Striant

— THERAPEUTIC CATEGORIES —
  • Hypogonadism

Striant Generic Name & Formulations

General Description

Testosterone 30mg; mucoadhesive buccal tab.

Pharmacological Class

Androgen.

How Supplied

Buccal tabs (systems)—60

Manufacturer

Striant Indications

Indications

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.

Striant Dosage and Administration

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.

Striant Contraindications

Contraindications

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

Striant Boxed Warnings

Not Applicable

Striant Warnings/Precautions

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.

Striant Pharmacokinetics

See Literature

Striant Interactions

Interactions

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

Striant Adverse Reactions

Adverse Reactions

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

Striant Clinical Trials

See Literature

Striant Note

Not Applicable

Striant Patient Counseling

See Literature