Amoxicillin Trihydrate

FORMULATION
Each capsule contains:
Amoxicillin (as trihydrate BP)      ………………………………        500 mg

PHARMACOKINETICS
Amoxicillin is resistant to inactivation by gastric acid. It is more rapidly and more completely absorbed than ampicillin when given by mouth. Peak plasma-amoxicillin concentrations of about 5 micrograms/mL have been observed 1 to 2 hours after a dose of 250 mg, with detectable amounts present for up to 8 hours. Doubling the dose can double the concentration. The presence of food in the stomach does not appear to diminish the total amount absorbed.
Concentrations of amoxicillin after intramuscular injection are similar to those achieved with oral doses. About 20% is bound to plasma proteins and plasma half-lives of I to 1.5 hours have been reported. Amoxicillin is widely distributed at varying concentrations in body tissues and fluids. It crosses the placenta; small amounts are distributed into breast milk. Little amoxicillin passes into the CSF unless the meninges are inflamed.

INDICATIONS
Amoxicillin is used similarly in susceptible infections. These include actinomycosis, anthrax, biliary-tract infections, bronchitis, endocarditis (particularly for prophylaxis), gastro-enteritis (including salmonella enteritis, but not shigellosis), gonorrhoea, Lyme disease, mouth infections, otitis media, pneumonia, spleen disorders (pneumococcal infection prophylaxis), typhoid and paratyphoid fever, and urinary-tract infections and also given as part of regimens to eradicate Helicobacter pylori infection in patients with peptic ulcer disease.

CONTRAINDICATIONS
Penicillin hypersensitivity or hypersensitivity to any of the ingredients of this preparation.

ADVERSE EFFECTS
Skin rashes are among the most common adverse effects and are generally either urticarial or maculopapular; the urticarial reactions are typical of penicillin hypersensitivity, while the erythematous maculopapular eruptions are characteristic of ampicillin and amoxicillin and often appear more than 7 days after commencing treatment. The incidence of diarrhea is less with amoxicillin than ampicillin.

PRECAUTION
Amoxicillin should be stopped if a skin rash occurs. It should preferably not be given to patients with infectious mononucleosis since they are especially susceptible to ampicillin-induced skin rashes; patients with lymphatic leukemia or possibly HIV infection may also be at increased risk of developing skin rashes.

DOSAGE & ADMINISTRATION
The usual oral dose is 500 mg every 8 hours, or 500 to 875 mg every 12 hours. Children up to 10 years: 125 to 250 mg every 8 hours; under 40 kg, a dose of 20 to 40 mg/kg daily in divided doses every 8 hours, or 25 to 45 mg/kg daily in divided doses every 12 hours. Infants less than 3 months old, the maximum dose should be 30 mg/kg daily in divided doses every 12 hours. Higher oral doses of amoxicillin: a dose of 3 g repeated once after 8 hours may be used for dental abscesses. A 3 g dose may be given for uncomplicated acute urinary-tract infections 3g twice daily for severe or recurrent infections of the respiratory tract. Children aged 3 to 10 years with otitis media may be given 750 mg twice daily for 2 days. For the prophylaxis of endocarditis in patients at risk, amoxicillin 2 to 3 g is given about 1 hour before dental procedures. Or as prescribed by the physician.

CAUTION
Foods, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.

STORAGE CONDITION
Store at temperatures not exceeding 30’C.

Keep out of reach of children.

AVAILABILITY
Alu-PVC blister pack of 10’S (Box of 100 capsules).

“For suspected adverse drug reaction , report to the FDA: www.fda.gov.ph“.