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STRIANT
Hypogonadism
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Drug Name:

STRIANT CIII

Generic Name and Formulations:
Testosterone 30mg; mucoadhesive buccal tab.

Company:
Endo Pharmaceuticals

Therapeutic Use:

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.

Adult:

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.

Children:

<18yrs: not established.

Contraindications:

Male breast or prostate cancer. Pregnancy (Cat.X). Nursing mothers.

Warnings/Precautions:

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.

Interactions:

May potentiate oral anticoagulants, oxyphenbutazone. May affect insulin requirements. Corticosteroids, ACTH increase risk of edema. May affect thyroid levels.

Pharmacological Class:

Androgen.

Adverse Reactions:

Gum or mouth irritation, bitter taste, gum pain/tenderness/edema, headache, taste perversion; polycythemia, hypertension, increased serum cholesterol or PSA, gynecomastia.

How Supplied:

Buccal tabs (systems)—60

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