Rx Item-Depo-Subq Pro 104Mg 0.65 Inj 0.65Ml By Pfizer Pharma

DEPO-SUBQ PROVERA- medroxyprogesterone acetate injection, suspension
Pharmacia and Upjohn Company

Physician Information

WARNING: LOSS OF BONE MINERAL DENSITY

Women who use depo-subQ provera 104 may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible.

It is unknown if use of depo-subQ provera 104 during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.



depo-subQ provera 104 should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate (see WARNINGS, section 1).

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

DESCRIPTION

depo-subQ provera 104 contains medroxyprogesterone acetate (MPA), a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white to off-white, odorless crystalline powder that is stable in air and that melts between 205� and 209�C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water.

The chemical name for medroxyprogesterone acetate is 17-hydroxy-6?-methylpregn-4-ene-3, 20-dione 17-acetate. The structural formula is as follows:

Chemical Structure
(click image for full-size original)
depo-subQ provera 104 for subcutaneous (SC) injection is available in pre-filled syringes (160 mg/mL), each containing 0.65 mL (104 mg) of medroxyprogesterone acetate sterile aqueous suspension.

Each 0.65 mL contains:

Medroxyprogesterone acetate 104 mg
Methylparaben 1.040 mg
Propylparaben 0.098 mg
Sodium Chloride 5.200 mg
Polyethylene Glycol 18.688 mg
Polysorbate 80 1.950 mg
Monobasic Sodium Phosphate ? H2 O 0.451 mg
Dibasic Sodium Phosphate ? 12H2 O 0.382 mg
Methionine 0.975 mg
Povidone 3.250 mg
Water for Injection qs
When necessary, the pH is adjusted with sodium hydroxide or hydrochloric acid, or both.

CLINICAL PHARMACOLOGY

depo-subQ provera 104 (medroxyprogesterone acetate injectable suspension), when administered at 104 mg/0.65 mL to women every 3 months (12 to 14 weeks), inhibits the secretion of gonadotropins, which prevents follicular maturation and ovulation and causes endometrial thinning. These actions produce its contraceptive effect.

Supression of serum estradiol concentrations and a possible direct action of depo-subQ provera 104 on the lesions of endometriosis are likely to be responsible for the therapeutic effect on endometriosis-associated pain.

RX ITEM-Depo-Subq Pro 104Mg 0.65 Inj 0.6
NDC 00009-4709-13 UPC/GTIN No.3-00094-70913-2 Mfg.Part No.484

Depo-Subq Pro 104Mg 0.65 Inj 0.65Ml By P
BRAND: DEPO-SUBQ NDC: 00009-4709-13,9470913 UPC: 3-00094-70913-2,300094709132 Pfizer Pharmaceutical

MEDROXYPROGESTERONE ACETA
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