"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
DOSAGE AND ADMINISTRATION
It is recommended that MYCOBUTIN (rifabutin) Capsules be administered at a dose of 300 mg once daily. For those patients with propensity to nausea, vomiting, or other gastrointestinal upset, administration of MYCOBUTIN (rifabutin) at doses of 150 mg twice daily taken with food may be useful. For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the dose of MYCOBUTIN (rifabutin) should be reduced by 50%. No dosage adjustment is required for patients with mild to moderate renal impairment. Reduction of the dose of MYCOBUTIN (rifabutin) may also be needed for patients receiving concomitant treatment with certain other drugs (see PRECAUTIONS - DRUG INTERACTIONS).
MYCOBUTIN Capsules (rifabutin capsules, USP) are supplied as hard gelatin capsules having an opaque red-brown cap and body, imprinted with MYCOBUTIN (rifabutin) /PHARMACIA & UPJOHN in white ink, each containing 150 mg of rifabutin, USP.
MYCOBUTIN (rifabutin) is available as follows:
NDC 0013-5301-17..................Bottles of 100 capsules
Keep tightly closed and dispense in a tight container as defined in the USP. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Distributed By: Pharmacia and Upjohn Company, Division of Pfizer Inc, NY, NY 10017. Revised October 2007. FDA Rev date: 5/14/2008
Last reviewed on RxList: 6/16/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Mycobutin Information
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