NORVIR ritonavir tablet film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

REMEDYREPACK INC.

INN (Rahvusvaheline Nimetus):

RITONAVIR

Koostis:

RITONAVIR 100 mg

Retsepti tüüp:

PRESCRIPTION DRUG

Volitamisolek:

New Drug Application

Toote omadused

NORVIR- RITONAVIR TABLET, FILM COATED
REMEDYREPACK INC.
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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) 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)
RECENT MAJOR CHANGES
Indications and Usage (1)
6/2017
Dosage and Administration (2)
6/2017
General Dosing and Administration Recommendations (2.1)
Recommended Adult Dosage (2.2)
Recommended Pediatric Dosage (2.3)
Preparation of Norvir Oral Powder (2.4)
Dose Modification due to Drug Interaction (2.5)
6/2017
6/2017
6/2017
6/2017
6/2017
Contraindications (4)
6/2017
Warnings and Precautions
Diabetes Mellitus/Hyperglycemia (5.8)
11/2016
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
Dose modification for NORVIR is necessary when used with other
protease inhibitors (2)
NORVIR oral solution is not recommended for use with polyurethane
feeding tubes due to potential incompatibility
(2.1)
Adult patients: 600 mg twice-day with meals (2.2)
Pediatrics patients: The recomm