Depo-Provera 400 MG/ML Injectable Suspension
Generic Name: MEDROXYPROGESTERONE ACETATE
Brand Name: Depo-Provera
- Substance Name(s):
- MEDROXYPROGESTERONE ACETATE
WARNINGS
1.
Thromboembolic Disorders The physician should be alert to the earliest manifestations of thrombotic disorder (thrombophlebitis, cerebrovascular disorder, pulmonary embolism, and retinal thrombosis).
Should any of these occur or be suspected, the drug should be discontinued immediately.
2.
Ocular Disorders Medication should be discontinued pending examination if there is a sudden partial or complete loss of vision, or if there is a sudden onset of proptosis, diplopia or migraine.
If examination reveals papilledema or retinal vascular lesions, medication should be withdrawn.
3.
Multi-dose Use Multi-dose use of DEPO-PROVERA Sterile Aqueous Suspension from a single vial requires special care to avoid contamination.
Although initially sterile, any multi-dose use of vials may lead to contamination unless strict aseptic technique is observed.
DRUG INTERACTIONS
Aminoglutethimide administered concomitantly with DEPO-PROVERA Sterile Aqueous Suspension may significantly depress the serum concentrations of medroxyprogesterone acetate.
DEPO-PROVERA users should be warned of the possibility of decreased efficacy with the use of this or any related drugs.
In vitro Medroxyprogesterone acetate is metabolized primarily by hydroxylation via the CYP3A4.
Though no formal drug interaction trials have been conducted, concomitant administration of strong CYP3A inhibitors is expected to increase concentrations of medroxyprogesterone acetate, whereas the concomitant administration of strong CYP3A inducers is expected to decrease medroxyprogesterone acetate concentrations.
Therefore, coadministration with strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) or strong CYP3A inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, St.
John’s Wort) should be avoided.
DESCRIPTION
DEPO-PROVERA Sterile Aqueous Suspension contains medroxyprogesterone acetate, which is a derivative of progesterone and is active by the parenteral and oral routes of administration.
It is a white to off-white, odorless crystalline powder, stable in air, melting between 200° and 210° C.
It is freely soluble in chloroform, soluble in acetone and in 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: medroxyprogesterone acetate DEPO-PROVERA for intramuscular injection is available as 400 mg/mL medroxyprogesterone acetate.
Each mL of the 400 mg/mL suspension contains: Medroxyprogesterone acetate 400 mg Polyethylene glycol 3350 20.3 mg Sodium sulfate anhydrous 11 mg with Myristyl-gamma-picolinium chloride 1.69 mg added as preservative When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.
Chemical Structure
HOW SUPPLIED
DEPO-PROVERA Sterile Aqueous Suspension is available as 400 mg/mL in 2.5 mL vials.
NDC 0009-0626-01 2.5ml vial
GERIATRIC USE
Geriatric Use Renal Carcinoma Of the 349 subjects in a clinical study of Depo Provera in renal carcinoma, 30 percent were 65 and over, while 5 percent were 75 and over.
No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Endometrial Carcinoma This product has been used primarily in post-menopausal women for the treatment of endometrial carcinoma.
Clinical experience has not identified differences in safety or effectiveness between elderly and younger patients.
INDICATIONS AND USAGE
INDICATIONS AND USES Adjunctive therapy and palliative treatment of inoperable, recurrent, and metastatic endometrial or renal carcinoma.
PEDIATRIC USE
17.
Pediatric Use Safety and efficacy of DEPO- PROVERA for endometrial and renal carcinoma have not been established in pediatric patients.
Studies in pre-menopausal women show that Depo-Provera is associated with loss of BMD.
It is unknown if use of Depo-Provera during adolescence and early adulthood, a critical period of bone accretion, will reduce peak bone mass.
(See PRECAUTIONS: Decrease in Bone Mineral Density)
PREGNANCY
15.
Pregnancy Teratogenic effects It is not known whether medroxyprogesterone acetate can cause fetal harm when administered to a pregnant woman.
Medroxyprogesterone acetate should be given to a pregnant woman only if clearly needed.
NUSRING MOTHERS
16.
Nursing Mothers Published studies report the presence of medroxyprogesterone acetate in human milk.
Caution should be exercised when medroxyprogesterone acetate is administered to a nursing woman.
DOSAGE AND ADMINISTRATION
The suspension is intended for intramuscular administration only, rotating the sites with every injection.
As with any intramuscular 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 intramuscular injection.
When multi-dose vials are used, special care to prevent contamination of the contents is essential [see WARNINGS and PRECAUTIONS].
Endometrial or Renal Carcinoma Doses of 400 mg to 1000 mg of DEPO-PROVERA Sterile Aqueous Suspension per week are 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.
Medroxyprogesterone acetate is not recommended as primary therapy, but as adjunctive and palliative treatment in advanced inoperable cases including those with recurrent or metastatic disease.
Geriatric Use Renal Carcinoma Of the 349 subjects in a clinical study of Depo Provera in renal carcinoma, 30 percent were 65 and over, while 5 percent were 75 and over.
No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Endometrial Carcinoma This product has been used primarily in post-menopausal women for the treatment of endometrial carcinoma.
Clinical experience has not identified differences in safety or effectiveness between elderly and younger patients.
Hepatic Impairment DEPO-PROVERA Sterile Aqueous Suspension should not be used by women with significant liver disease and should be discontinued if jaundice or disturbances of liver function occur [see PRECAUTIONS].
Renal Impairment The effect of renal impairment on DEPO-PROVERA pharmacokinetics has not been studied.