Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
AMPICILLIN TRIHYDRATE
Athlone Laboratories Ltd
250 Milligram
Capsules Hard
1981-05-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ampicillin Capsules BP 250 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains Ampicillin Trihydrate equivalent to 250 mg of Ampicillin. For full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard (Capsule) An opaque capsule with a grey cap and a red body with ‘AMP 250’ printed on the capsule shell and containing a white to creamy granular powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ampicillin capsules BP are indicated for the oral therapy of bacterial infections caused by ampicillin-sensitive organisms. Such indications include infections of the upper and lower respiratory tract, genito-urinary tract and the gastro-intestinal tract. Specific indications include ear and soft tissue infections and gonorrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Usual Adult/Elderly Dosage The usual dosage is 250mg every 6 hours. All recommended dosages below are a guide only. In severe infections, the dosages may be increased at the direction of the physician. Doses should be taken half to one hour before meals. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Consult local or national prescribing guidelines for antibiotic use before prescribing. Where possible, use only where antibiotic sensitivity is known or suspected. Ear, nose and throat infections: 250mg four times a day Bronchitis: Routine therapy: 250mg four times daily High dose therapy: 1g four times a day Pneumonia: 500mg four times daily Urinary tract infections: 500mg three times daily Gastro-intestinal infections: 500 - 750mg three to four times daily Enteric fevers: Acute: 1-2g four times daily for two weeks Carriers: 1-2g four times daily for four to 12 weeks Read the complete document