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SHANTOU JINSHI GENERAL PHARMACEUTICAL FACTORY No. 36, Taishan Rd., Shantou, Guangdong, China
Dosage Form, Composition & NAFDAC Registration Number (NRN)
Capsules (NRN:B4-2927): Each capsule contains: Amoxicillin 500 mg Excipients q.s.
Pack Size: 2 X 10 Capsules per pack
Amoxicillin is an analog of ampicillin antibiotic with a bactericidal action against a broad spectrum of gram-positive and gram-negative pathogens. It acts by interfering with bacterial cell wall synthesis then bacterium can quickly become spherical body and dissolve, rupture. Amoxicillin is stable to acid and well absorbed when given orally.
Amoxicillin is rapidly absorbed by the gastrointestinal tract after oral administration and is stable in the presence of gastric acid. Peak serum concentrations are usually attained within 1 to 2 hours following oral administration and are generally 2 to 2.5 times greater than those obtained with an equivalent dose of oral ampicillin.
Amoxicillin diffuses readily into most body tissues and fluids, with the exception of the cerebrospinal fluid, although higher concentrations of the drug may be attained in patients with inflamed meninges.
Amoxicillin is 17% to 20% protein-bound. Its elimination half-life ranges from 0.7 to 1.4 hours in patients with normal renal function. Amoxicillin is partially metabolized to microbiologically inactive metabolites and both are then rapidly excreted in urine. Small amounts of the compounds are excreted in bile.
Infections caused by susceptible (non-penicillinase producing) organisms; respiratory tract infections; uncomplicated gastro-enteritis and enteric fever including shigella, and typhoid; uncomplicated gonococcal infections; infections of the genitourinary tract; skin and soft tissue infections; sinusitis, pharyngitis, otitis media, acute and chronic bronchitis.
Hypersensitivity to penicillins, cross-sensitivity with other ß-Iactam antibiotics, e.g. cephalosporins, previous history of penicillin associated jaundice/hepatic dysfunction.
Changes in liver, renal, and hematopoietic function tests may be observed (use with caution in hepatic, renal and hematopoietic dysfunction as clinical significance of such changes is uncertain) during prolonged therapy, rarely cholestatic jaundice may occur.
Not recommended in moderate or severe renal impairment.
Superinfection with fungi or non-susceptible bacteria (discontinue drug and institute appropriate therapy).
There has been no evidence of a teratogenic effect in animals or untoward effect in humans.
When antibiotic therapy is required during pregnancy, Amoxicillin may be considered appropriate.
Trace quantities of amoxicillin can be detected in breast milk.
Allopurinol (increased incidence of skin rash)
Probenecid (increased blood levels of amoxicillin and other penicillins by deplaying their renal tubular secretion).
Oestrogen containing oral contraceptive (reduced contraceptive efficacy)
Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin.
Nausea, vomiting, diarrhoea, rashes (discontinue therapy), hypersensitivity reaction may occur, anemia, thrombocytopenia, eosinophilia and central nervous system reaction.
Dosage & Administration
By mouth, the usual dose is 500 mg every 8 hours.
Severe or recurrent purulent respiratory-tract infections, adult 3g every 12 hours.
The recommended dose of children is 20 to 40 mg/kg/day in divided doses every 8 hours.
For children less than 3 months the recommended dose is 30 mg/kg/day in divided doses every 12 hours.
Pneumonia by mouth, adult 0.5-1 g every 8 hours.
Chlamydia, by mouth, 500 mg every 8 hours for 7 days.
Gonorrhoea, the usual dose 3g given as a single dose.
Patients with severe impaired renal function generally require an adjustment in dose.
The symptoms of overdose are essentially the same as the side effects.
With very high doses nausea, vomiting, diarrhea, renal failure and oliguria can occur.
Renal impairment appears to be reversible with cessation of drug administration.
Store in a cool and dry place.
Protect from light.
Keep all medicines out of reach of children.