OSPAMOX Powder for oral suspension / Paediatric drops Ref.[51083] Active ingredients: Amoxicillin

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2019  Publisher: Novartis New Zealand Limited, PO Box 99102, Newmarket, AUCKLAND 1149 Telephone: 0800 354 335

Product name and form

Amoxicillin Trihydrate dried suspension 125 mg/5 ml, 250 mg/5 ml and 100 mg/ml (as amoxicillin).

Pharmaceutical Form

Ospamox powder for oral suspension:

125 mg/5 ml: Suspension, oral, powder for, white to yellowish colour.

250 mg/5 ml: Suspension, oral, powder for, white to yellowish colour.

500 mg/5 ml: Suspension, oral, powder for, white to yellowish colour.

Ospamox Paediatric Drops 100 mg/ml:

Suspension, oral, granules for, white to yellowish colour.

Qualitative and quantitative composition

Ospamox powder for oral suspension

125 mg/5 ml: Reconstituted suspension contains in 5 ml, Amoxicillin Trihydrate Ph Eur equivalent to amoxicillin 125 mg.

250 mg/5 ml: Reconstituted suspension contains in 5 ml, Amoxicillin Trihydrate Ph Eur equivalent to amoxicillin 250 mg.

500 mg/5 ml: Reconstituted suspension contains in 5 ml, Amoxicillin Trihydrate Ph Eur equivalent to amoxicillin 500 mg.

Ospamox Paediatric Drops 100 mg/ml

Reconstituted suspension contains in 1 ml, Amoxicillin Trihydrate Ph Eur equivalent to amoxicillin 100 mg.

For the full list of excipients, see Section 6.1.

Active Ingredient Description
Amoxicillin

Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bactericidal peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death.

List of Excipients

Ospamox powder for oral suspension:

Guar gum, aspartame
Citric acid anhydrous
Sodium benzoate
Talc
Trisodium citrate anhydrous
Colloidal anhydrous silica
Lemon flavour
Orange flavour
Peach-apricot flavour

Ospamox Paediatric Drops:

Sucrose
Trisodium citrate anhydrous
Sodium benzoate
Simethicone
Guar gum
Saccharin sodium
Strawberry flavour
Raspberry flavour
Passion fruit flavour

Pack sizes and marketing

Ospamox powder for oral suspension:

125 mg/5 ml: Bottle of 100 ml.

250 mg/5 ml: Bottle of 100 ml.

500 mg/5 ml: Bottle of 100 ml.

Ospamox Paediatric Drops 100 mg/ml:

Bottle of 30 ml with graduated dosing syringe.

Not all pack sizes and/or strengths may be currently marketed.

Marketing authorization holder

Novartis New Zealand Limited, PO Box 99102, Newmarket, AUCKLAND 1149
Telephone: 0800 354 335

Marketing authorization dates and numbers

Date of first approval: 30 September 2015.

Drugs

Drug Countries
OSPAMOX Austria, Estonia, Hong Kong, Croatia, Lithuania, Nigeria, New Zealand, Poland, Romania, Singapore

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.