Monograph Details
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Endocrine System
> Hypogonadism
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STRIANT |
| Manufacturer |
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Columbia Laboratories |
| Legal Classification |
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CIII |
| Pharmacological Class |
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Androgen. |
| Generic Name |
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Testosterone 30mg; mucoadhesive buccal tab. |
| Indications |
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Testosterone replacement therapy. |
| Children |
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<18yrs: not recommended. |
| Adults |
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Do not chew or swallow tab. ≥18yrs: 30mg applied to the gum (above incisors) every 12 hours (AM & PM); hold in place for 30 seconds; rotate application sites. |
| Contraindications |
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Breast or prostate cancer. Not for use in women. Pregnancy (Cat.X). Nursing mothers. |
| Precautions |
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Inspect gum region regularly. Cardiac, renal, or hepatic disease. Sleep apnea. Monitor hemoglobin, hematocrit, liver function, PSA, cholesterol, HDL-C, serum testosterone. Elderly (increased risk of prostatic hyperplasia). May increase growth of subclinical prostatic carcinoma. Discontinue if edema, CHF, or jaundice occurs. |
| Interactions |
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May potentiate oral anticoagulants, oxyphenbutazone. May affect insulin requirements. Corticosteroids, ACTH increase risk of edema. |
| Adverse Reactions |
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Local irritation, taste perversion, dry mouth, toothache, edema, peliosis hepatis, prostatic hypertrophy, GI upset, jaundice, hirsutism, acne, polycythemia, headache, anxiety, depression, hypertension, increased serum cholesterol or PSA, gynecomastia. |
| How Supplied |
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Buccal tabs (systems)—60 |
| Additional Resources |
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• Related Prescribing Note |
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