VIRACEPT- nelfinavir mesylate tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

NELFINAVIR MESYLATE (UNII: 98D603VP8V) (NELFINAVIR - UNII:HO3OGH5D7I)

Tilgjengelig fra:

AGOURON

INN (International Name):

NELFINAVIR MESYLATE

Sammensetning:

NELFINAVIR 250 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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 .

Autorisasjon status:

New Drug Application

Preparatomtale

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