COMPOSITIONS :
Amoxicillin Trihydrate Dry syrup 100 mg/ml, each ml syrup contains : Amoxicillin trihydrate equivalent with Amoxicillin 100 mg.
DESCRIPTIONS :
Amoxicillin Trihydrate contains Amoxicillin trihydrate (equivalent to Amoxicillin) as its active ingredient, available as dry syrup 100 mg/ml and 125 mg/5 ml and caplet 500 mg.
INDICATIONS :
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- Upper respiratory tract infections e.g., tonsillitis, sinusitis and otitis media.
- Lower respiratory tract infections e.g., acute and chronic bronchitis, lobar and bronchopneumoniae.
- Genitourinary tract infections e.g., cystitis, urethritis, pyelonephritis, septic abortion and puerperal sepsis.
- Skin and soft tissue infections.
- Gonorrhea disease caused by susceptible microorganism to N. gonorrhoae (non penicilinase produced).
- Bone infection.
DOSAGE AND ADMINISTRATIONS :
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- Adult and children with body weight > 20 kg : 250 – 500 mg every 8 hours.
- Children with body weight < 20 kg : 20 – 40 mg/kgBW daily in divided doses every 8 hours.
- For patients with renal impairment, it may be necessary to reduce the total daily dosage. In patients who received peritoneal dialysis, the recommended maximum dose of 500 mg a day.
- Gonococcus urethritis : Amoxicillin 3 g as a single dose.
- Children > 8 kg should be given dry syrup.
Preparation of Amoxicillin Trihydrate Dry syrup 100 mg/ml :
Add 8 ml drinking water to the bottle. Shake well until evenly suspended. Keep suspension in tightly closed container. Use this suspension within 7 days. Shake well before use.
CONTRAINDICATIONS :
Amoxicillin is a Penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g., Penicillins, Cephalosporins).
WARNINGS AND PRECAUTIONS :
- Before initiating therapy with Amoxicillin, careful inquiry should be made concerning previous hypersensitivity reactions to Penicillin or Cephalosporin.
- Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on Penicillin therapy.
- If an allergic reaction occurs, Amoxicillin should be discontinued and appropriate therapy instituted.
- Pseudomembranous colitis has been reported with nearly all antibacterial agents, including Amoxicillin.
- Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of Clostridia.
- This drug should be used during pregnancy only if clearly needed.
- Caution should be exercised when Amoxicillin is administered to a nursing woman because Penicillin have been shown to be excreted in breast milk.
- Prolonged use or high dose may also occasionally result in overgrowth of non-susceptible organisms (usually involving Enterobacterium, Pseudomonas, S. aureus, Candida) especially in the gastrointestinal tractus, the drug should be discontinued.
- Caution should be taken for patient with lymphatic leukemia, because of sensitivity to rash that caused by Ampicillin.
- Close clinical observation of blood, renal and liver function in prolonged treatment of Amoxicillin.
- Urine and serum level of Amoxicillin should be monitor in patients with impaired renal functions. Dose should be adjusted.
- Should not be given for meningitis or joint infection Amoxicillin do not passed cerebrospinal or sinovial barrier.
- Prolonged use can lead to the growth of resistant organisms.
- Rarely, prothrombin time extension occurs in joint use with anticoagulants. If necessary adjust the anticoagulant dose.
DRUG INTERACTIONS :
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- Probenecid decreases the renal tubular secretions of Amoxicillin. Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin.
- Chloramphenicol, Macrolides, Sulfonamides and Tetracyclines may interfere the bactericidal effects of Penicillin.
- It is recommended that when testing for the present of glucose in urine during Amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of Amoxicillin, false positive reading are common with chemical methods.
- In common with other broad-spectrum antibiotics, Amoxicillin may reduce the efficacy of oral contraceptives.
- Concurrent administration of Allopurinol during treatment with Amoxicillin can increase the likelihood of allergic skin reactions.
- Prolongation of prothrombin time has been reported rarely in patients receiving Amoxicillin.
ADVERSE REACTIONS :
- Gastrointestinal : Nausea, vomiting, diarrhea and hemorrhagic/pseudomembranous colitis.
- Hypersensitivity reactions :
- Skin rash, pruritus and urticaria have been reported occasionally.
- Rarely, skin reactions e.g., erythema multiforme and Steven-Johnson syndrome, toxic epidermal necrolysis, bullous and extensive dermatitis.
- As with other antibiotics, severe allergic reactions including angioneurotic oedema, anaphylaxis, serum sickness and hypersensitivity vasculitis have been reported rarely.
- Interstitial nephritis can occur rarely.
- Hepatic effects :
- A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted, but the significance of this finding is unknown.
- Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis.
- Renal : Crystalluria.
- Hemic and lymphatic systems : Anemia, including haemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia and agranulocytosis have been reported during therapy with Penicillin. Prolongation of bleeding time and prothrombin time.
- Central nervous system : Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioural changes and/or dizziness.
- Miscellaneous : Tooth discoloration (brown, yellow or gray staining) has been rarely reported.
PRESENTATIONS :
Amoxicillin Trihydrate Dry syrup 100 mg/ml Box, 10 bottles @ 10 ml
Reg. No. GKL1802316238B1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
Keep suspension in tight closed container. Use this suspension within 7 days in temperature below 30ºC. Shake well before use.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
