STRIANT- testosterone tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O)

Available from:

Endo Pharmaceuticals Inc.

INN (International Name):

TESTOSTERONE

Composition:

TESTOSTERONE 30 mg

Administration route:

BUCCAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Striant is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: - Primary hypogonadism (congenital or acquired) – testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. - Hypogonadotropic hypogonadism (congenital or acquired) – Gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary hypothalamic injury from tumors, trauma, or radiation. These patients have low serum testosterone levels but have gonadotropins in the normal or low range. Limitations of use: - Safety and efficacy of Striant in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. - Safety a

Product summary:

Striant (testosterone buccal system) mucoadhesive is supplied in transparent blister packs containing 10 doses. It is white to off-white colored with a flat edge on one side and a convex surface on the other. Striant is debossed on its flat side, as shown below: Each Striant buccal system contains 30 mg of testosterone and is supplied as follows: Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from heat and moisture. Damaged blister packages should not be used. Discard used Striant buccal systems in household trash in a manner that prevents accidental application or ingestion by children or pets.

Authorization status:

New Drug Application

Summary of Product characteristics

STRIANT- TESTOSTERONE TABLET
ENDO PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
STRIANT SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR STRIANT.
STRIANT (TESTOSTERONE BUCCAL SYSTEM) MUCOADHESIVE FOR BUCCAL
ADMINISTRATION, CIII
INITIAL U.S. APPROVAL: 1953
RECENT MAJOR CHANGES
Warnings and Precautions (5.6) 10/2016
INDICATIONS AND USAGE
Striant (testosterone buccal system) mucoadhesive is an androgen
indicated for replacement therapy in adult males for
conditions associated with a deficiency or absence of endogenous
testosterone:
Primary hypogonadism (congenital or acquired). (1)
Hypogonadotropic hypogonadism (congenital or acquired). (1)
Limitations of use:
Safety and efficacy of Striant in men with “age-related
hypogonadism” have not been established (1).
Safety and efficacy of Striant in males less than 18 years old have
not been established. (1, 8.4)
DOSAGE AND ADMINISTRATION
Prior to initiating Striant, confirm the diagnosis of hypogonadism by
ensuring that serum testosterone has been
measured in the morning on at least two separate days and that these
concentrations are below the normal range (2).
Apply one buccal system (30 mg) to the gum region twice daily; morning
and evening (about 12 hours apart). (2.1, 2.2)
Place Striant in a comfortable position just above the incisor tooth
(on either side of the mouth). (2.2)
With each application, rotate Striant to alternate sides of the mouth.
(2.2)
Measure morning, pre-dose serum testosterone concentration at 4 to 12
weeks after initiating therapy and periodically
thereafter. (2.1)
Discontinue Striant if serum testosterone concentrations are
consistently outside of the normal range.
DOSAGE FORMS AND STRENGTHS
30 mg per buccal system (3)
CONTRAINDICATIONS
Men with carcinoma of the breast or known or suspected prostate
cancer. (4, 5.2)
Pregnant or breastfeeding women. Testosterone may cause fetal harm.
(4, 8.1, 8.3)
WARNINGS AND PRECAUTIONS
Gum-related adverse