País: Tanzània
Idioma: anglès
Font: Tanzania Medicinces & Medical Devices Authority
Amoxicillin
THEON PHARMACEUTICALS LIMITED, INDIA
Antibacterials for systemic use, beta-lactam anti
Amoxicillin
250
Tablets
theon pharmaceuticals limited, INDIA
Physical description: Each hard gelatin capsule has maroon color cap and yellow color body; size ‘2’ having white granular powder; Local technical representative: Heko Pharmacy Limited (7718)
Registered/Compliant
2021-08-20
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Amoxicillin Capsules USP 250 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard gelatin capsule contains: Amoxicillin Trihydrate USP eq. to Amoxicillin. 250 mg ......... Excipients q.s. ....................... Approved colour used in capsule shells For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral Solid Dosage form, hard gelatin capsules Each hard gelatin capsule shell having maroon color cap and yellow color body, size “2” filled with off white powder. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS The treatment of bacterial infections caused by amoxicillin-susceptible organisms. It is principally indicated for respiratory, middle ear and urinary tract infections. • Respiratory tract - pneumonia, acute and chronic bronchitis, upper respiratory tract infections • Chronic bronchial sepsis • Lobar and bronchopneumonia • ENT - otitis media • Urinary tract - cystitis, urethritis, pyelonephritis • Biliary and intra-abdominal infections • Bacteriuria in pregnancy • Gynaecological infections including puerperal sepsis and septic abortion • Gonorrhoea • Peritonitis • Intra-abdominal sepsis • Septicaemia • Bacterial endocarditis • Skin and soft tissue infections • Osteomyelitis • Meningitis • Enteric fevers (typhoid and paratyphoid fevers) • Dental abscess (as an adjunct to surgical management) • In children with urinary tract infection the need for investigation should be considered. Prophylaxis of endocarditis: The prevention of bacteraemia, associated with procedures (e.g. dental), in patients at risk of developing bacterial endocarditis. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Treatment of Infection: Adult dosage (including elderly patients): Standard adult dosage: 250mg every 8 hours, increasing to 500mg every 8 hours in severe infections. High dosage therapy (maximum recommended oral dosage 6 g daily in divided doses): A dosage of 3 g twice daily is recommended in app Llegiu el document complet