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



WARNING

Medroxyprogesterone Acetate Tablets: THE USE OF MEDROXYPROGESTERONE ACETATE DURING THE FIRST FOUR MONTHS OF PREGNANCY IS NOT RECOMMENDED.

Progestational agents have been used beginning with the first trimester of pregnancy in an attempt to prevent habitual abortion. There is no adequate evidence that such use is effective when such drugs are given during the first four months of pregnancy. 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. Therefore, the use of such drugs during the first four months of pregnancy is not recommended.

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, but insofar as some of these drugs induce mild virilization of the external genitalia of the female fetus, and because of the increased association of hypospadias in the male fetus, it is prudent to avoid the use of these drugs during the first trimester of pregnancy.

If the patient is exposed to medroxyprogesterone 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.


DESCRIPTION

Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Medroxyprogesterone acetate is a derivative of progesterone and is active by the parenteral and oral routes of administration. It is a white to off-white, odorless crystalline powder, stable in air, melting between 200 and 210°C. It is freely soluble in chloroform, soluble in acetone and in dioxane, sparingly soluble in alcohol and in methanol, slightly soluble in ether, and insoluble in water.

The chemical name for medroxyprogesterone acetate is Pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-,(6a)-.

Tablets: Each Provera tablet for oral administration contains 2.5 mg, 5 mg or 10 mg of medroxyprogesterone acetate. Inactive ingredients: Calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose, talc. The 2.5 mg tablet contain FD&C yellow no. 6.

Sterile Aqueous Suspension: Depo-Provera sterile aqueous suspension for intramuscular injection is available as 400 mg/ml medroxyprogesterone acetate.

Each ml of the 400 mg/ml suspension contains:

Medroxyprogesterone Acetate: 400 mg

Polyethylene Glycol 3350: 20.3 mg

Sodium Sulfate Anhydrous: 11 mg

Myristyl-Gamma-Picolinium Chloride (Added as a Perservative): 1.69 mg

When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.

Contraceptive Injection: Depo-Provera contraceptive injection for intramuscular (IM) injection is available in vials and prefilled syringes, each containing 1 ml medroxyprogesterone acetate sterile aqueous suspension 150 mg/ml.

Each ml contains:

Medroxyprogesterone Acetate: 150 mg

Polyethylene Glycol 3350: 28.9 mg

Polysorbate 80: 2.41 mg

Sodium Chloride: 8.68 mg

Methylparaben: 1.37 mg

Propylparaben: 0.150 mg

Water for Injection: qs

When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid.

CATEGORIES, BRAND NAMES

CATEGORIES: Amenorrhea; Carcinoma, endometrium, adjunct; Carcinoma, renal, adjunct; Contraception; Hemorrhage, uterine; FDA Approved 1962 Apr; Top 200 Drugs; Pregnancy Category X; WHO Formulary

FDA Drug Classes: Antineoplastics; Contraceptives; Progestins

BRAND NAMES:

BRAND NAMES: Amen; Aragest; Aragest 5; Asconale; Clinofem; Clinovir; Curretab; Cycrin; Depo-Provera; Depo-Provera Contraceptive; Farlutal; Gestapuran; Hysron; Lutoral; Med-Pro; Medrone; Meprate; Perlutex; Perlutex Leo; Prodasone; Progeston; Progevera; Provera; Ralovera
(Foreign Brand names outside U.S. in italics)

FOREIGN BRAND AVAILABILITY:
Aragest 5 (Israel)
Clinofem (Germany)
Farlutal (Bahrain; Belgium; Cyprus; Egypt; Iran; Iraq; Israel; Italy; Jordan; Kuwait; Lebanon; Libya; Netherlands; Oman; Qatar; Republic-Of-Yemen; Saudi-Arabia; Syria; United-Arab-Emirates)
Gestapuran (Finland; Sweden)
Medrone (Taiwan)
Meprate (India)
Perlutex (Denmark; Norway)
Perlutex Leo (Costa-Rica; Dominican-Republic; El-Salvador; Guatemala; Honduras; Panama)
Progevera (Spain)
Ralovera (Australia)

HCFA JCODE(S): J1050 100 mg IM; J1055 150 mg IM





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