ARROW ROXITHROMYCIN Coated tablet Ref.[8989] Active ingredients: Roxithromycin

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2017  Publisher: Teva Pharma (New Zealand) Limited, PO Box 128 244, Remuera, Auckland 1541, Telephone: 0800 800 097

Product name and form

Arrow – Roxithromycin 150, 150 mg, coated tablets.

Arrow – Roxithromycin 300, 300 mg, coated tablets.

Pharmaceutical Form

White, round, coated tablets.

Qualitative and quantitative composition

Each tablet contains 150 mg or 300 mg of roxithromycin.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Roxithromycin

Roxithromycin is a semi-synthetic macrolide antibiotic. Roxithromycin is bacteriostatic at low concentrations and bactericidal at high concentrations. It binds to the 50S subunit of the 70S ribosome, thereby disrupting bacterial protein synthesis.

List of Excipients

Low substituted hydroxypropyl cellulose (hyprolose)
Colloidal anhydrous silica
Povidone
Purified talc
Maize starch
Magnesium stearate
Hypromellose
Anhydrous glucose
Titanium dioxide
Propylene glycol

Pack sizes and marketing

PVC/PVdC/Aluminium foil blister strips. Pack size of 10 tablets (150 mg) and 5 tablets (300 mg).

Marketing authorization holder

Teva Pharma (New Zealand) Limited, PO Box 128 244, Remuera, Auckland 1541, Telephone: 0800 800 097

Marketing authorization dates and numbers

28 September 2006

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