Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
AMOXICILLIN TRIHYDRATE
Athlone Laboratories Ltd
125 Milligram
Powder for Oral Suspension
1993-10-21
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Amoxycillin Sachet Sugar Free 125mg Powder for Oral Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of product contains 125 mg of amoxicillin as amoxicillin trihydrate. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Powder for oral suspension A lemon coloured, dry, free flowing powder with a characteristic lemon flavour for reconstitution in water. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Amoxycillin is a broad spectrum antibiotic indicated for the treatment of commonly occurring bacteria infections such as: Upper respiratory infections, otitis media, acute and chronic bronchitis, lobar and bronchopneumonia, cystitis, urethritis, pyelonephritis, bacteriuria in pregnancy, gynaecological infections including puerperal sepsis and septic abortion, gonorrhoea, peritonitit, intra - abdominal sepsis, septiceamia, bacterial endocarditis, typhoid and parathphoid fever, skin and soft tissue infections, osteomyelitis. Amoxycillin may be used for the prevention of bacteraemia associated with procedures such as dental extraction in patients as risk of developing bacterial endocarditis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION DOSAGE: The absorption of Amoxycillin is virtually unimpaired by the presence of food. STANDARD ADULT DOSE: 250mg three times daily by the oral route. In cases of severe infection the dosage may be doubled. CHILDREN: (Up to 10 years). 125mg three times daily by the oral route. 4.3 CONTRAINDICATIONS Use in patients with hypersensitivity to traditional and semi-synthetic penicillins or cephalosporins. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE As with other penicillins, side effects are rare and usually of a mild and transitory nature. Gastrointestinal side effects, such as nausea, vom Read the complete document