ATAZANAVIR MYL atazanavir (as sulfate) 150 mg capsule bottle

País: Austràlia

Idioma: anglès

Font: Department of Health (Therapeutic Goods Administration)

ingredients actius:

atazanavir sulfate

Disponible des:

Alphapharm Pty Ltd

Estat d'Autorització:

Registered

Fitxa tècnica

AUSTRALIAN PRODUCT INFORMATION
ATAZANAVIR MYLAN
_atazanavir (as sulfate) capsule _
1
NAME OF THE MEDICINE
Atazanavir (as sulfate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains either 150 mg, 200 mg or 300 mg of atazanavir
(as sulfate) as the active ingredient.
Excipients with known effect: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
ATAZANAVIR MYLAN 150 mg capsule: a.No.1, greenish-blue opaque cap and
blue opaque body, hard-shell
gelatin capsule filled with white to pale yellow powder. The capsule
is axially printed with MYLAN over AR150
in black ink on both the cap and body.
ATAZANAVIR MYLAN 200 mg capsule: a.No.0, blue opaque cap and
greenish-blue opaque body, hard-shell
gelatin capsule filled with white to pale yellow powder. The capsule
is axially printed with MYLAN over AR200
in black ink on both the cap and body.
ATAZANAVIR MYLAN 300 mg capsule: a.No.00, red opaque cap and
greenish-blue opaque body, hard-shell
gelatin capsule filled with white to pale yellow powder. The capsule
is axially printed with MYLAN over AR300
in black ink on both the cap and body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atazanavir is indicated for the treatment of HIV-1 infection, in
combination with other antiretroviral agents.
This indication is based on analyses of plasma HIV-1 RNA levels and
CD4 cell counts from controlled studies
(see section 5.1 Pharmacodynamic Properties – Clinical Trials).
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL DOSING RECOMMENDATIONS
ATAZANAVIR MYLAN capsules must be taken with food.
ATAZANAVIR MYLAN capsules should be taken WHOLE. The recommended doses
are to be administered
using combinations of registered capsule strengths; e.g. a dose of 300
mg may be administered as one 300 mg
capsule or two 150 mg capsules.
The recommended oral dosage of atazanavir depends on the treatment
history of the patient and the use of other
co-administered drugs. When co-administered with H
2
-receptor antagonists, or pr