Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMOXYCILLIN TRIHYDRATE; DILUTED POTASSIUM CLAVULANATE
ZULAT PHARMACY SDN. BHD.
AMOXYCILLIN TRIHYDRATE; DILUTED POTASSIUM CLAVULANATE
10 x 10'stablet Tablets
Medopharma Private Limited
_Consumer Medication Information Leaflet (RiMUP) _ CLEDOMOX 625MG TABLET Amoxicillin/Clavulanic Acid (500mg/125mg) WHAT IS IN THIS LEAFLET 1. What Cledomox 625mg Tablet is used for 2. How Cledomox 625mg Tablet works. 3. Before you use Cledomox 625mg Tablet. 4. How to use Cledomox 625mg Tablet. 5. While you are using it. 6. Side effects. 7. Storage and disposal of Cledomox 625mgTablet. 8. Product description. 9. Manufacturer and Product Registration Holder. 10. Date of revision. WHAT CLEDOMOX 625MGTABLET IS USED FOR Cledomox 625mg Tablet is used for the treatment of Upper respiratory tract infections - Lower respiratory tract infections - Genito-urinary tract and abdominal infections - Skin and soft tissue infections - Bone and joint infections - Dental infections - Other infections HOW CLEDOMOX 625MGTABLET WORKS Cledomox 625mgTablet is an antibiotic and works by killing bacteria that cause infections. It contains two active ingredients. One of these is a penicillin called amoxicillin and the other is clavulanic acid. BEFORE YOU USE CLEDOMOX 625MGTABLET _- When you must not use it _ Do not take Cledomox 625mgTablet if: If you are having history of Allergic reactions to any penicillin, _beta-lactamase _ _inhibitors _ or _other beta-lactam _ _antibiotics_ . Some of the symptoms of an allergic reaction may include skin rash, itching, difficulty in breathing and swelling of the face or tongue. If you are patients with previous history of amoxicillin with Clavulanate or penicillin associated jaundice/liver dysfunction. Please consult your doctor before start to use Cledomox 625mgTablet if you are pregnant, plan to become pregnant, breast- feeding or intend to breast-feed. Your doctor will have weighed the risks of you taking Cledomox 625mgTablet against the benefits they expect it will have for you. - _Before you start to use it _ Tell your doctor if: If you have liver problem/ cholestatic jaundice. If you have moderate or severe kidney impairment. If you are hypersensitive to penicillin. If Olvassa el a teljes dokumentumot
1 4 COMPOSITION: CLEDOMOX 625 Each film-coated tablet contains: Amoxicillin Trihydrate BP 574.05mg is equivalent to Amoxicillin 500 mg Diluted Potassium Clavulanate BP ..297.87mg (Diluted Potassium Clavulanate contains 148.937mg Potassium Clavulanate (equivalent to 125mg Clavulanic acid) + Avicel Blend (microcrystalline cellulose) …148.937mg DESCRIPTION: CLEDOMOX625: White oval shaped film coated tablets PHARMACODYNAMICS: Amoxicillin is semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillinbinding proteins, PBPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death. Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes. Clavulanic acid is a beta-lactam structurally related to penicillin. It inactivates some beta-lactamase enzymes thereby preventing inactivation of amoxicillin. Clavulanic acid alone does not exert a clinically useful antibacterial effect. PK/PD relationship The time above the minimum inhibitory concentration (T>MIC) is considered to be the major determinant of efficacy for amoxicillin. Mechanisms of resistance The two main mechanisms of resistance to amoxicillin/clavulanic acid are: • Inactivation by those bacterial beta-lactamases that are not themselves inhibited by clavulanic acid, including class B, C and D. • Alteration of PBPs, which reduce the affinity of the antibacterial agent for the target. Impermeability of bacteria or efflux pump mechanisms may cause or contribute to bacterial resistance, particularly in Gram-negative bacteria. Commonly susceptible species Aerobic Gram-positive micro-organisms _Enterococcus faecalis_ _Gardnerella vaginalis_ _Staphylococcus aureus_ (methicil Olvassa el a teljes dokumentumot