Testoderm

Name: Testoderm

Description

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
(mg/day)

Size
(cm2)

Application Site

Testoderm (testosterone transdermal) ® TTS

5

60

Arm, Back, Upper Buttocks

Testoderm®*

5

60

Scrotum

Testoderm®*

4

40

Scrotum

Testoderm (testosterone transdermal) ® with
Adhesive

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.

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

Where can i get more information?

Your pharmacist can provide more information about testosterone topical.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 12.02. Revision date: 4/18/2012.

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Uses of Testoderm

Topical:

Testosterone is a prescription medication used to treat low testosterone levels in men who do not produce enough natural testosterone.

Injectable:

Testosterone is a prescription medication used to treat low testosterone levels in men who do not produce enough natural testosterone. Injectable forms of testosterone may also be used to treat delayed puberty in adolescent males. Testosterone may also be administered to women to treat certain types of cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Testoderm Drug Class

Testoderm is part of the drug class:

  • 3 oxoandrosten 4 derivatives

Side Effects of Testoderm

Serious side effects have been reported with testosterone. See the ‚ÄúTestosterone Precautions‚ÄĚ section.

Topical:

Common side effects of topical testosterone include the following:

  • Breast enlargement
  • Decreased sexual desire
  • Acne
  • Hair loss
  • Hot flashes
  • Depression
  • Changes in mood
  • Nervousness
  • Headache
  • Weakness
  • Insomnia
  • Dry skin
  • Changes in the ability to taste or smell
  • Skin irritation at the site of application

Injectable:

Common side effects of injectable testosterone include the following:

  • Nausea and vomiting
  • Changes in skin color
  • Ankle swelling
  • Increased calcium levels in the blood
  • Enlarged breasts
  • Enlarged prostate in men
  • Deepening of the voice, the appearance of facial hair, and acne in women

This is not a complete list of testosterone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Testoderm Precautions

Serious side effects have been reported with topical testosterone including the following:

  • Swelling of the hands, feet, ankles, and lower legs
  • Breathing problems, especially during sleep
  • Excessive frequency or duration of penile erections in males
  • Difficulty urinating or changes in urination habits
  • Changes in skin color
  • Liver dysfunction or liver cancer

Serious side effects have been reported with injectable testosterone including the following:

  • Virilization in women, which includes amenorrhea or menstrual irregularities, deepening of the voice, clitoral enlargement
  • Sexual changes or dysfunction in males, which includes breast enlargement and excessive frequency or duration of penile erections

Do not take testosterone if you:

  • are allergic to testosterone or to any of its ingredients
  • are a male with breast or prostate cancer
  • are a woman who is or may become pregnant

Testoderm Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of testosterone, there are no specific foods that you must exclude from your diet when receiving this medication.

Testoderm and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Testosterone falls into category X. It has been shown that women taking testosterone during pregnancy may have babies born with problems. There are no situations where the benefits of the medication for the mother outweigh the risks of harm to the baby. Testosterone should never be used by pregnant women.

Testoderm FDA Warning

WARNING: SECONDARY EXPOSURE TO TESTOSTERONE

  • Virilization has been reported in children who were secondarily exposed to testosterone gel.
  • Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel.
  • Healthcare providers should advise patients to strictly adhere to recommended instructions for use.
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