4.2 Recommended Dose and Dosage Adjustment
Conception Control: The recommended dose for contraception is 150 mg of DEPO-PROVERA every 3 months, administered by deep intramuscular injection.
To increase assurance that the woman is not pregnant at the time of the first administration, it is recommended that this injection be given only within the 5 five days of the onset of a normal menstrual period or, only within the first 5 days post-partum if not breastfeeding. If the woman has chosen to breastfeed, discuss the risks of pregnancy and possible risks of DEPO-PROVERA to determine the most appropriate course of action for the individual woman (see 7 WARNINGS AND PRECAUTIONS).
If administered within the first 5 days after the onset of a normal menstrual period, DEPO-PROVERA is effective from the day of injection. When DEPO-PROVERA is given later in the menstrual cycle it may not be effective for the first 3 to 4 weeks after the injection and another method of contraception (non-hormonal) should be used during this time.
After miscarriage or first trimester therapeutic abortion, the injection is normally given within 5 days of the procedure and no extra precautions are required. After a late (second trimester) abortion, some further delay is recommended to reduce the risk of heavy and prolonged bleeding, therefore, the first injection should not be given until 4 weeks after the procedure.
The woman must return every 10 to 13 weeks for a repeat intramuscular injection to maintain contraceptive effectiveness. Intervals between intramuscular injections must not exceed 13 weeks (3 months).
When switching from other contraceptive methods, DEPO-PROVERA 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 within 7 days after taking their last active pill).
Endometriosis: The recommended dose of DEPO-PROVERA is 50 mg weekly or 100 mg every 2 weeks intramuscularly for at least 6 months. It should be noted that return of ovulation may be delayed following this therapy due to the depot properties of the drug (see 7 WARNINGS AND PRECAUTIONS).
Use in Children: DEPO-PROVERA should not be used before menarche (see 2 CONTRAINDICATIONS).
See 7 WARNINGS AND PRECAUTIONS, Loss of Bone Mineral Density for available data for adolescent females (12-18 years).
4.4 Administration
DEPO-PROVERA is intended for INTRAMUSCULAR ADMINISTRATION ONLY.
Immediately before use, the sterile aqueous suspension should be vigorously shaken to assure that the dose being administered represents a uniform suspension.
The prefilled syringe presentation is supplied as an ungraduated syringe. Therefore, it is difficult to extract a precise and accurate 50 or 100 mg dose for the treatment of endometriosis. Therefore, the prefilled syringe presentation is recommended for the conception control (prevention of pregnancy) indication. The vial can be used for both the conception control (prevention of pregnancy) and endometriosis indications.
4.5 Missed Dose
If an injection is not given within 13 weeks of the last DEPO-PORVERA dose, a pregnancy test should be done before any further treatment with DEPO-PROVERA.