TESTOSTERONE- testosterone gel
Lupin Pharmaceuticals, Inc.
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Testosterone Gel 1.62%, for topical use, CIII
(tes TOS ter one)
What is the most important information I should know about testosterone gel 1.62%?
1.Testosterone gel 1.62% can transfer from your body to others including, children and women. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where testosterone gel 1.62% has been applied to your skin. Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used testosterone gel 1.62%.
Children
Signs and symptoms of early puberty in a child when they come in direct contact with testosterone gel 1.62% may include:
Abnormal sexual changes:
Signs and symptoms in women when they come in direct contact with testosterone gel 1.62% may include:
Stop using testosterone gel 1.62% and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have happened through accidental touching of the area where you have applied testosterone gel 1.62%.
2.To lower the risk of transfer of testosterone gel 1.62% from your body to others, follow these important instructions:
What is testosterone gel 1.62%?
Testosterone gel 1.62% is a prescription medicine that contains testosterone. Testosterone gel 1.62% is used to treat adult males who have low or no testosterone due to certain medical conditions.
Testosterone gel 1.62% is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your testosterone gel 1.62% in a safe place to protect it. Never give your testosterone gel 1.62% to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.
Testosterone gel 1.62% is not meant for use in women.
Do not use testosterone gel 1.62% if you:
Before using testosterone gel 1.62%, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using testosterone gel 1.62% with certain other medicines can affect each other.
Especially, tell your healthcare provider if you take:
How should I use testosterone gel 1.62%?
What are the possible side effects of testosterone gel 1.62%?
Testosterone gel 1.62% can cause serious side effects including:
See "What is the most important information I should know about testosterone gel 1.62%?"
Call your healthcare provider right away if you have any of the serious side effects listed above.
The most common side effects of testosterone gel 1.62% include:
Other side effects include more erections than are normal for you or erections that last a long time.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of testosterone gel 1.62%. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of testosterone gel 1.62%
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use testosterone gel 1.62% for a condition for which it was not prescribed. Do not give testosterone gel 1.62% to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about testosterone gel 1.62% that is written for health professionals.
What are the ingredients in testosterone gel 1.62%?
Active ingredient: testosterone USP
Inactive ingredients: carbomer homopolymer type C, dehydrated alcohol (68.1%w/w), isopropyl myristate, sodium hydroxide and purified water.
For more information, call 1-800-399-2561.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
INSTRUCTIONS FOR USE
Testosterone Gel 1.62%, for topical use, CIII
(tes TOS ter one)
Read this Instructions for Use for testosterone gel 1.62% before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment.
Applying testosterone gel 1.62%:
If you are using testosterone gel 1.62% pump:
Find Your Dose as Prescribed by Your Healthcare Provider
| Application Method
|
|
1 pump | 20.25 mg | Apply 1 pump of testosterone gel 1.62% to 1 upper arm and shoulder. |
2 pumps | 40.5 mg | Apply 1 pump of testosterone gel 1.62% to 1 upper arm and shoulder and then apply 1 pump of testosterone gel 1.62% to the opposite upper arm and shoulder. |
3 pumps | 60.75 mg | Apply 2 pumps of testosterone gel 1.62% to 1 upper arm and shoulder and then apply 1 pump of testosterone gel 1.62% to the opposite upper arm and shoulder. |
4 pumps | 81 mg | Apply 2 pumps of testosterone gel 1.62% to 1 upper arm and shoulder and then apply 2 pumps of testosterone gel 1.62% to the opposite upper arm and shoulder. |
How should I store testosterone gel 1.62%?
Keep testosterone gel 1.62% and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured for:
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
United States
Manufactured by:
Lupin Limited
Pithampur (M.P.) – 454 775
India
August 2019 ID#: 261052