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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
What is testosterone topical?
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.
What is the most important information I should know about testosterone topical?This medication should not be used by a woman. Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with testosterone topical gel, or with a man's skin areas where a testosterone topical patch has been worn or the gel has been applied. If contact does occur, wash with soap and water right away. Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with the medication. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics. The testosterone transdermal patch may burn your skin if you wear the patch during an MRI (magnetic resonance imaging). Remove the patch before undergoing such a test.
What should I discuss with my healthcare provider before using testosterone topical?Do not use this medication if you are allergic to testosterone patches or gels, or if you have prostate cancer or male breast cancer.
If you have any of these other conditions, you may need a testosterone dose adjustment or special tests:
sleep apnea or chronic breathing problems;
- liver disease or kidney disease; or
if you are overweight.
How should I use testosterone topical?
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions 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 medicine is helping your condition, your blood will need to be tested often. Your prostate or liver function may also need to be tested. Visit your doctor regularly.
Use testosterone topical regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.Store 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.
What happens if I miss a dose?
Apply the gel or skin patch as soon as you remember. Skip the missed dose if it is almost time to apply your next dose. 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.
What happens if I overdose?Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using testosterone topical?Do not apply AndroGel or Testim testosterone gel to your penis or your scrotum. Testim testosterone gel should also not be applied to your stomach area.
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.
Testosterone topical side effectsGet emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using testosterone topical and call your doctor at once if you have any of these serious side effects:
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.
Testosterone topical Dosing Information
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.
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.
Testosterone 30 mg/1.5 mL transdermal solution:
Starting dose is 60 mg of testosterone (1 pump actuation of 30 mg of testosterone to each axilla), applied once daily, at the same time each morning. The dose of testosterone may be decreased from 60 mg (2 pump actuations) to 30 mg (1 pump actuation) or increased from 60 mg to 90 mg (3 pump actuations) or from 90 mg to 120 mg (4 pump actuations) based on the serum testosterone concentration from a single blood draw 2 to 8 hours after applying the solution and at least 14 days after starting treatment or following dose adjustment.
Testosterone 10 mg/0.5 g transdermal gel:
Starting dose is 40 mg of testosterone (4 pump actuations of 30 mg to clean, dry intact skin of the front and inner thighs), applied once daily, at the same time each morning. Let application site dry before putting on pants or shorts. The dose can be adjusted between a minimum of 10 mg of testosterone (1 pump actuation) and a maximum of 70 mg of testosterone (7 pump actuations) on the basis of total serum testosterone concentrations 2 hours post application. The dose should be titrated based on the serum testosterone concentration from a single blood draw 2 hours after applying and at approximately 14 days and 35 days after starting treatment or following dose adjustment. In addition, serum testosterone concentration should be assessed periodically thereafter.
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 months
Testosterone 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:
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.
What other drugs will affect testosterone topical?
Tell your doctor about all other medicines you use, especially:
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 other drugs may interact with testosterone topical. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.Copyright 1996-2006 Cerner Multum, Inc. Version: 8.03. Revision Date: 12/15/2010 5:01:39 PM.
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