Description
Contents
Medroxyprogesterone
Indications/Uses
Depot-Medroxyprogesterone acetate (DMPA) injectable suspension is indicated for: Contraception: Contraception (ovulation suppression).
Gynecology: Treatment of endometriosis.
Treatment of menopausal vasomotor symptoms.
Oncology: Adjunctive and/or palliative treatment of recurrent and/or metastatic endometrial or renal carcinoma.
Treatment of hormonally-dependent, recurrent breast cancer in post-menopausal women.
Long-term Use: Since loss of bone mineral density (BMD) may occur in pre-menopausal women who use DMPA injection long-term (see Additional Warnings and Precautions for Specific Use or Formulation: Contraception/Endometriosis – Injectable Formulations: Loss of Bone Mineral Density under Precautions and Pharmacology: Pharmacodynamics: Clinical Studies: Bone Mineral Density Studies under Actions), a risk/benefit assessment, which also takes into consideration the decrease in BMD that occurs during pregnancy and/or lactation, should be considered.
Gynecology: Treatment of endometriosis.
Treatment of menopausal vasomotor symptoms.
Oncology: Adjunctive and/or palliative treatment of recurrent and/or metastatic endometrial or renal carcinoma.
Treatment of hormonally-dependent, recurrent breast cancer in post-menopausal women.
Long-term Use: Since loss of bone mineral density (BMD) may occur in pre-menopausal women who use DMPA injection long-term (see Additional Warnings and Precautions for Specific Use or Formulation: Contraception/Endometriosis – Injectable Formulations: Loss of Bone Mineral Density under Precautions and Pharmacology: Pharmacodynamics: Clinical Studies: Bone Mineral Density Studies under Actions), a risk/benefit assessment, which also takes into consideration the decrease in BMD that occurs during pregnancy and/or lactation, should be considered.
Dosage/Direction for Use
Injectable suspensions should be shaken well before use.
Contraception: Contraception (Ovulation Suppression): DMPA intramuscular (IM) injectable suspension should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension.
Intramuscular (IM): The recommended dose is 150 mg of DMPA injectable suspension every 3 months administered by intramuscular injection in the gluteal or deltoid muscle. The IM suspension is not formulated for subcutaneous injection.
First injection: The initial IM injection should be given during the first 5 days after the onset of a normal menstrual period; within 5 days postpartum if not breast-feeding; or, if exclusively breast-feeding, at or after 6 weeks postpartum.
Second and subsequent injection: If the interval from the preceding injection is greater than 89 days (12 weeks and 5 days) for any reason, then pregnancy should be excluded before the next injection is given and the patient should use additional contraceptive measures (e.g., barrier) for 14 days after this subsequent injection.
Switching from other methods of contraception: When switching from other contraceptive methods, (DMPA IM) 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 DMPA within 7 days after taking their last active pill).
Use in Children: DMPA IM is not indicated before menarche. Data are available in adolescent females (12-18 years) (see Pharmacology: Pharmacodynamics: Clinical Studies: BMD Changes in Adolescent Females (12-18 years) under Actions). Other than concerns about loss of BMD, the safety and effectiveness of DMPA IM are expected to be the same for postmenarcheal adolescent and adult females.
Gynecology: Use of combined estrogen/progestin therapy in post-menopausal women should be limited to the lowest effective dose and shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically evaluated. (See Precautions.)
Periodic check-ups are recommended with a frequency and nature adapted to the individual woman. (See Precautions.)
Endometriosis: Injectable DMPA given intramuscularly 50 mg weekly or 100 mg every 2 weeks for at least 6 months.
Menopausal Vasomotor Symptoms: Injectable DMPA given intramuscularly 150 mg every 12 weeks.
Oncology: Recurrent and/or Metastatic Endometrial or Renal Cancer: Injectable DMPA 400 to 1000 mg intramuscularly per week is recommended initially. If improvement is noted within a few weeks or months and the disease appears stabilized, it may be possible to maintain improvement with as little as 400 mg per month.
Treatment of hormonally-dependent, recurrent breast cancer in post-menopausal women: Injectable DMPA initial dose 500 mg intramuscularly per day for 28 days. The patient should then be placed on a maintenance schedule of 500 mg twice weekly as long as she responds to treatment.
Hepatic Insufficiency: The effect of hepatic disease on the pharmacokinetics of Depo-Provera is unknown. As Depo-Provera largely undergoes hepatic elimination it may be poorly metabolised in patients with severe liver insufficiency (see Contraindications).
Renal Insufficiency: The effect of renal disease on the pharmacokinetics of Depo-Provera is unknown. No dosage adjustment should be necessary in women with renal insufficiency, since Depo-Provera is almost exclusively eliminated by hepatic metabolism.
Contraception: Contraception (Ovulation Suppression): DMPA intramuscular (IM) injectable suspension should be vigorously shaken just before use to ensure that the dose being administered represents a uniform suspension.
Intramuscular (IM): The recommended dose is 150 mg of DMPA injectable suspension every 3 months administered by intramuscular injection in the gluteal or deltoid muscle. The IM suspension is not formulated for subcutaneous injection.
First injection: The initial IM injection should be given during the first 5 days after the onset of a normal menstrual period; within 5 days postpartum if not breast-feeding; or, if exclusively breast-feeding, at or after 6 weeks postpartum.
Second and subsequent injection: If the interval from the preceding injection is greater than 89 days (12 weeks and 5 days) for any reason, then pregnancy should be excluded before the next injection is given and the patient should use additional contraceptive measures (e.g., barrier) for 14 days after this subsequent injection.
Switching from other methods of contraception: When switching from other contraceptive methods, (DMPA IM) 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 DMPA within 7 days after taking their last active pill).
Use in Children: DMPA IM is not indicated before menarche. Data are available in adolescent females (12-18 years) (see Pharmacology: Pharmacodynamics: Clinical Studies: BMD Changes in Adolescent Females (12-18 years) under Actions). Other than concerns about loss of BMD, the safety and effectiveness of DMPA IM are expected to be the same for postmenarcheal adolescent and adult females.
Gynecology: Use of combined estrogen/progestin therapy in post-menopausal women should be limited to the lowest effective dose and shortest duration consistent with treatment goals and risks for the individual woman, and should be periodically evaluated. (See Precautions.)
Periodic check-ups are recommended with a frequency and nature adapted to the individual woman. (See Precautions.)
Endometriosis: Injectable DMPA given intramuscularly 50 mg weekly or 100 mg every 2 weeks for at least 6 months.
Menopausal Vasomotor Symptoms: Injectable DMPA given intramuscularly 150 mg every 12 weeks.
Oncology: Recurrent and/or Metastatic Endometrial or Renal Cancer: Injectable DMPA 400 to 1000 mg intramuscularly per week is recommended initially. If improvement is noted within a few weeks or months and the disease appears stabilized, it may be possible to maintain improvement with as little as 400 mg per month.
Treatment of hormonally-dependent, recurrent breast cancer in post-menopausal women: Injectable DMPA initial dose 500 mg intramuscularly per day for 28 days. The patient should then be placed on a maintenance schedule of 500 mg twice weekly as long as she responds to treatment.
Hepatic Insufficiency: The effect of hepatic disease on the pharmacokinetics of Depo-Provera is unknown. As Depo-Provera largely undergoes hepatic elimination it may be poorly metabolised in patients with severe liver insufficiency (see Contraindications).
Renal Insufficiency: The effect of renal disease on the pharmacokinetics of Depo-Provera is unknown. No dosage adjustment should be necessary in women with renal insufficiency, since Depo-Provera is almost exclusively eliminated by hepatic metabolism.
*The product images shown are for illustration purposes only and may not be an exact representation of the product.
