Androxy

Name: Androxy

What is Androxy (fluoxymesterone)?

Fluoxymesterone is a man-made form of testosterone, a naturally occurring sex hormone that is produced in a man's testicles. Small amounts of testosterone are also produced in a woman's ovaries and adrenal system.

Fluoxymesterone is used in men and boys to treat conditions caused by a lack of this hormone, such as delayed puberty or other hormonal imbalances.

Fluoxymesterone is also used in women to treat breast cancer that has spread to other parts of the body. Fluoxymesterone treats only the symptoms of metastatic breast cancer but does not treat the cancer itself.

Fluoxymesterone may also be used for purposes not listed in this medication guide.

What other drugs will affect Androxy (fluoxymesterone)?

Other drugs may interact with fluoxymesterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What do I need to tell my doctor BEFORE I take Androxy?

  • If you have an allergy to fluoxymesterone or any other part of Androxy (fluoxymesterone).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are male and have breast or prostate cancer.
  • If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with Androxy.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Androxy, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Androxy (fluoxymesterone). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Androxy.

Review Date: October 4, 2017

Androxy™ (Fluoxymesterone Tablets, USP)

CIII

Rx only

Overdosage

There have been no reports of acute overdosage with androgens.

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

NDC 0832-0086-00
CIII

Androxy™
Fluoxymesterone
Tablets, USP

10 mg

100 Tablets
Rx only

UPSHER-SMITH

Androxy 
fluoxymesterone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0832-0086
Route of Administration ORAL DEA Schedule CIII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
fluoxymesterone (fluoxymesterone) fluoxymesterone 10 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium  
D&C Yellow No. 10  
FD&C Blue No. 1  
FD&C Yellow No. 6  
anhydrous lactose  
magnesium stearate  
cellulose, microcrystalline  
starch, corn  
sodium lauryl sulfate  
aluminum oxide  
Product Characteristics
Color GREEN Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code 832;86
Contains     
Packaging
# Item Code Package Description
1 NDC:0832-0086-00 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088342 10/21/1983
Labeler - Upsher-Smith Laboratories Inc. (809088862)
Establishment
Name Address ID/FEI Operations
Upsher-Smith Laboratories Inc. 809088862 MANUFACTURE(0832-0086)
Establishment
Name Address ID/FEI Operations
Upsher-Smith Laboratories Inc. 079111820 PACK(0832-0086), LABEL(0832-0086)
Establishment
Name Address ID/FEI Operations
Upsher-Smith Laboratories Inc. 047251004 ANALYSIS(0832-0086)
Revised: 10/2014   Upsher-Smith Laboratories Inc.

Fluoxymesterone Breastfeeding Warnings

A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.

Introduction

Synthetic androgenic anabolic steroid hormone.a b c

Actions

  • Replaces diminished or absent endogenous testicular hormone in hypogonadal males.a b c

  • Endogenous androgens are essential hormones that are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics.a b c

  • Responsible for the growth spurt that occurs during adolescence and for the eventual termination of linear growth that results from the fusion of the epiphyseal growth centers.a b c

  • Produces retention of nitrogen, potassium, sodium, and phosphorus; increases protein anabolism; and decreases amino acid catabolism and urinary calcium concentrations.a b c

  • Approximately 5 times as potent as methyltestosterone; has androgenic activity equal to that of parenterally administered testosterone.a

  • Halogenated derivative of 17-α-methyltestosteronea and, like methyltestosterone, is less extensively metabolized by the liver than testosterone.c

  • Stimulates the production of erythrocytes, apparently by enhancing the production of erythropoietic stimulating factor.a b c

  • Inhibits the release of endogenous testosterone via feedback inhibition of pituitary LH.a b c

  • Large doses of androgens may suppress spermatogenesis.a b c

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Fluoxymesterone is subject to control under the Federal Controlled Substances Act of 1970, as amended by the Anabolic Steroids Control Act of 1990 and 2004, as a schedule III (C-III) drug.a b c

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Fluoxymesterone

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

10 mg*

Androxy (C-III)

Upsher-Smith

Fluoxymesterone Tablets (C-III)

(web3)