ANDRODERM- testosterone patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Actavis Pharma, Inc.

INN (International Name):

TESTOSTERONE

Composition:

TESTOSTERONE 2 mg in 1 d

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ANDRODERM 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 conditions such as cryptorchidism,  bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter Syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (FSH, 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 men have low testosterone serum concentrations but have gonadotropins in the normal or low range. Limitations of use - Safety and efficacy of ANDRODERM in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. - Safety and efficacy of ANDRO

Product summary:

ANDRODERM (testosterone transdermal system) 2 mg/day. Each system contains 9.7 mg testosterone USP for delivery of 2 mg of testosterone per day [see  Description (11) ]. Cartons of 60 systems NDC 52544-076-60 ANDRODERM (testosterone transdermal system) 4 mg/day. Each system contains 19.5 mg testosterone USP for delivery of 4 mg of testosterone per day [see  Description (11) ]. Cartons of 30 systems NDC 52544-077-30 Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Apply to skin immediately upon removal from the protective pouch. Do not store outside the pouch provided. Damaged systems should not be used. The drug reservoir may be burst by excessive pressure or heat. Discard systems in household trash in a manner that prevents accidental application or ingestion by children, pets or others.

Authorization status:

New Drug Application

Summary of Product characteristics

ANDRODERM- TESTOSTERONE PATCH
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ANDRODERM SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ANDRODERM.
ANDRODERM (TESTOSTERONE TRANSDERMAL SYSTEM), FOR TOPICAL USE CIII
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Warnings and Precautions (5.5) 10/2016
INDICATIONS AND USAGE
ANDRODERM is an androgen indicated for replacement therapy in males
for conditions associated with a deficiency or
absence of endogenous testosterone (1):
Primary hypogonadism (congenital or acquired)
Hypogonadotropic hypogonadism (congenital or acquired)
Limitations of use:
Safety and efficacy of ANDRODERM in men with “age-related
hypogonadism” have not been established. (1)
Safety and efficacy of ANDRODERM in males less than 18 years old have
not been established. (1, 8.4)
DOSAGE AND ADMINISTRATION
Prior to initiating ANDRODERM 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 (2.1).
The recommended starting dose is one ANDRODERM 4 mg/day system (not
two 2 mg/day systems) applied nightly for
24 hours, delivering approximately 4 mg of testosterone per day. (2.1)
To ensure proper dosing, approximately 2 weeks after starting therapy,
the early morning serum testosterone
concentration should be measured following system application in the
previous evening. (2.1, 12.3)
Serum testosterone concentrations measured in the early morning
outside the range of 400 - 930 ng/dL require increasing
the daily dose to 6 mg (i.e., one 4 mg/day and one 2 mg/day system) or
decreasing the daily dose to 2 mg (i.e., one 2
mg/day system), maintaining nightly application. (2.1)
Patients currently maintained on ANDRODERM 2.5 mg/day systems applied
once daily may be switched to ANDRODERM
2 mg/day systems applied once daily in the evening at the next
scheduled dose. (2.1)
Patient