Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLAVULANIC ACID; AMOXYCILLIN
RANBAXY (MALAYSIA) SDN. BHD.
CLAVULANIC ACID; AMOXYCILLIN
60ml mL
Sun Pharmaceutical Industries Limited
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ ENHANCIN SUSPENSION Amoxicillin/clavulanic acid (312.5mg/5mL) WHAT IS IN THIS LEAFLET 1. What Enhancin is used for 2. How Enhancin works 3. Before you use Enhancin 4. How to use Enhancin 5. While you are using Enhancin 6. Side Effects 7. Storage and Disposal of Enhancin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT ENHANCIN IS USED FOR Enhancin is used to treat the following bacterial infections in different parts of the body: • respiratory tract infections • urinary tract infections • skin and soft tissue infections including dental infections, animal bites • bone and joint infections HOW ENHANCIN WORKS Enhancin Suspension is an antibiotic that contains amoxicillin and clavulanic acid, which works by killing bacteria that cause infections. BEFORE YOU USE ENHANCIN - _When you must not use it _ Do not give Enhancin to your child if they: • are allergic to amoxicillin, clavulanic acid, other penicillin- based antibiotics, or similar antibiotics called cephalosporinsor any of the other ingredients of this medicine (listed in Product Description). • have ever had liver problems or jaundice (yellowing of the skin and/or whites of the eyes) when taking an antibiotic. If you are not sure your child should take Enhancin Suspension or not, talk to their doctor or pharmacist before giving Enhancin. - _Before you start to use it _ Tell your doctor if your child: • have any viral infections (example, common cold) • are being treated for liver or kidney problems • are not urinating regularly - _Taking other medicines _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Tell your doctor or pharmacist if your child is taking: • probenecid, allopurinol (medication to treat gout/ joint disease) • warfarin (to prevent blood clot) • methotrexate (a medicine used to treat cancer or rheuma Lire le document complet
1 _For the use of a Registered Medical Practitioner Only_ _ _ PRESCRIBING INFORMATION ENHANCIN SUSPENSION (AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION USP) COMPOSITION ENHANCIN SUSPENSION Each 5 ml of the constituted suspension contains: Amoxicillin USP (as trihydrate) Equivalent to amoxicillin………………..…………………250 mg Potassium clavulanate Equivalent to clavulanic acid ….…………………….……62.5 mg _EXCIPIENTS:_ Butylated Hydroxytoluene, Xanthan Gum, Monosodium Citrate, Sodium Citrate, Passion Fruit Flavour, Aspartame, Sorbitol, Sodium Benzoate DESCRIPTION White to off - white powder forming a white to pale yellow suspension on constitution with water. The resulting suspension has a characteristic flavour. PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES _PHARMACODYNAMIC PROPERTIES_ _ _ Pharmacotherapeutic group: Combinations of penicillins, incl. Beta-lactamase inhibitors; ATC code: J01CR02. Mechanism of action Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding 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 penicillins. It inactivates some b e t a -lactamase enzymes thereby preventing inactivation of amoxicillin. Clavulanic acid alone does not exert a clinically useful antibacterial effect. Pharmacokinetic/pharmacodynamic relationship The time above the minimum inhibitory concentration (T>MIC) is considered to be the major determinant of efficacy for amoxicillin. 2 Mechanisms of resistance The two m Lire le document complet