Each tablet contains Megestrol Acetate USP 160 mg.
Mechanism of action:
Megestrol Acetate is a synthetic progestational anticancer drug. It may work by interfering with the hormone balance in the body, which may stop the cancer growing. It may also act directly on cancer cells so that they can't grow. Moreover, Megestrol Acetate causes weight gain by increasing the fat and body cell mass and this weight gain is associated with increased appetite. Therefore this drug is used as an appetizer for the cancer patients suffering from anorexia, significant weight loss or cachexia.
Absorption: tmax=2-3 hrs.
Distribution: Plasma concentrations (90-110 ng/mL) occur after the administration of one 160 mg tablet or four 40 mg tablets given over 24 hours.
Metabolism: Mainly hepatic metabolism. The metabolites are three glucuronide conjugates with hydroxylation occurring at either the 2-alpha, or the 6 methyl position or at both positions.
Elimination: 66% in Urine and 20% in feces.
Half-life: t1/2=33-38 hrs.
Apetiz is used in anorexia, cachexia or a significant weight loss. Apetiz is also indicated for the palliative treatment of advanced carcinoma of the breast (i.e. recurrent, inoperable or metastatic diseases). It should not be used in lieu of currently accepted procedures such as surgery, radiation or chemotherapy.
Dosage & Administration
Breast cancer: The recommended dose is 160 mg/day in single or divided doses.
Endometrial carcinoma: Up to 320 mg/day in divided doses.
At least two months of continuous treatment is considered an adequate period for determining the efficacy of Apetiz.
Allergy to Megestrol acetate or any of the excipients. Women of child bearing potential should be advised to avoid becoming pregnant.
Warning & Precautions
Pregnancy: Pregnancy category D. Megestrol Acetate can cause fetal abnormalities and risks, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
Nursing mothers: Very small amounts (approximately 0.1%) are excreted in mother's milk. It is however, not known whether these amounts exert any harmful effect on the newborn. Because of the potential for adverse effects on the new born, nursing should be discontinued during treatment with Megestrol Acetate.
Pediatric use: The safety and efficacy of Megestrol Acetate has not been established in pediatric cases. In general, dose selection for a pediatric patient should be cautious.
Geriatric use: Insufficient data from clinical studies of Megestrol acetate are available for patients 65 years of age and older to determine whether they respond differently than younger patients. In general, dose selection for an elderly patient should be cautious.
Hepatic impairment: Dose selection for a hepatic impaired patient should be cautious.
Renal impairment: Dose selection for a renal impaired patient should be cautious.
Nausea, vomiting, edema occur in approximately 1% to 2% of patients. Dyspnea, pain, hypertension, hot flashes, sweating mood changes, hyperglycemia, alopecia, asthenia, malaise, lethargy, rash, flatulence, diarrhoea and impotence have been reported. Constipation and urinary frequency have been reported in patients who received high doses of Megestrol acetate in clinical trials.
Thromboembolic phenomena: Thromboembolic phenomena including thrombophlebitis and pulmonary embolism (in some cases fatal) have been reported. Other adverse reactions: Breakthrough uterine bleeding occur in approximately 1% to 2% of patients. Heart failure, cushingoid facies, tumor flare (with or without hypercalcemia), carpal tunnel syndrome and urticaria have been reported.
No information is available regarding interactions with food, alcohol or other drugs.
Each box contains 30 Apetiz 160 mg tablets in Alu-Alu blister pack.