RITONAVIR tablet, film coated

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

REMEDYREPACK INC.

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Ritonavir tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. - When co-administering ritonavir tablets with other protease inhibitors, see the full prescribing information for that protease inhibitor including contraindication information. - Ritonavir tablets are contraindicated in patients with known hypersensitivity (e.g., toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome) to ritonavir or any of its ingredients. - Ritonavir tablets are 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, flecain

ملخص المنتج:

Ritonavir Tablets USP, 100 mg are white to off-white, film-coated, ovaloid tablets, debossed with ‘Z’ on one side and ‘24’ on other side.       Bottles of 30               NDC 65862-687-30       Bottles of 100             NDC 65862-687-01        Bottles of 500             NDC 65862-687-05       Bottles of 1,000          NDC 65862-687-99 Recommended Storage Store at or below 30°C (86°F). Exposure to temperatures up to 50°C (122°F) for seven days permitted. Dispense in original container or USP equivalent tight container (75 mL, 200 mL, 1300 mL and 2000 mL). For patient use: exposure of this product to high humidity outside the original or USP equivalent tight container (75 mL, 200 mL, 1300 mL and 2000 mL) for longer than 2 weeks is not recommended.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

RITONAVIR- 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
RITONAVIR TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RITONAVIR TABLETS.
RITONAVIR TABLETS, 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 RITONAVIR 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 RITONAVIR ON THE HEPATIC
METABOLISM OF CERTAIN DRUGS. REVIEW
MEDICATIONS TAKEN BY PATIENTS PRIOR TO PRESCRIBING RITONAVIR OR WHEN
PRESCRIBING OTHER MEDICATIONS TO
PATIENTS ALREADY TAKING RITONAVIR. ( 4, 5.1)
RECENT MAJOR CHANGES
Contraindications ( 4) 8/2019
INDICATIONS AND USAGE
Ritonavir tablets are HIV protease inhibitors indicated in combination
with other antiretroviral agents for the treatment of
HIV-1 infection ( 1)
DOSAGE AND ADMINISTRATION
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)
Ritonavir 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)
Ritonavir oral powder can only be used for dosing increments of 100 mg
( 2.4)
Dose modification for ritonavir tablet is necessary when used with
other protease inhibitors ( 2.6)
DOSAGE FORMS AND STRENGTHS
Tablet: 100 mg (3)
CONTRAINDICATIONS
Ritonavir tablets are contraindicated in patients with known
hypersensitivity to ritonavir (e.g., toxic epidermal
necrolysis, Stevens-Johnson syndrome) or any