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Testoderm

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Testoderm

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Testoderm

INDICATIONS

The TESTODERM (testosterone (transdermal)) ® products are indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone:

1. Primary hypogonadism (congenital or acquired) testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchidectomy, Klinefelters syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range.

2. Hypogonadotropic hypogonadism (congenital or acquired) -- idiopathic gonadotropin or LHRH deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range.

The TESTODERM (testosterone (transdermal)) products have not been evaluated clinically in males under 18 years of age.

DOSAGE AND ADMINISTRATION

TESTODERM (testosterone (transdermal)) TTS
One system is applied at about the same time each day. The adhesive side of the TESTODERM (testosterone (transdermal)) TTS system should be placed on a clean, dry area of skin on the arm, back or upper buttocks immediately upon removal from the protective pouch. DO NOT APPLY TO THE SCROTUM. The area selected should not be oily, damaged, or irritated. The system should be pressed firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact, especially around the edges. In the event that a system should fall off, the same system may be reapplied. If the system comes off after it has been worn for more than 12 hours and it cannot be reapplied, a new system may be applied at the next routine application time. In either case, the daily treatment schedule should be continued. The TESTODERM (testosterone (transdermal)) TTS system should be worn approximately 24 hours and then replaced. To ensure proper dosing, serum testosterone concentration may be measured 2-4 hours after an application of TESTODERM (testosterone (transdermal)) TTS. If the serum testosterone concentrations are low, the dosing regimen may be increased to 2 systems. Because of variability in analytical values among diagnostic laboratories, all testosterone measurements should be performed at the same laboratory.

TESTODERM (testosterone (transdermal)) and TESTODERM (testosterone (transdermal)) WITH ADHESIVE
Patients should start therapy with a 6 mg/d system of either TESTODERM (testosterone (transdermal)) or TESTODERM (testosterone (transdermal)) WITH ADHESIVE applied daily; if the scrotal area cannot accommodate a 6 mg/d system, a 4 mg/d TESTODERM (testosterone (transdermal)) system should be used. One TESTODERM (testosterone (transdermal)) or TESTODERM (testosterone (transdermal)) WITH ADHESIVE system should be placed on clean, dry, scrotal skin. Scrotal hair should be dry-shaved for optimal skin contact. Chemical depilatories should not be used (see Patient Information). TESTODERM (testosterone (transdermal)) or TESTODERM (testosterone (transdermal)) WITH ADHESIVE should be worn 22-24 hours.

After 3-4 weeks of daily system use, blood should be drawn 2-4 hours after system application for determination of serum total testosterone. Because of variability in analytical values among diagnostic laboratories, this laboratory work and later analyses for assessing the effect of the TESTODERM (testosterone (transdermal)) and TESTODERM (testosterone (transdermal)) WITH ADHESIVE therapy should be performed at the same laboratory.

If patients have not achieved desired results by the end of 6-8 weeks of treatment with any of the TESTODERM (testosterone (transdermal)) products, another form of testosterone replacement therapy should be considered.

HOW SUPPLIED

TESTODERM (testosterone (transdermal)) TTS, TESTODERM (testosterone (transdermal)) , and TESTODERM (testosterone (transdermal)) WITH ADHESIVE testosterone transdermal systems contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.

TESTODERM (testosterone (transdermal)) TTS
TESTODERM (testosterone (transdermal)) TTS systems are supplied as individually pouched systems, 30 per carton. TESTODERM (testosterone (transdermal)) TTS 5 mg/d (Testosterone Transdermal System) -- each 60 cm2 system contains 328 mg testosterone USP for nominal dose of 5 mg/day

Carton of 30 TESTODERM (testosterone (transdermal)) TTS 5 mg/d systemsNDC 17314-4717-3

TESTODERM (testosterone (transdermal)) and TESTODERM (testosterone (transdermal)) WITH ADHESIVE
TESTODERM (testosterone (transdermal)) and TESTODERM (testosterone (transdermal)) WITH ADHESIVE systems are supplied as individually pouched systems, 30 per carton.

TESTODERM (testosterone (transdermal)) 4 mg/d (Testosterone Transdermal System) -- each 40 cm2 system contains 10 mg testosterone USP for nominal delivery of 4 mg for one day.

Carton of 30 TESTODERM (testosterone (transdermal)) 4 mg/d systems.NDC 17314-4608-3

TESTODERM (testosterone (transdermal)) and TESTODERM (testosterone (transdermal)) WITH ADHESIVE
6 mg/d (Testosterone Transdermal System) -- each 60 cm2 system contains 15 mg testosterone USP for nominal delivery of 6 mg for one day.

Carton of 30 TESTODERM (testosterone (transdermal)) 6 mg/d systems.NDC 17314-4609-3

Carton of 30 TESTODERM (testosterone (transdermal)) WITH ADHESIVE 6 mg/d systemsNDC 17314-2836-3

Storage

TESTODERM (testosterone (transdermal)) TTS
Store at controlled room temperature below 25oC (77oF).
TESTODERM (testosterone (transdermal)) and TESTODERM (testosterone (transdermal)) WITH ADHESIVE
Store at room temperature 15-30oC (59-86oF).

Disposal
TESTODERM (testosterone (transdermal)) products should be discarded in household trash in a manner that prevents accidental application or ingestion by children or pets.

Caution: Federal law prohibits dispensing without prescription.

REFERENCE

1. Matsumoto AM, Sandblom RE, Schoene RB et al. Testosterone replacement in hypogonadal men: Effects on obstructive sleep apnoea, respiratory drives, and sleep. Clin Endocrinol (1985) 22: 713-721.

2. Schneider BK, Pickett CK, Zwillich CW et al. Influence of testosterone on breathing during sleep. J Appl Physiol (1986) 61: 618-623.

3. Matsumoto AM. Hormonal therapy of male hypogonadism. Endocrinol Metab Clin North Am. (1994) 23: 857-875.

4. Bardin CW, Swerdloff RS, Santen RJ. Androgens: Risks and benefits. J Clin Endocinol Metab (1991) 73: 4-7.

5. Nieschlag E, Wang CCL. Guidelines for the use of androgens in men. Geneva: World Health Organization (1992); 1-16.

6. Walle T, Walle UK, Mathur RS et al. Propranolol metabolism in normal subjects: Association with sex steroid hormones. Curr Pharmacol Ther (1994) 56:127-132.

7. Physicians Generic Rx: The Complete Drug Reference. (1996); II-1972

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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