Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
NORFLOXACIN
MILRIN PHARMACEUTICAL CO. (M) SDN BHD
NORFLOXACIN
100Tablet Tablets
The United Drug (1996) Co., Ltd.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ NORFOX TABLET Norfloxacin (400mg) 1 WHAT IS IN THIS LEAFLET 1. What is Norfox used for 2. How does Norfox work 3. Before you take Norfox 4. How to take Norfox 5. While you are using it 6. Possible side-effects 7. Storage and disposal of Norfox 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT IS NORFOX USED FOR? Norfox contains the active ingredient norfloxacin. It is used for the treatment of urinary tract and gastrointestinal infections, gonorrhea (sexually transmitted infection) and prostate inflammation. HOW DOES NORFOX WORK? Norfox is a quinolone antibiotic that kills susceptible bacteria which is the cause of infections. BEFORE YOU TAKE NORFOX - _When must you not take it _ _ _ Do not take Norfox if you: • are still a growing adolescent, pregnant or breastfeeding • are allergic to norfloxacin and/or any antibiotics that belong to the group of quinolone. If you are not sure, talk to your doctor or pharmacist before taking Norfox. - _Before taking Norfox _ You should tell your doctor if you have: • kidney and/or liver impairment • damaged central nervous system • seizures or any other condition that causes fits • a condition causing tired and weak muscles, called myasthenia gravis Tell your healthcare providers if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm). Tell your healthcare providers if you have experienced a previous episode of aortic dissection (a tear in the aorta wall). Tell your healthcare providers if you have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e.g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers- Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet´s disease, high blood pressure, or known atherosclerosis). You should not take fluoroquinolone antibacterial medic Lire le document complet
PACKAGE INSERT NORFOX TABLETS COMPOSITION: Norfloxacin 400mg per tablet. INDICATION: Indicated for the oral treatment of adults with complicated and uncomplicated urinary tract infections that are caused by susceptible strains of microorganisms. Consideration should be given to official guidance on the appropriate use of antibacterial agents. PHARMACOLOGY: Norfloxacin is a fluorinated 4 quinolone antimicrobial agent structurally related to nalidixic acid but with a wider antibacterial spectrum and greater activity. It has been shown to be bactericidal with the MIC being close to the MBC and to act by inhibiting the A subunit of DNA gyrase (topoisomerase) which is essential in the reproduction of bacterial DNA. The reported minimum inhibitory concentrations for susceptible bacteria range from 0.006 to 1.6 microgram per mL. Sensitive Gram negative organism includes Escherichia coli, Citrobacter, Enterobacter, Klebsiella, Proteus, Salmonella, Shigella, Yersinia, Pseudomonas aeruginosa, Haemophilus, Neisseria, Acinetobacter, Campylobacter, Providencia, Serratia and Legionella. Susceptible Gram positive organism includes Staphylococci, Streptococci and Listeria. Norfloxacin has little antifungal activity. Maximum plasma concentration of about 1.5 microgram of Norfloxacin per ml have been achieved 1 to 2 hours after the administration of a 400 mg dose by mouth. Norfloxacin is 14% bound to plasma protein. The plasma half life is about 4 hours. 30 % is excreted unchanged in the urine within 24 hours and thus producing a high urinary concentration. Some metabolism occurs, possibly in the liver have been identified, some of which has antibacterial activity. Norfloxacin has been detected in bile, prostatic fluid, umbilical cord blood and amniotic fluid. DOSAGE AND ADMINISTRATION: Norfloxacin is administered orally, 1 hour before or 2 hours after a meal. Urinary Tract Infections: Complicated or Uncomplicated: 400 mg twice daily Gastrointestinal Infections: 400 mg twice daily Gonorrhea: 800 mg single dose Acute or chronic pro Lire le document complet