Monograph Details
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Endocrine System
> Hypogonadism
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TESTIM |
| Manufacturer |
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Auxilium Pharmaceuticals, Inc. |
| Legal Classification |
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CIII |
| Pharmacological Class |
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Androgen. |
| Generic Name |
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Testosterone 1%; gel. |
| Indications |
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Testosterone replacement therapy. |
| Children |
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<18 years: not recommended. |
| Adults |
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Apply to clean, dry intact skin of the shoulders and/or upper arms; do not apply to genitals or abdomen. ≥18 years: initially apply 5g (1 tube) once daily in the AM; may increase to 10g after 2 weeks. Do not wash site for at least 2 hours after application. |
| Contraindications |
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Breast or prostate cancer. Not for use in women. Pregnant and nursing women must avoid skin contact with application sites on men. Pregnancy (Cat.X). Nursing mothers. |
| Precautions |
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Other persons must avoid contact with application site. Avoid showering or swimming for at least 2 hours after application. Cardiac, renal, or hepatic disease. Sleep apnea. Monitor hemoglobin, hematocrit, liver function, PSA, cholesterol, HDL-C, and serum testosterone. Elderly (may increase risk of prostatic hyperplasia). May increase growth of subclinical prostatic carcinoma. Discontinue if edema or jaundice occurs. |
| Interactions |
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May potentiate oral anticoagulants, oxyphenbutazone. May alter insulin effects. Increased risk of edema with corticosteroids or ACTH. |
| Adverse Reactions |
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Local reactions, headache, increased hemoglobin/hematocrit or BP, depression, hot flushes, insomnia, mood swings, gynecomastia, dysgeusia. |
| How Supplied |
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Gel (5g)—30 |
| Additional Resources |
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• Related Prescribing Note |
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