NORVIR- ritonavir tablet, film coated NORVIR- ritonavir solution NORVIR- ritonavir powder

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

AbbVie Inc.

INN (International Nazwa):

RITONAVIR

Skład:

RITONAVIR 100 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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

Podsumowanie produktu:

The package sizes, strengths, and storage and handling recommendations for NORVIR (ritonavir) tablets, oral solution and oral powder are shown in the table below.

Status autoryzacji:

New Drug Application

Charakterystyka produktu

NORVIR- RITONAVIR TABLET, FILM COATED
NORVIR- RITONAVIR SOLUTION
NORVIR- RITONAVIR POWDER
ABBVIE 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) 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