BENZYLPENICILLIN SODIUM FOR INJECTION 1mega 7ml

BENZYLPENICILLIN SODIUM FOR INJECTION 1mega 7ml

  • Documents: GMP,COPP,CTD

BENZYLPENICILLIN SODIUM FOR INJECTION 1mega 7ml

Indications:

Benzylpenicillin is indicated for most wound infections, pyogenic infections of the skin, soft tissue infections and infections of the nose, throat, nasal sinuses, respiratory tract and middle ear, etc.

It is also indicated for the following infections caused by penicillin-sensitive microorganisms: Generalised infections, septicaemia and pyaemia from susceptible bacteria. Acute and chronic osteomyelitis, sub-acute bacterial endocarditis and meningitis caused by susceptible organisms. Suspected meningococcal disease. Gas gangrene, tetanus, actinomycosis, anthrax, leptospirosis, rat-bite fever, listeriosis, severe Lyme disease, and prevention of neonatal group B streptococcal infections. Complications secondary to gonorrhoea and syphilis (e.g. gonococcal arthritis or endocarditis, congenital syphilis and neurosyphilis). Diphtheria, brain abscesses and pasteurellosis.

Dosage and Administration:

Routes of administration: Intramuscular, intravenous.

Precautions & Warning:

Massive doses of Benzylpenicillin Sodium can cause hypokalaemia and sometimes hypernatraemia.

In the presence of impaired renal function, large doses of penicillin can cause cerebral irritation, convulsions and coma.

It should be recognised that any patient with a history of allergy, especially to drugs, is more likely to develop a hypersensitivity reaction to penicillin. Patients should be observed for 30 minutes after administration and if an allergic reaction occurs the drug should be withdrawn and appropriate treatment given.

Delayed absorption from the intramuscular depot may occur in diabetics.

Prolonged use of benzylpenicillin may occasionally result in an overgrowth of non-susceptible organisms or yeast and patients should be observed carefully for superinfections.

Pseudomembranous colitis should be considered in patients who develop severe and persistent diarrhoea during or after receiving benzylpenicillin. In this situation, even if Clostridium difficile is only suspected, administration of benzylpenicillin should be discontinued and appropriate treatment given

Benzylpenicillin is contraindicated in patients who are hypersensitive to penicillins. Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterials may also be hypersensitive to benzylpenicillin. Benzylpenicillin should be used with caution in patients with a history of non-severe hypersensitivity reactions to any other beta-lactam antibiotics (e.g. cephalosporins or carbapenems) and not at all in patients with history of severe hypersensitivity reactions. If a severe allergic reaction or SCAR occurs during treatment with benzylpenicillin, treatment with the medicinal product should be discontinued and appropriate measures taken.

Contra-indications:

Allergy to penicillins. Hypersensitivity to any ingredient of the preparation.

Cross allergy to other beta-lactams such as cephalosporins should be taken into account.

Drug interactions:

There is reduced excretion of methotrexate (and therefore increased risk of methotrexate toxicity) when used with benzylpenicillin sodium.

Probenecid inhibits tubular secretion of benzylpenicillin sodium and so may be given to increase the plasma concentrations.

Penicillins may interfere with:

• Urinary glucose test

• Coomb's tests

• Tests for urinary or serum proteins

• Tests which use bacteria e.g. Guthrie test

Storage instructions:

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing and out of the reach of children.