MEGESTA™ -80

Megesta™– 80 Tablets contains megestrol acetate, a synthetic derivative of the naturally occurring steroid hormone, progesterone. Megestrolis 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:

Indication:

Megesta 80 is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of:

Acquired Immunodeficiency Syndrome (AIDS), Cancer associated Anorexia/Cachexia Renal failure patients on dialysis

Dosage:

Anorexia in dialysis patients - 160mg/day

Cancer related Cachexia - 480-600 mg/day

AIDS related Cachexia - 800 mg/day.

Drug Interactions

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

Use in Diabetics:

Exacerbation of pre-existing diabetes with increased insulin requirements has been reported in association with the use of Megestrol Acetate.

Use in Pregnancy:

Pregnancy Category X. (Should not be given to pregnant women)

Side Effects

In patients with cachexia: Diarrhoea, flatulence, nausea, vomiting, hypertension, impotence, decreased libido, asthenia, rash, insomnia, anaemia, fever, hyperglycaemia, pain.

In patients with breast cancer or endometrial cancer: Weight gain, nausea, vomiting, hypertension, vaginalbleeding and discharge (including breakthrough bleeding), hyperglycaemia, asthenia, rash.

Overdosage

No serious unexpected side effects have resulted from studies involving Megestrol 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 diarrhoea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain. There is no specific antidote for overdose with Megestrol Acetate. In case of overdose, appropriate supportive measures should be taken. Megestrol has not been tested for dualizability.

How Supplied

Megesta - 80 tablets are supplied as an uncoated Alu-Alu Packaging containing 80 mg of Megestrol per tablet.

Storage

Store in a Cool, Dry & Dark place. Protect from Light & Moisture.