Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2015 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Mycobutin is indicated for:
Mycobutin can be administered as a single, daily, oral dose at any time independently of meals.
Pprophylaxis of M. avium intracellulare complex (MAC) infections in patients with HIV disease with CD4 counts lower than 75 cells/mcl: 300 mg (2 capsules) as a single agent.
Treatment of non-tuberculous mycobaterial disease: 450-600 mg (3-4 capsules) in combination regimens for up to 6 months after negative cultures are obtained.
When Mycobutin is given in association with clarithromycin (or other macrolides) and/or fluconazole (or related compounds) the Mycobutin dosage may need to be reduced to 300 mg (see Section 4.5).
Treatment of pulmonary tuberculosis: 150-450 mg (1-3 capsules) in combination regimens for at least 6 months.
In accordance with the commonly accepted criteria for the treatment of mycobacterial infections, Mycobutin should always be given in combination with other anti-mycobacterial drugs not belonging to the family of rifamycins.
There are inadequate data to support the use of Mycobutin in children at the present time.
No specific recommendations for dosage alterations in the elderly are suggested.
Gastric lavage and diuretic treatment should be carried out. Supportive care and symptomatic treatment should be administered.
Shelf life: 2 years.
Store below 25°C.
Transparent PVC/Al blisters in cardboard cartons containing 30 capsules.
No special requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
