Indications: Treatment of infections caused by penicillin-sensitive Gram-positive bacteria as well as H.Influenzas, E.Coli, P.Mirabilis, Salmonella and some Shigellosis species. Treatment of bronchitis, otitis media, bacterial pharyngitis, bacterial pneumonia, sinusitis, urinary tract infections.
Contra-indications: Individuals with a history of an allergic reaction to the penicillins. It is also contraindicated in patients with a history of amoxicillin associated hepatic dysfunction of jaundice.
Adverse Effects: Sensitivity reactions are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever or urticaria. The hypersensitivity reactions are Erythematous maculopapular rashes, urticaria, fever and joint pains. Anaphylactic shock may occur. Gastrointestinal :diarrhoea, nausea, vomiting, heartburn, pseudomembranous colitis Liver: A moderate rise in serum glutamic oxalacetic transaminase has been noted, but the significance of this finding is unknown. Haemic and Lymphatic Systems: Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and granulocytopenia have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Central Nervous System: Reversible hyperactivity, agitation, anxiety, confusion, behavioural changes and/or dizziness.
Drug Interactions: This product is synergistically active with aminoglycoside with balanced dosages and it also shows a good synergistic effect with TMP. If employed together with benemid, tubular secretion will be decreased, serum concentration of amoxicillin will go up and half life extend. Chloromycetin, macrolides, sulfa and tetracycline will interfere the product's antibacterial activity. Amoxicillin must not be employed together with vitamin C and sodium bicarbonate.
Precautions & Warning: Hypersensitivity reactions: Erythrematous maculopapular rashes, urticaria, erythema multiforme and exfoliative dermatitis. Whenever such reactions occur, Amoxicillin should be discontinued. Hepatic: A moderate rise in AST has been noted, but the significance of this finding is unknown. Haematologic: Reactions such as anaemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leucopenia and agranulocytosis have been reported during therapy with other penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.
Use in Pregnancy and Nursing Mothers: Animal reproduction test shows, 10 times of the human dose of amoxicillin don't damage the fertility and fetal of rats and mice. But it is still lack of adequate study for human. As animal reproduction test can not fully predict the human response, pregnant women will not use it except necessary. As breast milk can secrete little amoxicillin, so it may cause infant allergies.
Treatment/antidote in The Event of Overdose: There is a forward-looking studies which involved in 51 pediatric patients shows that when The amoxicillin dosage does not exceed 250mg/kg, it will not cause significant clinical symptoms. It's reported that minority patients have renal insufficiency, oliguria after overdose, but renal dysfunction is reversible when stop to use it.
Storage instructions: Store below 25ºC. Protect from moisture. Keep out of reach of children.
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