מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
RITONAVIR (UNII: O3J8G9O825) (RITONAVIR - UNII:O3J8G9O825)
Avera McKennan Hospital
RITONAVIR
RITONAVIR 100 mg
PRESCRIPTION DRUG
New Drug Application
NORVIR- RITONAVIR TABLET, FILM COATED AVERA MCKENNAN HOSPITAL ---------- 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 קרא את המסמך השלם