"The US Food and Drug Administration (FDA) has approved class-wide labeling changes for all prescription testosterone products, the agency announced today.
New safety information from published literature and case reports on the risks "...
AndroGel 1.62 Consumer
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
TESTOSTERONE GEL PUMP - TRANSDERMAL
COMMON BRAND NAME(S): Androgel
WARNING: Children accidentally exposed to this medication by direct contact with someone using it may absorb this drug through their skin. If this occurs, the child may have unwanted side effects due to testosterone gel. Children should avoid contact with the unwashed or unclothed area where the medication has been applied. Tell both of your doctors immediately if you notice unexpected signs of puberty in a child such as unusual increase in size of genitals (penis or clitoris), early development of pubic hair, increased erections (in boys) or sex drive, or aggressive behavior. To decrease this risk, carefully follow all directions for the proper use of this drug.
USES: This medicated gel contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (e.g., hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels.
Testosterone helps the body to produce sperm and to develop and maintain the male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire.
This drug should not be used by women.
HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using testosterone gel and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
There are many testosterone products available for use on the skin. They may have different amounts of testosterone and may not have the same effects. Read the dosing instructions carefully for each product. Do not change products without asking your doctor or pharmacist.
Learn how to prepare the pump for use. Follow your doctor's instructions on the exact number of pumps for each dose. You may pump this medication into the palm of your hand or directly onto the desired application site. If you are not sure how to use the pump, ask your pharmacist.
Apply the medication as directed to clean, dry skin of the shoulders/upper arms once daily in the morning or as directed by your doctor. Apply only to areas that would be covered if you were to wear a short sleeve t-shirt. Certain products may also be applied to the stomach area (abdomen). Check your product's instructions or ask your pharmacist if your product may be applied to the abdomen. Avoid applying this medication to broken, irritated skin. Do not apply to the genitals (penis or scrotum). Do not let others apply this medication to your body.
Dosage is based on your medical condition and response to treatment.
After applying this medication, wash your hands thoroughly with soap and water to reduce the risk of accidentally spreading it from your hands to other people. Before dressing, wait a few minutes for the application site to dry completely. Be sure to always wear clothing (such as a t-shirt) to cover the application site until you wash the areas well with soap and water.
To get the best effect, wait several hours (2 to 5 hours depending on the product) before showering/swimming to allow the drug to be absorbed through the skin. Check the manufacturer's information or ask your pharmacist for details. See also Warning and Precautions sections.
Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.
This medication is flammable until dry. Let the gel dry before smoking or going near an open flame.
Tell your doctor if your condition does not improve or if it worsens.
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