Monograph Details
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Endocrine System
> Hypogonadism
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ANDROGEL |
| Manufacturer |
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Solvay 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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<18yrs: not recommended. |
| Adults |
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Apply to clean, intact, dry skin of the shoulders, upper arms, and/or abdomen; do not apply to scrotum. ≥18yrs: 5g (delivers 5mg testosterone systemically) once daily in the AM; check serum testosterone level after 2 weeks; may increase to 7.5g/day, then to 10g/day. Wash hands after application. Allow gel to dry before it touches clothing. |
| Contraindications |
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Male breast or prostate cancer. Not for use in women. Pregnant women must avoid skin contact with application sites in 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 1 hour (preferably 5–6 hours) after application. Evaluate for prostate cancer before starting therapy. Cardiac, renal, or hepatic disease (discontinue if edema occurs). May worsen sleep apnea. Monitor hemoglobin, hematocrit, liver function, PSA, cholesterol, lipid profile, serum testosterone levels. Elderly. |
| Interactions |
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Monitor antidiabetic drugs. Increases propranolol clearance. ACTH, corticosteroids may increase edema. |
| Adverse Reactions |
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Local reactions, lab abnormalities, acne, prostate disorders, emotional lability, hypertension, breast pain, gynecomastia, nervousness, testis disorders, edema. |
| How Supplied |
Gel (2.5g, 5g)—30 packets
Pump 75g (60 metered 1.25g doses)—1, 2 |
| Additional Resources |
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• Related Prescribing Note |
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