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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (M's) » Megestrol




THE USE OF MEGACE ® (megestrol acetate) Oral Suspension IS CONTRAINDICATED IN PREGNANCY.

Progestational agents have been used beginning with the first trimester of pregnancy in an attempt to prevent habitual abortion. There is no evidence that the use of a high dose progestational agent such as MEGACE Oral Suspension during any phase of pregnancy is effective for this purpose. Furthermore, in the vast majority of women, the cause of abortion is a defective ovum, which progestational agents could not be expected to influence. In addition, the 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 1,000 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. Because of increased genital abnormalities in male and female fetuses induced by some progestational drugs, it is prudent to avoid the use of MEGACE Oral Suspension during pregnancy.

If the patient is exposed to MEGACE Oral Suspension during pregnancy or if she becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus.

MEGACE ® (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 17a( 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:

MEGACE Oral Suspension is supplied as an oral suspension containing 40 mg of micronized megestrol acetate per mL.

MEGACE Oral Suspension contains the following inactive ingredients: alcohol (max. 0.06% v/ v from flavor), citric acid, lemon- lime flavor, polyethylene glycol, polysorbate 80, purified water, sodium benzoate, sodium citrate, sucrose and xanthan gum.

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