Full Prescribing Info
Amoxicillin trihydrate.
Each capsule contains Amoxicillin Trihydrate equivalent to Amoxicillin 250 mg and 500 mg.
Pharmacology: Pharmacodynamics: Amoxicillin is active against various gram-positive and gram-negative bacteria including Streptococci, Haemophilus influenza, Proteus mirabilis, Escherichia coli, and Neisseria spp. Amoxicillin is inactivated by penicillinase.
Pharmacokinetics: Amoxicillin is readily absorbed when administered orally. Food does not interfere with its absorption. It is more completely absorbed than ampicillin and is reported to peak antibiotic plasma concentration that are up to 2½ times as high as those from the same dose of ampicillin. Peak plasma concentration of about 3.5-5 μg/ml or 5.5-11 μg/ml have been observed 1-2 hours after a dose of 250 mg or 500 mg respectively. It is 17-20% bound to plasma protein. The elimination half-life is 0.7-1.4 hours. Most of the dose is excreted unchanged in the urine by tubular excretion, therefore probenecid can delay its excretion.
Amoxicillin is used for the treatment of infection caused by susceptible gram-negative bacteria (Haemophilus influenzae, Escherichia coli, Proteus mirabilis, Salmonella) and gram-positive bacteria (Streptococcus pneumoniae, enterococci, non-penicillinase-producing staphylococci, Listeria) e.g., otitis media, infection of the respiratory tract, ear, nose and throat, gastrointestinal tract genito-urinary tract, skin and soft tissues.
Dosage/Direction for Use
Infection of ear, nose, throat, skin and genitourinary tract: Adults and children over 12 years: Oral, 500 mg every 12 hours or 250 mg every 8 hours.
Dosage may be increased according to the infections: in severe infection: 500 mg every 8 hours.
Duration of therapy for most infection should be continued for at least 2-3 days after the patient becomes asymptomatic.
Gonorrhea: Single 3 g of oral dose.
Prevention of bacterial endocarditis: Single 2 g oral amoxicillin given 1 hour before dental procedure or minor upper respiratory tract surgery or instrumentation.
Symptoms of penicillin overdose include neuromuscular hypersensitivity (agitation, hallucinations, asterixis, encephalopathy, confusion, and seizures) and electrolyte imbalance (with potassium or sodium salts), especially in renal failure. Hemodialysis may be helpful to aid in the removal of the drug from the blood, otherwise most treatment is supportive or symptom-directed.
It is contraindicated in patients who are hypersensitive to penicillins.
(based on the Ministry of Public Health Announcement): It is contraindicated in patients who are hypersensitive to penicillins.
It may cause hypersensitivity reactions including anaphylactic reactions.
Discontinue the drug and consult the physician if there is skin rashes, itching, or edema.
Discontinue the drug and consult the physician immediately if there is skin rashes or flu-like syndrome.
Discontinue the drug and consult the physician when getting any of these symptoms, maybe Stevens-Johnson syndrome e.g., fever; skin rashes; blistering; peeling skin, such as mouth, throat, nose, sexual organ; and conjunctivitis.
Special Precautions
It should be used with caution in patients with a history of allergy, impaired renal function, in pregnant or nursing women. During prolonged therapy, periodic determinations of renal, hepatic and hemapoietic function are recommended.
Use In Pregnancy & Lactation
Use in Pregnancy: Safe use of amoxicillin during pregnancy has not been definitely established. There are no adequate or controlled studies using amoxicillin in pregnant women, and amoxicillin should be used during pregnancy only when clearly needed. However, amoxicillin has been administered to pregnant women without evidence of adverse effects to the fetus. It is the drug of choice for the treatment of chlamydial infections in pregnancy and for the treatment and for postexposure prophylaxis of anthrax following exposure to Bacillus anthracis spores.
Use in Lactation: Because amoxicillin is distributed into milk and may lead to sensitization of infants, the drug should be used with caution in nursing women. Amoxicillin is an option for anti-infective prophylaxis in breast-feeding woman when Bacillus anthracis is susceptible to penicillin.
Side Effects
Central nervous system: Agitation, Anxiety, confusion, dizziness, headache, insomnia, seizure.
Dermatologic: Erythematous maculopapular rash. Stevens-Johnson syndrome, urticaria.
Gastrointestinal: Nausea, vomiting, diarrhea.
Hematologic: Agranulocytosis, anemia.
Hepatic: ALT increased, AST increased.
Drug Interactions
Combination of amoxicillin with clavulanic acid results in synergistic effect against β-lactamase producing bacteria, because clavulanic acid have a high affinity binding to β-lactamase that can inactivate amoxicillin.
Combination of amoxicillin with methotrexate may decrease renal secretion of methotrexate. Increase serum methotrexate results in GI or hematologic toxicity. Patients should be monitored carefully.
Oral probenecid administered shortly before amoxicillin slow the rate of renal secretion of amoxicillin; produced higher an prolonged concentration of the drugs. This effect is used in treatment of gonorrhea or acute pelvic inflammatory disease.
Allopurinol may potentiate aminopenicillin allergy. Concomitant use of the drugs should be avoid of possible.
Keep in tight container, in a dry place, controlled temperature below 30°C.
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 (creamy white granules in green-blue opaque, hard gelatin capsule No. 1 with 250 marked in black color on both part of capsule shells) x 50 x 10's. 500 mg (creamy white granules in yellow-black opaque, hard gelatin capsule No. 0 with 500 marked in white color on both part of capsule shells) x 50 x 10's.
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