Sterile Ampicillin Sodium T P

White sterile powder for solution for injection.
STERILE AMPICILLIN SODIUM 250 mg: Each vial contains 250 milligram Ampicillin as Ampicillin sodium.
STERILE AMPICILLIN SODIUM 500 mg: Each vial contains 500 milligram Ampicillin as Ampicillin sodium.
STERILE AMPICILLIN SODIUM 1,000 mg: Each vial contains 1,000 milligram Ampicillin as Ampicillin sodium.
Ampicillin is broad spectrum antibiotic. It is bactericidal for both gram-positive and gram-negative bacteria.
Excipients/Inactive Ingredients: None.

Pharmacotherapeutic group: Penicillins with extended spectrum, ampicillin. ATC code: J01CA01.
Pharmacology: Pharmacodynamics: Ampicillin is a broad spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin sensitive organisms.
Pharmacokinetics: Ampicillin is excreted mainly in the bile and urine with a plasma half life of 1-2 hours.
Toxicology: Preclinical safety data: No further information of relevance.

Ampicillin is a broad-spectrum penicillin, indicated for the treatment of a wide range of bacterial infections caused by ampicillin-sensitive organisms. Typical indications include: ear, nose and throat infections, bronchitis, pneumonia, urinary tract infections, gonorrhoea, gynaecological infections, septicaemia, peritonitis, endocarditis, meningitis, enteric fever, gastro-intestinal infections.
Extraperitoneal application of Ampicillin to wounds can be used to prevent infection following abdominal surgery.
Parenteral usage is indicated where oral dosage is inappropriate.
Routes of administration: Intramuscular, intravenous.
500 mg: Infections due to susceptible strains of gram positive and gram negative pathogens and responding to Ampicillin.

Posology: Usual adult dosage (including elderly patients): Septicaemia, endocarditis, osteomyelitis: 500 mg four to six times a day IM or IV for one to six weeks.
Peritonitis, intra-abdominal sepsis: 500 mg four times a day IM or IV.
Meningitis: Adult dosage: 2 g six-hourly IV.
Children dosage: 150 mg/kg daily IV in divided doses.
Ampicillin may also be administered by other routes of conjunction with systemic therapy.
Local use in abdominal surgery: 1 g sterile powder sprinkled into the wound extraperitoneally or into muscle layers to prevent wound infection post operatively.
Paediatric population: Half adult routine dosage for children under 10 years.
All recommended dosages are a guide only. In severe infections the previously mentioned dosages may be increased.
Renal Impairment: In the presence of severe renal impairment (creatinine clearance <10 ml/min) a reduction in dose or extension of dose interval should be considered. In cases of dialysis, an additional dose should be administered after the procedure.
Ampicillin sodium may be administered by IM or slow IV injection or IV infusion. For IV injection, it should be used only in the treatment of moderately severe or severe infections. Direct IV injections should be made slowly over 10-15 minutes to avoid the possibility of convulsive seizures. For intermittent IV infusion, the concentration of ampicillin and rate of infusion should be adjusted so that the total dose of the drug is administered before 10% or more of the drug is inactivated in IV solution.
The usual adult dosage for the treatment of respiratory tract or skin and skin structure infections is 250-500 mg every 6 hours.
For the treatment of GI or urinary tract infections, the usual adult dosage is 500 mg every 6 hours. For severe infections, larger doses may be required.
For the treatment of septicemia or bacterial meningitis is 8-14 g or 150-200 mg/kg daily given parenterally in equal divided doses every 3-4 hours.
For the initial treatment of septicemia or meningitis, ampicillin should be given IV for at least 3 days and continuing with IM.
Pediatric Dosage: For the treatment of respiratory tract or skin and skin structure infections, the usual dosage of ampicillin for children weighing 40 kg or less is 25-50 mg/kg daily, administered in equally divided doses every 6 hours. For the treatment of GI or urinary tract infections, the usual dosage for children weighing 40 kg or less is 50-100 mg/kg daily given in equally divided doses every 6 hours, septicemia or CNS infections the usual dosage is 100-200 mg/kg daily given in divided doses every 3-4 hours, starting with IV for 3 days and continuing with IM.
Sterile Ampicillin sodium 250 mg, 500 mg, should be reconstituted with 3 mL distilled water before injection, and 6 mL for 1 g vial.
500 mg: 1-14 g a day. It depends on body weight and severity of infection.
Adults: By injection 500 mg-1 gram a day.
Children: By injection 12.5-50 mg per kg body weight a day.
Method of administration: Intramuscular: Add 1.5 ml water for injections to 250 mg vial contents.
Add 3 ml water for injections to 500 mg vial contents.
Add 6 ml water for injections to 1,000 mg vial contents.
Intravenous: Dissolve 500 mg in 5 ml water for injections.
Administer by slow injection (three to four minutes). Ampicillin may also be added to infusion fluids or injected, suitably diluted, into the drip tube over a period of three to four minutes.
Direction for Reconstitution: 500 mg: For I.M. use: Add 1.5 mL of sterile water and shake well. The solution must be used within one hour after reconstitution.
For I.V. use: Add 5 mL of sterile water and shake well. The solutions must be used within one hour after reconstitution.

Gastrointestinal effects such as nausea, vomiting and diarrhoea may be evident and should be treated symptomatically.
Ampicillin may be removed from the circulation by haemodialysis.

Hypersensitivity to the active.
Ampicillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. ampicillin, penicillins, cephalosporins) or excipients.

Before initiating therapy with ampicillin, careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics.
Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity.
Ampicillin should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin.
Prolonged use may occasionally result in overgrowth of non-susceptible organisms.
Dosage should be adjusted in patients with renal impairment (see Dosage & Administration).
This medicine contains 33.7 mg of sodium per vial, equivalent to 1.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
500 mg: Ampicillin should preferably not to be given to patients with infectious mononucleosis since they are especially susceptible to ampicillin-induced skin rashes; patients with lymphatic leukemia and patients with hyperuricaemia being treated with allopurinol may also be increased risk of developing skin rashes.
Ampicillin may decrease the efficacy of oestrogen-containing oral contraceptives and it may also affect the absorption of other drug due to its effect on the gastro-intestinal flora.
Effects on ability to drive and use machines: No studies on the effects to drive and use machines have been performed. Based on reported adverse drug reactions, it is presumed that ampicillin has no or negligible influence on the ability to drive and use machines.

Pregnancy: Animal studies with Ampicillin have shown no teratogenic effects. The product has been in extensive clinical use since 1961 and its use in human pregnancy has been well documented in clinical studies. When antibiotic therapy is required during pregnancy, Ampicillin may be considered appropriate.
Breast-feeding: During lactation, trace quantities of penicillins can be detected in breast milk. Adequate human and animal data on use of Ampicillin during lactation are not available.

Hypersensitivity reactions: If any hypersensitivity reaction occurs, the treatment should be discontinued.
Skin rash, pruritis and urticaria have been reported occasionally. The incidence is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura has also been reported. Rarely, skin reactions such as erythema multiforme and Stevens Johnson syndrome, and toxic epidermal necrolysis have been reported.
As with other antibiotics, anaphylaxis (see Precautions) has been reported rarely.
Renal effects: Interstitial nephritis can occur rarely.
Gastrointestinal reactions: Effects include nausea, vomiting and diarrhoea. Pseudomembraneous colitis and haemorrhagic colitis has been reported rarely.
Hepatic effects: As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely. As with most other antibiotics, a moderate and transient increase in transaminases has been reported.
Haematological effects: As with other beta-lactams, haematological effects including transient leucopenia, transient thrombocytopenia and haemolytic anaemia have been reported rarely. Prolongation of bleeding time and prothrombin time has also been reported rarely.
500 mg: Gastrointestinal adverse effects particularly diarrhoea and also nausea and vomiting occur quite frequently, usually following administration by mouth. Pseudomembranous colitis has also been reported. Supra-infections with non-susceptible organism may occur particularly with prolonged use.

If Ampicillin is prescribed concurrently with an aminoglycoside, the antibiotics should not be mixed in the syringe, intravenous fluid container or giving set because loss of activity of the aminoglycoside can occur under these conditions.
Bacteriostatic drugs may interfere with the bactericidal action of ampicillin.
In common with other oral broad-spectrum antibiotics, ampicillin may reduce the efficacy of oral contraceptives and patients should be warned accordingly.
Probenecid decreases the renal tubular secretion of ampicillin. Concurrent use with ampicillin may result in increased and prolonged blood levels of ampicillin.
Concurrent administration of allopurinol during treatment with ampicillin can increase the likelihood of allergic skin reactions.
It is recommended that when testing for the presence of glucose in urine during ampicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of ampicillin, false positive readings are common with chemical methods.

Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with blood products or other proteinaceous fluids (e.g. protein hydrolysates) or with intravenous lipid emulsions.

Shelf life: 36 months.
Special precautions for storage: Store below 30°C.
500 mg: Store at room temperature.

Penicillins

J01CA01 - ampicillin ; Belongs to the class of penicillins with extended spectrum. Used in the systemic treatment of infections.

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