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Malerone Dosage |
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Malerone (Malerone (transdermal)) TTS
One system is applied at about the same time each day. The adhesive side of the Malerone (Malerone (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 Malerone (Malerone (transdermal)) TTS system should be worn approximately 24 hours and then replaced. To ensure proper dosing, serum Malerone concentration may be measured 2-4 hours after an application of Malerone (Malerone (transdermal)) TTS. If the serum Malerone concentrations are low, the dosing regimen may be increased to 2 systems. Because of variability in analytical values among diagnostic laboratories, all Malerone measurements should be performed at the same laboratory.
Malerone (Malerone (transdermal)) and Malerone (Malerone (transdermal)) WITH ADHESIVE
Patients should start therapy with a 6 mg/d system of either Malerone (Malerone (transdermal)) or Malerone (Malerone (transdermal)) WITH ADHESIVE applied daily; if the scrotal area cannot accommodate a 6 mg/d system, a 4 mg/d Malerone (Malerone (transdermal)) system should be used. One Malerone (Malerone (transdermal)) or Malerone (Malerone (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. Malerone (Malerone (transdermal)) or Malerone (Malerone (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 Malerone. Because of variability in analytical values among diagnostic laboratories, this laboratory work and later analyses for assessing the effect of the Malerone (Malerone (transdermal)) and Malerone (Malerone (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 Malerone (Malerone (transdermal)) products, another form of Malerone replacement therapy should be considered.
Malerone (Malerone (transdermal)) TTS, Malerone (Malerone (transdermal)), and Malerone (Malerone (transdermal)) WITH ADHESIVE Malerone transdermal systems contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.
Malerone (Malerone (transdermal)) TTS
Malerone (Malerone (transdermal)) TTS systems are supplied as individually pouched systems, 30 per carton. Malerone (Malerone (transdermal)) TTS 5 mg/d (Malerone Transdermal System) -- each 60 cm2 system contains 328 mg Malerone USP for nominal dose of 5 mg/day
Carton of 30 Malerone (Malerone (transdermal)) TTS 5 mg/d systemsNDC 17314-4717-3
Malerone (Malerone (transdermal)) and Malerone (Malerone (transdermal)) WITH ADHESIVE
Malerone (Malerone (transdermal)) and Malerone (Malerone (transdermal)) WITH ADHESIVE systems are supplied as individually pouched systems, 30 per carton.
Malerone (Malerone (transdermal)) 4 mg/d (Malerone Transdermal System) -- each 40 cm2 system contains 10 mg Malerone USP for nominal delivery of 4 mg for one day.
Carton of 30 Malerone (Malerone (transdermal)) 4 mg/d systems. NDC 17314-4608-3
Malerone (Malerone (transdermal)) and Malerone (Malerone (transdermal)) WITH ADHESIVE
6 mg/d (Malerone Transdermal System) -- each 60 cm2 system contains 15 mg Malerone USP for nominal delivery of 6 mg for one day.
Carton of 30 Malerone (Malerone (transdermal)) 6 mg/d systems. NDC 17314-4609-3
Carton of 30 Malerone (Malerone (transdermal)) WITH ADHESIVE 6 mg/d systemsNDC 17314-2836-3
Storage
Malerone (Malerone (transdermal)) TTS
Store at controlled room temperature below 25oC (77oF).
Malerone (Malerone (transdermal)) and Malerone (Malerone (transdermal)) WITH ADHESIVE
Store at room temperature 15-30oC (59-86oF).
Disposal
Malerone (Malerone (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. Malerone 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 Malerone 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
Tell your doctor about all your other medicines, especially:
insulin or oral diabetes medicine;
medicine to treat pain, cough, or cold symptoms;
a blood thinner--warfarin, Coumadin, Jantoven; or
steroid medicine--prednisone, dexamethasone, and others.
This list is not complete. Other drugs may affect Malerone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Malerone drug interactions (in more detail)
Drug Interactions
Anticoagulants: C-17 substituted derivatives of Malerone, such as methandrostenolone, have been reported to decrease the anticoagulant requirements of patients receiving oral anticoagulants. Patients receiving oral anticoagulant therapy require close monitoring, especially when androgens are started or stopped.
Oxyphenbutazone: Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.
Insulin: In diabetic patients, the metabolic effects of androgens may decrease blood glucose and therefore, insulin requirements.
Propranolol: In a published pharmacokinetic study of an injectable Malerone product, administration of Malerone cypionate led to an increased clearance of propranolol in the majority of men tested.6
Corticosteroids: The concurrent administration of Malerone with ACTH or corticosteroids may enhance edema formation; thus these drugs should be administered cautiously, particularly in patients with cardiac or hepatic disease.7
Drug/Laboratory Test Interactions
Androgens may decrease levels of thyroxin-binding globulin, resulting in decreased total T. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.
The Malerone (Malerone (transdermal)) products contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.
Malerone (Malerone (transdermal)) TTS is designed for application to arm, back or upper buttocks skin.
Malerone (Malerone (transdermal)) and Malerone (Malerone (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only. Because scrotal skin is at least five times more permeable to Malerone than other skin sites, Malerone (Malerone (transdermal)) or Malerone (Malerone (transdermal)) WITH ADHESIVE will not produce adequate serum Malerone concentrations if applied to non-scrotal skin.
Ingestion of Malerone, or the contents of any of the Malerone (Malerone (transdermal)) products will not result in clinically significant serum Malerone concentrations due to extensive first-pass metabolism. In addition, an intramuscular injection of Malerone from any of the Malerone (Malerone (transdermal)) products will not produce adequate serum Malerone levels due to its short half-life (about 10 minutes).
Users | % | ||
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201-500mg | 1 | 100.0% |
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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