Drugs Details

Drugs Info of Megace, Megace ES
Drugs Details
  • Drugs Type  : FDA
  • Date : 25th Feb 2015 10:55 pm
  • Brand Name : Megace, Megace ES
  • Generic Name : megestrol (Pronunciation: meh JESS trol)
Descriptions

MEGACE® (megestrol acetate, USP) Oral Suspension contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone,progesterone. Megestrol acetate is a white, crystalline solid chemically designated as 17α-(acetyloxy)6-methylpregna-4,6-diene-3,20-dione. Solubility at 37°C in water is 2 μg per mL, solubility in plasma is 24 μg per mL. Its molecular weight is 384.51.

The empirical formula is C24H32O4 and the structural formula is represented as follows:

megestrol acetate, USP

Megace® (megestrol acetate) Structural Formula Illustration

 

MEGACE Oral Suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL.

MEGACE Oral Suspension contains the following inactive ingredients: alcohol (max. 0.06% v/v from flavor), citric acid, lemon-lime flavor, polyethylene glycol, polysorbate 80, purified water, sodium benzoate, sodium citrate, sucrose, and xanthan gum.

 

What are the possible side effects of megestrol (Megace, Megace ES)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
  • nausea, vomiting, dizziness, weakness, or feeling like you might pass out;
  • sudden numbness or weakness, especially on one side of the body;
  • chest pain, sudden cough,...

Read All Potential Side Effects and See Pictures of Megace »

 

This monograph has been modified to include the generic and brand name in many instances.

Indications

MEGACE Oral Suspension is indicated for the treatment of anorexia,cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).

Dosage Administration

The recommended adult initial dosage of MEGACE Oral Suspension is 800 mg/day (20 mL/day). Shake container well before using.

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective.

A plastic dosage cup with 10 mL and 20 mL markings is provided for convenience.

How Supplied

MEGACE® (megestrol acetate, USP) Oral Suspension is available as a lemon-lime flavored oral suspension containing 40 mg of micronized megestrol acetate per mL.

NDC 0015-0508-42 Bottles of 240 mL (8 fl. oz.)

Storage

Store MEGACE Oral Suspension between 15°C-25°C (59°F-77°F) and dispense in a tight container. Protect from heat.

Special Handling

Health Hazard Data

There is no threshold limit value established by OSHA, NIOSH, or ACGIH.

Exposure or “overdose” at levels approaching recommended dosing levels could result in side effects described above (see WARNINGS and ADVERSE REACTIONS). Women at risk of pregnancy should avoid such exposure.

Distributed by: Bristol-Myers Squibb Company Princeton, New Jersey 08543 USA. Rev March 2012

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Clinical Adverse Events

Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks. These adverse events should be considered by the physician when prescribing MEGACE Oral Suspension.

ADVERSE EVENTS % of Patients Reporting

MEGESTROL ACETATE, MG/DAY NO. OF PATIENTS TRIAL 1 
(N=236)
TRIAL 2
(N=87)
OPEN LABEL TRIAL
PLACEBO 0 
N=34
100 
N=68
400
N=69
800 N=65 PLACEBO 0 
N=38
800
N=49
1200 
N=176
Diarrhea 15 13 8 15 8 6 10
Impotence 3 4 6 14 0 4 7
Rash 9 9 4 12 3 2 6
Flatulence 9 0 1 9 3 10 6
Hypertension 0 0 0 8 0 0 4
Asthenia 3 2 3 6 8 4 5
Insomnia 0 3 4 6 0 0 1
Nausea 9 4 0 5 3 4 5
Anemia 6 3 3 5 0 0 0
Fever 3 6 4 5 3 2 1
Libido Decreased 3 4 0 5 0 2 1
Dyspepsia 0 0 3 3 5 4 2
Hyperglycemia 3 0 6 3 0 0 3
Headache 6 10 1 3 3 0 3
Pain 6 0 0 2 5 6 4
Vomiting 9 3 0 2 3 6 4
Pneumonia 6 2 0 2 3 0 1
Urinary Frequency 0 0 1 2 5 2 1

 

Adverse events which occurred in 1% to 3% of all patients enrolled in the two clinical efficacy trials with at least one follow-up visit during the first 12 weeks of the study are listed below by body system. Adverse events occurring less than 1% are not included. There were no significant differences between incidence of these events in patients treated with megestrol acetate and patients treated with placebo.

Body as a Whole: abdominal pain, chest pain, infection, moniliasis andsarcoma

Cardiovascular System: cardiomyopathy and palpitation

Digestive System: constipation, dry mouth, hepatomegaly, increased salivation and oral moniliasis

Hemic and Lymphatic System: leukopenia

Metabolic and Nutritional: LDH increased, edema and peripheral edema

Nervous System: paresthesia, confusion, convulsion, depression,neuropathy, hypesthesia and abnormal thinking

Respiratory System: dyspnea, cough, pharyngitis and lung disorder

Skin and Appendages: alopecia, herpes, pruritus, vesiculobullous rash, sweating and skin disorder

Special Senses: amblyopia

Urogenital System: albuminuria, urinary incontinence, urinary tract infectionand gynecomastia

Postmarketing

Postmarketing reports associated with MEGACE Oral Suspension include thromboembolic phenomena including thrombophlebitis and pulmonary embolism, and glucose intolerance (see WARNINGS and PRECAUTIONS).

Read the Megace (megestrol acetate) Side Effects Center for a complete guide to possible side effects

Learn More »
 
 
 

Interactions

Pharmacokinetic studies show that there are no significant alterations in pharmacokinetic parameters of zidovudine or rifabutin to warrant dosage adjustment when megestrol acetate is administered with these drugs. The effects of zidovudine or rifabutin on the pharmacokinetics of megestrol acetate were not studied.

Animal Toxicology

Long-term treatment with MEGACE may increase the risk of respiratory infections. A trend toward increased frequency of respiratory infections, decreased lymphocyte counts, and increased neutrophil counts was observed in a 2-year chronic toxicity/carcinogenicity study of megestrol acetate conducted in rats.

Read the Megace Drug Interactions Center for a complete guide to possible interactions

Learn More »
 

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Megestrol acetate may cause fetal harm when administered to a pregnant woman. For animal data on fetal effects, see PRECAUTIONS:Carcinogenesis, Mutagenesis, Impairment of Fertility: Impairment of Fertility. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

Megestrol acetate is not intended for prophylactic use to avoid weight loss. (See also PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility.)

The glucocorticoid activity of MEGACE (megestrol acetate, USP) Oral Suspension has not been fully evaluated. Clinical cases of new onsetdiabetes mellitus, exacerbation of preexisting diabetes mellitus, and overt Cushing's syndrome have been reported in association with the chronic use of MEGACE. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic MEGACE therapy in the stressed and non-stressed state. Furthermore, adrenocorticotropin (ACTH) stimulation testing has revealed the frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic MEGACE therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic MEGACE therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or weakness) in either the stressed or non-stressed state. Laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are strongly recommended in such patients. Failure to recognize inhibition of the hypothalamic-pituitary-adrenal axis may result in death. Finally, in patients who are receiving or being withdrawn from chronic MEGACE therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid in conditions of stress or serious intercurrent illness (e.g., surgery, infection).

Precautions

General

Therapy with MEGACE Oral Suspension for weight loss should only be instituted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease, and renal or psychiatric diseases.

Effects on HIV viral replication have not been determined.

Use with caution in patients with a history of thromboembolic disease.

Use in Diabetics

Exacerbation of preexisting diabetes with increased insulin requirements has been reported in association with the use of MEGACE.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Data on carcinogenesis were obtained from studies conducted in dogs, monkeys, and rats treated with megestrol acetate at doses 53.2, 26.6, and 1.3 times lower than the proposed dose (13.3 mg/kg/day) for humans. No males were used in the dog and monkey studies. In female beagles, megestrol acetate (0.01, 0.1, or 0.25 mg/kg/day) administered for up to 7 years induced both benign and malignant tumors of the breast. In female monkeys, no tumors were found following 10 years of treatment with 0.01, 0.1, or 0.5 mg/kg/day megestrol acetate. Pituitary tumors were observed in female rats treated with 3.9 or 10 mg/kg/day of megestrol acetate for 2 years. The relationship of these tumors in rats and dogs to humans is unknown but should be considered in assessing the risk-to-benefit ratio when prescribing MEGACE Oral Suspension and in surveillance of patients on therapy. (See WARNINGS.)

Mutagenesis

No mutagenesis data are currently available.

Impairment of Fertility

Perinatal/postnatal (segment III) toxicity studies were performed in rats at doses (0.05–12.5 mg/kg) less than that indicated for humans (13.3 mg/kg); in these low dose studies, the reproductive capability of male offspring of megestrol acetate-treated females was impaired. Similar results were obtained in dogs. Pregnant rats treated with megestrol acetate showed a reduction in fetal weight and number of live births, and feminization of male fetuses. No toxicity data are currently available on male reproduction (spermatogenesis).

Pregnancy

Pregnancy Category X. (See WARNINGS and PRECAUTIONS:Carcinogenesis, Mutagenesis, Impairment of Fertility: Impairment of Fertility.) No adequate animal teratology information is available at clinically relevant doses.

Nursing Mothers

Because of the potential for adverse effects on the newborn, nursing should be discontinued if MEGACE Oral Suspension is required.

Use in Women

Breakthrough bleeding was observed in all 10 female patients participating in the clinical trials. Megace is a progesterone derivative, which may induce vaginal bleeding in women.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of MEGACE Oral Suspension in the treatment of anorexia,cachexia, or an unexplained, significant weight loss in patients with AIDS did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Megestrol acetate is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.


This monograph has been modified to include the generic and brand name in many instances

OverDose

No serious unexpected side effects have resulted from studies involving MEGACE Oral Suspension administered in dosages as high as 1200 mg/day. In post-marketing experience, limited reports of overdose have been received. Signs and symptoms reported in the context of overdose included diarrhea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain. There is no specific antidote for overdose with MEGACE Oral Suspension. In case of overdose, appropriate supportive measures should be taken. Megestrol acetate has not been tested for dialyzability; however, due to its low solubility, it is postulated thatdialysis would not be an effective means of treating overdose.

ContrainDications

History of hypersensitivity to megestrol acetate or any component of the formulation. Known or suspected pregnancy.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Several investigators have reported on the appetite enhancing property of megestrol acetate and its possible use in cachexia. The precise mechanism by which megestrol acetate produces effects in anorexia and cachexia is unknown at the present time.

There are several analytical methods used to estimate megestrol acetate plasma concentrations, including gas chromatography-mass fragmentography (GC-MF), high pressure liquid chromatography (HPLC), and radioimmunoassay (RIA). The GC-MF and HPLC methods are specific for megestrol acetate and yield equivalent concentrations. The RIA method reacts to megestrol acetate metabolites and is, therefore, non-specific and indicates higher concentrations than the GC-MF and HPLC methods. Plasma concentrations are dependent, not only on the method used, but also on intestinal and hepatic inactivation of the drug, which may be affected by factors such as intestinal tract motility, intestinal bacteria, antibiotics administered, body weight, diet, and liver function.

The major route of drug elimination in humans is urine. When radiolabeled megestrol acetate was administered to humans in doses of 4 to 90 mg, the urinary excretion within 10 days ranged from 56.5% to 78.4% (mean 66.4%) and fecal excretion ranged from 7.7% to 30.3% (mean 19.8%). The total recovered radioactivity varied between 83.1% and 94.7% (mean 86.2%). Megestrol acetate metabolites which were identified in urine constituted 5% to 8% of the dose administered. Respiratory excretion as labeled carbon dioxide and fat storage may have accounted for at least part of the radioactivity not found in urine and feces.

Plasma steady-state pharmacokinetics of megestrol acetate were evaluated in 10 adult, cachectic male patients with acquired immunodeficiency syndrome (AIDS) and an involuntary weight loss greater than 10% of baseline. Patients received single oral doses of 800 mg/day of MEGACE Oral Suspension for 21 days. Plasma concentration data obtained on day 21 were evaluated for up to 48 hours past the last dose.

Mean (±1SD) peak plasma concentration (Cmax) of megestrol acetate was 753 (±539) ng/mL. Mean area under the concentration-time-curve (AUC) was 10476 (±7788) ng × hr/mL. Median Tmax value was five hours. Seven of 10 patients gained weight in three weeks.

Additionally, 24 adult, asymptomatic HIV seropositive male subjects were dosed once daily with 750 mg of MEGACE Oral Suspension. The treatment was administered for 14 days. Mean Cmax and AUC values were 490 (±238) ng/mL and 6779 (±3048) hr × ng/mL respectively. The median Tmax value was three hours. The mean Cmin value was 202 (±101) ng/mL. The mean percent of fluctuation value was 107 (±40).

The effect of food on the bioavailability of MEGACE Oral Suspension has not been evaluated.

Description Of Clinical Studies

The clinical efficacy of MEGACE Oral Suspension was assessed in two clinical trials. One was a multicenter, randomized, double-blind, placebo-controlled study comparing megestrol acetate (MA) at doses of 100 mg, 400 mg, and 800 mg per day versus placebo in AIDS patients with anorexia/cachexia and significant weight loss. Of the 270 patients entered on study, 195 met all inclusion/exclusion criteria, had at least two additional post baseline weight measurements over a 12-week period, or had one post baseline weight measurement but dropped out for therapeutic failure. The percent of patients gaining five or more pounds at maximum weight gain in 12 study weeks was statistically significantly greater for the 800 mg (64%) and 400 mg (57%) MA-treated groups than for the placebo group (24%). Mean weight increased from baseline to last evaluation in 12 study weeks in the 800 mg MA-treated group by 7.8 pounds, the 400 mg MA group by 4.2 pounds, the 100 mg MA group by 1.9 pounds, and decreased in the placebo group by 1.6 pounds. Mean weight changes at 4, 8, and 12 weeks for patients evaluable for efficacy in the two clinical trials are shown graphically. Changes in body composition during the 12 study weeks as measured by bioelectrical impedance analysis showed increases in non-water body weight in the MA-treated groups (see Clinical Studies table). In addition, edema developed or worsened in only 3 patients.

Greater percentages of MA-treated patients in the 800 mg group (89%), the 400 mg group (68%), and the 100 mg group (72%), than in the placebo group (50%), showed an improvement in appetite at last evaluation during the 12 study weeks. A statistically significant difference was observed between the 800 mg MA-treated group and the placebo group in the change in caloric intake from baseline to time of maximum weight change. Patients were asked to assess weight change, appetite, appearance, and overall perception of well-being in a 9-question survey. At maximum weight change, only the 800 mg MA-treated group gave responses that were statistically significantly more favorable to all questions when compared to the placebo-treated group. A dose response was noted in the survey with positive responses correlating with higher dose for all questions.

The second trial was a multicenter, randomized, double-blind, placebo-controlled study comparing megestrol acetate 800 mg/day versus placebo in AIDS patients with anorexia/cachexia and significant weight loss. Of the 100 patients entered on study, 65 met all inclusion/exclusion criteria, had at least two additional post baseline weight measurements over a 12-week period or had one post baseline weight measurement but dropped out for therapeutic failure. Patients in the 800 mg MA-treated group had a statistically significantly larger increase in mean maximum weight change than patients in the placebo group. From baseline to study week 12, mean weight increased by 11.2 pounds in the MA-treated group and decreased 2.1 pounds in the placebo group. Changes in body composition as measured by bioelectrical impedance analysis showed increases in non-water weight in the MA-treated group (see Clinical Studies table). No edema was reported in the MA-treated group. A greater percentage of MA-treated patients (67%) than placebo-treated patients (38%) showed an improvement in appetite at last evaluation during the 12 study weeks; this difference was statistically significant. There were no statistically significant differences between treatment groups in mean caloric change or in daily caloric intake at time to maximum weight change. In the same 9-question survey referenced in the first trial, patients' assessments of weight change, appetite, appearance, and overall perception of well-being showed increases in mean scores in MA-treated patients as compared to the placebo group.

In both trials, patients tolerated the drug well and no statistically significant differences were seen between the treatment groups with regard to laboratory abnormalities, new opportunistic infections, lymphocyte counts, T4counts, T8 counts, or skin reactivity tests (see ADVERSE REACTIONS).

MEGACE (megestrol acetate, USP) Oral Suspension Clinical Efficacy Trials

  TRIAL 1 
STUDY ACCRUAL DATES 
11/88 TO 12/90
TRIAL 2 
STUDY ACCRUAL DATES 
5/89 TO 4/91
Megestrol Acetate, mg/day 0 100 400 800 0 800
Entered Patients 38 82 75 75 48 52
Evaluable Patients 28 61 53 53 29 36
Mean Change in Weight (lb.) Baseline to 12 Weeks 0.0 2.9 9.3 10.7 -2.1 11.2
% Patients ≥5-Pound Gain at Last Evaluation in 12 Weeks 21 44 57 64 28 47
Mean Changes in Body Composition*
  Fat Body Mass (lb.) 0.0 2.2 2.9 5.5 1.5 5.7
  Lean Body Mass (lb.) -1.7 -0.3 1.5 2.5 -1.6 -0.6
  Water (liters) -1.3 -0.3 0.0 0.0 -0.1 -0.1
% Patients With Improved Appetite
  At Time of Maximum Wt. Change 50 72 72 93 48 69
  At Last Evaluation in 12 Weeks 50 72 68 89 38 67
Mean Change in Daily Caloric Intake:
  Baseline to Time of Maximum Weight Change -107 326 308 646 30 464
*Based on bioelectrical impedance analysis determinations at last evaluation in 12 weeks

 

 

Presented below are the results of mean weight changes for patients evaluable for efficacy in Trials 1 and 2.

 

View Enlarged Table

 

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Patients using megestrol acetate should receive the following instructions:

  1. This medication is to be used as directed by the physician.
  2. Report any adverse reaction experiences while taking this medication.
  3. Use contraception while taking this medication if you are a woman capable of becoming pregnant.
  4. Notify your physician if you become pregnant while taking this medication.

This monograph has been modified to include the generic and brand name in many instances.

 

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Megace, Megace ES

Generic Name: megestrol (Pronunciation: meh JESS trol)

  • What is megestrol (Megace)?
  • What are the possible side effects of megestrol (Megace)?
  • What is the most important information I should know about megestrol (Megace)?
  • What should I discuss with my healthcare provider before taking megestrol (Megace)?
  • How should I take megestrol (Megace)?
  • What happens if I miss a dose (Megace)?
  • What happens if I overdose (Megace)?
  • What should I avoid while taking megestrol (Megace)?
  • What other drugs will affect megestrol (Megace)?
  • Where can I get more information?

What is megestrol (Megace)?

 

Megestrol is a man-made chemical similar to the female hormone progesterone.

Megestrol is used to treat loss of appetite and weight loss in people with acquired immunodeficiency syndrome (AIDS). Megestrol is also used in the treatment of advanced breast cancer and endometrial cancer.

Megestrol may also be used for purposes not listed in this medication guide.

Megestrol 20 mg-BAR

round, white, imprinted with 555 606, b

What are the possible side effects of megestrol (Megace)?

 

Get emergency medical help if you have any of thesesigns of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
  • nausea, vomiting, dizziness, weakness, or feeling like you might pass out;
  • sudden numbness or weakness, especially on one side of the body;
  • chest pain, sudden cough, wheezing, rapid breathing, fast heart rate; or
  • high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion).

Less serious side effects may include:

  • upset stomach;
  • vaginal bleeding;
  • mild skin rash;
  • weakness,
  • sleep problems (insomnia); or
  • decreased interest in sex, impotence, trouble having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Megace (megestrol acetate) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about megestrol (Megace)?

 

Megestrol can harm an unborn baby or cause birth defects. Do not use megestrol if you are pregnant.

Before you take megestrol, tell your doctor if you have diabetes or a history of stroke or blood clot.

Your dosage needs may change if you have surgery, are ill, are under stress, or have an infection. Do not change your medication dose or schedule without your doctor's advice.

Megace ES contains a higher concentration of megestrol than Megace. Ask your pharmacist if you have any questions about the medicine you receive at the pharmacy.

Side Effects Centers
  • Megace ES
  • Megace

Patient Detailed How Take

What should I discuss with my healthcare provider before taking megestrol (Megace)?

 

You should not use megestrol if you are allergic to it, or if you are pregnant.

To make sure you can safely take megestrol, tell your doctor if you have any of these other conditions:

  • diabetes; or
  • a history of stroke or blood clot.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use megestrol if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication.

It is not known whether megestrol passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking megestrol.

How should I take megestrol (Megace)?

 

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Megace ES contains a higher concentration of megestrol than Megace. If your doctor changes your brand, strength, or type of megestrol, your dosage needs may change. Ask your pharmacist if you have any questions about the medicine you receive at the pharmacy.

Your dosage needs may change if you have surgery, are ill, are under stress, or have an infection. Do not change your medication dose or schedule without your doctor's advice.

Store at room temperature away from moisture and heat.

Side Effects Centers
  • Megace ES
  • Megace

Patient Detailed Avoid Taking

What happens if I miss a dose (Megace)?

 

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Megace)?

 

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking megestrol (Megace)?

 

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect megestrol (Megace)?

 

Tell your doctor about all other medicines you use, especially:

  • indinavir (Crixivan); or
  • insulin or oral diabetes medications.

This list is not complete and other drugs may interact with megestrol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

 

Your pharmacist can provide more information about megestrol.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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