Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Amoxicilin Trihydrate; POTASSIUM CLAVULANATE
Ascend Laboratories Sdn Bhd
Amoxicilin Trihydrate; POTASSIUM CLAVULANATE
1 BOTTLE
ALKEM LABORATORIES LIMITED
2 ALCLAV 642.9MG/5ML POWDER FOR ORAL SUSPENSION (AMOXICILLIN 600MG/5ML AND CLAVULANIC ACID 42.9MG/5ML POWDER FOR ORAL SUSPENSION) _Consumer Medication Information Leaflet (RIMUP) _ WHAT IS IN THIS LEAFLET 1. What Alclav is used for 2. How Alclav works 3. Before you use Alclav 4. How to use Alclav 5. While you are using it 6. Side effects 7. Storage and disposal of Alclav 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial number WHAT ALCLAV_ _IS USED FOR Alclav _ _ is used to treat recurrent or persistent infections in the ears (acute otitis media) of pediatrics. This infection is caused by the bacterias ( _Streptococcus _ _pneumoniae,_ _Haemophilus influenzae and _ _Moraxella catarrhalis_ ). HOW ALCLAV_ _WORKS_ _ Alclav _ _ is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins” that can sometimes be stopped from working (made inactive). The other active component (clavulanic acid) stops this from happening. BEFORE YOU USE ALCLAV_ _ - _When you must not use it _ • If your child is allergic (hypersensitive) to Amoxicillin, Clavulanic acid, Penicillin, Cephalosporin or any of the other ingredients of Alclav _ _ • If your child has ever had a severe allergic (hypersensitive) reaction to any other antibiotic. This can include a skin rash or swelling of the face or neck. • If your child has ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic. • If your child has has Clostridium difficile associated diarrhea (CDAD) after taking antibiotic • If you are not sure, talk to the doctor or pharmacist before giving Alclav _Pregnancy and lactation _ Do not use Alclav if you are pregnant, trying to get pregnant or think you may be pregnant. Do not use Alclav if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start to us Baca dokumen lengkap
1 ALCLAV 642.9MG/5ML POWDER FOR ORAL SUSPENSION NAME AND STRENGTH OF ACTIVE INGREDIENTS Amoxicillin 600 mg, Clavulanic acid 42.9 mg per 5 ml COMPOSITION Amoxicillin USP as a Trihydrate equivalent to Amoxicillin 600 mg Potassium Clavulanate diluted Ph.Eur equivalent to Clavulanic Acid 42.9 mg PRODUCT DESCRIPTION Description as is: White to off-white free flowing powder filled in HDPE bottle. Reconstituted: On reconstitution with water, gives white to off-white homogeneous suspension having characteristic of orange odour PHARMACODYNAMICS ATC CODE: J01CR02 AMOXICILLIN AND ENZYME INHIBITOR Mechanism of Action Amoxicillin binds to penicillin-binding proteins within the bacterial cell wall and inhibits bacterial cell wall synthesis. Clavulanic acid is a beta-lactam, structurally related to penicillin, which may inactivate certain beta-lactamase enzymes. PK/PD relationship The time above the minimum inhibitory concentration (T>MIC) is considered to be the major determinant of efficacy for amoxicillin. Mechanism of Resistance Resistance to penicillins may be mediated by destruction of the beta-lactam ring by a betalactamase, altered affinity of penicillin for target, or decreased penetration of the antimicrobial drug to reach the target site. Amoxicillin alone is susceptible to degradation by beta-lactamases, and therefore its spectrum of activity does not include bacteria that produce these enzymes. WARNING: UNSUITABLE FOR PHENYLKETONURICS NOT TO BE USED IN PATIENTS WITH KNOWN HYPERSENSITIVITY TO PENICILLIN 2 Spectrum of Activity Amoxicillin/clavulanic acid has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS section. _Gram-positive bacteria:_ _Streptococcus pneumoniae _ (including isolates with penicillin MICs ≤ 2 mcg/mL) _Gram-negative bacteria:_ _Haemophilus influenzae _ (including beta-lactamase-producing isolates) _Moraxella catarrhalis _ (including beta-lactamase-producing isolates) The following in vitro data Baca dokumen lengkap