Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CLOXACILLIN SODIUM
IDAMAN PHARMA MANUFACTURING SDN. BHD.
CLOXACILLIN SODIUM
500 Capsules; 500 Capsules
IDAMAN PHARMA MANUFACTURING SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ CLOXACILLA CAPSULE Cloxacillin (250mg) _ _ _ _ 1 WHAT IS IN THIS LEAFLET 1. What Cloxacilla Capsule is used for 2. How Cloxacilla Capsule works 3. Before you use Cloxacilla Capsule 4. How to use Cloxacilla Capsule 5. While you are using it 6. Side effects 7. Storage and disposal of Cloxacilla Capsule 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT CLOXACILLA CAPSULE IS USED FOR Cloxacilla Capsule is from a group of antibiotics called penicillin. Its active ingredient is Cloxacillin. It is used to treat infections due to Staphylococci resistant to benzyl-penicillin. It is also used for mixed Streptococcal and Staphylococcal infection when the Staphylococci are penicillin-resistant. HOW CLOXACILLA CAPSULE WORKS Cloxacilla Capsule acts by inhibiting bacterial cell-wall synthesis and subsequently killing the bacteria. BEFORE YOU USE CLOXACILLA CAPSULE _-When you must not use it _ Do not take Cloxacilla Capsule if you are allergic to cloxacillin or any history of allergy to penicillin group of drugs. _ _ _-Before you start to use it _ Your doctor needs to know before you take Cloxacilla Capsule if you have or have had any of the following conditions: • Hypersensitivity reactions to penicillins, cephalosporin, carbapenems or other beta-lactams. • Kidney and liver problems _-Taking other medicines _ Tell your doctor if you are taking any other medicine, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines and Cloxacillin may interfere with each other. This includes: • amoxicillin, nafcillin and ticarcillin • oral contraceptives • probenecid • anticoagulant (medicine to prevent blood clot) HOW TO USE CLOXACILLA CAPSULE -_How much to use _ Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information contained in this leaflet. If you do not understand the instructions on the label, ask your doctor Baca dokumen lengkap
IDAMAN PHARMA MANUFACTURING CLOXACILLA CAPSULE 250 MG COMPOSITION Each capsule contains _CLOXACILLIN SODIUM_ equivalent to 250 mg of _CLOXACILLIN_. DESCRIPTION A white to slightly yellow powder filled into Scarlet/Ivory (Red/Yellow). Size: No. 2 Capsules. Free from dust and powder. PHARMACODYNAMICS Cloxacillin sodium is an antibiotic belonging to the semi-synthetic penicillin family. Cloxacillin is a bactericidal antibiotic which inhibits bacterial cell wall synthesis, probably by acylation of membrane-bound transpeptidase enzymes. This prevents cross-linkage of peptidoglycan chains which is necessary for bacterial cell wall strength and rigidity. Also, cell division and growth are inhibited and lysis of susceptible bacteria frequently occurs. Rapidly dividing bacteria are most susceptible to penicillin group of antibiotics. Cloxacillin is resistant to staphylococcal penicillinase. It has an antibacterial spectrum similar to that of methicillin. PHARMACOKINETICS Cloxacillin sodium is incompletely absorbed from the gastrointestinal tract after oral administration, and absorption is further reduced by the presence of food in the stomach. After an oral dose of 500mg, a peak plasma concentration of 7 to 15 microgram per ml is obtained in fasting subjects in 1 to 2 hours. Doubling the dose can double the plasma concentration. About 94% of cloxacillin in the circulation are bound to plasma proteins. Cloxacillin has been reported to have a plasma half-life of approximately 0.5 to 1 hour. The half-life is prolonged in neonates. Cloxacillin diffuses across the placenta into the foetal circulation and is excreted in human breast milk. There is little diffusion into the CFS except when the meninges are inflamed. Therapeutic concentrations can be achieved in pleural and synovial fluids and in bone. Cloxacillin is metabolized to a limited extent, and the unchanged drug and metabolites are excreted in the urine by glomerular filtration and renal tubular secretion. About 35% of an oral dose is excreted in the urine and up to 10 Baca dokumen lengkap