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TESTODERM (testosterone transdermal) ®TTS, TESTODERM (testosterone transdermal) ® and TESTODERM (testosterone transdermal) ® WITH ADHESVIE Testosterone Transdermal Systems (referred to collectively as the TESTODERM (testosterone transdermal) ® products) are designed to release controlled amounts of testosterone, the primary circulating endogenous androgen, continuously upon application to the arm, back or upper buttocks (TESTODERM (testosterone transdermal) ®TTS) or scrotal skin (TESTODERM (testosterone transdermal) ® and TESTODERM (testosterone transdermal) ® WITH ADHESVIE). The TESTODERM (testosterone transdermal) ® products are described below.
| Product |
Dose |
Size |
Application Site |
|
Testoderm (testosterone transdermal) ® TTS |
5 |
60 |
Arm, Back, Upper Buttocks |
| Testoderm®* |
5 |
60 |
Scrotum |
| Testoderm®* |
4 |
40 |
Scrotum |
|
Testoderm (testosterone transdermal) ® with |
6 |
60 |
Scrotum |
* The composition of the two sizes per unit area is identical.
The active component of each of the systems is testosterone. Testosterone USP is a white or creamy-white crystalline powder or crystals chemically described as 17-beta hydroxyandrost-4-en-3-one. The remaining components of the systems are pharmacologically inactive.
TESTODERM (testosterone transdermal) ® TTS is composed of the following layers: a flexible backing of polyester/ethylene-vinyl acetate copolymer film, a drug reservoir of testosterone USP and 1.2 mL alcohol USP gelled with hydroxypropyl cellulose, and an ethylene-vinyl acetate copolymer membrane coated with a layer of a polyisobutylene adhesive formulation that controls the rate of release of testosterone from the system. A protective liner of silicone-coated polyester covers the adhesive surface. The liner must be removed before application.
TESTODERM (testosterone transdermal) ® is composed of two layers: a soft flexible backing of polyester and a testosterone-containing film of ethylene-vinyl acetate copolymer that contacts the skin surface and modulates the availability of the steroid. A protective liner of fluorocarbon diacrylate or silicone-coated polyester covers the drug film. The liner must be removed before application.
TESTODERM (testosterone transdermal) ® WITH ADHESVIE is composed of three layers: a soft flexible backing of polyester and a testosterone-containing film of ethylene-vinyl acetate copolymer. The surface of the drug film is partially covered by the third layer: thin and narrow adhesive stripes composed of polyisobutylene and colloidal silicon dioxide. A protective liner of fluorocarbon diacrylate covers the adhesive stripes and the adhesive-free area of the drug film. The liner must be removed before application.
The active component of the systems is testosterone. The remaining components of the systems are pharmacologically inactive.
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.
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.
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
Adverse events are reported in this section by product. Adverse events reported during use of a given product may occur in patients who are treated with any TESTODERM (testosterone (transdermal)) product.
Adverse Events with TESTODERM (testosterone (transdermal)) TTS
In clinical studies of 457 participants (116 hypogonadal males and 341 healthy adult males) treated for up to 6 weeks with TESTODERM (testosterone (transdermal)) TTS, the most commonly reported adverse events were application site reactions of transient itching (12%) and moderate or severe erythema (3%).
Adverse events reported by less than 1% of TESTODERM (testosterone (transdermal)) TTS users in clinical trials that were of probable or unknown relationship to drug were:
Body as a Whole: abdominal pain, back pain, infection; Cardiovascular System: congestive heart failure, hypertension, tachycardia; Digestive System: diarrhea, nausea; Metabolic and Nutritional System: hyperglycemia, hyperlipemia, hyponatremia; Musculoskeletal System: arthralgia; Nervous System: nervousness, depression, dizziness, dry mouth, insomnia, decreased libido, personality disorder, CNS stimulation; Respiratory System: bronchitis; Skin System: application site reactions--papules/pustules, edema, vesicles, pain, other--, acne, alopecia, hirsutism; Urogenital System: abnormal ejaculation, breast pain, dysuria, urinary tract infection, and impaired urination.Topical Reactions
Of 457 study participants, 3 men (1%) discontinued prematurely because of application site reactions.
There were no clinically significant differences in skin tolerability in younger ( 500 ng/dL. The mean 24 hour steady-state AUC (area under the curve) value was 9132 ng/dL. The mean DHT serum concentrations ranged from 134 to 162 ng/dL. Normal levels of testosterone have been maintained in patients who have worn the systems for up to six years. DHT levels also remain stable. The increase in serum testosterone concentration is proportional to the size of the system.
The variability of total testosterone concentrations among patients receiving TESTODERM (testosterone (transdermal)) treatment was 35% to 49%. The coefficient of variation of total testosterone concentrations within individual patients was 30% to 41%. This variability is comparable to the values reported in the literature for both normal and hypogonadal men.
In two 12-week clinical studies in 72 hypogonadal men, TESTODERM (testosterone (transdermal)) therapy produced positive effects on mood and sexual behavior. By five weeks, 45 patients not previously treated with TESTODERM (testosterone (transdermal)) showed statistically significant increases in sexual activity. Compared to baseline, mean sexual events per week increased for sexual intercourse (0.3 to 0.8), orgasm (0.4 to 1.2), waking erections (1.0 to 3.5), and spontaneous erections (0.4 to 2.8).
Changes in nonfasting serum lipid concentrations were observed during TESTODERM (testosterone (transdermal)) therapy. By three months total cholesterol and high-density lipoprotein cholesterol decreased an average of 8% and 13%, respectively. High-density lipoprotein cholesterol remained stable thereafter. Total cholesterol continued to decrease through two years. At the end of two years, the total cholesterol/high-density lipoprotein cholesterol ratio was not different from pretreatment values.
Estradiol levels increased to the normal range with treatment. Sporadic elevations of estradiol above the normal range for men were observed in 3 of 72 patients and these were not associated with feminizing side effects.
An information brochure containing instructions for the use of TESTODERM (testosterone (transdermal)) TTS is available. A separate instruction booklet is available for TESTODERM (testosterone (transdermal)) and TESTODERM (testosterone (transdermal)) WITH ADHESIVE. These booklets contain important information and instructions on how to properly use and dispose of the TESTODERM (testosterone (transdermal)) products. Patients should be encouraged to ask questions of the physician and pharmacist.
Advise patients of the following:
