return to pretreatment levels approximately 8 weeks after discontinuation of treatment with eflornithine topical.


Store eflornithine topical at room temperature away from moisture and heat. Do not allow the medication to freeze.

What happens if I miss a dose?


If you miss a dose of eflornithine topical, skip the dose you missed and apply your next regularly scheduled dose as directed. Do not apply a double dose of this medication or try to "make up" a missed dose.


What happens if I overdose?


An overdose of eflornithine topical is not likely to occur. If the cream has been ingested, or if you suspect an overdose has occurred, contact your doctor, hospital emergency room, or poison control center for advice.


What should I avoid while using eflornithine topical?


Avoid getting this medication in your eyes, nose, or mouth. If this occurs, wash the area with water. If eflornithine topical gets in your eyes, rinse thoroughly with water and contact your doctor.

Eflornithine topical side effects


Eflornithine topical may cause temporary redness, rash, burning, stinging, or tingling, especially if it is applied to broken or irritated skin. If irritation develops, reduce the application of eflornithine topical to once a day. If irritation continues, stop using eflornithine topical and contact your doctor.


Hair bumps (folliculitis) may also occur. If these continue, contact your doctor.


Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.


Eflornithine topical Dosing Information


Usual Adult Dose for Hirsutism:

Apply a thin layer of eflornithine topical cream to affected areas of the face and adjacent involved areas under the chin and rub in thoroughly. Do not wash treated area for at least 4 hours. Use twice a day, allowing at least 8 hours between applications or as directed by a physician.

Continue to use hair removal techniques as needed in conjunction with eflornithine. Apply eflornithine at least 5 minutes after hair removal. Cosmetics or sunscreens may be applied over treated areas after cream has dried.


What other drugs will affect eflornithine topical?


Before using eflornithine topical, talk to your doctor if you are taking any other prescription or over-the-counter medications, especially if you are using any other topical preparations. You may not be able to use eflornithine topical, or you may require a dosage adjustment or special monitoring during treatment.


Drugs other than those listed here may also interact with eflornithine topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines.



More eflornithine topical resources


  • Eflornithine topical Side Effects (in more detail)
  • Eflornithine topical Dosage
  • Eflornithine topical Use in Pregnancy & Breastfeeding
  • Eflornithine topical Support Group
  • 8 Reviews for Eflornithine - Add your own review/rating


  • Vaniqa Monograph (AHFS DI)

  • Vaniqa Topical Advanced Consumer (Micromedex) - Includes Dosage Information

  • Vaniqa Cream MedFacts Consumer Leaflet (Wolters Kluwer)

  • Vaniqa Consumer Overview



Compare eflornithine topical with other medications


  • Hirsutism


Where can I get more information?


  • Your pharmacist has additional information about eflornithine topical written for health professionals that you may read.

See also: eflornithine side effects (in more detail)


Eye Cool



Generic Name: phenylephrine (Ophthalmic route)

fen-il-EF-rin

Commonly used brand name(s)

In the U.S.


  • AK-Dilate

  • Altafrin

  • Eye Cool

  • Mydfrin

  • Neofrin

  • Neo-Synephrine

  • Ocu-Phrin

  • Prefrin Liquifilm

Available Dosage Forms:


  • Solution

Therapeutic Class: Mydriatic-Cycloplegic


Pharmacologic Class: Sympathomimetic


Chemical Class: Alkylarylamine


Uses For Eye Cool


Ophthalmic phenylephrine in strengths of 2.5 and 10% is used to dilate (enlarge) the pupil. It is used before eye examinations, before and after eye surgery, and to treat certain eye conditions. In the U.S., these preparations are available only with your doctor's prescription.


Before Using Eye Cool


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Children may be especially sensitive to the effects of phenylephrine. This may increase the chance of side effects during treatment. In addition, the 10% strength is not recommended for use in infants. Also, the 2.5 and 10% strengths are not recommended for use in low birth weight infants.


Geriatric


Repeated use of 2.5 or 10% phenylephrine may increase the chance of problems during treatment with this medicine. In addition, heart and blood vessel problems have occurred more often in elderly patients than in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Clorgyline

  • Iproniazid

  • Isocarboxazid

  • Nialamide

  • Phenelzine

  • Procarbazine

  • Rasagiline

  • Selegiline

  • Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Amitriptyline

  • Amoxapine

  • Clomipramine

  • Desipramine

  • Dothiepin

  • Doxepin

  • Furazolidone

  • Imipramine

  • Lofepramine

  • Midodrine

  • Nortriptyline

  • Opipramol

  • Pargyline

  • Protriptyline

  • Trimipramine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Guanethidine

  • Propranolol

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Type 2 diabetes mellitus or

  • Heart or blood vessel disease or

  • High blood pressure—The 2.5 and 10% strengths of phenylephrine may make the condition worse

  • Idiopathic orthostatic hypotension (a certain kind of low blood pressure)—Use of this medicine may cause a large increase in blood pressure to occur

Proper Use of phenylephrine

This section provides information on the proper use of a number of products that contain phenylephrine. It may not be specific to Eye Cool. Please read with care.


Do not use if the solution turns brown or becomes cloudy.


To use:


  • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 2 or 3 minutes to allow the medicine to be absorbed by the eye.

  • Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.

  • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

For patients using the 2.5 or 10% eye drops:


  • It is very important that you use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects. This is especially important when this medicine is used in children or in patients with heart disease or high blood pressure, since high doses of this medicine may cause an irregular heartbeat and an increase in blood pressure.

Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For ophthalmic solution (eye drops) dosage form:
    • For eye redness:
      • Adults and children—Use one drop of 0.12% solution every three or four hours as needed.


    • For eye exams:
      • Adults and children—Use one drop of 2.5% solution. Depending on the eye test to be done, it will take from fifteen minutes to one or two hours for the medicine to work before you can have the eye test.


    • For use before eye surgery:
      • Adults and teenagers—Use one drop of 2.5 or 10% solution thirty to sixty minutes before the start of eye surgery.

      • Children—Use one drop of 2.5% solution thirty to sixty minutes before the start of eye surgery.


    • For certain eye conditions:
      • Adults and teenagers—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5 or 10% solution in the eye from once a day to three times a day.

      • Children—Depending on the eye condition being treated, your doctor may tell you to use one drop of 2.5% solution in the eye from once a day to three times a day.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


For non-prescription strength eye drops, follow the package directions.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Eye Cool


If eye pain or change in vision occurs or if redness or irritation of the eye continues, gets worse, or lasts for more than 72 hours, stop using the medicine and check with your doctor.


For patients using the 2.5 or 10% eye drops:


  • After you apply this medicine to your eyes, your pupils will become unusually large. This will cause your eyes to become more sensitive to light than they are normally. When you go out during the daylight hours, even on cloudy days, wear sunglasses that block ultraviolet (UV) light to protect your eyes from sunlight and other bright lights. Ordinary sunglasses may not protect your eyes. If you have any questions about the kind of sunglasses to wear, check with your doctor. Also, if this effect continues for longer than 12 hours after you have stopped using this medicine, check with your doctor.

Eye Cool Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


Symptoms of too much medicine being absorbed into the body - Less common with 10% solution; rare with 2.5% or weaker solution
  • Dizziness

  • fast, irregular, or pounding heartbeat

  • increased sweating

  • increase in blood pressure

  • paleness

  • trembling

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common with 2.5 or 10% solution
  • Burning or stinging of eyes

  • headache or browache

  • sensitivity of eyes to light

  • watering of eyes

Less common
  • Eye irritation not present before use of this medicine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Eye Cool resources


  • Eye Cool Use in Pregnancy & Breastfeeding
  • Eye Cool Drug Interactions
  • Eye Cool Support Group
  • 0 Reviews for Eye Cool - Add your own review/rating


Compare Eye Cool with other medications


  • Eye Dryness/Redness
  • Eye Redness/Itching
  • Pupillary Dilation

Exubera



insulin human (rDNA origin)

Dosage Form: inhalation powder

Rx only



Exubera Description


Exubera® consists of blisters containing human insulin inhalation powder, which are administered using the Exubera® Inhaler. Exubera blisters contain human insulin produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Chemically, human insulin has the empirical formula C257H383N65O77S6 and a molecular weight of 5808. Human insulin has the following primary amino acid sequence:



Exubera (insulin human [rDNA origin]) Inhalation Powder is a white to off-white powder in a unit dose blister (fill mass, see Table 1). Each unit dose blister of Exubera contains a 1 mg or 3 mg dose of insulin (see Table 1) in a homogeneous powder formulation containing sodium citrate (dihydrate), mannitol, glycine, and sodium hydroxide. After an Exubera blister is inserted into the inhaler, the patient pumps the handle of the inhaler and then presses a button, causing the blister to be pierced. The insulin inhalation powder is then dispersed into the chamber, allowing the patient to inhale the aerosolized powder.


Under standardized in vitro test conditions, Exubera delivers a specific emitted dose of insulin from the mouthpiece of the inhaler (see Table 1). A fraction of the total particle mass is emitted as fine particles capable of reaching the deep lung. Up to 45% of the 1 mg blister contents, and up to 25% of the 3 mg blister contents, may be retained in the blister.

















Table 1: Dose Nomenclature and Information
Fill Mass

(mg powder)
Nominal Dose

(mg insulin)
Emitted Dose*,

(mg insulin)
Fine Particle Dose,

(mg insulin)

*

Flow rate of 30 L/min for 2.5 seconds


Emitted dose and fine particle dose information are not intended to predict actual pharmacodynamic response.


Flow rate of 28.3 L/min for 3 seconds

1.71.00.530.4
5.13.02.031.0

The actual amount of insulin delivered to the lung will depend on individual patient factors, such as inspiratory flow profile. In vitro, emitted aerosol metrics are unaffected at flow rates above 10 L/min.



Exubera - Clinical Pharmacology



Mechanism of Action


The primary activity of insulin is regulation of glucose metabolism. Insulin lowers blood glucose concentrations by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis in the adipocyte, inhibits proteolysis, and enhances protein synthesis.



Pharmacokinetics


Absorption

Exubera delivers insulin by oral inhalation. The insulin is absorbed as quickly as subcutaneously administered rapid-acting insulin analogs and more quickly than subcutaneously administered regular human insulin in healthy subjects and in patients with type 1 or type 2 diabetes (see Figure 1).


Figure 1: Mean Changes in Free Insulin Serum Concentrations (µU/mL) in Patients with Type 2 Diabetes Following Administration of Single Doses of Inhaled Insulin from Exubera (6 mg) and Subcutaneous Regular Human Insulin (18U)


In clinical studies in patients with type 1 and type 2 diabetes, after inhalation of Exubera, serum insulin reached peak concentration more quickly than after subcutaneous injection of regular human insulin, 49 minutes (range 30 to 90 minutes) compared to 105 minutes (range 60 to 240 minutes), respectively.


In clinical studies, the absorption of subcutaneous regular human insulin declined with increasing patient body mass index (BMI). However, the absorption of insulin following inhalation of Exubera was independent of BMI.


In a study in healthy subjects, systemic insulin exposure (AUC and Cmax) following administration of Exubera increased with dose over a range of 1 to 6 mg when administered as combinations of 1 and 3 mg blisters.


In a study where the dosage form of three 1 mg blisters was compared with one 3 mg blister, Cmax and AUC after administration of three 1 mg blisters were approximately 30% and 40% greater, respectively, than that after administration of one 3 mg blister (see DOSAGE AND ADMINISTRATION).


Distribution and Elimination

Because recombinant human insulin is identical to endogenous insulin, the systemic distribution and elimination are expected to be the same. However, this has not been confirmed for Exubera.



Pharmacodynamics


Exubera, like subcutaneously administered rapid-acting insulin analogs, has a more rapid onset of glucose-lowering activity than subcutaneously administered regular human insulin. In healthy volunteers, the duration of glucose-lowering activity for Exubera was comparable to subcutaneously administered regular human insulin and longer than subcutaneously administered rapid-acting insulin analogs (see Figure 2).


Figure 2. Mean Glucose Infusion Rate (GIR) Normalized to GIRmax for Each Subject Treatment Versus Time in Healthy Volunteers


*Determined as amount of glucose infused to maintain constant plasma glucose concentrations, normalized to maximum values (percent of maximum values); indicative of insulin activity.


When Exubera is inhaled, the onset of glucose-lowering activity in healthy volunteers occurs within 10–20 minutes. The maximum effect on glucose lowering is exerted approximately 2 hours after inhalation. The duration of glucose-lowering activity is approximately 6 hours.


In patients with type 1 or type 2 diabetes, Exubera has a greater glucose-lowering effect within the first two hours after dosing when compared with subcutaneously administered regular human insulin.


The intra-subject variability of glucose-lowering activity of Exubera is generally comparable to that of subcutaneously administered regular human insulin in patients with type 1 and 2 diabetes.



Special Populations


Pediatric Patients

In children (6–11 years) and adolescents (12–17 years) with type 1 diabetes, time to peak insulin concentration for Exubera was achieved faster than for subcutaneous regular human insulin, which is consistent with observations in adult patients with type 1 diabetes.


Geriatric Patients

There are no apparent differences in the pharmacokinetic properties of Exubera when comparing patients over the age of 65 years and younger adult patients.


Gender

In subjects with and without diabetes, no apparent differences in the pharmacokinetic properties of Exubera were observed between men and women.


Race

A study was performed in 25 healthy Caucasian and Japanese non-diabetic subjects to compare the pharmacokinetic and pharmacodynamic properties of Exubera, versus subcutaneous injection of regular human insulin. The pharmacokinetic and pharmacodynamic properties of Exubera were comparable between the two populations.


Obesity

The absorption of Exubera is independent of patient BMI.


Renal Impairment

The effect of renal impairment on the pharmacokinetics of Exubera has not been studied. Careful glucose monitoring and dose adjustments of insulin may be necessary in patients with renal dysfunction (see PRECAUTIONS, Renal Impairment).


Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetics of Exubera has not been studied. Careful glucose monitoring and dose adjustments of insulin may be necessary in patients with hepatic dysfunction (see PRECAUTIONS, Hepatic Impairment).


Pregnancy

The absorption of Exubera in pregnant patients with gestational and pre-gestational type 2 diabetes was consistent with that in non-pregnant patients with type 2 diabetes (see PRECAUTIONS, Pregnancy).


Smoking

In smokers, the systemic insulin exposure for Exubera is expected to be 2 to 5 fold higher than in non-smokers. Exubera is contraindicated in patients who smoke or who have discontinued smoking less than 6 months prior to starting Exubera therapy. If a patient starts or resumes smoking, Exubera must be discontinued immediately due to the increased risk of hypoglycemia, and an alternative treatment must be utilized (see CONTRAINDICATIONS).


In clinical studies of Exubera in 123 patients (69 of whom were smokers), smokers experienced a more rapid onset of glucose-lowering action, greater maximum effect, and a greater total glucose-lowering effect (particularly during the first 2–3 hours after dosing), compared to non-smokers.


Passive Cigarette Smoke

In contrast to the increase in insulin exposure following active smoking, when Exubera was administered to 30 healthy non-smoking volunteers following 2 hours of exposure to passive cigarette smoke in a controlled experimental setting, insulin AUC and Cmax were reduced by approximately 20% and 30%, respectively. The pharmacokinetics of Exubera have not been studied in nonsmokers who are chronically exposed to passive cigarette smoke.


Patients with Underlying Lung Diseases

The use of Exubera in patients with underlying lung disease, such as asthma or COPD, is not recommended because the safety and efficacy of Exubera in this population have not been established (see WARNINGS). The use of Exubera is contraindicated in patients with unstable or poorly controlled lung disease, because of wide variations in lung function that could affect the absorption of Exubera and increase the risk of hypoglycemia or hyperglycemia (see CONTRAINDICATIONS).


In a pharmacokinetic study in 24 non-diabetic subjects with mild asthma, the absorption of insulin following administration of Exubera, in the absence of treatment with a bronchodilator, was approximately 20% lower than the absorption seen in subjects without asthma. However, in a study in 24 non-diabetic subjects with Chronic Obstructive Pulmonary Disease (COPD), the systemic exposure following administration of Exubera was approximately two-fold higher than that in normal subjects without COPD (see PRECAUTIONS, Underlying Lung Disease).


Administration of albuterol 30 minutes prior to administration of Exubera in non-diabetic subjects with both mild asthma (n=36) and moderate asthma (n=31) resulted in a mean increase in insulin AUC and Cmax of between 25 and 50% compared to when Exubera was administered alone (see PRECAUTIONS, Drug Interactions).



Clinical Studies


The safety and efficacy of Exubera has been studied in approximately 2500 adult patients with type 1 and type 2 diabetes. The primary efficacy parameter for most studies was glycemic control, as measured by the reduction from baseline in hemoglobin A1c (HbA1c).



Type 1 Diabetes


A 24-week, randomized, open-label, active-control study (Study A) was conducted in patients with type 1 diabetes to assess the safety and efficacy of Exubera administered pre-meal three times daily (TID) with a single nighttime injection of Humulin® U Ultralente® (human insulin extended zinc suspension) (n = 136). The comparator treatment was subcutaneous regular human insulin administered twice daily (BID) (pre-breakfast and pre-dinner) with BID injection of NPH human insulin (human insulin isophane suspension) (n = 132). In this study, the mean age was 38.2 years (range: 20–64) and 52% of the subjects were male.


A second 24-week, randomized, open-label, active-control study (Study B) was conducted in patients with type 1 diabetes to assess the safety and efficacy of Exubera (n = 103) compared to subcutaneous regular human insulin (n = 103) when administered TID prior to meals. In both treatment arms, NPH human insulin was administered BID (in the morning and at bedtime) as the basal insulin. In this study, the mean age was 38.4 years (range: 19–65) and 54% of the subjects were male.


In each study, the reduction in HbA1c and the rates of hypoglycemia were comparable for the two treatment groups. Exubera-treated patients had a greater reduction in fasting plasma glucose than patients in the comparator group. The percentage of patients reaching an HbA1c level of <8% (per American Diabetes Association treatment Action Level at the time of study conduct) and an HbA1c level of <7% was comparable between the two treatment groups. The results for Studies A and B are shown in Table 2.






























































































































Table 2: Results of Two 24-Week, Active-Control, Open-Label Trials in Patients With Type 1 Diabetes (Studies A and B)
Study AStudy B
Exubera (TID) + UL (QD)SC R (BID) + NPH (BID)Exubera (TID) + NPH (BID)SC R (TID) + NPH (BID)
Sample Size136132103103
UL = Humulin® U Ultralente®; SC R = subcutaneous regular human insulin

*

A negative treatment difference favors Exubera


American Diabetes Association treatment Action Level at the time of study conduct


1 mg inhaled insulin from Exubera is approximately equivalent to 3 IU of subcutaneously injected regular human insulin (See DOSAGE AND ADMINISTRATION)

HbA1c (%)
  Baseline mean7.98.07.87.8
  Adj. mean change from baseline-0.2-0.4-0.3-0.2
    Exubera minus SC R*0.14-0.11
    95% CI for treatment difference(-0.03, 0.32)(-0.30, 0.08)
Fasting Plasma Glucose (mg/dL)
  Baseline mean191198178191
  Adj. mean change from baseline-32-6-2313
    Exubera minus SC R-27-35
    95% CI for treatment difference(-47, -6)(-58, -13)
2-hr Post-Prandial Glucose Concentration (mg/dL)
  Baseline mean283305273293
  Adj. mean change from baseline-2114-1-3
    Exubera minus SC R-352
    95% CI for treatment difference(-61, -8)(-29, 32)
Patients with end-of-study HbA1c < 8%64.0%68.2%74.8%66.0%
Patients with end-of-study HbA1c < 7%16.9%19.7%28.2%30.1%
Body Weight
  Baseline mean (kg)77.476.476.076.9
  Adj. mean change from baseline (kg)0.41.10.40.6
    Exubera minus SC R-0.72-0.24
    95% CI for treatment difference(-1.48, 0.04)(-1.07, 0.59)
End of study daily insulin dose
  Short-acting insulin13.4 mg18.3 IU10.9 mg25.7 IU
  Long-acting insulin26.4 IU37.1 IU31.5 IU31.9 IU

Type 2 Diabetes


Monotherapy in Patients Not Optimally Controlled With Diet and Exercise Treatment

A 12-week, randomized, open-label, active-control study (Study C) was conducted in patients with type 2 diabetes not optimally controlled with diet and exercise, assessing the safety and efficacy of pre-meal TID Exubera (n = 75) compared to an insulin-sensitizing agent. In this study, the mean age was 53.7 years (range: 28–80), 55% of the subjects were male and the mean body mass index was 32.3 kg/m2.


At 12 weeks, HbA1c levels in patients treated with Exubera decreased 2.2% (SD = 1.0) from a baseline of 9.5% (SD = 1.1). The proportion of patients treated with Exubera reaching an end-of-study HbA1c level of <8% increased to 82.7%. The proportion of patients treated with Exubera reaching an end-of-study HbA1c level of <7 % was 44.6%. Fasting plasma glucose levels in patients treated with Exubera decreased 60 mg/dl from a baseline of 208 mg/dl. Patients treated with Exubera experienced a mean increase in body weight of 2 kg. The rate of hypoglycemia was higher in the Exubera group than the group receiving an insulin-sensitizing agent.


Monotherapy and Add-On Therapy in Patients Previously Treated With Oral Agent Therapy

A 12-week, randomized, open-label, active-control study (Study D) was conducted in patients with type 2 diabetes who were currently receiving treatment, but were poorly controlled, with two oral agents (OA). Baseline OAs included an insulin secretagogue, and either metformin or a thiazolidinedione. Patients were randomized to one of three arms: continuing OA therapy alone (n = 96), switching to pre-meal TID Exubera monotherapy (n = 102) or adding pre-meal TID Exubera to continued OA therapy (n = 100). In this study, the mean age was 57.4 years (range: 33–80), 66% of the subjects were male and the mean body mass index was 30 kg/m2.


Exubera monotherapy and Exubera in combination with OA therapy were superior to OA therapy alone in reducing HbA1c levels from baseline. The rates of hypoglycemia for the two Exubera treatment groups were slightly higher than in the OA therapy alone group. Compared to OA therapy alone, the percentage of patients reaching an HbA1c level of <8% (per American Diabetes Association treatment Action Level at time of study conduct) and an HbA1c level of <7% was greater for patients treated with Exubera monotherapy and Exubera in combination with OA therapy. Patients in both Exubera treatment groups had greater reductions in fasting plasma glucose than patients treated with OA therapy alone. The results for Study D are shown in Table 3.










































































































Table 3: Results of a 12-Week, Active-Control, Open-Label Trial in Patients With Type 2 Diabetes Not Optimally Controlled With Dual Oral Agent Therapy (Study D)
Study DExubera monotherapyOAs*Exubera + OAs
Sample Size10296100

*

OAs = treatment with two oral agents (an insulin secretagogue in addition to metformin or a thiazolidinedione)


A negative treatment difference favors Exubera


Comparison of Exubera monotherapy to combination oral agent therapy alone

§

p < 0.0001


Comparison of Exubera plus oral agents to combination oral agent therapy alone

#

American Diabetes Association treatment Action Level at the time of study conduct

HbA1c (%)
  Baseline mean9.39.39.2
  Adj. mean change from baseline-1.4-0.2-1.9
    Exubera group minus OAs-1.18,,§    -1.67,,§
    95% CI for treatment difference(-1.41, -0.95)(-1.90, -1.44)
Fasting Plasma Glucose (mg/dL)
  Baseline mean203203195
  Adj. mean change from baseline-231-53
    Exubera group minus OAs-24        -53
    95% CI for treatment difference(-36, -11)(-66, -41)
Patients with end-of-study HbA1c < 8%#55.9%18.8%86.0%
Patients with end-of-study HbA1c < 7%16.7%1.0%32.0%
Body Weight
  Baseline mean (kg)89.588.088.6
  Adj. mean change from baseline (kg)2.80.02.7
    Exubera group minus OAs2.80        2.75
    95% CI for treatment difference(1.94, 3.65)(1.89, 3.61)

A 24-week, randomized, open-label, active-control study (Study E) was conducted in patients with type 2 diabetes, currently receiving sulfonylurea therapy. This study was designed to assess the safety and efficacy of the addition of pre-meal Exubera to continued sulfonylurea therapy (n = 214) compared to the addition of pre-meal metformin to continued sulfonylurea therapy (n = 196). Subjects were stratified according to their HbA1c at Week -1. Two strata were defined: a low HbA1c stratum (HbA1c ≥8% to ≤9.5%) and a high HbA1c stratum (HbA1c >9.5 to ≤12%).


Exubera in combination with sulfonylurea was superior to metformin and sulfonylurea in reducing HbA1c values from baseline in the high stratum group. Exubera in combination with sulfonylurea was comparable to metformin in combination with sulfonylurea in reducing HbA1c values from baseline in the low stratum group. The rate of hypoglycemia was higher after the addition of Exubera to sulfonylurea than after the addition of metformin to sulfonylurea. The percentage of patients reaching target HbA1c values of 8% and 7% was comparable between treatment groups in both strata, as was reduction in fasting plasma glucose (see Table 4).


Another 24-week, randomized, open-label, active-control study (Study F) was conducted in patients with type 2 diabetes, currently receiving metformin therapy. This study was designed to assess the safety and efficacy of the addition of pre-meal Exubera to continued metformin therapy (n = 234) compared to the addition of pre-meal glibenclamide to continued metformin therapy (n = 222). Subjects in this study were also stratified to one of two strata as defined in Study E.


Exubera in combination with metformin was superior to glibenclamide and metformin in reducing HbA1c values from baseline and achieving target HbA1c values in the high stratum group. Exubera in combination with metformin was comparable to glibenclamide in combination with metformin in reducing HbA1c values from baseline and achieving target HbA1c values in the low stratum group. The rate of hypoglycemia was slightly higher after the addition of Exubera to metformin than after the addition of glibenclamide to metformin. Reduction in fasting plasma glucose was comparable between treatment groups (see Table 4).




















































































































































Table 4: Results of Two 24-Week, Active-Control, Open-Label Trials in Patients With Type 2 Diabetes Previously On Oral Agent Therapy (Studies E and F)
Study EStudy F
Exubera + SU*Met*+ SU*Exubera + SU*Met*+ SU*Exubera + Met*Gli* + Met*Exubera + Met*Gli* + Met*
High stratumLow stratumHigh stratumLow stratum
Sample Size11310310193109103125119

*

SU = sulfonylurea, Met = metformin, Gli = glibenclamide


Low stratum = entry HbA1c ≥8.0% to ≤9.5%; high stratum = entry HbA1c >9.5% to ≤12%


A negative treatment difference favors Exubera

§

p = 0.002


p = 0.004

#

American Diabetes Association treatment Action Level at the time of study conduct

HbA1c (%)
  Baseline mean10.510.68.88.810.410.68.68.7
  Adj. mean change from baseline-2.2-1.8-1.9-1.9-2.2-1.9-1.8-1.9
    Exubera minus OA-0.38,§-0.07-0.37,0.04
    95% CI for treatment difference(-0.63, -0.14)(-0.33, 0.19)(-0.62, -0.12)(-0.19, 0.27)
Fasting Plasma Glucose (mg/dL)
  Baseline mean241237197198223243187196
  Mean change from baseline-46-47-48-52-42-40-46-49
    Exubera minus OA14-24
    95% CI for treatment difference(-11, 12)(-8, 16)(-14, 10)(-7, 15)
Subjects with end-of-study HbA1c < 8%#48.7%44.7%81.2%73.1%72.5%56.3%80.8%86.6%
Subjects with end-of-study HbA1c < 7%20.4%14.6%30.7%32.3%33.9%17.5%40.0%42.9%
Body Weight
  Baseline mean (kg)80.879.579.981.988.387.890.388.2
  Adj. mean change from baseline (kg)3.6-0.02.4-0.32.82.52.01.6
    Exubera minus OA3.602.670.260.38
    95% CI for treatment difference(2.81, 4.39)(1.84, 3.51)(-0.70, 1.21)(-0.52, 1.27)
Use in Patients Previously Treated With Subcutaneous Insulin

A 24-week, randomized, open-label, active-control study (Study G) was conducted in insulin-treated patients with type 2 diabetes to assess the safety and efficacy of Exubera administered pre-meal TID with a single nighttime injection of Humulin® U Ultralente® (n = 146) compared to subcutaneous regular human insulin administered BID (pre-breakfast and pre-dinner) with BID injection of NPH human insulin (n = 149). In this study, the mean age was 57.5 years (range: 23–80), 66% of the subjects were male and the mean body mass index was 30.3 kg/m2.


The reductions from baseline in HbA1c, percent of patients reaching an HbA1c level of <8% (per American Diabetes Association treatment Action Level at time of study conduct) and an HbA1c level of <7%, as well as the rates of hypoglycemia, were similar between treatment groups. Exubera-treated patients had a greater reduction in fasting plasma glucose than patients in the comparator group. The results for Study G are shown in Table 5.































































Table 5: Results of a 24-Week, Active-Control, Open-Label Trial in Patients With Type 2 Diabetes Previously Treated With Subcutaneous Insulin (Study G)
Study GExubera (TID) + UL (QD)SC R (BID) + NPH (BID)
Sample Size146149
UL = Humulin® U Ultralente®; SC R = subcutaneous regular human insulin

*

A negative treatment difference favors Exubera


American Diabetes Association treatment Action Level at the time of study conduct


1 mg inhaled insulin from Exubera is approximately equivalent to 3 IU of subcutaneously injected regular human insulin. See DOSAGE AND ADMINISTRATION

HbA1c (%)
  Baseline mean8.18.2
  Adj. mean change from baseline-0.7-0.6
    Exubera minus SC R*-0.07
    95% CI for treatment difference(-0.31, 0.17)
Fasting Plasma Glucose (mg/dL)
  Baseline mean152159
  Adj. mean change from baseline-22-6
    Exubera minus SC R-16.36
    95% CI for treatment difference(-27.09, -5.36)
Patients with end-of-study HbA1c < 8%76.0%69.1%
Patients with end-of-study HbA1c < 7%45.2%32.2%
Body Weight
  Baseline mean (kg)90.689.0
  Adj. mean change from baseline (kg)0.11.3
    Exubera minus SC R-1.28
    95% CI for treatment difference(-1.96, -0.60)
End of study daily insulin dose
  Short-acting insulin16.6 mg25.5 IU
  Long-acting insulin37.9 IU52.3 IU

Indications and Usage for Exubera


Exubera is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. Exubera has an onset of action similar to rapid-acting insulin analogs and has a duration of glucose-lowering activity comparable to subcutaneously administered regular human insulin. In patients with type 1 diabetes, Exubera should be used in regimens that include a longer-acting insulin. In patients with type 2 diabetes, Exubera can be used as monotherapy or in combination with oral

ethacrynic acid


eth-a-KRIN-ik AS-id


Commonly used brand name(s)

In the U.S.


  • Edecrin

Available Dosage Forms:


  • Tablet

Therapeutic Class: Cardiovascular Agent


Pharmacologic Class: Diuretic, Loop


Uses For ethacrynic acid


Ethacrynic acid belongs to a group of medicines called loop diuretics or "water pills." Ethacrynic acid is given to help treat fluid retention (edema) and swelling that is caused by congestive heart failure, liver disease, kidney disease, or other medical conditions. It works by acting on the kidneys to increase the flow of urine .


ethacrynic acid is available only with your doctor's prescription .


Before Using ethacrynic acid


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ethacrynic acid, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to ethacrynic acid or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of ethacrynic acid in children below 2 years of age. Safety and efficacy have not been established .


Geriatric


Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ethacrynic acid in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment of dosage in patients receiving ethacrynic acid .


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking ethacrynic acid, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using ethacrynic acid with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Amikacin

  • Arsenic Trioxide

  • Bepridil

  • Digitoxin

  • Dofetilide

  • Droperidol

  • Furosemide

  • Gentamicin

  • Kanamycin

  • Ketanserin

  • Levomethadyl

  • Lithium

  • Metolazone

  • Neomycin

  • Netilmicin

  • Sotalol

  • Streptomycin

  • Tobramycin

Using ethacrynic acid with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Alacepril

  • Apazone

  • Aspirin

  • Benazepril

  • Bromfenac

  • Captopril

  • Celecoxib

  • Cilazapril

  • Cortisone

  • Delapril

  • Diclofenac

  • Diflunisal

  • Enalaprilat

  • Enalapril Maleate

  • Etodolac

  • Fenoprofen

  • Flurbiprofen

  • Fosinopril

  • Germanium

  • Ginseng

  • Gossypol

  • Ibuprofen

  • Ibuprofen Lysine

  • Imidapril

  • Indomethacin

  • Ketoprofen

  • Ketorolac

  • Licorice

  • Lisinopril

  • Magnesium Salicylate

  • Meclofenamate

  • Mefenamic Acid

  • Meloxicam

  • Moexipril

  • Nabumetone

  • Naproxen

  • Nepafenac

  • Oxaprozin

  • Pentopril

  • Perindopril

  • Piroxicam

  • Quinapril

  • Ramipril

  • Salicylic Acid

  • Salsalate

  • Spirapril

  • Sulindac

  • Temocapril

  • Tolmetin

  • Trandolapril

  • Zofenopril

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of ethacrynic acid. Make sure you tell your doctor if you have any other medical problems, especially:


  • Anuria (not able to form urine) or

  • Electrolyte imbalance (low or high amounts of minerals in the blood), severe or

  • Watery diarrhea, severe—Should not use in patients with these conditions .

  • Diabetes—ethacrynic acid may increase the amount of sugar in the blood .

  • Hearing problems or

  • Hypochloremia (low chloride in the blood) or

  • Hypokalemia (low potassium in the blood) or

  • Hypomagnesemia (low magnesium in the blood) or

  • Hyponatremia (low sodium in the blood) or

  • Hypovolemia (low blood volume) or

  • Liver disease (cirrhosis), advanced—Use with caution. ethacrynic acid may make these conditions worse .

  • Hypoproteinemia (low protein in the blood)—May decrease the effect of the medicine in the body .

  • Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body .

Proper Use of ethacrynic acid


It is best to take ethacrynic acid after meals .


Dosing


The dose of ethacrynic acid will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ethacrynic acid. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablets):
    • For edema:
      • Adults—At first, 50 milligrams (mg) once a day. Your doctor may adjust your dose if needed.

      • Children 2 to 18 years of age—At first, 25 milligrams (mg) once a day. Your doctor may adjust your dose if needed.

      • Children below 2 years of age—Use and dose must be determined by your doctor .



Missed Dose


If you miss a dose of ethacrynic acid, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using ethacrynic acid


It is very important that your doctor check your progress at regular visits to make sure ethacrynic acid is working properly. Blood tests may be needed to check for unwanted effects. You may also need to weigh yourself daily and record your weight .


ethacrynic acid may cause you to lose more potassium from your body than normal. Your doctor will monitor the potassium in your blood while you are taking ethacrynic acid. To prevent the loss of too much water and potassium, tell your doctor if you become sick with severe or continuing nausea, vomiting, or diarrhea. Check with your doctor right away if you have one or more of these symptoms: dry mouth; increased thirst; muscle cramps; or nausea or vomiting .


ethacrynic acid may cause changes in your blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor .


ethacrynic acid Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Rare
  • Bleeding gums

  • bloating

  • clay-colored stools

  • constipation

  • darkened urine

  • indigestion

  • itching

  • large, flat, blue or purplish patches in the skin

  • loss of appetite

  • nausea

  • painful knees and ankles

  • pains in stomach, side, or abdomen, possibly radiating to the back

  • pinpoint red spots on skin

  • raised red swellings on the skin, the buttocks, legs, or ankles

  • skin rash

  • unpleasant breath odor

  • vomiting of blood

  • yellow eyes or skin

Incidence not determined
  • Anxiety

  • black, tarry stools

  • blood in urine

  • blurred vision

  • cold sweats

  • coma

  • confusion

  • convulsions (seizures)

  • cool, pale skin

  • cough or hoarseness

  • depression

  • dizziness

  • dry mouth

  • fast heartbeat

  • fever with or without chills

  • flushed, dry skin

  • fruit-like breath odor

  • general feeling of tiredness or weakness

  • headache

  • increased hunger

  • increased thirst

  • increased urination

  • joint pain, stiffness, or swelling

  • lower back, side, or stomach pain

  • nausea

  • nervousness

  • nightmares

  • painful or difficult urination

  • pale skin

  • shakiness

  • shortness of breath

  • slurred speech

  • sore throat

  • sores, ulcers, or white spots on the lips or in the mouth

  • sweating

  • swelling of the feet or lower legs

  • troubled breathing

  • unexplained weight loss

  • unusual bleeding or bruising

  • unusual tiredness or weakness

  • vomiting

  • watery and severe diarrhea

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Confusion

  • decreased urination

  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

  • increase in heart rate

  • irregular heartbeat

  • muscle cramps or pain

  • numbness, tingling, pain, or weakness in the hands or feet

  • rapid breathing

  • sunken eyes

  • thirst

  • trembling

  • weakness and heaviness of the legs

  • wrinkled skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Incidence not determined
  • Continuing ringing or buzzing or other unexplained noise in ears

  • difficulty swallowing

  • fear

  • feeling of constant movement of self or surroundings

  • feeling of fullness in the ears

  • general feeling of discomfort or illness

  • hearing loss

  • mild diarrhea

  • sensation of spinning

  • stomach soreness or discomfort

  • weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: ethacrynic acid side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More ethacrynic acid resources


  • Ethacrynic acid Side Effects (in more detail)
  • Ethacrynic acid Dosage
  • Ethacrynic acid Use in Pregnancy & Breastfeeding
  • Ethacrynic acid Drug Interactions
  • Ethacrynic acid Support Group
  • 0 Reviews for Ethacrynic acid - Add your own review/rating


  • ethacrynic acid Concise Consumer Information (Cerner Multum)

  • Ethacrynic Acid Monograph (AHFS DI)

  • Ethacrynic Acid MedFacts Consumer Leaflet (Wolters Kluwer)

  • Edecrin Prescribing Information (FDA)



Compare ethacrynic acid with other medications


  • Ascites
  • Edema
  • Nonobstructive Oliguria
  • Pulmonary Edema
  • Renal Failure

Enjuvia


Generic Name: estrogen (Oral route, Parenteral route, Topical application route, Transdermal route)


Commonly used brand name(s)

In the U.S.


  • Alora

  • Cenestin

  • Climara

  • Divigel

  • Elestrin

  • Emcyt

  • Enjuvia

  • Esclim

  • Estinyl

  • EstroGel

  • Evamist

  • Femtrace

  • Gynodiol

  • Menest

  • Menostar

  • Ogen .625

  • Ogen 1.25

  • Ogen 2.5

  • Premarin

  • Vivelle

  • Vivelle-Dot

In Canada


  • Estraderm

  • Estradot Transdermal

  • Estradot Transdermal Therapeutic System

  • Estradot Transdermal Therapeutic System

  • Estrogel

  • Oesclim

  • Rhoxal-Estradiol Derm 50

  • Rhoxal-Estradiol Derm 75

  • Roxal-Estradiol Derm 100

  • Vivelle 100 Mcg

  • Vivelle 25 Mcg

Available Dosage Forms:


  • Tablet

  • Patch, Extended Release

  • Gel/Jelly

  • Spray

  • Emulsion

  • Tablet, Enteric Coated

  • Capsule

Uses For Enjuvia


Estrogens are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.


The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.


Estrogens are prescribed for several reasons:


  • To provide additional hormone when the body does not produce enough of its own, such as during menopause or when female puberty (development of female sexual organs) does not occur on time. Other conditions include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or ovary problems (female hypogonadism or failure or removal of both ovaries).

  • To help prevent weakening of bones (osteoporosis) in women past menopause.

  • In the treatment of selected cases of breast cancer in men and women.

  • In the treatment of cancer of the prostate in men.

Estrogens may also be used for other conditions as determined by your doctor.


There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.


Estrogens are available only with your doctor's prescription.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, estrogen is used in certain patients with the following medical conditions:


  • Gender identity disorder, male-to-female transsexualism (person who is born as a man but adapts to a woman's lifestyle, sees himself as a woman, and feels like a woman instead of a man.

  • Osteoporosis caused by lack of estrogen before menopause.

  • Turner's syndrome (a genetic disorder).

Before Using Enjuvia


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Use of this medicine before puberty is not recommended. Growth of bones can be stopped early. Girls and boys may develop growth of breasts. Girls may have vaginal changes, including vaginal bleeding.


This medicine may be used to start puberty in teenagers with some types of delayed puberty.


Geriatric


Elderly people are especially sensitive to the effects of estrogens. This may increase the chance of side effects during treatment, especially stroke, invasive breast cancer, and memory problems.


Pregnancy


Estrogens are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.


Certain estrogens have been shown to cause serious birth defects in humans and animals. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina or cervix (opening to the uterus) when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.


Breast Feeding


Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and their possible effect on the baby is not known.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.


  • Rotavirus Vaccine, Live

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Adenovirus Vaccine Type 4, Live

  • Adenovirus Vaccine Type 7, Live

  • Bacillus of Calmette and Guerin Vaccine, Live

  • Boceprevir

  • Felbamate

  • Influenza Virus Vaccine, Live

  • Isotretinoin

  • Measles Virus Vaccine, Live

  • Mumps Virus Vaccine, Live

  • Paclitaxel

  • Paclitaxel Protein-Bound

  • Rotavirus Vaccine, Live

  • Rubella Virus Vaccine, Live

  • Smallpox Vaccine

  • St John's Wort

  • Theophylline

  • Tizanidine

  • Tranexamic Acid

  • Typhoid Vaccine

  • Varicella Virus Vaccine

  • Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:


For all patients


  • Asthma or

  • Calcium, too much or too little in blood or

  • Diabetes or

  • Epilepsy or seizures or

  • Heart problems or

  • Kidney problems or

  • Liver tumors, benign or

  • Lupus erythematosus, systemic or

  • Migraine headaches—Estrogens may worsen these conditions.

  • Blood clotting problems, or history of during previous estrogen therapy—Estrogens usually are not used until blood clotting problems stop; using estrogens is not a problem for most patients without a history of blood clotting problems due to estrogen use.

  • Breast cancer or

  • Bone cancer or

  • Cancer of the uterus or

  • Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present.

  • Bulging eyes or

  • Double vision or

  • Migraine headache or

  • Vision changes, sudden onset including or

  • Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems, especially while taking estrogen or oral contraceptives (“birth control pills”).

  • Changes in genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen condition. The reason for the bleeding should be determined before estrogens are used.

  • Endometriosis or

  • Gallbladder disease or gallstones, or history of or

  • High cholesterol or triglycerides, or history of or

  • Liver disease, or history of or

  • Pancreatitis (inflammation of pancreas) or

  • Porphyria—Estrogens may worsen these conditions. Although estrogens can improve blood cholesterol, they can worsen blood triglycerides for some people.

  • Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.

For males treated for breast or prostate cancer:


  • Blood clots or

  • Heart or circulation disease or

  • Stroke—Males with these medical problems may be more likely to have clotting problems while taking estrogens; the high doses of estrogens used to treat male breast or prostate cancer have been shown to increase the chances of heart attack, phlebitis (inflamed veins) caused by a blood clot, or blood clots in the lungs.

Proper Use of estrogen

This section provides information on the proper use of a number of products that contain estrogen. It may not be specific to Enjuvia. Please read with care.


Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered. For patients taking any of the estrogens by mouth, try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.


This medicine usually comes with patient information or directions. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.


For patients taking any of the estrogens by mouth or by injection:


  • Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

For patients using the transdermal (skin patch):


  • Wash and dry your hands thoroughly before and after handling the patch.

  • Apply the patch to a clean, dry, non-oily skin area of your lower abdomen, hips below the waist, or buttocks that has little or no hair and is free of cuts or irritation. The manufacturer of the 0.025-mg patch recommends that its patch be applied to the buttocks only. Furthermore, each new patch should be applied to a new site of application. For instance, if the old patch is taken off the left buttock, then apply the new patch to the right buttock.

  • Do not apply to the breasts. Also, do not apply to the waistline or anywhere else where tight clothes may rub the patch loose.

  • Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact, especially around the edges.

  • If a patch becomes loose or falls off, you may reapply it or discard it and apply a new patch.

  • Each dose is best applied to a different area of skin on your lower abdomen, hips below the waist, or buttocks so that at least 1 week goes by before the same area is used again. This will help prevent skin irritation.

For patients using the topical emulsion (skin lotion):


  • Washing and drying hands thoroughly before each application.

  • Apply while you are sitting comfortably. Apply one pouch to each leg every morning.

  • Apply the entire contents of one pouch to clean, dry skin on the left thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.

  • Apply entire contents of the second pouch to clean, dry skin on the right thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.

  • Rub any remaining emulsion on both hands on the buttocks.

  • Washing and drying hands thoroughly after application.

  • To avoid transfer to other individuals, allow the application areas to dry completely before covering with clothing.

If you are using the Evamist® transdermal spray:


  • Spray the medicine on your skin on the inside of your forearm, between the elbow and the wrist.

  • Do not allow your child to touch the area of the arm where the medicine was sprayed. If you cannot avoid to come nearer with your child, wear clothes with long sleeves to cover the application site.

  • If your child comes in direct contact with the arm where the medicine was sprayed, wash your child's skin right away with soap and water.

  • Do not allow your pets to lick or touch the arm where the medicine was sprayed.

Dosing


The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For conjugated estrogens

  • For oral dosage form (tablets):
    • For treating breast cancer in women after menopause and in men:
      • Adults—10 milligrams (mg) three times a day for at least 3 months.


    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
      • Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.


    • To prevent loss of bone (osteoporosis):
      • Adults—0.3 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.


    • For treating ovary problems (female hypogonadism or for starting puberty):
      • Adults and teenagers—0.3 to 0.625 milligram (mg) a day. Your doctor may want you to take the medicine only on certain days of the month.


    • For treating ovary problems (failure or removal of both ovaries):
      • Adults—1.25 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating prostate cancer:
      • Adults—1.25 to 2.5 milligram (mg) three times a day.



  • For injection dosage form:
    • For controlling abnormal bleeding of the uterus:
      • Adults—25 milligrams (mg) injected into a muscle or vein. This may be repeated in six to twelve hours if needed.



  • For esterified estrogens

  • For oral dosage form (tablets):
    • For treating breast cancer in women after menopause and in men:
      • Adults—10 milligrams (mg) three times a day for at least three months.


    • For treating a genital skin condition (vulvar atrophy) or inflammation of the vagina (atrophic vaginitis), or to prevent loss of bone (osteoporosis):
      • Adults—0.3 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating ovary problems (failure or removal of both ovaries):
      • Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating ovary problems (female hypogonadism):
      • Adults—2.5 to 7.5 mg a day. This dose may be divided up and taken in smaller doses. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating symptoms of menopause:
      • Adults—0.625 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating prostate cancer:
      • Adults—1.25 to 2.5 mg three times a day.



  • For estradiol

  • For oral dosage form:
    • For treating breast cancer in women after menopause and in men:
      • Adults—10 milligrams (mg) three times a day for at least 3 months.


    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), ovary problems (female hypogonadism or failure or removal of both ovaries), or symptoms of menopause:
      • Adults—At first, 1 to 2 milligrams (mg) one time per day for at least 3 months. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may also need to change the dose based on how your body responds to the medication.


    • For treating prostate cancer:
      • Adults—1 to 2 milligrams (mg) three times a day.


    • To prevent loss of bone (osteoporosis):
      • Adults—0.5 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.



  • For topical emulsion dosage form (skin lotion):
    • For treating symptoms of menopause:
      • Adults—1.74 grams (one pouch) applied to the skin of each leg (thigh and calf) once a day in the morning.



  • For transdermal dosage form (skin patches):
    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, ovary problems (female hypogonadism or failure or removal of both ovaries), or to prevent loss of bone (osteoporosis):
      • For the Climara patches

      • Adults—0.025 to 0.1 milligram (mg) (one patch) applied to the skin and worn for one week. Then, remove that patch and apply a new one. A new patch should be applied once a week for three weeks. During the fourth week, you may or may not wear a patch. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.

      • For the Alora, Estraderm, Estradot, Vivelle, or Vivelle-Dot patches

      • Adults—0.025 to 0.1 mg (one patch) applied to the skin and worn for one half of a week. Then, remove that patch and apply and wear a new patch for the rest of the week. A new patch should be applied two times a week for three weeks. During the fourth week, you may or may not apply new patches. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.



  • For estradiol cypionate

  • For injection dosage form:
    • For treating ovary problems (female hypogonadism):
      • Adults—1.5 to 2 milligrams (mg) injected into a muscle once a month.


    • For treating symptoms of menopause:
      • Adults—1 to 5 milligrams (mg) injected into a muscle every 3 to 4 weeks.



  • For estradiol valerate

  • For injection dosage form:
    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, or ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—10 to 20 milligrams (mg) injected into a muscle every 4 weeks as needed.


    • For treating prostate cancer:
      • Adults—30 milligrams (mg) injected into a muscle every 1 or 2 weeks.



  • For estrone

  • For injection dosage form:
    • For controlling abnormal bleeding of the uterus:
      • Adults—2 to 5 milligrams (mg) a day, injected into a muscle for several days.


    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
      • Adults—0.1 to 0.5 milligram (mg) injected into a muscle 2 or 3 times a week. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.


    • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—0.1 to 1 milligram (mg) a week. This is injected into a muscle as a single dose or divided into more than one dose. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.


    • For treating prostate cancer:
      • Adults—2 to 4 milligrams (mg) injected into a muscle 2 or 3 times a week.



  • For estropipate

  • For oral dosage form (tablets):
    • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
      • Adults—0.75 to 6 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—1.5 to 9 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • To prevent loss of bone (osteoporosis):
      • Adults—0.75 milligram (mg) a day. Your doctor may want you to take the medicine each day for twenty-five days of a thirty-one–day cycle.



  • For ethinyl estradiol

  • For oral dosage form (tablets):
    • For treating breast cancer in women after menopause and in men:
      • Adults—1 milligram (mg) three times a day.


    • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
      • Adults—0.05 milligram (mg) one to three times a day for 3 to 6 months. Your doctor may want you to take the medicine each day or only on certain days of the month.


    • For treating prostate cancer:
      • Adults—0.15 to 3 milligrams (mg) a day.


    • For treating symptoms of menopause:
      • Adults—0.02 to 0.05 milligram (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.



  • For ethinyl estradiol and norethindrone

  • For oral dosage form (tablets):
    • For treating symptoms of menopause:
      • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.


    • To prevent loss of bone (osteoporosis):
      • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using Enjuvia


It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every year, but some doctors require them more often.


In some patients using estrogens, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.


Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast, ovaries, or uterus (womb). Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it. Because breast cancer has occurred in men taking estrogens, regular breast self-exams and exams by your doctor for any unusual lumps or discharge should be done.


If your menstrual periods have stopped, they may start again. This effect will continue for as long as the medicine is taken. However, if taking the continuous treatment (0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops within 10 months.


Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long time, if your period has not started within 45 days of your last period, or if you think you are pregnant.


Tell the doctor in charge that you are using this medicine before having any laboratory test because some results may be affected.


Check with your child's doctor right away if your child starts to have the following symptoms: nipple or breast swelling or tenderness in females, or enlargement of the breasts in males. Your child may have been exposed to Evamist® transdermal spray.


Do not allow your pets to lick or touch the arm where Evamist® transdermal spray was applied. Small pets may be sensitive to this medicine. Call your pet's veterinarian if your pet starts to have the following symptoms: nipple or breast enlargement, swelling of the vulva, or any signs of illness.


Enjuvia Side Effects


Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:


The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.


Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast. Breast cancer has been reported in men taking estrogens.


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


The following side effects may be caused by blood clots, which could lead to stroke, heart attack, or death. These side effects occur rarely, and, when they do occur, they occur in men treated for cancer using high doses of estrogens.


Check with your doctor immediately if any of the following side effects occur:


More common
  • Breast pain (in females and males)

  • fast heartbeat

  • fever

  • hives

  • hoarseness

  • increased breast size (in females and males)

  • irritation of the skin

  • itching of the skin

  • joint pain, stiffness, or swelling

  • rash

  • redness of the skin

  • shortness of breath

  • swelling of the eyelids, face, lips, hands, or feet

  • swelling of the feet and lower legs

  • tightness in the chest

  • troubled breathing or swallowing

  • weight gain (rapid)

  • wheezing

Less common or rare
  • Changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)

  • chest pain

  • chills

  • cough

  • heavy non-menstrual vaginal bleeding

  • lumps in, or discharge from, breast (in females and males)

  • pains in the stomach, side, or abdomen

  • yellow eyes or skin

Rare - for males being treated for breast or prostate cancer only
  • Headache (sudden or severe)

  • loss of coordination (sudden)

  • loss of vision or change of vision (sudden)

  • pains in the chest, groin, or leg, especially in the calf of leg

  • shortness of breath (sudden and unexplained)

  • slurring of speech (sudden)

  • weakness or numbness in the arm or leg

Incidence not known
  • Abdominal or stomach bloating

  • abdominal or stomach cramps

  • acid or sour stomach

  • anxiety

  • backache

  • belching

  • blindness

  • blistering, peeling, or loosening of the skin

  • blue-yellow color blindness

  • blurred vision

  • change in vaginal discharge

  • changes in skin color

  • changes in vision

  • chest discomfort

  • clay-colored stools

  • clear or bloody discharge from nipple

  • confusion

  • constipation

  • convulsions

  • dark urine

  • decrease in the amount of urine

  • decreased vision

  • depression

  • diarrhea

  • difficulty with breathing

  • difficulty with speaking

  • dimpling of the breast skin

  • dizziness

  • double vision

  • dry mouth

  • eye pain

  • fainting

  • fluid-filled skin blisters

  • full feeling in upper abdomen or stomach

  • full or bloated feeling or pressure in the stomach

  • headache

  • heartburn

  • inability to move the arms, legs, or facial muscles

  • inability to speak

  • incoherent speech

  • increased urination

  • indigestion

  • inverted nipple

  • irregular heartbeats

  • light-colored stools

  • lightheadedness

  • loss of appetite

  • loss of bladder control

  • lump under the arm

  • metallic taste

  • migraine headache

  • mood or mental changes

  • muscle cramps in the hands, arms, feet, legs, or face

  • muscle pain

  • muscle spasm or jerking of all extremities

  • muscle weakness

  • nausea

  • noisy breathing

  • numbness or tingling of the hands, feet, or face

  • pain in the ankles or knees

  • pain or discomfort in the arms, jaw, back or neck

  • pain or feeling of pressure in the pelvis

  • pain, tenderness, swelling of the foot or leg

  • painful or tender cysts in the breasts

  • painful, red lumps under the skin, mostly on the legs

  • pains in the chest, groin, or legs, especially calves of the legs

  • partial or complete loss of vision in the eye

  • pelvic pain

  • persistent crusting or scaling of nipple

  • pinpoint red or purple spots on the skin

  • prominent superficial veins over affected area

  • red, irritated eyes

  • redness or swelling of the breast

  • sensitivity to the sun

  • severe headaches of sudden onset

  • skin thinness

  • skin warmth

  • slow speech

  • sore on the skin of the breast that does not heal

  • sore throat

  • sores, ulcers, or white spots in the mouth or on the lips

  • stomach discomfort, upset, or pain

  • sudden loss of consciousness

  • sudden loss of coordination

  • sudden onset of shortness of breath for no apparent reason

  • sudden onset of slurred speech

  • sudden vision changes

  • swelling of the abdominal or stomach area

  • swelling of the fingers or hands

  • thirst

  • tremor

  • unpleasant breath odor

  • unusual tiredness or weakness

  • vomiting

  • vomiting of blood

  • weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Abnormal growth filled with fluid or semisolid material

  • accidental injury

  • bladder pain

  • bloated full feeling

  • bloody or cloudy urine

  • body aches or pain

  • coating or white patches on tongue

  • congestion

  • cough producing mucus

  • decrease in amount of urine

  • difficult, burning, or painful urination

  • discouragement

  • dryness of the throat

  • ear congestion or pain

  • excess air or gas in the stomach or intestines

  • fear

  • feeling of warmth

  • feeling sad or empty

  • frequent urge to urinate

  • general feeling of discomfort or illness

  • headache, severe and throbbing

  • increased clear or white vaginal discharge

  • irritability

  • itching of the vaginal, rectal or genital areas

  • lack of appetite

  • lack or loss of strength

  • loss of interest or pleasure

  • mild dizziness

  • neck pain

  • nervousness

  • pain

  • pain during sexual intercourse

  • painful or difficult urination

  • pain or tenderness around the eyes and cheekbones

  • passing gas

  • redness of the face, neck, arms, and occasionally, upper chest

  • runny nose

  • skin irritation or redness where skin patch was worn

  • shivering

  • sleeplessness

  • sneezing

  • sore mouth or tongue

  • stuffy nose

  • sudden sweating

  • tender, swollen glands in the neck

  • thick, white vaginal discharge with no odor or with a mild odor

  • tiredness

  • trouble concentrating

  • trouble sleeping

  • unable to sleep

  • voice changes

Less common
  • Blemishes on the skin

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • burning or stinging of the skin

  • diarrhea (mild)

  • difficulty with moving

  • dizziness (mild)

  • increased hair growth, especially on the face

  • lower abdominal or stomach pain or pressure

  • mood or mental changes

  • muscle stiffness

  • painful cold sores or blisters on the lips, nose, eyes, or genitals

  • pimples

  • pounding in the ears

  • problems in wearing contact lenses

  • slow heartbeat

  • tooth or gum pain

  • unusual decrease in sexual desire (in males)

  • unusual increase in sexual desire (in females)

  • white or brownish vaginal discharge

Incidence not known
  • Abnormal turning out of cervix

  • changes in appetite

  • dull ache or feeling of pressure or heaviness in the legs

  • flushed, dry skin

  • fruit-like breath odor

  • increased hunger

  • irritability

  • large amount of triglyceride in the blood

  • leg cramps

  • patchy brown or dark brown discoloration of the skin

  • poor insight and judgment

  • problems with memory or speech

  • trouble recognizing objects

  • trouble thinking and planning

  • trouble walking

  • twitching, uncontrolled movements of the tongue, lips, face, arms, or legs

  • unexpected or excess milk flow from the breasts

Also, many women who are taking estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding, similar to menstrual periods, again. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).


This medicine may cause loss or thinning of the scalp hair in some people.


Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.