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AndroGel (testosterone gel) 1%.


CONTRAINDICATIONS

AndroGel should not be used in any of the following patients:

* Men with carcinoma of the breast or known or suspected carcinoma of the prostate ...

* Women who are or may become pregnant, or who are breastfeeding. AndroGel can cause fetal harm when administered to a pregnant woman. Androgel may cause serious adverse reactions in nursing infants. Exposure of a female fetus or nursing infant to androgens may result in varying degrees of virilization virilization /vir·il·iza·tion/ (vir?i-li-za´shun) masculinization; usually used for that occurring in a female or prepubertal male.

vir·il·i·za·tion
n.
. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated with AndroGel ...

* Men with known hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen.  to any of its ingredients, including alcohol and soy products.

WARNINGS AND PRECAUTIONS

Worsening of BPH BPH
abbr.
benign prostatic hyperplasia


BPH
Benign prostatic hypertrophy, a very common noncancerous cause of prostatic enlargement in older men.
 and Potential Risk of Prostate Cancer

Potential for Testosterone Transfer to Others

Use in Women

Potential for Adverse Effects on Spermatogenesis

Hepatic Adverse Effects

Gynecomastia gynecomastia

Breast enlargement in a male. It usually involves only the nipple and nearby tissue of one breast. More rarely, the whole breast grows to a size normal in a female. True gynecomastia is related to an increase in estrogens.
 

Sleep Apnea

Laboratory Tests

Flammable until Dry

ADVERSE REACTIONS

Clinical Trial Experience

Clinical Trials in Hypogonadal Men

Postmarketing Experience

DRUG INTERACTIONS

Corticosteroids Corticosteroids Definition

Corticosteroids are group of natural and synthetic analogues of the hormones secreted by the hypothalamic-anterior pituitary-adrenocortical (HPA) axis, more commonly referred to as the pituitary gland.
 

Oral Anticoagulants Anticoagulants
Drugs that suppress, delay, or prevent blood clots. Anticoagulants are used to treat embolisms.

Mentioned in: Embolism, Heart Valve Replacement
 

USE IN SPECIFIC POPULATIONS

Pregnancy

Nursing Mothers

Geriatric Use

Renal or Hepatic Impairment

PATIENT COUNSELING INFORMATION

Potential Adverse Reactions with Androgens

Instructions for Use of AndroGel

PATIENT PACKAGE INSERT

What Disease or Condition Does AndroGel Treat?

How to use the AndroGel Pump?

The Major Risks of AndroGel include ...
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Article Details
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Title Annotation:Contraindications and warnings
Publication:Adverse Event Reporting News
Article Type:Brief article
Geographic Code:1USA
Date:May 6, 2008
Words:215
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