Drugs Details

Drugs Info of Megace, Megace ES
Drugs Details
  • Drugs Type  : FDA
  • Date : 26th Feb 2015 12:57 am
  • Brand Name : Megace, Megace ES
  • Generic Name : megestrol (Pronunciation: meh JESS trol)
Descriptions

Megace® ES (megestrol acetate) 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 17-Hydroxy-6-methylpregna-4,6-diene-3,20-dione acetate. Solubility at 37° C in water is 2 µg per mL, solubility in plasma is 24 µg per mL. Its molecular weight is 384.52.

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

 

Megace-es (Megestrol acetate) Structural Formula Illustration

 

Megace® ES (megestrol acetate) is a concentrated formula supplied as an oral suspension containing 125 mg of megestrol acetate per mL.

Megace® ES (megestrol acetate) oral suspension contains the following inactive ingredients: alcohol (max 0.06% v/v from flavor), artificial lime flavor, citric acid monohydrate, docusate sodium, hydroxypropyl methylcellulose (hypromellose), natural and artificial lemon flavor, purified water, sodium benzoate, sodium citrate dihydrate, and sucrose.

 

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 ES »

What are the precautions when taking megestrol acetate (Megace ES)?

Before taking megestrol, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems (e.g., Cushing's syndrome), blood clots, congestive heart failure, diabetes, high blood pressure, kidney problems, unusual vaginal bleeding.

High blood sugar (hyperglycemia) and worsening of diabetes may occur. Symptoms of high blood sugar include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor...

Read All Potential Precautions of Megace ES »

 

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

Indications

Megace® ES (megestrol acetate) 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® ES (megestrol acetate) oral suspension is 625 mg/day (5 mL/day or one teaspoon daily). Please refer to the table below for correct dosing and administration. Shake container well before using.

 

PRODUCT DIFFERENCES
  MEGACE® ES
ORAL SUSPENSION
MEGACE® AND OTHER
MEGESTROL ACETATE ORAL SUSPENSIONS
MG/ML 125 MG/ML 40 MG/ML
Recommended
Daily Dose
625 mg 800 mg
Daily VolumeIntake 5 mL 20 mL
(teaspoon) Megace-es (Megestrol acetate)  teaspoon (dosing cup) Megace-es (Megestrol acetate)  dosing cup
Formulation Concentrated formula Regular formula

 

In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day of megestrol acetate oral suspension (800 mg/20 mL equivalent to 625 mg/5 mL of Megace® ES formula) were found to be clinically effective.

How Supplied

Megace® ES (megestrol acetate) oral suspension is a concentrated formula available as a milky white, lemon-lime flavored oral suspension containing 125 mg of megestrol acetate per mL.

 

NDC 49884-949-69 Bottles of 150 mL (5 fl. oz.)
NDC 49884-949-52 Unit Dose Bottles of 5 mL (0.17 fl. Oz.)-Institutional Use Only

 

 

Storage

Store Megace® ES (megestrol acetate) oral suspension between 15°-25° C (59°-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 sections). Women at risk of pregnancy should avoid such exposure.

Manufactured by:
PAR PHARMACEUTICAL COMPANIES, INC.
Spring Valley, New York 10977
www.MegaceES.com
Megace® is a registered trademark of Bristol-Myers Squibb Company licensed to Par Pharmaceutical, Inc.
FDA rev date: 8/12/2008.

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® ES (megestrol acetate) oral suspension.

 

View Enlarged Table

 

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 and sarcoma

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 tractinfection and gynecomastia

Postmarketing

Postmarketing reports associated with megestrol acetate oral suspension include thromboembolic phenomena including thrombophlebitis, deep vein thrombosis, and pulmonary embolism; and glucose intolerance (seeWARNINGS and PRECAUTIONS sections).

Read the Megace ES (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. A pharmacokinetic study demonstrated that coadministration of megestrol acetate and indinavir results in a significant decrease in the pharmacokinetic parameters (~36% for Cmax and ~28% for AUC) of indinavir. Administration of a higher dose of indinavir should be considered when coadministering with megestrol acetate. The effects of indinavir, zidovudine or rifabutin on the pharmacokinetics of megestrol acetate were not studied.

Read the Megace ES 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: Impairment of Fertility section). 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, and Impairment of Fertility section).

The glucocorticoid activity of megestrol acetate oral suspension has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and overt Cushing's Syndrome have been reported in association with the chronic use of megestrol acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol acetate 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 megestrol acetate therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic Megace® ES 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® ES therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid during stress or serious intercurrent illness (e.g., surgery, infection).

 
 

Precautions

General

Therapy with Megace® ES (megestrol acetate) 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, endocrinedisease 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 pre-existing diabetes with increased insulin requirements have been reported in association with the use of megestrol acetate.

Carcinogenesis, Mutagenesis, and 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® ES (megestrol acetate) oral suspension and in surveillance of patients on therapy. (See WARNINGS section).

Mutagenesis

No mutagenesis data are currently available.

Impairment of Fertility

Perinatal/postnatal (segment III) toxicity studies were performed in rats at doses (0.05 to 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: Impairment of Fertility sections). 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® ES (megestrol acetate) oral suspension is required.

Use in HIV Infected Women

Although megestrol acetate has been used extensively in women for the treatment of endometrial and breast cancers, its use in HIV infected women has been limited.

All 10 women in the clinical trials reported breakthrough bleeding.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of megestrol acetate oral suspension in the treatment ofanorexia, 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 megestrol acetate oral suspension administered in dosages as high as 1200 mg/day. Megestrol acetate has not been tested for dialyzability; however, due to its low solubility it is postulated that dialysis 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

There are several analytical methods used to estimate megestrol acetateplasma 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.

Mechanism of Action:

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.

Pharmacokinetic Properties:

Plasma concentrations of megestrol acetate after administration of 625 mg (125 mg/mL) of Megace® ES oral suspension are equivalent under fed conditions to 800 mg (40 mg/mL) of megestrol acetate oral suspension (see figure below).

Mean plasma concentrations of megestrol acetate after oral administration of 625 mg of Megace® ES (megestrol acetate) oral suspension and 800 mg of megestrol acetate oral suspension to healthy volunteers under fed conditions

 

Megace-es (Megestrol acetate)Mean plasma concentrations of megestrol acetate after oral administration of 625 mg of Megace® ES (megestrol acetate) oral suspension and 800 mg of megestrol acetate oral suspension to healthy volunteers under fed conditions

In order to characterize the dose proportionality of Megace® ES, pharmacokinetic studies across a range of doses were conducted when administered under fasting and fed conditions. Pharmacokinetics of megestrol was linear in the dosing range between 150mg and 675mg after Megace® ES administration regardless of meal condition. The Cmax and AUC under a high fat meal were increased by 48% and 36%, respectively, compared to those under the fasting after 625mg Megace® ES administration (Table 1). However, a high fat meal significantly increased AUC and Cmax of megestrol to 2-fold and 7-fold, respectively, compared to those under fasting condition after administration of 800mg in the original formulation. There was no difference in safety following administration in the fed state, therefore Megace® ES could be taken without regard to meals.

Table 1 - Pharmacokinetic Studies Conducted with Megace® ES

 

View Enlarged Table

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 megestrol acetate 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 x 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 megestrol acetate oral suspension. The treatment was administered for 14 days. Mean Cmax and AUC values were 490 (±238) ng/mL and 6779 (±3048) hr x ng/mL, respectively. The median Tmax value was three hours. The mean Cmax value was 202 (±101) ng/mL. The mean % of fluctuation value was 107 (±40).

Metabolism:

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.

Elimination:

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, theurinary 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%).

Special Populations:

The pharmacokinetics of megestrol acetate has not been studied in any special populations.

Clinical Studies

Description of clinical Studies

Megestrol acetate oral suspension at a dose of 800 mg/20 mL is equivalent to 625 mg/5 mL of Megace® ES. The clinical efficacy of megestrol acetate 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, T4 counts, T8 counts, or skin reactivity tests (see ADVERSE REACTIONSsection).

 

View Enlarged Table

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

 

Megace-es (Megestrol acetate) Presented below are the results of mean weight changes for patients evaluable for efficacy in trial 1 Megace-es (Megestrol acetate) Presented below are the results of mean weight changes for patients evaluable for efficacy in trial 2

Animal Toxicology

Long-term treatment with Megace® ES (megestrol acetate) may increase the risk of respiratory infections. A trend toward increased frequency of respiratory infections, decreased lymphocyte counts and increasedneutrophil counts was observed in a two-year chronic toxicity/carcinogenicity study of megestrol acetate conducted in rats.

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

Patient Information

Patients using Megace® ES (megestrol acetate) should receive the following instructions:

  1. This medication is to be used as directed by the physician.
  2. Megace® ES (625 mg/5 mL) does not contain the same amount of megestrol acetate as Megace® oral suspension or any of the other megestrol acetate oral suspensions. Megace® ES contains 625 mg of megestrol acetate per 5 mL whereas Megace® oral suspension and other megestrol acetate oral suspensions contain 800 mg per 20 mL.
  3. The prescriber should inform the patient about the product differences to avoid overdosing or underdosing of megestrol acetate. The recommended adult dosage of Megace® ES is one teaspoon (5 mL) once a day. Please see table in DOSAGE AND ADMINISTRATION section.
  4. Report any adverse reaction experiences while taking this medication.
  5. Use contraception while taking this medication if you are a woman capable of becoming pregnant.
  6. 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

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

MEGESTROL SUSPENSION - ORAL

 

(meh-JESS-troll)

 

COMMON BRAND NAME(S): Megace

 

USES: This medication is used to increase your appetite and to prevent or reverse significant weight loss (e.g., muscle wasting in cancer or AIDS). By preventing weight loss from disease, you will feel better and may be able to be more active.

This medication may also be used to treat cancer of the breast or uterus. It may be used alone or with other treatments, including surgery and radiation, to stop the growth of your tumor.

Megestrol is similar to a natural substance made by the body called progesterone. It is not known how megestrol helps appetite or stops tumor growth.

 

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat cancer of the ovaries.

 

HOW TO USE: Take this medication by mouth, exactly as prescribed by your doctor. Shake well before measuring the dose each time you take this medication. Do not switch between different forms of megestrol because they may not have the same amount of medication. Your dosage is based on your medical condition and response to therapy.

Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day. It may take several weeks of continued use to see a benefit. Inform your doctor if your condition does not improve or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: This medication can cause weight gain, changes in appetite, stomach upset, diarrhea, gas, trouble sleeping, decreased sexual ability/desire, or fever. Women may experience changes in their menstrual periods, including unpredictable bleeding. If any of these effects persist or worsen, inform your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: fast/pounding heartbeat, headache, swelling of hands/feet, fatigue.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, confusion, mental/mood changes, weakness/numbness on one side of the body, pain/redness/swelling of arms or legs, slurred speech, trouble breathing, severe or sudden vision changes.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

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

Learn More »
 

PRECAUTIONS: Before taking megestrol, tell your doctor or pharmacist if you are allergic to it or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal gland problems (e.g., Cushing's syndrome), blood clots, congestive heart failure, diabetes, high blood pressure, kidney problems, unusual vaginal bleeding.

High blood sugar (hyperglycemia) and worsening of diabetes may occur. Symptoms of high blood sugar include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. People with diabetes should monitor their blood sugar levels more frequently when they start taking this medication and whenever the dose changes since they may need to change their doses of diabetic medications.

This drug may decrease adrenal gland activity. Make sure you tell your doctors and dentists of your megestrol use and when you stopped using it. After stopping this drug, additional corticosteroids (e.g., prednisone or hydrocortisone) may be necessary in stressful situations such as trauma, major surgery or serious infection. Consult your doctor or pharmacist for details. Symptoms of adrenal problems include unusual weakness, dizziness, nausea and rapid weight loss.

Older adults may be more sensitive to the side effects of this drug, especially the risk for blood clots.

This medication must not be used during pregnancy. Megestrol may cause harm to your unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Women of child-bearing age should use an effective form of birth control while using this medication. Consult your doctor for more details.

It is unknown if this drug passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: dofetilide, indinavir.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others. Make sure you see your doctor regularly to see how well the medication is working and to check for any side effects, including high blood pressure or high blood sugar levels.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Megace, Megace ES

Generic Name: megestrol (Pronunciation: meh JESS trol)

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

What is megestrol (Megace ES)?

 

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 ES)?

 

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 ES (megestrol acetate) Side Effects Center for a complete guide to possible side effects

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

 

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.

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Patient Detailed How Take

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

 

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 ES)?

 

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
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Patient Detailed Avoid Taking

What happens if I miss a dose (Megace ES)?

 

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 ES)?

 

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

What should I avoid while taking megestrol (Megace ES)?

 

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

What other drugs will affect megestrol (Megace ES)?

 

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.

Copyright 1996-2013 Cerner Multum, Inc. Version: 3.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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