Indications

Infections caused by susceptible strains of microorganism such as:
– Treatment of infections of respiratory tract, digestive and hepatobiliary system, genitourinary tract.
– Skin diseases.

Present

Blister of 10 capsules. Box of 10 blisters.

Composition

Amoxicillin trihydrate equivalent to Amoxicillin ………250mg
Excipients s.q. for ……………………………………………..1 capsule
(Magnesium stearate).

Pharmacology

Amoxicillin is a b– lactam antibiotic. Amoxicillin exerts its killing action on growing and dividing bacteria by inhibiting bacterial cell– wall mucopeptide synthesis.

Pharmacokinetics

Amoxicillin is resistant to inactivation by gastric acid. The presence of food in the stomach does not appear to diminish the total amount absorbed. It widely distributed at varying concentration in body tissues and fluids. About 60% of an oral dose of Amoxicillin is excreted unchanged in the urine in
6 – 8 hrs, some may be excreted in the feces.

Contra-Indications

– Hypersensitivity to Penicillins and Cephalosporins.
– Infectious mononucleosis.

Side effect

– Common: skin rash, occurred about 7 days after initiation of the therapy.
– Rare: nausea, vomiting, diarrhea, erythema, maculopapular rash and urticaria, especially Stevens– Johnson syndrome.
Inform your doctor about side– effects when using this medicine.

Precaution

– In patients with impaired kidney, adjust the dosage.
– Routine liver function test should be carried out, caution should be exercised in long– term treatment.
– Whenever there are signs of allergic reactions, Amoxicillin should be discontinued. Apply appropriate alternative therapies.
– In high– dose therapy, adequate water intake and output should be maintained to avoid Amoxicillin crystaluria.
PREGNANCY & LACTATION:
This drug should be used during pregnancy only when clearly needed.

Interaction

– Probenecid reduces renal tubular secretion of Amoxicillin.
– Nifedipine increases absorption of Amoxicillin.
– An increased frequency of skin rashes has been reported in patients receiving Amoxicillin, with Allopurinol.
– Bacteriostatic antibiotics: Chloramphenicol, Erythromycin, Sulfonamide, Tetracyclines may affect the bactericidal effects of Amoxicillin.
OVERDOSAGE:
Cases of overdosage with Amoxicillin are usually asymptomatic.
Pay special attention to electrolyte and water balance.

Shelf life

36 months from the manufacturing date.

Storage

Store in a dry place (RH ≤ 70%), not exceeding 30^oC.

Dosage

– As prescribed by physician.
– Usual dosage:
+ Adults: 1 – 2 capsules, 2 – 3 times daily.
+ Children: 25 – 50mg/kg/day in 2 – 3 divided doses.