VIRACEPT- nelfinavir mesylate tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

NELFINAVIR MESYLATE

Composition:

NELFINAVIR 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 ]. 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 ]. Pregnancy Category B VIRACEPT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There are no adequate and well-controlled studies in pregnant women taki

Product summary:

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 tablets and oral powder should be stored at 15° to 30°C (59° to 86°F). Keep container tightly closed. Dispense in original container .

Authorization status:

New Drug Application

Summary of Product characteristics

VIRACEPT- NELFINAVIR MESYLATE TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
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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
RECENT MAJOR CHANGES
Contraindications ( 4)
9/2016
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
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)
DOSAGE FORMS AND STRENGTHS
Tablet: 250 mg, 625 mg nelfinavir free base ( 3)
Oral Powder: 50 mg/g nelfinavir free base ( 3)
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.
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 phenylalanine per
gram of powder ( 5.3)
Diabetes mellitus/hyperglycemia: new onset or exacerbation of
pre-existing diabetes mellitus