Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMOXYCILLIN TRIHYDRATE
IDAMAN PHARMA MANUFACTURING SDN. BHD.
AMOXYCILLIN TRIHYDRATE
500 Capsules; 20 Capsules
IDAMAN PHARMA MANUFACTURING SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ SYNAMOX CAPSULES Amocixillin (250mg, 500mg) 1 WHAT IS IN THIS LEAFLET 1. What Synamox Capsules is used for 2. How Synamox Capsules works 3. Before you use Synamox Capsules 4. How to use Synamox Capsules 5. While you are using it 6. Side effects 7. Storage and Disposal of Synamox Capsules 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT SYNAMOX CAPSULES IS USED FOR Synamox Capsules contain amoxicillin as the active ingredient. Amoxicillin belongs to a class of antibiotics called “penicillins”. This medicine is used to treat infections caused by bacteria that are sensitive to amoxicillin. These include: • Ear, nose and throat infections • Gynaecological and urinary tract infections • Gonorrhaea • Skin and soft tissue infections HOW SYNAMOX CAPSULES WORKS The amoxicillin in Synamox Capsules fights bacteria and stops them from growing by preventing them from strengthening and rigid the cell walls. This kills the bacterial growth and helps treat the infection. BEFORE YOU USE SYNAMOX CAPSULES _-When you must not use it _ You must not take Synamox Capsules and should talk to your doctor or pharmacist if: • You have an allergy to penicillin, penicillin type antibiotics including other beta-lactam antibiotics or any of the ingredients found in this product as listed at the end of this leaflet • You suffer from kidney problems as you may need a lower dose • You have a history of gastrointestinal disease especially ulcerative colitis or antibiotic related colitis (inflammation of the large intestine) • You have any other conditions such as leukemia or HIV infection as this may make you more likely to get a skin rash. _ _ _ _ _Pregnancy and lactation _ If you are pregnant, breastfeeding or planning to become pregnant, ask your doctor or pharmacist for advice first before taking any medicine. Synamox Capsules may only be used when the potential benefits outweigh the potential risks. Amoxicillin taken by the mo Baca dokumen lengkap
IDAMAN PHARMA MANUFACTURING SYNAMOX CAPSULES 500MG DESCRIPTION SYNAMOX CAPSULES 500MG Clean, uniform, dry, telescope type hard gelatin. Capsules are shiny and not smudged or sticky. Printed “SYNAMOX 500mg” and “Idaman” on the capsules. Colour: Cap: Opaque Purple Body: Opaque White Odour: Characteristics of penicillin Size: No.0 Powder: A white to slightly yellow coarse powder Each capsule contains AMOXICILLIN TRIHYDRATE equivalent to 500 mg of AMOXICILLIN. PHARMACODYNAMICS 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 bactericidal 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. PHARMACOKINETICS Absorption: Amoxicillin is stable in the presence of gastric acid and is rapidly and well absorbed after oral administration, even in the presence of food. Orally administered doses of 250 mg and 500 mg amoxicillin result in average peak serum levels 1 to 2 hours after administration of 5.0mcg/mL – 10.8mcg/L respectively. Distribution: Amoxicillin diffuses rapidly into most body tissues and fluids, with the exception of brain and spinal fluid except when meninges are inflamed. Amoxicillin has been shown to diffuse into sputum and saliva. It is not highly protein-bound which only 17% protein-bound in serum. Excretion: Amoxicillin is excreted mainly via urine where it exists in a high concentration and is excreted in the urine both unchanged and as penicilloic acid. About 75% of a 1g dose is excreted in the urine in 6 hours in the presence of normal renal function (60% is biologically active and 15% is penicill Baca dokumen lengkap