Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
RITONAVIR (UNII: O3J8G9O825) (RITONAVIR - UNII:O3J8G9O825)
AbbVie Inc.
RITONAVIR
RITONAVIR 100 mg
ORAL
PRESCRIPTION DRUG
NORVIR tablets and oral solution are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. NORVIR oral powder is indicated in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infection. - When co-administering NORVIR with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. - NORVIR is contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome) to ritonavir or any of its ingredients. - NORVIR 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 reactions [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.3 )] . ○ Alpha 1- Adrenoreceptor Antagonist : alfuzosin ○ Antianginal: ranolazine ○ Antiarrhythmics: amiodarone, dronedarone, flecainide, propaf
The package sizes, strengths, and storage and handling recommendations for NORVIR (ritonavir) tablets, oral solution and oral powder are shown in the table below.
New Drug Application
NORVIR- RITONAVIR TABLET, FILM COATED NORVIR- RITONAVIR SOLUTION NORVIR- RITONAVIR POWDER ABBVIE INC. ---------- 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) TABLETS, FOR ORAL USE NORVIR (RITONAVIR) ORAL SOLUTION NORVIR (RITONAVIR) ORAL POWDER 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. (4, 5.1) INDICATIONS AND USAGE NORVIR tablets and oral solution are HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection (1) NORVIR oral powder is indicated in combination with other antiretroviral agents for the treatment of pediatric patients with HIV-1 infection (1) DOSAGE AND ADMINISTRATION NORVIR oral solution is not recommended for use with polyurethane feeding tubes due to potential incompatibility. Feeding tubes composed of silicone or polyvinyl chloride (PVC) can be used. (2.2) Adult patients: 600 mg twice-day with meals (2.3) 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 (2.4) 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 (2.4, 5.2) NORVIR oral powder can Lugege kogu dokumenti