NORVIR- ritonavir tablet, film coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

A-S Medication Solutions

INN（国际名称）:

RITONAVIR

组成:

RITONAVIR 100 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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. - NORVIR is contraindicated with drugs that are potent CYP3A inducers where significantly reduced lopinavir plasma concentrations may be associated with the potential for loss of virologic response and possib

產品總結:

Product: 50090-1162 NDC: 50090-1162-0 30 TABLET, FILM COATED in a BOTTLE

授权状态:

New Drug Application

产品特点

NORVIR- RITONAVIR TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
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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) 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)
RECENT MAJOR CHANGES
Indications and Usage (1)
6/2017
Dosage and Administration
General Dosing and Administration Recommendations (2.1)
Administering Oral Solution by Feeding Tube (2.2)
Recommended Adult Dosage (2.3)
Recommended Pediatric Dosage (2.4)
Preparation of Norvir Oral Powder (2.5)
Dose Modification due to Drug Interaction (2.6)
9/2017
9/2017
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
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