国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
amoxicillin trihydrate,potassium clavulanate
Southern Cross Pharma Pty Ltd
amoxicillin trihydrate,potassium clavulanate
Registered
C:Products/Amoxiclav/Apo/CMI Apo 9jul08 9/7/09 Page 1 of 8 APO-AMOXYCILLIN AND CLAVULANIC ACID 500 MG/125 MG [AMOXICILLIN TRIHYDRATE AND POTASSIUM CLAVULANATE] CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 being given this medication against the benefits it is expected to have for you. If you have any concerns about being given this medicine, ask your doctor or pharmacist. Keep this leaflet. You may need to read it again. WHAT APO-AMOXYCILLIN AND CLAVULANIC ACID 500 MG/125 MG IS USED FOR APO-Amoxycillin and Clavulanic acid 500 mg/125 mg tablets contain two active ingredients. One of these is from the penicillin group of antibiotics and is called amoxicillin (from amoxicillin trihydrate) and the other is clavulanic acid (from potassium clavulanate). APO-Amoxycillin and Clavulanic acid 500 mg/125 mg tablets are used to treat a wide range of infections caused by bacteria. These infections may affect the chest (bronchitis or pneumonia), bladder (cystitis), sinuses (sinusitis), the ears (otitis media) or the skin. APO-Amoxycillin and Clavulanic acid 500 mg/125 mg tablets work by killing the bacteria that cause these infections. APO-Amoxycillin and Clavulanic acid 500 mg/125 mg tablets will not work against infections caused by viruses such as colds or the flu. Your doctor may prescribe APO-Amoxycillin and Clavulanic acid 500 mg/125 mg tablets for another use. If you want more information ask your doctor. There is no evidence that APO-Amoxycillin and Clavulanic acid 500 mg/125 mg tablets are addictive. BEFORE TAKING APO-AMOXYCILLIN AND CLAVULANIC ACID 500 MG/125 MG FOR THE FIRST TIME _Do not take APO-Amoxycillin and Clavulanic acid 500 mg/125 mg tablets if: _ _ _ C:Products/Amoxiclav/Apo/CMI Apo 9jul08 9/7/09 Page 2 of 8 you have had an allergic rea 阅读完整的文件
Product Information – Australia APO-Amoxycillin and Clavulanic Acid 500 mg / 125 mg tablets Page 1 APO-AMOXYCILLIN / CLAVULANIC ACID 500/125 TABLETS NAME OF THE MEDICINE Amoxycillin trihydrate and potassium clavulanate. CHEMICAL NAMES: Amoxycillin trihydrate: (2S,5R,6R)-6-[(R)-2-amino-2-(4-hydroxyphenyl)acetamido]-3,3- dimethyl-7oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. Potassium Clavulanate: potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1- azabicyclo[3.2.0]heptane-2-carboxylate. STRUCTURAL FORMULAE: Amoxycillin trihydrate: Potassium clavulanate: MOLECULAR FORMULAE: Amoxycillin trihydrate: C 16 H 19 N 3 O 5 S.3H 2 0 Potassium clavulanate: C 8 H 8 KNO 5 MOLECULAR WEIGHTS: Amoxycillin trihydrate: 419.5 Potassium clavulanate: 237.3 CAS REGISTRY NUMBERS: Amoxycillin trihydrate: 61336-70-7 Potassium clavulanate: 61177-45-5 Product Information – Australia APO-Amoxycillin and Clavulanic Acid 500 mg / 125 mg tablets Page 2 DESCRIPTION Amoxycillin and Clavulanic Acid 500 mg / 125 mg is a combination product containing the semi-synthetic antibiotic, amoxycillin (as the trihydrate) and the β-lactamase inhibitor, potassium clavulanate (the potassium salt of clavulanic acid). Amoxycillin is susceptible to hydrolysis by β-lactamases. Clavulanic acid is produced by the fermentation of _Streptomyces clavuligerus_. It is an irreversible inhibitor of many β-lactamase enzymes except type 1 (Richmond). It is a β-lactam compound with only weak antibacterial activity. PHARMACOLOGY ACTIONS: Semisynthetic penicillin antibiotic (amoxycillin) and beta-lactamase inhibitor (clavulanic acid). PHARMACOKINETICS Pharmacokinetic parameters obtained for 875 mg/125 mg and 500 mg/125 mg amoxycillin/clavulanic acid tablets show a linear relationship for both strengths. Absorption: Amoxycillin and Clavulanic Acid tablets are stable in the presence of gastric acid. The two components are rapidly absorbed if administered before or with a meal, but if given after meals, the serum levels of clavulanic acid ar 阅读完整的文件