Sustiva package insert

SUSTIVA  ® Sustiva package insert
(efavirenz) capsules and tablets
Admission only
DESCRIPTION
SUSTIVA (efavirenz) is an HIV-1 specific non nucleoside, reverse transcriptase inhibitor (NNRTI).
Capsules: SUSTIVA in the form of capsules for oral administration containing either 50 mg, 100 mg, or
efavirenz 200 mg, and the following inactive ingredients: lactose monohydrate, magnesium stearate,
sodium lauryl sulfate and sodium starch glycolate. In capsule shell contains the following inactive
ingredients and dyes: gelatin, sodium lauryl sulfate, titanium dioxide and / or iron oxide yellow. V capsule
shells may also contains silicon dioxide. In capsules are printed with ink containing carmine 40 blue,

sustiva package insert
FD and C Blue № 2, and titanium dioxide.
Tablets: SUSTIVA is available as film-coated tablets for oral administration containing 600 mg
efavirenz, and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The film coatings
contains Opadry
®
Yellow and Opadry
®
Clear. In pill polished with carnauba wax, and printed
purple ink, Opacode
®
WB.
sustiva package insert
Important updates to the package Sustiva Insert


31 2007 year

In Sustiva (efavirenz) insert package has been updated to include drug-drug interaction information on the coadministration of efavirenz with rifampin, diltiazem, itraconazole, voriconazole, atorvastatin, pravastatin, simvastatin, pimozide and bepridil.

In clinical pharmacology section (Tables 1 and 2) have been revised to include the results of drug interaction studies with the drug diltiazem, itraconazole, voriconazole, atorvastatin, pravastatin, and simvastatin.

In CONTRAINIDCATION section has been reviewed in a position Sustiva should not be administered concurrently with bepridil, pimozide and standard doses of voriconazole.

In PRECAUTION: Drug Interaction section (Tablets 5 and 6) has been updated with information about the coadministration of efavirenz with rifampin, diltiazem (and other calcium channel blockers), itraconazole, ketoconazole, voriconazole, pimozide and bepridil.
sustiva package insert
In Dosing and Administration section is updated to include dosing information for the joint management and efavirenz voriconazole. In particular, if Sustiva was coadministered with voriconazole year voriconazole maintenance dose should be increased to 400 mg every 12 hours and SUSTIVA dose should be reduced to 300 mg once a day, using a capsule formulation (three 100 mg or 200 mg capsule and one 100 mg capsules). SUSTIVA tablets should not be disturbed.

Please refer to the attached pdf file for a detailed report on changes in the revised package insert.
sustiva package insert