"The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women's Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years"...
DOSAGE AND ADMINISTRATION
The suspension is intended for intramuscular administration only.
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.
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.
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.
The effect of renal impairment on DEPO-PROVERA pharmacokinetics has not been studied.
DEPO-PROVERA Sterile Aqueous Suspension is available as 400 mg/mL in 2.5 mL vials.
Distributed by: Pharmacia & Upjohn Company, Division of Pfizer Inc., NY, NY 10017. Revised June 2015
Last reviewed on RxList: 2/11/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Depo-Provera Information
Depo Provera - User Reviews
Depo Provera User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.