Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
NELFINAVIR MESYLATE (UNII: 98D603VP8V) (NELFINAVIR - UNII:HO3OGH5D7I)
AGOURON
NELFINAVIR MESYLATE
NELFINAVIR 250 mg
ORAL
PRESCRIPTION DRUG
VIRACEPT in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection. Coadministration of VIRACEPT is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. These drugs and other contraindicated drugs (which may lead to reduced efficacy of nelfinavir) are listed in Table 3 [also see Drug Interactions (7), Table 6 ]. Alpha 1-adrenoreceptor antagonist Alfuzosin Potentially increased alfuzosin concentrations can result in hypotension. Antiarrhythmics Amiodarone, quinidine Potential for serious and/or life-threatening cardiac arrhythmia. Antimycobacterial Agents Rifampin Plasma concentrations of nelfinavir can be reduced by concomitant use of rifampin. This may lead to loss of therapeutic effect and possible development of resistance to VIRACEPT or other coadministered antiretroviral agents. Antipsychotics Ergot Derivatives Dihydroergotamine, ergotamin
VIRACEPT (nelfinavir mesylate) 250 mg: Light-blue, capsule-shaped tablets with a clear film coating engraved with "VIRACEPT" on one side and "250 mg" on the other. VIRACEPT (nelfinavir mesylate) 625 mg: White oval tablet with a clear film coating engraved with "V" on one side and "625" on the other. VIRACEPT (nelfinavir mesylate) Oral Powder is available as a 50 mg/g off-white powder containing 50 mg (as nelfinavir free base) in each level scoopful (1 gram). VIRACEPT tablets and oral powder should be stored at 15° to 30°C (59° to 86°F). Keep container tightly closed. Dispense in original container .
New Drug Application
VIRACEPT- NELFINAVIR MESYLATE TABLET, FILM COATED AGOURON ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VIRACEPT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VIRACEPT. VIRACEPT (NELFINAVIR MESYLATE) TABLETS, FOR ORAL USE VIRACEPT (NELFINAVIR MESYLATE) ORAL POWDER, FOR ORAL USE INITIAL U.S. APPROVAL: 1997 INDICATIONS AND USAGE VIRACEPT is a protease inhibitor indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. (1) DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS Coadministration with drugs that are highly dependent on CYP3A for clearance and which elevated concentrations are associated with serious and/or life-threatening events (4) WARNINGS AND PRECAUTIONS ALERT: FIND OUT ABOUT MEDICINES THAT SHOULD NOT BE TAKEN WITH VIRACEPT. • • • • • • • ADVERSE REACTIONS • • TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PFIZER INC AT 1-800-438-1985 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. ® ® See full prescribing information for administration instructions (2) Adults and adolescents 13 years and older (tablets): 1250 mg twice daily or 750 mg three times daily with a meal (2.1) Children 2 to less than 13 years (oral powder or 250 mg tablets): 45 to 55 mg/kg twice daily or 25 to 35 mg/kg three times daily with a meal. Refer to Tables 1 and 2 of the full prescribing information for specific dosing guidelines based on age and body weight (2.2) Tablet: 250 mg, 625 mg nelfinavir free base (3) Oral Powder: 50 mg/g nelfinavir free base (3) The concomitant use of VIRACEPT and certain other drugs may result in known or potentially significant drug interactions. Consult the full prescribing information prior to and during treatment for potential drug interactions (5.1, 7.3) Hepatic impairment: should not be used in patients with either moderate or severe hepatic impairment (2.4, 5.2) Phenylketonuria: the oral powder contains 11.2 mg phenyl Διαβάστε το πλήρες έγγραφο