Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
flucloxacillin sodium monohydrate
Apotex Pty Ltd
flucloxacillin sodium monohydrate
Registered
APO-FLUCLOXACILLIN _Flucloxacillin sodium_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about flucloxacillin. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT THIS MEDICINE IS USED FOR Flucloxacillin is used to treat infections in different parts of the body caused by bacteria. It belongs to a group of medicines called penicillins. _HOW IT WORKS_ Flucloxacillin is an antibiotic that works by killing the bacteria that are causing your infection. Flucloxacillin will not work against infections caused by viruses, such as colds or flu. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. This medicine is not addictive. There is not enough information to recommend the use of this medicine for children under the age of 2 years BEFORE YOU TAKE THIS MEDICINE WARNING: FLUCLOXACILLIN CAN CAUSE SEVERE LIVER DAMAGE, PARTICULARLY IN OLDER PATIENTS AND THOSE WHO TAKE IT FOR MORE THAN 14 DAYS. _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE IF YOU ARE ALLERGIC TO: • flucloxacillin • penicillin antibiotics • cephalosporin antibiotics • beta-lactam antibiotics including imipenem and aztreonam • any of the ingredients listed at the end of this leaflet. Symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue, throat or other parts of the body • rash, itching or hives on the skin DO NOT TAKE Read the complete document
1 AUSTRALIAN PRODUCT INFORMATION – APO-FLUCLOXACILLIN (FLUCLOXACILLIN SODIUM MONOHYDRATE) 1 NAME OF THE MEDICINE Flucloxacillin sodium monohydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg or 500 mg flucloxacillin (as sodium monohydrate) as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM 500 MG CAPSULE: Size 0 capsule with blue cap and blue body printed with “F500”. 250 MG CAPSULE: Size 2 capsule with blue cap and blue body printed with “F250”. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of confirmed or suspected staphylococcal and other Gram-positive coccal infections including pneumonia, osteomyelitis, skin and soft tissue and wound infections, infected burns, cellulitis. 4.2 DOSE AND METHOD OF ADMINISTRATION The oral dose should be administered half to one hour before meals. _Usual Adult Dose:_ 250 mg, 6 hourly. _Children:_ 2–10 years: half adult dose. NOTE: In severe infections the dosage may be increased. IMPAIRED HEPATIC FUNCTION Adjustment of dosage may not be necessary as flucloxacillin is not metabolised in the liver to any appreciable extent. However, during prolonged treatment, it is advisable to check periodically for hepatic dysfunction (see section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). IMPAIRED RENAL FUNCTION As flucloxacillin is excreted to a large extent by the kidney, the dose or dose interval may need modification in patients with renal failure, as the half-life in these patients is increased. Dosage recommendations for various plasma creatinine levels for patients with impaired renal function are not available. Flucloxacillin is not significantly removed by haemodialysis. 2 4.3 CONTRAINDICATIONS Flucloxacillin is contraindicated for: • patients who are hypersensitive to beta-lactam antibiotics (e.g. penicillins, cephalosporins) • patients with a previous history of flucloxacillin-associated jaundice/hepatic dysfunction • use in the eye. 4.4 SPECIAL WARNINGS Read the complete document