Source: Health Products Regulatory Authority (ZA) Revision Year: 2022 Publisher: Novartis New Zealand Limited, PO Box 99102, Newmarket, Auckland 1149 Telephone: 0800 354 335
Curam Powder for oral suspension.
Curam Film coated tablet.
Curam Duo 500/125 Film coated tablet.
| Pharmaceutical Form |
|---|
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Curam tablet: Tablet, film-coated, oblong biconvex formed, off-white colour, scored on both sides. Curam Duo 500/125 tablet: Tablet, film-coated, oval biconvex formed, off-white colour, scored on both sides. Curam powder for oral suspension: Suspension, oral, powder for, white to yellowish colour. |
250 + 125 mg: Each tablet contains Amoxicillin Trihydrate Ph. Eur. equivalent to amoxicillin 250 mg and Potassium Clavulanate Ph. Eur. equivalent to clavulanic acid 125 mg.
500 + 125 mg: Each tablet contains Amoxicillin Trihydrate Ph. Eur. equivalent to amoxicillin 500 mg and Potassium Clavulanate Ph. Eur. equivalent to clavulanic acid 125 mg.
125 + 31.25 mg/5 mL: Reconstituted suspension contains in 5 mL, Amoxicillin Trihydrate Ph. Eur. equivalent to amoxicillin 125 mg and Potassium Clavulanate Ph. Eur. equivalent to clavulanic acid 31.25 mg.
250 + 62.5 mg/5 mL: Reconstituted suspension contains in 5 mL, Amoxicillin Trihydrate Ph. Eur. equivalent to amoxicillin 250 mg and Potassium Clavulanate Ph. Eur. equivalent to clavulanic acid 62.5 mg.
List of excipients with known effect: Aspartame.
For the full list of excipients, see Section 6.1 List of excipients.
| 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. |
|
| Clavulanic acid |
Clavulanic acid is a beta-lactam structurally related to penicillins. It inactivates some beta-lactamase enzymes thereby preventing inactivation of amoxicillin. |
| List of Excipients |
|---|
|
Curam tablet: Microcrystalline cellulose, croscarmellose sodium, talc, povidone, magnesium stearate, titanium dioxide, hypromellose, ethylcellulose, sodium lauryl sulfate, cetyl alcohol, triethyl citrate. Curam powder for oral suspension: Colloidal silicon dioxide, guar gum, aspartame, talc, trisodium citrate, citric acid, orange flavour, lemon flavour, peach-apricot flavour. These medicines do not contain lactose or gluten. |
Curam tablet: Blisters of 15, 21 and 100 tablets.
Curam Duo 500/125 tablet: Blisters of 10, 15, 21, 50, 80 and 100 tablets.
Curam powder for oral suspension: Bottles of 60 and 100 mL with a 5 mL dosing syringe.
All presentations, strengths or pack sizes may not be currently marketed.
Novartis New Zealand Limited, PO Box 99102, Newmarket, Auckland 1149
Telephone: 0800 354 335
Date of first approval: 21 August 2016
| Drug | Countries | |
|---|---|---|
| CURAM | Austria, Australia, Ecuador, Hong Kong, New Zealand, Singapore, South Africa |
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