Generic Name and Formulations:
Testosterone 30mg; mucoadhesive buccal tab.
Indications for STRIANT:
Testosterone replacement therapy in adult males with congenital or acquired primary hypogonadism or hypogonadotropic hypogonadism.
Limitations Of use:
Not established in men with age-related hypogonadism.
Prior to treatment, confirm diagnosis by ensuring serum testosterone is below normal range as measured in the AM on at least 2 separate days. 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.
<18yrs: not established.
Male breast or prostate cancer. Pregnancy (Cat.X). Nursing mothers.
Not for use in women. Inspect gum region regularly. Increased risk of worsening BPH; monitor. Evaluate for prostate cancer prior to and during treatment. Monitor hematocrit prior to initiation, at 3–6 months after starting therapy, then annually; if elevation occurs, withhold until acceptable level. Preexisting cardiac, renal or hepatic disease (discontinue if edema occurs). Discontinue and evaluate if signs/symptoms of hepatic dysfunction (eg, jaundice) occur. Possible sleep apnea in patients with obesity or chronic lung diseases. Testosterone and/or other anabolic androgenic steroid abuse. Monitor serum testosterone, PSA, liver function, cholesterol, lipid profile, serum calcium (in cancer patients at risk for hypercalcemia/hypercalciuria) periodically. Monitor for venous thromboembolism; discontinue if suspected. Inform patients of possible increased risk of MI, stroke. Elderly.
May potentiate oral anticoagulants, oxyphenbutazone. May affect insulin requirements. Corticosteroids, ACTH increase risk of edema. May affect thyroid levels.
Gum or mouth irritation, bitter taste, gum pain/tenderness/edema, headache, taste perversion; polycythemia, hypertension, increased serum cholesterol or PSA, gynecomastia.
Buccal tabs (systems)—60
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