Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
AMOXYCILLIN TRIHYDRATE
AVERROES PHARMACEUTICALS SDN. BHD.
AMOXYCILLIN TRIHYDRATE
1 BOTTLE
Milan Laboratories Private Limited
MILOXY GRANULES FOR ORAL SUSPENSION 125MG/5ML Amoxicillin (125mg/5ml) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Miloxy is used for 2. How Miloxy works 3. Before you use Miloxy 4. How to use Miloxy 5. While you are using it 6. Side effects 7. Storage and Disposal of Miloxy 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT MILOXY IS USED FOR Miloxy is used to treat infections caused by certain bacteria and other microorganisms which include: • Infections of the ear, throat and nose • Infections of the lower respiratory tract (bronchitis and pneumonia, lung disease, whooping cough) • Kidney infection, inflammation of prostate, bladder, urethra, gonorrhoea. • Gynaecological infection (septic abortion, adnexitis, endometritis) • Gastrointestinal infections (typhoid fever, paratyphoid, shigellosis cause infection, infection of the biliary system (cholangitis, cholecystitis) • Skin and soft tissue infections • Prevention of infections during mouth or throat surgery. HOW MILOXY WORKS Miloxy is a group of medicines called penicillin. Penicillin is an antibiotic and works by killing bacteria that causes infection. BEFORE YOU USE MILOXY - _When you must not use it_ _ _ • If you are allergy to penicillin-type antibiotics and any of the ingredients contained in this medicine. • If you have ever developed allergy symptoms when taking other antibiotics (eg: cephalosporins). _ _ _Pregnancy and lactation _ Miloxy may be suitable if you are pregnant, however please consult your doctor first before starting this antibiotic therapy. - _Before you start use it _ You should check with your doctor: • If have hypersensitivity to penicillin and beta-lactam antibiotics. E.g.: cephalosporin. • If you have kidney disease • If you are premature children or in neonate period. • If you have use this antibiotics for a prolonged period. - _Taking other medicines _ Tell your doctor if you are taking any other medicines, including any Soma hati kamili
MILOXY GRANULES FOR ORAL SUSPENSION 125MG/5ML AMOXICILLIN 125MG/5ML NOT TO BE USED IN PATIENTS WITH KNOWN HYPERSENSITIVITY TO PENICILLIN PRODUCT DESCRIPTION _MILOXY Granules for Oral Suspension 125mg/5ml: _ Light pink coloured powder with pleasant flavour. After reconstitution: Pink coloured oral suspension having pleasant flavour. COMPOSITION _MILOXY Granules for Oral Suspension 125mg/5ml: _ Each 5ml contains Amoxicillin Trihydrate BP equivalent to Amoxicillin 125 mg. PHARMACODYNAMICS Amoxicillin is a beta-lactam antibiotic that inhibits synthesis of the bacterial cell wall. It is a broad- spectrum penicillin and active against both gram-positive and gram-negative microorganisms. Clinically relevant gram-negative pathogens covered by amoxicillin are _Escherichia coli, Proteus _ _mirabilis, Salmonella, Shigella, Haemophilus influenzae, Helicobacter pylori, Chlamydia _ and others. Other microorganisms responding to amoxicillin include all those susceptible to penicillin G, e. g. Streptococcus groups A, B, C and G, H, L and M, _Streptococcus pneumoniae,_ non-penicillinase- producing _Staphylococcus aureus Neisseri, Erysipelothrix rhusiopathiae, Corynebacterium, Bacillus _ _anthracis, _ _Actinomycetes, _ _streptobacilli, _ _spirillium _ _minus, _ _Pasteurella _ _multicoda, _ _Listeria _ and _Spirochetal_ organisms, as well as numerous aerobic organisms (among them _peptococci, Clostridia _ and _Fuso_ -bacteria). PHARMACOKINETIC Amoxicillin is rapidly absorbed from the gastrointestinal tract. The absorption of amoxicillin is unaffected by meals. Following oral administration, peak serum levels are reached within 1 – 2 hours. Amoxicillin readily distributes in body tissue and fluids including purulent and mucoid sputum. Elimination of amoxicillin is predominantly via renal. Approximately, 60 – 70% of amoxicillin is excreted unchanged in the urine in 6 hours after administration. The elimination half-life of amoxicillin is similar for children aged around 3 months and above. For very young children (including prete Soma hati kamili