ATAZANAVIR capsule

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S)

Beschikbaar vanaf:

Amneal Pharmaceuticals NY LLC

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Atazanavir capsules are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients 6 years and older weighing at least 15 kg. Limitations of Use: - Atazanavir is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus [see Use in Specific Populations (8.4)] . - Use of atazanavir with ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Microbiology (12.4)] . Atazanavir capsules are contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (e.g., Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of atazanavir capsules [see Warnings and Precautions (5.2)] . - when co-administered with drugs that are highly dependent on CYP3A or UGT1A1 for clearance, and for which elevated plasma concentrations of the interacting drugs

Product samenvatting:

Atazanavir Capsules, 100 mg are supplied as size ‘2’ hard gelatin capsules having imprinted ‘Amneal 100 mg’ on blue opaque cap with white ink and ‘1135’ on white opaque body with blue ink, filled with off-white to yellow granular powder. They are available as follows: Bottles of 60:                                                  NDC 69238-1135-6 Atazanavir Capsules, 150 mg are supplied as size ‘1’ hard gelatin capsules having imprinted ‘Amneal 150 mg’ on blue opaque cap with white ink and ‘1136’ on powder blue opaque body with blue ink, filled with off-white to yellow granular powder. They are available as follows: Bottles of 60:                                                  NDC 69238-1136-6 Atazanavir Capsules, 200 mg are supplied as size ‘0’ hard gelatin capsules having imprinted ‘Amneal 200 mg’ on blue opaque cap and ‘1137’on blue opaque body with white ink, filled with off-white to yellow granular powder. They are available as follows: Bottles of 60:                                                  NDC 69238-1137-6 Atazanavir Capsules, 300 mg are supplied as size ‘00’ hard gelatin capsules having imprinted ‘Amneal 300 mg’ on red opaque cap and ‘1138’ on blue opaque body with white ink, filled with off-white to yellow granular powder. They are available as follows: Bottles of 30:                                                  NDC 69238-1138-3 Keep capsules in a tightly closed container. Store atazanavir capsules at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ATAZANAVIR- ATAZANAVIR CAPSULE
AMNEAL PHARMACEUTICALS NY LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATAZANAVIR CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ATAZANAVIR CAPSULES.
ATAZANAVIR CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Atazanavir is a protease inhibitor indicated for use in combination
with other antiretroviral agents for the
treatment of HIV-1 infection in adults and in pediatric patients 6
years and older weighing at least 15 kg.
(1)
DOSAGE AND ADMINISTRATION
_Pretreatment testing: _Renal laboratory testing should be performed
in all patients prior to initiation of
atazanavir capsules and continued during treatment with atazanavir
capsules. Hepatic testing should
be performed in patients with underlying liver disease prior to
initiation of atazanavir capsules and
continued during treatment with atazanavir capsules. (2.2)
_Treatment-naive adults: _Atazanavir capsules 300 mg with ritonavir
100 mg once daily with food or
atazanavir capsules 400 mg once daily with food. (2.3)
_Treatment-experienced adults:_ Atazanavir capsules 300 mg with
ritonavir 100 mg once daily with food.
(2.3)
_Pediatric patients:_ Atazanavir capsule dosage is based on body
weight not to exceed the adult dose
and must be taken with food. (2.4)
_Pregnancy: _Atazanavir capsules 300 mg with ritonavir 100 mg once
daily with food, with dosing
modifications for some concomitant medications. (2.6)
_Dosing modifications:_ may be required for concomitant therapy (2.3,
2.4, 2.6), renal impairment (2.7)
and hepatic impairment. (2.8)
DOSAGE FORMS AND STRENGTHS
Capsules: 100 mg, 150 mg, 200 mg, 300 mg. (3, 16)
CONTRAINDICATIONS
Atazanavir capsule is contraindicated in patients with previously
demonstrated hypersensitivity (e.g.,
Stevens-Johnson syndrome, erythema multiforme, or toxic skin
eruptions) to any of the components of
this product. (4)
Co-administration with alfuzosin, amiodarone (if atazanavir is
co-admin