Amoxicillin-Apotex

Active ingredient:

Amoxicillin trihydrate 31.2854 mg/mL equivalent to Amoxycillin 25 mg/mL (5% overage);  

Available from:

Apotex NZ Ltd

INN (International Name):

Amoxicillin trihydrate 31.2854 mg/mL (=Amoxycillin 25 mg/mL; 5% overage)

Dosage:

125 mg/5mL

Pharmaceutical form:

Powder for oral suspension

Composition:

Active: Amoxicillin trihydrate 31.2854 mg/mL equivalent to Amoxycillin 25 mg/mL (5% overage)   Excipient: Colloidal silicon dioxide Saccharin sodium Sodium citrate dihydrate Sorbitol Sunset yellow FCF Tutti frutti flavour 051880 AP0551 Xanthan gum

Units in package:

Bottle, plastic, HDPE, 100 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

DSM Sinochem Pharmaceuticals India Private Limited

Therapeutic indications:

Amoxicillin is indicated for the treatment of the following infections due to susceptible strains of sensitive organisms: Upper Respiratory Infections: Otitis media, pharyngitis, sinusitis and tonsillitis. Lower Respiratory Infections: Bronchitis, bronchopneumonia and lobar pneumonia. Urinary Tract Infections: Cystitis, cysto-pyelitis, urethritis, and gonococcal urethritis. Prophylaxis: against ??-haemolytic (viridans group) and ??-haemolytic Streptococci before dental, oral or upper respiratory tract surgery or instrumentation. Prophylaxis: of bacterial endocarditis in patients with any of the following conditions: congenital cardiac malformations, rheumatic and other acquired valvular lesions, prosthetic heart valves, previous history of bacterial endocarditis, hypertrophic cardiomyopathy, surgically constructed systemicpulmonary shunts, mitral valve prolapse with valvular regurgitation or mitral valve prolapse without valvular regurgitation but associated with thickening and/or redundancy of the valve leaflets. Amoxicillin is further indicated for the treatment of cutaneous infections. In emergency cases where the causative organism is not yet identified, therapy may be initiated with amoxicillin on the basis of clinical judgement, while awaiting the results of bacteriologic studies to determine its antimicrobial sensitivity.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE - 100 mL - 24 months from date of manufacture stored at or below 25°C 14 days reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2000-04-06