Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CIPROFLOXACIN HYDROCHLORIDE
ANTAH PHARMA SDN. BHD.
CIPROFLOXACIN HYDROCHLORIDE
14Tablet Tablets
Drogsan Ilaclari San.ve Tic.A.S
_Consumer medicine information leaflet (RIMUP)_ SIPROSAN FILM TABLET Ciprofloxacin Hydrochloride (500mg) WHAT IS IN THIS LEAFLET 1. What Siprosan is used for 2. How Siprosan works 3. Before you use Siprosan 4. How to use Siprosan 5. While you are using Siprosan 6. Side effects 7. Storage and Disposal of Siprosan 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT SIPROSAN IS USED FOR It is used to treat: -Infections of the respiratory tract. -Infections of the middle ear and the sinuses. -Infections of the eyes. -Infections of the kidneys and/or the urinary tract. -Infections of the genital organs. -Infections of the abdominal cavity. -Infections of the skin and soft tissue. -Infections of the bones and joints. -Sepsis (severe infection). HOW SIPROSAN WORKS Siprosan is an antibiotic belonging to the fluoroquinolone family. The active substance is Ciprofloxacin. _Siprosan _ works by killing bacteria that cause infections. It only works with specific strains of bacteria. BEFORE YOU USE SIPROSAN _- When you must not use it_ Do not take Siprosan: -If you are hypersensitive to, or have had an allergic reaction to Ciprofloxacin or other quinolones. Symptoms of an allergic reaction may include: cough, 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; fainting; or hay fever-like symptoms. If you think you are having an allergic reaction, stop taking the medicine and contact your doctor immediately or go to the nearest hospital. - If you are children who have not finished your skeletal growth period yet. _Pregnancy and lactation_ - Do not take Siprosan if you are pregnant, trying to get pregnant or think you may be pregnant. - Do not take Siprosan if you are breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to use it_ Tell your doctor if: -you have history of diarrhea induced by antibiotic. -you have liver problem Baca dokumen lengkap
Name of Product Siprosan Film Tablet Name and Strength of Active Ingredient Ciprofloxacin, 500 mg Dosage Form Film coated tablet Product Description White oblong tablet Pharmacodynamics Ciprofloxacin is a new synthetic fluoroquinolone antibacterial agent. Ciprofloxacin inhibits DNA-gyrase, in susceptible organism. Since it has bactericidal effect during both logarithmic and stationary phases of growth in susceptible organism, there is almost no possibility of recurrence. Unlike 13-lactam antibiotics, ciprofloxacin is very active against susceptible bacteria because it has no parallel resistance with other antibiotics. Ciprofloxacin has a spectrum of activity on the following bacterias: E. Coli, Shigella, Salmonella, Klebsiella, Citrobacter, Enterobacter, Edwardsiella, Serratia, Hafnia, Proteus, Providencia, Yersinia, Morganella, Vibrio, Pasteurella, Aeromanas, Pleisomonas, Haemophilus, Gardnerella, Pseudomonas aeruginosa, Legionella, Neisseria, Campylobacter, Acinobacter, Moraxella, Flavobacterium, Bruceila, Streptococcus pyogenes and pneumoniae, Staphylococcus, Corynebacterium, Fusobacterium, Peptococcus, Peptostreptococcus, Eubacterium, Actinomyces, Mycoplasma, Ureaplasma. Ciprofloxacin generally is less active against Gram-positive like most of Streptococcus and Streptococcus faecalis than Gram-negative bacteria. Most of the Anaerobes are not sensitive. Pharmacokinetics Ciprofloxacin given as an oral tablet is rapidly and well absorbed from the gastrointestinal tract after oral administration. The absolute bioavailability is approximately 70% with no substantial loss by first pass metabolism. Maximum serum concentrations are attained in 1 to 2 hours after oral dosing. The serum elimination half-life in subjects with normal renal function is approximately 4 hours. Serum concentrations increase proportionately with doses up to 1000 mg. Approximately 40 to 50% of an orally administered dose is excreted in the urine as unchanged drug. The urinary excretion of ciprofloxacin is virtually complete within 24 hours aft Baca dokumen lengkap