Megestrol Acetate (Megestrol Acetate)

Trade Name : Megestrol Acetate

West-Ward Pharmaceuticals Corp.

SUSPENSION

Strength 40 mg/mL

MEGESTROL ACETATE Progesterone Congeners [CS],Progestin [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Megestrol Acetate (Megestrol Acetate) which is also known as Megestrol Acetate and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 40 mg/mL per ml. Read more

Megestrol Acetate (Megestrol Acetate) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

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Megestrol acetate, is a synthetic derivative of the steroid hormone, progesterone. Megestrol acetate is a white to creamy white, crystalline powder chemically designated as pregna-4,6-diene-3,20-dione, 17-(acetyloxy)-6-methyl-. Solubility at 37u00b0C in water is 2 mcg per mL, solubility in plasma is 24 mcg per mL. Its molecular weight is 384.5. The empirical formula is CHO and the structural formula is represented as follows:
Each mL of Megestrol Acetate Oral Suspension USP contains 40 mg of micronized megestrol acetate USP and the following inactive ingredients: anhydrous citric acid, lemon-lime flavor, microcrystalline cellulose and carboxymethylcellulose sodium, polyoxl 35 castor oil, purified water, sodium benzoate, sodium citrate and sucrose.
The suspension meets the requirements of USP Dissolution Test 3 in the USP monograph for Megestrol Acetate Oral Suspension USP.

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 megestrol acetate for 21 days. Plasma concentration data obtained on day 21 were evaluated for up to 48 hours past the last dose.
Mean (u00b11SD) peak plasma concentration (C) of megestrol acetate was 753 (u00b1539) ng/mL. Mean area under the concentration-time-curve (AUC) was 10476 (u00b17788) ng x hr/mL. Median T 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. The treatment was administered for 14 days. Mean C and AUC values were 490 (u00b1238) ng/mL and 6779 (u00b13048) ng x hr/mL respectively. The median T value was three hours. The mean C value was 202 (u00b1101) ng/mL. The mean percent of fluctuation value was 107 (u00b140).
The effect of food on the bioavailability of megestrol acetate has not been evaluated.

The clinical efficacy of megestrol acetate 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 ). 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 ). 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, patientsu2019 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, no statistically significant differences were seen between the treatment groups with regard to laboratory abnormalities, new opportunistic infections, lymphocyte counts, T counts, T counts, or skin reactivity tests (see ).
Presented below are the results of mean weight changes for patients evaluable for efficacy in Trials 1 and 2.

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).

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

Megestrol acetate may cause fetal harm when administered to a pregnant woman. For animal data on fetal effects, (see ). 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 )
The glucocorticoid activity of megestrol acetate has not been fully evaluated. Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and overt Cushingu2019s syndrome have been reported in association with the chronic use of megestrol. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol 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 therapy. Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic megestrol therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (eg, 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 megestrol 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 (eg, surgery, infection).

No data

No data

No serious unexpected side effects have resulted from studies involving megestrol acetate 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 megestrol acetate 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 that dialysis would not be an effective means of treating overdose.

The recommended adult initial dosage of megestrol acetate 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 5 mL, 10 mL, 15 mL and 20 mL markings is provided for convenience.

Megestrol Acetate Oral Suspension USP
40 mg per mL oral suspension is supplied as a (lemon-lime flavored) smooth, viscous, white suspension.
NDC 0054-3542-58: Bottle of 240 mL (8 fl. oz).
Storage
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Dispense in a tight, child-resistant container as defined in the USP/NF. Protect from heat.

There is no threshold limit value established by OSHA, NIOSH, or ACGIH.
Exposure or u201coverdoseu201d at levels approaching recommended dosing levels could result in side effects described above (see and ). Women at risk of pregnancy should avoid such exposure.
Distr. by: n
Pharmaceuticals Corp.
Eatontown, NJ 07724
10000312/12
Revised July 2019

No data

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Megestrol Acetate (Megestrol Acetate)

Trade Name : Megestrol Acetate

SUSPENSION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Megestrol Acetate (Megestrol Acetate)

Trade Name : Megestrol Acetate

SUSPENSION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

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Losartan Potassium (Losartan Potassium)

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Disclaimer

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General

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