"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(fluoxymesterone) Tablets, USP
- Patient Information:
HALOTESTIN Tablets contain fluoxymesterone, an androgenic hormone.
Fluoxymesterone is a white or nearly white, odorless, crystalline powder, melting at or about 240° C, with some decomposition. It is practically insoluble in water, sparingly soluble in alcohol, and slightly soluble in chloroform.
The chemical name for fluoxymesterone is androst-4-en-3-one, 9-fluoro-11,17- dihydroxy-17-methyl-, (11β,17β)-. The molecular formula is C20H29FO3 and the molecular weight 336.45.
The structural formula is represented below:
Each HALOTESTIN (fluoxymesterone) tablet, for oral administration, contains 2 mg, 5 mg or 10 mg fluoxymesterone. Inactive ingredients: calcium stearate, corn starch, FD&C Yellow No. 5, lactose, sorbic acid, sucrose, tragacanth. In addition, the 2 mg tablet contains FD&C Yellow No. 6 and the 5 mg and 10 mg contain FD&C Blue No. 2.
What are the precautions when taking fluoxymesterone (Halotestin)?
Before taking fluoxymesterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: breast cancer in men, prostate cancer.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (such as heart failure, chest pain, heart attack), liver problems, kidney problems, other types of cancer, certain mineral imbalance (high calcium blood level), high cholesterol, high blood pressure, enlarged...
Last reviewed on RxList: 10/14/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Halotestin Information
- Halotestin Drug Interactions Center: fluoxymesterone oral
- Halotestin Side Effects Center
- Halotestin Overview including Precautions
- Halotestin FDA Approved Prescribing Information including Dosage
Halotestin - User Reviews
Halotestin 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.