NORVIR ritonavir tablet film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

RITONAVIR (UNII: O3J8G9O825) (RITONAVIR - UNII:O3J8G9O825)

Commercializzato da:

Avera McKennan Hospital

INN (Nome Internazionale):

RITONAVIR

Composizione:

RITONAVIR 100 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

NORVIR- RITONAVIR TABLET, FILM COATED
AVERA MCKENNAN HOSPITAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NORVIR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR NORVIR.
NORVIR (RITONAVIR) TABLET, FOR ORAL USE
NORVIR (RITONAVIR) SOLUTION, FOR ORAL USE
INITIAL U.S. APPROVAL: 1996
WARNING: DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR
LIFE
THREATENING REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
CO-ADMINISTRATION OF NORVIR WITH SEVERAL CLASSES OF DRUGS INCLUDING
SEDATIVE HYPNOTICS,
ANTIARRHYTHMICS, OR ERGOT ALKALOID PREPARATIONS MAY RESULT IN
POTENTIALLY SERIOUS AND/OR LIFE-THREATENING
ADVERSE EVENTS DUE TO POSSIBLE EFFECTS OF NORVIR ON THE HEPATIC
METABOLISM OF CERTAIN DRUGS. REVIEW
MEDICATIONS TAKEN BY PATIENTS PRIOR TO PRESCRIBING NORVIR OR WHEN
PRESCRIBING OTHER MEDICATIONS TO
PATIENTS ALREADY TAKING NORVIR _[SEE CONTRAINDICATIONS (4), WARNINGS
AND PRECAUTIONS (5.1), DRUG INTERACTIONS (7),_
AND_ CLINICAL PHARMACOLOGY (12.3)]._
RECENT MAJOR CHANGES
Dosage and Administration (2.1)
12/2016
Contraindications (4)
11/2016
Warnings and Precautions
Diabetes Mellitus/Hyperglycemia (5.8)
11/2016
INDICATIONS AND USAGE
NORVIR is an HIV protease inhibitor indicated in combination with
other antiretroviral agents for the treatment of HIV-1
infection (1)
DOSAGE AND ADMINISTRATION
Dose modification for NORVIR is necessary when used with other
protease inhibitors (2)
Adult patients: 600 mg twice-day with meals (2.1)
Pediatrics patients: The recommended twice daily dose for children
greater than one month of age is based on body
surface area and should not exceed 600 mg twice daily with meals (2.2)
NORVIR oral solution should not be administered to neonates before a
postmenstrual age (first day of the mother’s
last menstrual period to birth plus the time elapsed after birth) of
44 weeks has been attained (2.2, 5.2)
DOSAGE FORMS AND STRENGTHS
Tablet: 100 mg ritonavir (3)
Oral solution: 80 mg ritonavir per