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Depo-Provera (Medroxyprogesterone Acetate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

DEPO-PROVERA Contraceptive Injection is indicated only for the prevention of pregnancy. To ensure that DEPO-PROVERA Contraceptive Injection is not administered inadvertently to a pregnant woman, the first injection must 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. The efficacy of DEPO-PROVERA Contraceptive Injection depends on adherence to the recommended dosage schedule (see DOSAGE AND ADMINISTRATION). It is a long-term injectable contraceptive in women when administered at 3-month (13-week) intervals. Dosage does not need to be adjusted for body weight.

In five clinical studies using DEPO-PROVERA Contraceptive Injection, the 12-month failure rate for the group of women treated with DEPO-PROVERA Contraceptive Injection was zero (no pregnancies reported) to 0.7 by Life-Table method. Pregnancy rates with contraceptive measures are typically reported for only the first year of use as shown in Table 1. Except for intrauterine devices (IUD), implants, sterilization, and DEPO-PROVERA Contraceptive Injection, the efficacy of these contraceptive measures depends in part on the reliability of use. The effectiveness of DEPO-PROVERA Contraceptive Injection is dependent on the patient returning every 3 months (13 weeks) for reinjection.

Table 1
Lowest Expected and Typical Failure Rates *
Expressed as Percent of Women Experiencing
an Accidental Pregnancy
in the First Year of Continuous Use
Method Lowest Expected Typical
Injectable progestogen
DEPO-PROVERA
0.3 0.3
Implants Norplant (6 capsules) 0.2 **/* 0.2 **/*
Female sterilization 0.2 0.4
Male sterilization 0.1 0.15
Pill Combined Progestogen only 0.1
0.5
3
IUD Progestasert Copper T 380A 2
0.8
3
Condom 2 12
Diaphragm 6 18
Cap 6 18
Spermicides 3 21
Sponge Parous women Nulliparous women 9
6
28
18
Periodic abstinence 1-9 20
Withdrawal 4 18
No method 85 85
Source: Trussell et al1
* Lowest expected - when used exactly as directed.
Typical - includes those not following directions exactly.
**/* from Norplant® package insert

DOSAGE AND ADMINISTRATION

Both the 1 mL vial and the 1 mL prefilled syringe of DEPO-PROVERA Contraceptive Injection 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 Contraceptive Injection every 3 months (13 weeks) administered by deep, IM injection in the gluteal or deltoid muscle. To ensure the patient is not pregnant at the time of the first injection, the first injection MUST 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 Contraceptive Injection depends on adherence to the dosage schedule of administration.

HOW SUPPLIED

DEPO-PROVERA Contraceptive Injection (medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL) is available as:

NDC 0009-0746-30 1 mL vial

NDC 0009-0746-35 25 × 1 mL vials

NDC 0009-7376-01 1 mL prefilled syringe

NDC 0009-7376-02 6 × 1 mL prefilled syringes

NDC 0009-7376-03 24 × 1 mL prefilled syringes

DEPO-PROVERA Contraceptive Injection prefilled syringes are available packaged with 22-gauge × 1 1/2 inch BD SafetyGlide™ Needles in the following presentations:

NDC 0009-7376-04 1 mL prefilled syringe

NDC 0009-7376-05 6 × 1 mL prefilled syringes

NDC 0009-7376-06 24 × 1 mL prefilled syringes

Store at controlled room temperature 20 to 25C (68 to 77F) [see USP].

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