País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
ciprofloxacin hydrochloride
Amneal Pharma Australia Pty Ltd
ciprofloxacin hydrochloride
Registered
_Ciprofloxacin AN tablets – Consumer Medicine Information _ _ _ _Ciprofloxacin AN CMI v2.0 _ _ _ _ _ _Page 1 _ CIPROFLOXACIN AN TABLETS _Ciprofloxacin(as hydrochloride) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CIPROFLOXACIN AN tablets. 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 and benefits. Your doctor has weighed the risks of you taking CIPROFLOXACIN AN tablets 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 need to read it again. WHAT CIPROFLOXACIN AN IS USED FOR CIPROFLOXACIN AN tablets are used for the treatment of infections of the lungs, skin, bones, joints, kidneys, bladder, prostate and bowel. CIPROFLOXACIN AN is also used to treat inhalational anthrax (an infection caused by breathing in the spores of bacteria). CIPROFLOXACIN AN tablets contain the active ingredient, ciprofloxacin, which is an antibiotic belonging to a group of medicines called quinolones (pronounced kwin-o-lones). These antibiotics work by killing the bacteria that are causing your infection. CIPROFLOXACIN AN will not work against infections caused by viruses such as colds or the flu. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. BEFORE YOU TAKE CIPROFLOXACIN AN _WHEN YOU MUST NOT TAKE _ _IT _ DO NOT TAKE CIPROFLOXACIN AN IF YOU HAVE AN ALLERGY TO: ciprofloxacin, the active ingredient in CIPROFLOXACIN AN any of the ingredients listed at the end of this leaflet other medicines belonging to the quinolone chemical family (e.g. moxifloxacin, norfloxacin, nalidixic acid). Some of the symptoms of an allergic reaction may include: shortness of breath wheezing or difficulty breathing swelling of the face, lips, tongue or Leer el documento completo
_Ciprofloxacin AN tablets Product Information _ _ _ _Amneal Pharma Pty Ltd_ Doc ID: 49.AN.P.2.0 Page 1 of 17 CIPROFLOXACIN AN _ _ _(CIPROFLOXACIN HYDROCHLORIDE TABLETS) _ _ _ PRODUCT INFORMATION NAME OF THE MEDICINE The name of the medicine is ciprofloxacin as ciprofloxacin hydrochloride. O O F OH . HCL N N HN CHEMICAL NAME: 1-Cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3- carboxylic acid hydrochloride MOLECULAR FORMULA: C 17 H 19 ClFN 3 O 3 MOLECULAR WEIGHT: 367.8 CAS REGISTRY NUMBER: _[93107-08-5]_ DESCRIPTION Ciprofloxacin hydrochloride is a pale yellow crystalline powder, slightly hygroscopic. It is soluble in water, slightly soluble in methanol, very slightly soluble in ethanol, practically insoluble in acetone, in ethyl acetate and in methylene chloride. CIPROFLOXACIN AN is available as tablets containing 250 mg, 500 mg & 750 mg ciprofloxacin (as hydrochloride). CIPROFLOXACIN AN tablets contain the following inactive ingredients: m icrocrystalline cellulose, sodium starch glycollate type A, povidone, colloidal anhydrous silica, magnesium stearate, hypromellose, macrogol 400 & titanium dioxide. PHARMACOLOGY Ciprofloxacin hydrochloride is a synthetic carboxyquinolone derivative with broad spectrum antimicrobial activity. Ciprofloxacin 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. Serum concentrations increase in a dose-proportional manner and were, after multiple doses, as shown below: Dose (mg) Maximum Serum Concentration (μg/mL) Area Under Curve (AUC) (μg.hr/mL) 250 1.4 5.4 500 2.6 10.6 750 3.4 15.0 _Ciprofloxacin AN tablets Product Information _ _ _ _Amneal Pharma Pty Ltd_ Doc ID: 49.AN.P.2.0 Page 2 of 17 Maximum serum concentrations are attained 1 to 2 hours after oral dosing. Mean concentrations 12 hours after dosing with 250, 500 or 750 mg are 0.1, 0.2 and 0.4 μg/mL respectively. The serum elimination half-life in subjects with normal re Leer el documento completo