COMPOSITIONS :
Amobiotic® Dry syrup 100 mg/ml, each ml syrup contains : Amoxicillin trihydrate equivalent with Amoxicillin 100 mg.
DESCRIPTIONS :
Amobiotic® contains Amoxicillin trihydrate (equivalent to Amoxicillin) as its active ingredient, available as dry syrup 100 mg/ml, 125 mg/5 ml and 250 mg/5 ml and caplet 500 mg.
INDICATIONS :
- 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 gonorrhoae (non penicilinase produced).
- Bone infection.
DOSAGE AND ADMINISTRATIONS :
- 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.
- Forpatientswithrenal impairment, it may be necessary to reduce the total daily dosage. In patientswho receivedperitonial dialysis, the recommendedmaximumdose of500mga day.
- Gonococcus urethritis : Amoxicillin 3 g as a single dose.
- Children > 8 kg should be given dry syrup.
Preparation of Amobiotic® 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, 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.
PRESENTATIONS :
Amobiotic® Dry syrup 100 mg/ml Box, bottle @ 10 ml
Reg. No. DKL7802344338A1
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 :
PT. BERNOFARM
Sidoarjo – Indonesia
