500 mg CAPSULE
Each capsule contains Amoxicillin (as tribydrate) 500 mg
Amoxicillin, a penicillinase-susceptible semi-synthetic penicillin, is a close chemical and pharmacological relative of Ampicillin. The drug is stable in acid and is designed for oral use. It is more rapidly absorbed from the gastrointestinal tract. Peak concentrations of Amoxicillin in plasma are two to two and one-half times greater for Amoxicillin than for Ampicillin after oral administration of the same dose; they are reached at two hours and average about 5 µg/mL when 250 mg is administered. Food does not interfere with absorption. About 20% of Amoxicillin are protein-bound in plasma. Most of the dose of the antibiotic is excreted in an active form in the urine.
Probenecid delays excretion of the drug.
Amoxicillin is used in a variety of susceptible Gram-positive and Gram-negative infections. These include actinomycosis, biliary tract infections, bone and joint infections, bronchitis, endocarditis, gastro-enteritis (including E. coli enteritis and salmonella enteritis, but not shigellosis), gonorrhea, mouth infections, otitis media, pneumonia, spleen disorders, typhoid and paratyphoid fever, and urinary tract infections. Amoxicillin is also used in the treatment of Lyme disease.
DOSAGE AND ADMINISTRATION
Amoxicillin is given by mouth as the trihydrate and by injection as the sodium salt. The usual oral dose is 500 mg every 8 hours or as prescribed by the physician.
Children up to 10 years of age may be given 125 to 250 mg every 8 hours, under 20 kg body-weight of a dose of 20 to 40 mg per kg daily has been suggested. Higher oral doses of Amoxicillin, either as a single dose or in short courses are used in some conditions. For uncomplicated gonorrhoea in areas where gonococci have maintained sensitivity, Amoxicillin is given as a single dose of 3 g with Probenecid 1 g. A dose of 3 g repeated once after 8 or 10 to 12 hours may be used for dental abscesses or uncomplicated acute urinary tract infections respectively. For the prophylaxis of endocarditis in susceptible patients, Amoxicillin 3 g is given about 1 hour before procedures such as dental extractions. A high dose regimen of Amoxicillin 3 g twice daily may be used in patients with 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.
Amoxicillin should be used with caution in patients with known history of allergy or asthma. Serious and occasionally fatal hypersensitivity (anaphylactoid) reactions have been reported to 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. Safety during pregnancy has not been established. Dose should be reduced in severe renal failure.
It crosses the placenta, small amounts are distributed into breast milk. Little Amoxicillin passes into cerebro-spinal fluid unless the meninges are inflamed.
The most common adverse effects are hypersensitivity reactions, especially skin rashes. Anaphylaxis occasionally occurs and has sometimes been fatal. Patients with impaired renal function are also at increased risk. Hepatitis and cholestatic jaundice have been reported rarely, Pseudomembranous colitis has been associated with the use of amoxicillin. Erythema multiforme, including the Steven-Johnson syndrome has also been attributed occasionally to amoxicillin with clavulanic acid.
Amoxicillin should not be given to patients with infectious mononucleosis since they are especially susceptible to amoxicillin-induced skin rashes; patients with lymphatic Ieukemia or possibly HIV infection may also be at increased risk of developing skin rashes.
CAUTION: FOODS, DRUGS, DEVICES AND COSMETICS ACT prohibits dispensing without prescription.
Alu-Clear PVC blister pack of 10’s (box of 100’s)
Store at temperatures not exceeding 30oC.
Chez Resources Pharm. Ltd.
HARBIN PHARMACEUTICAL GROUP CO., LTD.
GENERAL PHARM. FACTORY
No. 109 Xuefu Road, Nangang District, Harbin, People’s Republic of China.