(Not approved by FDA)
400 mg orally or IV once a day
This regimen has been recommended by the Centers for Disease Control and Prevention, Infectious Diseases Society of America, and American Thoracic Society.
May be given in combination with at least 3 other active drugs for treatment of multi-drug resistant TB, or when the patient is intolerant of first-line agents. AFB smear and culture should be monitored monthly.
Duration: Treatment for TB should generally continue for 18 to 24 months, or for 12 to 18 months after culture results are negative.
Patients applied an ANDRODERM 4 mg/day system around 10 . once daily for 14 days, and then were titrated up to 6 mg/day or down to 2 mg/day according to a morning serum testosterone concentration obtained at 6 . on Day 8. Out of 36 patients who entered the study, 31 (86%) patients remained on the 4 mg/day dose, 4 (11%) were titrated downward to 2 mg/day, and 1 (3%) was titrated upward to 6 mg/day based on the Day 8 testosterone concentrations. The one patient that was titrated to 6 mg/day discontinued from the study for a non-safety related reason. Of the patients who were receiving ANDRODERM 5 mg/day prior to study entry (n = 11), 10 remained at 4 mg/day after titration, and 1 was titrated down to the 2 mg/day dose.
Administration advice :
-Administer with food; oral bioavailability enhanced when administered with fatty meal (estimated fat content 40 g).
-May crush or chew tablets and swallow with a drink of water; chewable tablets also available for patients unable to swallow tablet whole.
Storage requirements :
-Store at 20C to 25C (86F to 77F).
-Current guidelines should be consulted for additional information.
-Safety uncertain in patients younger than 6 years; studies using this drug in children as young as 1 year suggest that it is safe.
-According to WHO guidelines for mass prevention campaigns, this drug can be used in children as young as 1 year; many children younger than 6 years have used this drug (at reduced dose) in such campaigns.
-General: Pregnancy test in women of reproductive potential (before starting therapy)
-Hematologic: Blood counts in all patients (at the start of each 28-day treatment cycle and every 2 weeks while on therapy)
-Hepatic: Liver enzymes/transaminases in all patients (at the start of each 28-day treatment cycle and at least every 2 weeks during therapy)
-Ocular: For retinal lesions (before starting therapy for neurocysticercosis)