Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CEFUROXIME AXETIL
HEALOL PHARMACEUTICALS SDN. BHD.
CEFUROXIME AXETIL
50tablet Tablets
Aurobindo Pharma Limited (Unit VI)
AUROXETIL _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ Cefuroxime axetil (125mg, 250mg, 500mg) 1 WHAT IS IN THIS LEAFLET 1. What Auroxetil is used for 2. How Auroxetil works 3. Before you use Auroxetil 4. How to use Auroxetil 5. While you are using it 6. Side effects 7. Storage and Disposal of Auroxetil 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT IS AUROXETIL USED FOR Your doctor may have prescribed Auroxetil tablets to treat one of the following infections: • Upper respiratory tract infections (including infections occurring in the ears, sinuses, tonsils and throat) • Lower respiratory tract infections, inflammation to the lungs (pneumonia), inflammation of the lung air passages (acute bronchitis) and acute exacerbations of chronic bronchitis • Bladder infections • Skin infections recurring boils, ulcers, contagious infection of the skin (impetigo) • Sexually transmitted infections such as Gonorrhoea, Gonococcal urethritis and inflammation of the cervix (cervicitis) HOW AUROXETIL WORKS Auroxetil is an antibiotic and belongs to a class of medicines called ‘cephalosporins’. It is active against a wide range of bacteria. It is used to treat certain types of infections and works by killing certain types of bacteria. BEFORE YOU USE AUROXETIL _-When you must not use it _ If you are hypersensitive (allergic) to cephalosporin class of antibiotics or any of the other ingredients of Auroxetil. Tell your doctor if you are not sure about any of the above: your doctor will be able to advise you. _-Before you start to use it _ Tell your doctor before you start to take this medicine if: • You have previously suffered from an allergic reaction to penicillins or other beta-lactam antibiotics • You suffer from any other condition which causes vomiting, diarrhoea as this could stop your medicine from being absorbed properly. In this case your doctor may recommend an injection of cefuroxime If after starting treatment, you begin to experience symptoms of an Read the complete document
URINARY TRACT INFECTIONS: 125 mg twice daily. ACUTE EXACERBATIONS OF CHRONIC BRONCHITIS: Cefuroxime Sodium 750 mg 2-3 times a day (IV or IM) for 48-72 hrs, followed by Cefuroxime Axetil 500 mg twice a day oral therapy for 5-10 days. Sequential Therapy: PNEUMONIA: Cefuroxime Sodium 1.5 g 2-3 times a day (IV or IM) for 48-72 hrs followed by Cefuroxime Axetil (Cefuroxime axetil) 500 mg twice a day oral therapy for 7-10 days. PYELONEPHRITIS: 250 mg twice daily. UNCOMPLICATED GONORRHOEA: Single dose of 1 g. _ADULTS: _MOST INFECTIONS: 250 mg twice daily. MILD TO MODERATE LOWER TRACT INFECTIONS EG, BRONCHITIS: 250 mg twice daily. MORE SEVERE LOWER TRACT INFECTIONS (OR IF PNEUMONIA IS SUSPECTED): 500 mg twice daily. WARNING AND PRECAUTIONS Hypersensitivity to cephalosporins. CONTRAINDICATIONS Should be taken with food (Take immediately after food). Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe cutaneous adverse reactions) have been reported in patients receiving therapy with β – lactams. Before initiating therapy with cefuroxime axetil, careful inquiry should be Special care is indicated in patients who have experienced an allergic reaction to penicillins or other β-lactams. Peak serum levels (2-3 mg/L for a 125-mg dose, 4-6 mg/L for a 250-mg dose, 5-8 mg/L for a 500-mg dose and 9-14 mg/L for a 1-g dose) occur approximately 2-3 hrs after dosing when taken after food, unlike IV dosing which peaks immediately. Optimum absorption occurs when it is administered after a meal. TOXICOLOGY: Preclinical Safety Data: Animal toxicity studies indicated that Cefuroxime axetil is of low toxicity with no significant findings. Following administration of Cefuroxime axetil tablets, peak serum levels (2.9 mg/L for a 125-mg dose, 4.4 mg/L for a 250-mg dose, 7.7 mg/L for a 500-mg dose and 13.6 mg/L for a 1-g dose) occur approximately 2.4 hrs after dosing when taken with food. Serum levels of Cefuroxime are reduced by dialysis. tract and rapidly hydrolysed in the intestinal mucosa and blood Read the complete document