Atazanavir (Teva)

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Atazanavir sulfate 170.872mg (equiv 150 mg atazanavir)

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Atazanavir sulfate 170.872 mg (equiv 150 mg atazanavir)

Dosage:

150 mg

Pharmaceutical form:

Capsule

Composition:

Active: Atazanavir sulfate 170.872mg (equiv 150 mg atazanavir) Excipient: Crospovidone Gelatin Indigo carmine Lactose monohydrate Magnesium stearate Titanium dioxide

Prescription type:

Prescription

Manufactured by:

Laurus Labs Limited

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.

Product summary:

Package - Contents - Shelf Life: Blister pack, OPA/Al/PVC // Al blisters in cardboard carton - 60 capsules - 24 months from date of manufacture stored at or below 30°C - Bottle, HDPE bottle with CR polypropylene cap - 60 capsules - 24 months from date of manufacture stored at or below 30°C 3 months opened, Not Specified

Authorization date:

2017-07-21

Summary of Product characteristics

Version 1.0
1
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
Atazanavir 150 mg Capsules, Hard (Teva)
Atazanavir 200 mg Capsules, Hard (Teva)
Atazanavir 300 mg Capsules, Hard (Teva)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Atazanavir 150 mg Hard Capsules: Each capsule contains 150 mg of
atazanavir (as sulfate).
Atazanavir 200 mg hard capsules:
Each capsule contains 200 mg of atazanavir (as sulfate).
Atazanavir 300 mg hard capsules:
Each capsule contains 300 mg of atazanavir (as sulfate).
Excipient with known effect:
lactose monohydrate
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsule
ATAZANAVIR 150 MG HARD CAPSULES:
Atazanavir hard capsules 150 mg are non-transparent capsules, size 1,
with dark blue cap, and black
mark 150 on light blue body. The content of the capsule is light
yellow powder.
ATAZANAVIR 200 MG HARD CAPSULES:
Atazanavir hard capsules 200 mg are non-transparent capsules, size 0,
with blue cap, and black mark
200 on blue body. The content of the capsule is light yellow powder.
ATAZANAVIR 300 MG HARD CAPSULES:
Atazanavir hard capsules 300 mg are non-transparent capsules, size 00,
with red cap, and black mark
300 on blue body. The content of the capsule is light yellow powder.
4. CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Atazanavir is indicated for the treatment of HIV 1 infection, in
combination with other antiretroviral
agents, in adult patients and in paediatric patients 6 to 18 years of
age.
This indication is based on analyses of plasma HIV-1 RNA levels and
CD4 cell counts from
controlled studies (see 5.1 Pharmacodynamic properties – Clinical
efficacy and safety).
4.2
DOSE AND METHOD OF ADMINISTRATION
_General Dosing Recommendations _
Atazanavir capsules must be taken with food.
Atazanavir capsules should be taken WHOLE. The recommended doses are
to be administered using
combinations of registered capsule strengths; eg a dose of 300 mg may
be administered as one 300 mg
capsule or two 150 mg capsules.
The recommended oral dosage of Atazanavir capsules depend