Generic Name: testosterone topical (patches and gel) (tes TOS ter one TOP i kal)Brand Names: Androderm, AndroGel 2.5 g/packet, AndroGel 5 g/packet, AndroGel Pump 1.25 g/actuation, FIRST-Testosterone, FIRST-Testosterone MC, Testim
Testosterone is a naturally occurring male hormone necessary for many processes in the body.
Testosterone topical is used to treat conditions in men that result from a lack of natural testosterone.
Testosterone topical may also be used for other purposes not listed in this medication guide.
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using testosterone topical, tell your doctor if you have:
sleep apnea or chronic breathing problems;
if you are overweight.
Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Apply the testosterone topical (transdermal) patch to a flat, clean, dry, and undamaged area of skin on your back, stomach, upper arm, or thigh. Wear the patch for 24 hours and then replace it with a new patch. Apply your patch at the same time each evening.
Choose a different skin area to wear each new patch you put on. You should not use the same skin area twice in a 7-day period.
After removing a patch, fold it closed with the sticky side in, and throw it away in a place where pets and children cannot reach it.
Apply the testosterone gel at the same time each day (preferably in the morning) to clean, dry, unbroken skin on the shoulders or upper arms. Open the gel pouch, and squeeze the entire contents onto the palm of your hand. Apply the gel right away and allow it to dry for at least 5 minutes before you dress. Wash your hands with soap and water after applying the gel.Do not apply testosterone gel to your penis or your scrotum. The Testim brand of testosterone gel should also not be applied to your stomach area.
It is best to cover treated skin areas with clothing while using testosterone gel. This will help prevent getting this medicine on other people. If someone else does come into contact with a treated skin area, they must wash the contact area right away with soap and water.
To be sure this medication is helping your condition, your blood will need to be tested on a regular basis. Your prostate or liver function may also need to be tested. Do not miss any scheduled visits to your doctor.
It is important to use testosterone topical regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.Store this medication at room temperature away from moisture and heat. Keep each skin patch in the foil pouch until you are ready to use it. Do not use a skin patch that has been cut or damaged.
Apply the gel or skin patch as soon as you remember. If it is almost time to apply your next dose, skip the missed dose and apply the medicine at your next regularly scheduled time. Do not use extra patches or gel to make up the missed dose.
If a transdermal patch falls off in the morning, reapply it. If it does not stick well, apply a new patch. If the patch falls off in the afternoon and cannot be reapplied, wait until your regular patch replacement time in the evening before putting on a new patch.
Avoid swimming, bathing, or showering for at least 5 hours after applying AndroGel testosterone gel, or 2 hours after applying Testim testosterone gel.
Avoid using lotions, oils, or other skin products on the area where you will apply the skin patch. The patch may not stick properly to the skin.
If your doctor recommends a topical steroid medicine such as hydrocortisone to treat skin irritation caused by wearing a testosterone skin patch, avoid using an ointment form of the steroid.Testosterone gel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.
burn-like blistering of the skin where the transdermal patch is worn;
skin irritation with patch-wearing that does not get better with time;
problems with urination;
swelling of your ankles;
frequent, prolonged, or bothersome erections; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
redness, itching, burning, or hardened skin where the skin patch is worn;
breast swelling or tenderness;
increased acne or hair growth;
headache, depressed mood; or
changes in your sex drive.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Hypogonadism -- Male:
Parenteral: Short-acting (testosterone solution and propionate): 25 mg to 50 mg IM 2 to 3 times a week.Long-acting (enanthate and cypionate): 50 to 400 mg IM every 2 to 4 weeks.Subcutaneous implant: 2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 months.Topical film:Transdermal Film: 2.5 to 5 mg applied to the back, abdomen, upper arm, or upper thigh once a day, preferably at night. Gel (in tubes, packets or spray): 5 grams applied once daily, preferably in the morning. May increase as needed to a maximum of 10 grams once a day.Buccal: 30 mg patch to the gum region twice daily; morning and evening (about 12 hours apart). Patch should be placed just above the incisor tooth. With each application, the patch should be rotated to alternate sided of the mouth.
Usual Adult Dose for Breast Cancer--Palliative:
Parenteral: Short-acting (testosterone solution and propionate): 50 mg to 100 mg IM 2 to 3 times a week.Long-acting (enanthate and cypionate): 200 to 400 mg IM every 2 to 4 weeks.Subcutaneous implant: 2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 monthsTestosterone is approved by the FDA for the palliation of androgen-responsive metastatic breast cancer in women who are 1 to 5 years postmenopausal or who are proven to have a hormone-dependent tumor noted by previous beneficial response to castration.Female patients should be observed for signs of virilization. Women should be instructed to report any hoarseness, acne, changes in menstrual periods, or increases in facial hair. Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. A decision may be made by the patient and the physician that some virilization will be tolerated during the treatment for malignant disease.
Usual Adult Dose for Postpartum Breast Pain:
Parenteral: Short-acting (testosterone solution and propionate): 25 mg to 50 mg IM for 3 to 4 days, starting at the time of delivery.
Usual Pediatric Dose for Delayed Puberty -- Male:
Parenteral:Initiation of pubertal growth: Long-acting (enanthate and cypionate): 40 to 50 mg/square meter IM monthly until the growth rate falls to prepubertal levels.Terminal growth phase: Long-acting (enanthate and cypionate): 100 mg/square meter IM monthly until the growth ceases.Maintenance virilizing dose: Long-acting (enanthate and cypionate): 100 mg/square meter intramuscular twice monthly.Subcutaneous implant: 2 to 6 pellets (75 mg each) implanted subcutaneously every 3 to 6 months.Dosages used to treat delayed puberty are generally started at the lower end of the dosing range and titrated according to patient response and tolerance. The duration of therapy should be limited to 4 to 6 months. Serum concentrations of testosterone should be determined following 3 to 4 weeks of daily use. If desired results have not been achieved at 6 to 8 weeks an alternative testosterone regimen should be considered.Wrist and hand bone age should be assessed prior to initiation of testosterone therapy and every 6 months to monitor bone maturation. Exogenous androgen therapy can accelerate bone maturation without producing a compensatory gain in linear growth. Use over long periods can result in fusion of the epiphyseal growth centers and termination of the growth process.
Before using testosterone topical, tell your doctor if you are using any of the following drugs:
a blood thinner (warfarin, Coumadin);
oxyphenbutazone (Tandearil); or
a corticosteroid such as methylprednisolone (Depo-Medrol, Medrol, Solu-Medrol), prednisone (Deltasone, Orasone, others), and others.
This list is not complete and there may be other drugs that can interact with testosterone topical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.