Psorizide Ultra
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Medroxyprogesterone Acetate Injectable Suspension, USP 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, USP long-term [see Warnings and Precautions (5.1)].
History
There is currently no drug history available for this drug.
Other Information
Medroxyprogesterone Acetate Injectable Suspension, USP contains medroxyprogesterone acetate, a derivative of progesterone, as its active ingredient. Medroxyprogesterone acetate is active by the parenteral and oral routes of administration. It is a white to off-white; odorless crystalline powder that is stable in air and that melts between 200°C and 210°C. It is freely soluble in chloroform, soluble in acetone and dioxane, sparingly soluble in alcohol and methanol, slightly soluble in ether, and insoluble in water.
The chemical name for Medroxyprogesterone Acetate is pregn-4-ene-3,20-dione, 17-(acetyloxy)-6-methyl-, (6α-).
The structural formula is as follows:
Medroxyprogesterone Acetate Injectable Suspension, USP for intramuscular (IM) injection is available in vials and prefilled syringes, each containing 1 mL of medroxyprogesterone acetate sterile aqueous suspension 150 mg/mL.
For Medroxyprogesterone Acetate Injectable Suspension, USP vials, each mL contains:
| Medroxyprogesterone acetate | 150 mg |
| Polyethylene glycol 3350 | 28.9 mg |
| Polysorbate 80 | 2.41 mg |
| Sodium chloride | 8.68 mg |
| Methylparaben | 1.37 mg |
| Propylparaben | 0.150 mg |
| Water for injection | quantity sufficient |
When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
For Medroxyprogesterone Acetate Injectable Suspension, USP prefilled syringes, each mL contains:
| Medroxyprogesterone acetate | 150 mg |
| Polyethylene glycol 3350 | 28.5 mg |
| Polysorbate 80 | 2.37 mg |
| Sodium chloride | 8.56 mg |
| Methylparaben | 1.35 mg |
| Propylparaben | 0.147 mg |
| Water for injection | quantity sufficient |
When necessary, pH is adjusted with sodium hydroxide or hydrochloric acid, or both.
Sources
Psorizide Ultra Manufacturers
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Plymouth Pharmaceuticals Inc Dba Loma Lux Laboratories
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Psorizide Ultra | Remedyrepack Inc.
The recommended dose is 150 mg of Medroxyprogesterone Acetate Injectable Suspension, USP every 3 months (13 weeks) administered by deep, intramuscular (IM) injection in the gluteal or deltoid muscle. (2.1)Both the 1 mL vial and the 1 mL prefilled syringe of Medroxyprogesterone Acetate Injectable Suspension, USP 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, USP every 3 months (13 weeks) administered by deep IM injection in the gluteal or deltoid muscle. Medroxyprogesterone Acetate Injectable Suspension, USP 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, USP depends on adherence to the dosage schedule of administration.
When switching from other contraceptive methods, Medroxyprogesterone Acetate Injectable Suspension, USP 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, USP on the day after the last active tablet or at the latest, on the day following the final inactive tablet).
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