국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CIPROFLOXACIN HCL
APEX PHARMACY MARKETING SDN. BHD.
CIPROFLOXACIN HCL
100Tablet Tablets
DELORBIS PHARMACEUTICALS LTD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ CIPROX TABLET _ _ Ciprofloxacin (250mg & 500mg) 1 WHAT IS IN THIS LEAFLET 1. What Ciprox is used for 2. How it works 3. Before you use Ciprox 4. How to use Ciprox 5. While you are using it 6. Side effects 7. Storage and disposal of Ciprox 8. Product description 9. Manufacturer 10. Product registration holder 11. Date of revision 12. Serial number WHAT CIPROX IS USED FOR CIPROX is used to treat the following bacterial infections: Uncomplicated and complicated infections caused by ciprofloxacin- sensitive pathogens. Infections of the respiratory tract. In the treatment of outpatients with pneumonia due to Pneumococcus, ciprofloxacin should not be used as a first choice of drug. Ciprofloxacin can be regarded as an advisable treatment for pneumonias caused by Klebsiella, Enterobacter, Proteus, E. coli, Pseudomonas, Haemophilus, Branhamella, Legionella and Staphylococcus. Infections of the middle ear (otitis media), of the paranasal sinuses (sinusitis), especially if these are caused by gram- negative organisms including Pseudomonas or by Staphylococcus. Infections of the eyes. Infections of the kidneys and/or the efferent urinary tract. Infections of the genital organs, including adnexitis, gonorrhoea, prostatitis. Infections of the abdominal cavity (eg, infections of the gastrointestinal tract or of the biliary tract, peritonitis). Infections of the skin and soft tissue. Infections of the bones and joints. Sepsis. Infections or imminent risk of infection (prophylaxis) in patients whose immune system has been weakened (eg, patients on immunosuppressants or have neutropenia). HOW IT WORKS CIPROX is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria. BEFORE YOU USE CIPROX _- When you must not use it _ DO NOT TAKE CIPROX IF YOU ARE: allergic (hypersensitive) to the 전체 문서 읽기
COMPOSITION Each tablet contains equivalent to Ciprofloxacin 250 mg Each tablet contains equivalent to Ciprofloxacin 500 mg PRODUCT DESCRIPTION White oblong, 14.3 x 6.3 mm, film coated tablet, scored on both side White oblong, 17.3 x 8.3 mm, film coated tablet, scored on both side PHARMACODYNAMICS Ciprofloxacin is a synthetic 4-quinolone derivative, with bactericidal activity. It acts via inhibition of bacterial DNA gyrase, ultimately resulting in interference with DNA function. Ciprofloxacin is highly active against a wide range of Gram-positive and Gram-negative organisms and has shown activity against some anaerobes, Chlamydia spp. and Mycoplasma spp. Ciprofloxacin is also suitable for use in combination with penicillins, cephalosporins, aminoglycosides and tetracyclines where additive behaviour is usually observed. PHARMACOKINETICS Absorption of ciprofloxacin occurs rapidly, mainly from the small intestine (Abs. T1/2 = 2-15 min). Plasma levels are dose-related and peak 0.5-2.0 hrs after dosing. The AUC also increases dose proportionately after administration of both single and repeated oral doses. The oral bioavailability is approximately 70-80%. Distribution of ciprofloxacin within tissues is wide and the volume of distribution high, though slightly lower in the elderly. Protein binding is low (between 19-40%). Elimination of ciprofloxacin and its metabolites occurs rapidly, primarily by the kidney. After single dose of ciprofloxacin, 55% are eliminated by the kidney and 39% in the faeces within 5 days. The elimination half-life of unchanged ciprofloxacin over a period of 24 - 48 hrs post dose is 3.1-5.1 hrs. Even though, studies with severely renally impaired patients (creatinine clearance < 20ml/minute) do not give clear indications, it is recommended to reduce by half the total daily dose. Results of studies in paediatric cystic fibrosis patients have shown dosages of 20 mg/kg orally twice daily is recommended to achieve plasma concentration/time profiles comparable to those achieved in the adult populati 전체 문서 읽기