"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
Depo-Provera CI is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use Depo-Provera CI long-term [see WARNINGS AND PRECAUTIONS].
DOSAGE AND ADMINISTRATION
Prevention of Pregnancy
Both the 1 mL vial and the 1 mL prefilled syringe of Depo-Provera CI should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension. The recommended dose is 150 mg of Depo-Provera CI every 3 months (13 weeks) administered by deep IM injection in the gluteal or deltoid muscle. Depo-Provera CI 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. Dosage does not need to be adjusted for body weight [See Clinical Studies].
To ensure the patient is not pregnant at the time of the first injection, the first injection should be given ONLY during the first 5 days of a normal menstrual period; ONLY within the first 5-days postpartum if not breast-feeding; and if exclusively breast-feeding, ONLY at the sixth postpartum week. If the time interval between injections is greater than 13 weeks, the physician should determine that the patient is not pregnant before administering the drug. The efficacy of Depo-Provera CI depends on adherence to the dosage schedule of administration.
Switching from other Methods of Contraception
When switching from other contraceptive methods, Depo-Provera CI should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, (e.g., patients switching from oral contraceptives should have their first injection of Depo-Provera CI on the day after the last active tablet or at the latest, on the day following the final inactive tablet).
Dosage Forms And Strengths
Sterile Aqueous suspension: 150mg/ml
Prefilled syringes are available packaged with 22-gauge x 1 1/2 inch BD SafetyGlideTM Needles.
Storage And Handling
Depo-Provera CI is supplied in the following strengths and package configurations:
|Depo-Provera CI (medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL)|
|1 mL vial||150 mg/mL||NDC 0009-0746-30|
|25 x 1 mL vials||150 mg/mL||NDC 0009-0746-35|
|1 mL prefilled syringe||150 mg/mL||NDC 0009-7376-01|
|6 x 1 mL prefilled syringes||150 mg/mL||NDC 0009-7376-02|
|24 x 1 mL prefilled syringes||150 mg/mL||NDC 0009-7376-03|
|Depo-Provera CI prefilled syringes packaged with 22 gauge x 1 ½ inch BD SafetyGlide™ Needles|
|1 mL prefilled syringe||150 mg/mL||NDC 0009-7376-04|
|6 x 1 mL prefilled syringes||150 mg/mL||NDC 0009-7376-05|
|24 x 1 mL prefilled syringes||150 mg/mL||NDC 0009-7376-06|
Vials MUST be stored upright at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Distributed by: Pharmacia & Upjohn Company, Division of Pfizer Inc., NY, NY 10017. Revised July 2011
Last reviewed on RxList: 8/31/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Depo Provera Information
Depo Provera - User Reviews
Depo Provera User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.