RITONAVIR tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

REMEDYREPACK INC.

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

Ritonavir tablets, USP are available in the following strength and package sizes: Ritonavir Tablets USP, 100 mg Ritonavir USP Ritonavir tablets, USP are white to off white, capsule shaped, film coated tablets debossed with 'H' on one side and 'R9' on other side. Bottles of 30 tablets  NDC 31722-597-30 Bottles of 120 tablets  NDC 31722-597-12 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 (60 mL or less). For patient use: exposure of this product to high humidity outside the original or USP equivalent tight container (60 mL or less) for longer than 2 weeks is not recommended.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

RITONAVIR- RITONAVIR TABLET
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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
Indications and Usage ( 1) 6/2017
Dosage and Administration
General Dosing and Administration Recommendations (2.1) 9/2017
Recommended Adult Dosage (2.3) 6/2017
Recommended Pediatric Dosage ( 2.4) 6/2017
Dose Modification due to Drug Interaction ( 2.6) 6/2017
Contraindications ( 4) 6/2017
Warnings and Precautions
Diabetes Mellitus/Hyperglycemia ( 5.8) 11/2016
INDICATIONS AND USAGE
Ritonavir tablets are HIV protease inhibitors indicated in combination
with other antiretroviral agents for the treatment of
HIV-1 infection (1) (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)
• Dose modification for riton