Medroxyprogesterone Acetate 150mg/ml Vial 1ml by Amphastar Gen Depo Provera

MEDROXYPROGESTERONE ACETATE- medroxyprogesterone acetate injection, suspension
Teva Parenteral Medicines, Inc.

WARNING: LOSS OF BONE MINERAL DENSITY

Women who use medroxyprogesterone acetate injectable suspension may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible.

It is unknown if use of medroxyprogesterone acetate injectable suspension during adolescence or early adulthood, a critical period of bone accretion, will reduce peak bone mass and increase the risk for osteoporotic fracture in later life.



Medroxyprogesterone acetate injectable suspension 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 [see Warnings and Precautions (5.1) ].

1 INDICATIONS AND USAGE

Medroxyprogesterone Acetate Injectable Suspension 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 Medroxyprogesterone Acetate Injectable Suspension long-term [see Warnings and Precautions (5.1) ].

2 DOSAGE AND ADMINISTRATION

2.1 Prevention of Pregnancy
? The 1 mL vial of medroxyprogesterone acetate injectable suspension 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 medroxyprogesterone acetate injectable suspension every 3 months (13 weeks) administered by deep intramuscular (IM) injection using strict aseptic technique in the gluteal or deltoid muscle, rotating the sites with every injection. As with any IM injection, to avoid an inadvertent subcutaneous injection, body habitus should be assessed prior to each injection to determine if a longer needle is necessary particularly for gluteal IM injection.

Medroxyprogesterone acetate injectable suspension 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 (14.1) ].

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 medroxyprogesterone acetate injectable suspension depends on adherence to the dosage schedule of administration.

2.2 Switching from other Methods of Contraception
When switching from other contraceptive methods, medroxyprogesterone acetate injectable suspension 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 medroxyprogesterone acetate injectable suspension on the day after the last active tablet or at the latest, on the day following the final inactive tablet).

3 DOSAGE FORMS AND STRENGTHS

Sterile Aqueous suspension: 150 mg/mL

Medroxyprogesterone Acetate 15
Medroxyprogesterone Acetate 150mg/ml Vial 1ml by Amphastar Gen Depo Provera Item No.:RX721308/M, Item No. RX721308, 721308, NDC No.: 00548-5400-00, 00548-400-00, 0054840000, 00548540000, 5400-00, 5400

Teva Pharma
Teva Pharmaceuticals USA

Medroxyprogesterone Acetate
Medroxyprogesterone Acetate 150mg/ml Vial 1ml by Amphastar Pharma NDC No. 548540000 00548-5400-00 0548-5400-00 0548540000 00548540000 UPC/GTIN No. 3-05485-40000-1 305485-400001 305485400001 MPN 54

MEDROXYPROGESTERONE ACETA
This Item Can Only Be Ordered By A Drug Mfg, Wholesaler,Pharmacy,Physician, Dentist, Podiatrist, Optometrist,Veterinarian,Naturopath,Licensed Lab, Physical Therapist & Pharmacist(scope).

Teva Pharmaceuticals USA
Item No.:RX721308/M, Item No. RX721308, 721308, NDC No.: 00548-5400-00, 00548-400-00, 0054840000, 00548540000, 5400-00, 540000 UPC No. 3-05485-40000-1, 305485-400001, 305485400001

American Pharma
Americanpharmawholesale.com

Medroxyprogesterone Acetate
Medroxyprogesterone Acetate 150mg/ml Vial 1ml by Amphastar Pharma NDC No. 548540000 00548-5400-00 0548-5400-00 0548540000 00548540000 UPC/GTIN No. 3-05485-40000-1 305485-400001 305485400001 MPN 54

Medroxyprogesterone Acetate
MEDROXYPROGESTERONE 150MG/ML Brand Equivalent: DEPOPROVERA 150MG/ML NDC: 00703680101UPC: 307036801015 Item: 803073 Size: 1ML Form: INJECTABLE Manufacturer: TEVA Country of Origin: United Stat