"Entry Inhibitors (including Fusion Inhibitors) and CCR5 Co-receptor Antagonist
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RESCRIPTOR Tablets are indicated for the treatment of HIV-1 infection in combination with at least 2 other active antiretroviral agents when therapy is warranted.
The following should be considered before initiating therapy with RESCRIPTOR in treatment-naive patients. There are insufficient data directly comparing antiretroviral regimens containing RESCRIPTOR with currently preferred 3-drug regimens for initial treatment of HIV. In studies comparing regimens consisting of 2 nucleoside reverse transcriptase inhibitors (NRTIs) (currently considered suboptimal) to RESCRIPTOR plus 2 NRTIs, the proportion of patients receiving the regimen containing RESCRIPTOR who achieved and sustained an HIV-1 RNA level < 400 copies/mL over 1 year of therapy was relatively low (see Description Of Clinical Studies).
Resistant virus emerges rapidly when RESCRIPTOR is administered as monotherapy. Therefore, RESCRIPTOR should always be administered in combination with other antiretroviral agents.
DOSAGE AND ADMINISTRATION
The recommended dosage for RESCRIPTOR Tablets is 400 mg (four 100-mg or two 200-mg tablets) 3 times daily. RESCRIPTOR should be used in combination with other antiretroviral therapy. The complete prescribing information for other antiretroviral agents should be consulted for information on dosage and administration.
The 100-mg RESCRIPTOR Tablets may be dispersed in water prior to consumption. To prepare a dispersion, add four 100-mg RESCRIPTOR Tablets to at least 3 ounces of water, allow to stand for a few minutes, and then stir until a uniform dispersion occurs (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). The dispersion should be consumed promptly. The glass should be rinsed with water and the rinse swallowed to insure the entire dose is consumed. The 200-mg tablets should be taken as intact tablets, because they are not readily dispersed in water. Note: The 200-mg tablets are approximately one-third smaller in size than the 100-mg tablets.
RESCRIPTOR Tablets may be administered with or without food (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Absorption and Bioavailability). Patients with achlorhydria should take RESCRIPTOR with an acidic beverage (e.g., orange or cranberry juice). However, the effect of an acidic beverage on the absorption of delavirdine in patients with achlorhydria has not been investigated.
Patients taking both RESCRIPTOR and antacids should be advised to take them at least1 hour apart.
RESCRIPTOR Tablets are available as follows:
100-mg: white, capsule-shaped tablets marked with “U 3761”
Bottles of 360 tablets - NDC 49702-209-24.
200-mg: white, capsule-shaped tablets marked with “RES200”
Bottles of 180 tablets - NDC 49702-225-17.
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Keep container tightly closed. Protect from high humidity.
Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709. By: Pfizer Pharmaceuticals LLC Vega Baja, Puerto Rico 00693. August 2012
Last reviewed on RxList: 8/29/2012
This monograph has been modified to include the generic and brand name in many instances.
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