COMPOSITION :
Ampicillin Sodium Powder for Injection 1 g, each vial contains : Ampicillin sodium equivalent to Ampicillin 1 g.
DESCRIPTIONS :
Ampicillin Sodium with Ampicillin sodium as active ingredient is available in powder for injection 1 g.
INDICATIONS :
Infections caused by gram-positive and/or gram-negative bacteria which is sensitive to Ampicillin.
- Respiratory tract infections, bronchopneumonia, otitis media.
- Urinary tract infections such as acute and chronic pyelonephritis, cystitis.
- Uncomplicated gonorrhea.
- Infection of the female genitals in small pelvis such as septic abortion, adnexitis, endometritis, parametritis, pelvic peritonitis, puerperal fever.
- Gastrointestinal infections such as shigellosis, salmonelosis.
DOSAGE AND ADMINISTRATIONS :
Intramuscular and Intravenous :
- Adult : 2 – 12 g/day in divided doses every 6 – 8 hours.
- Children : 100 – 200 mg/kgBW/daily in divided doses every 6 – 8 hours.
For meningitis doses up to 400 mg/kgBW/daily in divided doses every 4 hours.
- Children > 2 kg : 100 mg/kgBW/daily in divided doses every 6 hours.
For meningitis : 200 mg/kgBW/daily in divided doses every 6 hours.
- Children aged > 7 days with body weight from 1.2 to 2 kg : 75 mg/kgBW/daily in divided doses every 8 hours.
For meningitis : 150 mg/kgBW/daily in divided doses every 8 hours.
Administration :
- Intramuscular
Ampicillin powder for injection 1 g dissolved in 3.4 ml sterile water for injection to a final volume of 4 ml (250 mg/ml).
- Intravenous
Ampicillin powder for injection 1 g dissolved in 10 ml sterile water for injection.
Ampicillin for intramuscular or intravenous should be used immediately after reconstitution.
OVERDOSAGE :
- In case of overdosage, treatment should be discontinued.
- In patients with renal impairment, antibiotic Ampicillin class may be reduced by haemodialysis.
CONTRAINDICATIONS :
- In patients who are hypersensitive to Penicillin and its derivatives.
- In infections which caused by bacteria Penicillinase-producing enzyme.
WARNINGS AND PRECAUTIONS :
- Superinfection may occur caused by Candida, Enterobacter, Pseudomonas on long-term use and high doses.
- Carefully use in pregnant and breastfeeding women because the safety of used have not been established.
- Use of Ampicillin should be discontinued immediately if there is side effect.
- Periodic checks of liver function, renal and blood should be done in long-term use.
DRUG INTERACTIONS :
- Concomitant use with Allopurinol, may be increased hypersensitivity reactions.
- The use of oral contraceptives will reduce the effectiveness of oral contraceptives.
- Concomitant use with Probenecid may increase the blood levels of Ampicillin.
ADVERSE REACTIONS :
- Allergic reactions : Urticaria and other skin rashes.
- Gastrointestinal : Glossitis, stomatitis, nausea, vomiting, diarrhea and pseudomembran colitis.
- Hematopoietic and lymphatic systems : Anaemia, thrombocytopenia, eosinofilia, leucopenia and agranulositosis.
PRESENTATIONS :
Ampicillin Sodium Powder for Injection 1 g Box, 10 vials @ 1 g
Reg. No. GKL9102315844A1
STORAGE :
STORE BELOW 30°C
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
