AndroGel (generic: testosterone) is a prescription medication used to treat adult men with low testosterone levels. AndroGel works by supplying testosterone that is normally produced in the body.
This medication is a gel that is applied once daily to the upper arms, shoulders, or stomach.
Common side effects of AndroGel include acne and skin irritation where the gel is applied.
AndroGel is a prescription medicine used to treat adult males who have low testosterone levels due to various causes.
This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
AndroGel can cause serious side effects.
- AndroGel may worsen your signs and symptoms of enlarged prostate if you already have enlargement of your prostate gland. This can include:
- increased urination at night and many times during the day
- trouble starting your urine stream
- having an urge that you have to urinate right away
- having a urine accident
- being unable to pass urine or weak urine flow
- AndroGel may increase the risk of prostate cancer. Your doctor will likely check you for prostate cancer or any other prostate problems before you start and while you use AndroGel.
- AndroGel may lower your sperm count especially if you use high doses.
- Ankle, feet, or body swelling, with or without heart failure, has occurred with AndroGel use.
- AndroGel may cause enlarged or painful breasts.
- While receiving AndroGel, you may have problems breathing while you sleep. This is known as sleep apnea.
- Blood clots in the legs may occur with AndroGel use. This can include pain, swelling or redness of your legs.
- If you experience any of the above side effects, call your doctor right away.
The most common side effects of AndroGel include:
- skin irritation where AndroGel is applied
- increased cholesterol levels
- increased prostate specific antigen (a test used to screen for prostate cancer)
- increased red blood cell count
- increased liver function tests
- more erections than normal
- erections that last a long time
This is not a complete list of AndroGel side effects. Ask your doctor or pharmacist for more information.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:
- anticoagulants ("blood thinners") such as warfarin (Coumadin)
This is not a complete list of AndroGel drug interactions. Ask your doctor or pharmacist for more information.
Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using AndroGel.
Signs and symptoms of early puberty in a child may include:
- enlarged penis or clitoris
- early development of pubic hair
- increased erections or sex drive
- aggressive behavior
Women and children should avoid contact with the unwashed or unclothed area where AndroGel has been applied to your skin as it can be transferred through contact.
To lower the risk of transfer of AndroGel from your body to others, you should follow these important instructions:
- Apply AndroGel only to areas that will be covered by a short sleeve T-shirt including shoulders, upper arms and stomach area.
- Wash your hands right away with soap and water after applying AndroGel.
- After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.
- If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
- If a woman or child makes contact with the AndroGel application area, that area on the woman or child should be washed well with soap and water right away.
Do not use AndroGel if you:
- have breast cancer
- have or might have prostate cancer
- are pregnant or may become pregnant or breast-feeding. AndroGel may harm your unborn or breast-feeding baby.
Women who are pregnant or who may become pregnant should avoid contact with the area of skin where AndroGel has been applied.
- are allergic to testosterone or any of the ingredients in AndroGel including soy. See the end of this Medication Guide for a complete list of ingredients in AndroGel.
Talk to your healthcare provider before taking this medicine if you have any of the above conditions.
Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of AndroGel there are no specific foods that you must exclude from your diet when receiving AndroGel.
Before receiving AndroGel, tell your doctor about all of your medical conditions including if you:
- have breast cancer or prostate cancer
- have urinary problems due to an enlarged prostate
- have heart problems
- have liver or kidney problems
- have problems breathing while you sleep (sleep apnea)
- have any other medical conditions
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tell your doctor if you are pregnant or plan to become pregnant. AndroGel may harm your unborn baby. Androgel is not meant for use in women.
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known how much testosterone transfers into human breast milk. AndroGel should not be used in breastfeeding women. It may harm your nursing baby.
- It is important that you apply AndroGel exactly as prescribed by your healthcare provider. Your healthcare provider will tell you how much AndroGel to apply and when to apply it.
- Your healthcare provider may change your AndroGel dose. Do not change your AndroGel dose without talking to your healthcare provider.
- AndroGel is for skin use only.
- Do not allow others to apply AndroGel to your body.
- Applying AndroGel:
- AndroGel comes in a pump or in packets.
- If you are using the AndroGel pump:
- Before using the pump for the first time, you will need to prime the pump. To prime AndroGel, fully push down on the pump 3 times. Do not use any AndroGel that came out while priming. Wash it down the sink or throw it in the trash to avoid accidental exposure to others. Your AndroGel pump is ready to use now.
- Your healthcare provider will tell you the number of times to press the pump for each dose.
- If you are using AndroGel packets:
- Tear open the packet completely at the dotted line.
- Squeeze all of the AndroGel out of the packet into the palm of your hand. Squeeze from the bottom of the packet to the top.
- Throw away the packet in the trash out of the reach of children to avoid accidental exposure.
- Squeeze the medicine into the palm of your hand and apply to clean dry, intact skin at the same time each day.
- You may also apply AndroGel from the pump or packet directly to your skin.
- Apply AndroGel only to areas that will be covered by a short sleeve t-shirt, as shown in the shaded areas in the figure below. These areas are your shoulders and upper arms, or stomach area, or shoulders, upper arm and stomach area.
- Do not apply AndroGel to your penis or scrotum.
- Wash your hands with soap and water right after you apply AndroGel.
- Let the application areas dry for a few minutes before putting on a shirt.
- To prevent transfer of AndroGel to others, clothes (such as a t-shirt) should always be worn to cover the AndroGel application areas until you have washed the application areas well with soap and water.
- Wait 5 hours before showering or swimming. This will ensure that the greatest amount of AndroGel is absorbed into your system.
- AndroGel is flammable until dry. Let the gel dry before smoking or going near an open flame.
Your healthcare provider will test your blood before you start and while you take AndroGel.
Use AndroGel exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.
The recommended starting dose of AndroGel is 5 g once daily (preferably in the morning) to clean, dry, intact skin of the shoulders and upper arms and / or stomach (area of application should be limited to the area that will be covered by a short sleeve t-shirt). AndroGel must not be applied to the genitals.
AndroGel is supplied as either a pump or in individual packets. After applying the gel, the application site should be allowed to dry for a few minutes prior to dressing. Avoid fire, flames or smoking until the gel has dried since alcohol based products, including AndroGel, are flammable. Hands should be washed with soap and water after AndroGel has been applied.
If you take too much AndroGel, call your local Poison Control Center or seek emergency medical attention right away.
AndroGel is supplied in non-aerosol, metered-dose pumps. The pump is composed of plastic and stainless steel and an LDPE/aluminum foil inner liner encased in rigid plastic with a polypropylene cap. Each 88 g AndroGel Pump in the twin package is capable of dispensing 75 g or 60 metered 1.25 g doses.
AndroGel is also supplied in unit-dose aluminum foil packets in cartons of 30. Each packet of 2.5 g or 5 g gel contains 25 mg or 50 mg testosterone, respectively.
Active ingredient: testosterone
Inactive ingredients: carbomer 980, ethyl alcohol 67.0%, isopropyl myristate, purified water and sodium hydroxide.
- Store AndroGel between 59ºF to 86ºF (15ºC to 30ºC).
- Safely throw away used AndroGel in household trash. Be careful to prevent accidental exposure of children or pets.
- Keep AndroGel away from fire.
AndroGel is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your AndroGel in a safe place to protect it. Selling or giving away this medicine may harm others and is against the law.
WARNING: SECONDARY EXPOSURE TO TESTOSTERONE
- Virilization has been reported in children who were secondarily exposed to testosterone gel.
- Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
- Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
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