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Questions & Answers
Side Effects & Adverse Reactions
The use of progestational drugs during the first four months of pregnancy is not recommended. Progestational agents have been used beginning with the first trimester of pregnancy in attempts to prevent abortion but there is no evidence that such use is effective. Furthermore, 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, 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 DEPO-PROVERA Sterile Aqueous Suspension 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.
The physician should be alert to the earliest manifestations of thrombotic disorder (thrombophlebitis, cerebrovascular disorder, pulmonary embolism, and retinal thrombosis). Should any of these occur or be suspected, the drug should be discontinued immediately.
Medication should be discontinued pending examination if there is a sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine. If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn.
Detectable amounts of drug have been identified in the milk of mothers receiving progestational drugs. The effect of this on the nursing infant has not been determined.
Multi-dose use of DEPOPROVERA Sterile Aqueous Suspension from a single vial requires special care to avoid contamination. Although initially sterile, any multi-dose use of vials may lead to contamination unless strict aseptic technique is observed.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial or renal carcinoma.
There is currently no drug history available for this drug.
DEPO-PROVERA Sterile Aqueous Suspension contains medroxyprogesterone acetate, which 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 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-, (6α)-. The structural formula is:
DEPO-PROVERA 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
chloride ............................................1.69 mg
added as preservative
When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.