What is MEGESTROL?

MEGESTROL 40 MG contains MEGESTROL ACETATE : 40 MG. It is listed in the Health Canada Drug Product Database under DIN 02195917, held by AA PHARMA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 23-Sep-2021. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is MEGESTROL used for?

MEGESTROL (megestrol acetate) is indicated for adjunctive or palliative treatment of recurrent, inoperable or metastatic carcinoma of the breast and endometrium and for palliative treatment of hormone responsive advanced (Stage D2) carcinoma of the prostate. MEGESTROL should not be used in lieu of currently accepted procedures such as surgery and radiation. Objective or subjective responses or arrest of tumour growth may occur for one to several months while on therapy. MEGESTROL is also indicated for the treatment of anorexia, cachexia or weightloss secondary to metastatic cancer.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

For the following indications, at least two months of continuous treatment with MEGESTROL (megestrol acetate) is recommended. For palliative or adjunctive treatment of breast carcinoma: 160 mg or 125 mg/m² daily (40 mg q.i.d. or 160 mg q.d.). For endometrial carcinoma: 80 - 320 mg or 62.5 - 250 mg/m² daily in divided doses (40 - 80 mg one to four times daily or one to two 160 mg tablets daily). For palliative treatment of hormone responsive advanced (Stage D₂) carcinoma of the prostate: 120 mg (93.8 mg/m²) as a single daily dose in combination with diethylstilbestrol tablet, 0.1 mg. For anorexia, cachexia, or significant weight loss in patients with cancer: usual adult dose: 400 to 800 mg as a single daily dose.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store MEGESTROL (Megestrol Acetate Tablets USP) at room temperature (15-30°C) in well-closed containers.

How is it supplied?

MEGESTROL (Megestrol Acetate Tablets USP) 40 mg: each light blue, round, flat-faced, bevelled-edged, scored tablet, engraved “40” on one side, contains 40 mg megestrol acetate. Available in bottles of 100 and 250 tablets. MEGESTROL (Megestrol Acetate Tablets USP) 160 mg: each white, oval, biconvex, scored tablet engraved "160" on one side, contains 160 mg megestrol acetate. Available in bottles of 100 and 250 tablets.

Contraindications

MEGESTROL (megestrol acetate) is contraindicated in those people who are sensitive to megestrol acetate or any ingredients in the tablets. MEGESTROL should not be used as a diagnostic test for pregnancy.

Warnings and precautions

The use of progestational agents during the first four months of pregnancy is not recommended. Progestational agents have been used beginning within the first trimester of pregnancy in an attempt to prevent habitual abortion or treat threatened abortion. There is no adequate evidence that such use is effective and there is evidence of potential harm to the fetus when such drugs are given during the first four months of pregnancy. Use of progestational agents, with their uterine- relaxant properties, in patients with fertilized defective ova may cause a delay in spontaneous abortion. Several reports suggest an association between intrauterine exposure to progestational drugs in the first trimester of pregnancy and genital abnormalities in male and female fetuses. The risk of hypospadias, 5 to 8 per 1000 male births in the general population, may be approximately doubled with exposure to these drugs. There are insufficient data to quantify the risk to exposed female fetuses, however some of these drugs induce mild virilization of the external genitalia of the female fetus. If the patient is exposed to MEGESTROL (megestrol acetate) during the first four months of pregnancy or if she becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

What can be used instead?

Other Canadian products sharing ATC code L02AB01 MEGESTROL. 2 of 13 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies MEGESTROL worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. MEGESTROL appears in 13 registered pack listings across 7 markets, published on 5 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.