DCH Auriga - Healthcare
Full Prescribing Info
Amoxicillin trihydrate.
Amoxicap: Amoxicap 250 Capsule: Amoxycillin (as trihydrate) 250 mg/capsule.
Amoxicap 500 Capsule: Amoxycillin (as trihydrate) 500 mg/capsule.
Pharmacology: Amoxycillin, a bactericidal antibiotic, inhibits bacterial cell wall synthesis by preventing cross-linkage of peptidoglycan chains which is necessary for bacterial cell wall strength and rigidity. Cell division and growth are inhibited and lysis of susceptible bacteria frequently occurs. Oral absorption is not greatly influenced by the presence of food and excretion is mainly via renal and biliary systems.
For treatment of: Ear, nose and throat infections caused by streptococci, pneumococci, nonpenicillinase-producing staphylococci and H. influenzae; Genitourinary tract infections caused by E. coli, P. mirabilis, S. faecalis; Skin and soft-tissues infections caused by streptococci, nonpenicillinase-producing staphylococci and E. coli; Anogenital and urethral gonorrhoea caused by N. gonorrhoea.
Dosage/Direction for Use
Adults: Oral, 250 to 500 mg every eight hours; or as directed.
Children: Infants up to 6 kg of body weight: Oral, 25 - 50 mg every 8 hours.
Infants 6 - 8 kg of body weight: Oral, 50 - 100 mg every 8 hours.
Infants and children 8 - 20 kg of body weight: Oral, 6.7 - 13.3 mg/kg of body weight every 8 hours.
Children 20 kg of body weight and over: See adult dose.
Clinical features: Anorexia, nausea, vomiting, abdominal discomfort, diarrhoea.
Treat overdosage by emesis or gastric lavage, if appropriate and other supportive measures.
Contraindicated in patients known to be sensitive to penicillin.
Avoid in patients with infectious mononucleosis because of increased risk of skin rashes.
Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with Cephalosporins. Before therapy with any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to Penicillins, Cephalosporins or other allergens. If an allergic reaction occurs, appropriate therapy should be instituted and discontinuance of amoxicillin therapy considered. Serious anaphylactoid reactions require immediate emergency treatment with Epinephrine. Oxygen, intravenous steroids and airway management, including intubation, should also be administered as indicated.
Special Precautions
As with any potent drug, periodic assessment of renal, hepatic and hematopoietic function should be made during prolonged therapy. The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur (usually involving Enterobacter, Pseudomonas or Candida), the drug should be discontinued and/or appropriate therapy instituted.
Caution in patients with known histories of allergy.
Reduced doses may be required in patients with severe impaired renal function.
Use in Pregnancy & Lactation: Should be used with caution in pregnancy and lactation. Safety for use in pregnancy has not been established.
Adverse Reactions
Hypersensitivity reaction: Rash and less frequently as exfoliative dermatitis or erythema multiforme.
Hemolytic effects: Hemolytic anemia / anemia / eosinophilia / leukopenia / neutropenia / agranulocytosis / thrombocytopenia / thrombocytopenic purpura.
G.I. effects: Diarrhoea, nausea, vomiting, black hairy tongue, glossitis, stomatitis, sore mouth or tongue.
Renal effects: Acute interstitial nephritis.
Hepatic effects: A moderate increase in serum concentration of AST (SGOT).
Drug Interactions
Concurrent use with Allopurinol or Probenecid requires careful monitoring.
Concurrent use with Chloramphenicol, Erythromycins, Sulfonamides and Tetracycline may interfere with the bactericidal effect of amoxycillin.
Store below 30°C. Protect from moisture.
MIMS Class
ATC Classification
J01CA04 - amoxicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.
Cap 250 mg (scarlet opaque and grey opaque capsule with "AX250" printed on one end and "HD" printed on the other end) x 100's. 500 mg (scarlet opaque and yellow opaque capsule with "AX500" printed on one end and "HD" printed on the other end) x 100's. Tab 250 mg (grenadine flavor) x 100's.
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