Indications:

Benzylpenicillin benzathine is indicated in adults, adolescents, children and neonates for the treatment and prophylaxis of the following infections:

For the treatment of:

- erysipelas

- syphilis: early syphilis (primary and secondary)

- latent syphilis (except for neurosyphilis and presence of pathological CSF findings)

- yaws

- pinta

For the prophylaxis of:

- rheumatic fever (chorea, rheumatic carditis)

- poststreptococcal glomerulonephritis

- erysipelas

Dosage and Administration:

Posology

The dosing recommendations depend on the severity and the type of infection, the age and the hepato-renal function of patients.

Method of administration

The preparation is strictly for intramuscular injection.

The injection must not be administered into tissue with reduced perfusion.

Precautions & Warning:

Benzylpenicillin benzathine should not be used in tissues with reduced perfusion.

Before initiating therapy with benzylpenicillin benzathine, a careful investigation should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins or other beta-lactam agents.

Prior to treatment, a hypersensitivity test should be performed if possible. The patient should be made aware of the possible occurrence of allergic symptoms and of the need to report them.

With long-term treatment (more than a single dose), periodic assessment of organ system functions, including renal, hepatic and haematopoietic function is recommended.

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

Antibiotic-associated colitis has been reported with nearly all antibacterial agents including benzylpenicillin benzathine and may range in severity from mild to life threatening . Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of any antibiotics. Should antibiotic-associated colitis occur, benzylpenicillin benzathine should be discontinued, a physician be consulted, and an appropriate therapy initiated. Anti-peristaltic drugs are contraindicated in this situation.

If neurological involvement cannot be excluded in patients with congenital syphilis, forms of penicillin that reach a higher level in cerebrospinal fluid should be used.

In diseases such as severe pneumonia, empyema, sepsis, meningitis or peritonitis, which require higher serum penicillin levels, alternative treatment such as the water-soluble alkali salt of benzylpenicillin should be considered.

Contra-indications:

- Hypersensitivity to penicillins or any of the excipients.

- History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. cephalosporin, carbapenem or monobactam).

- When lidocaine solution is used as a solvent, contraindications to lidocaine must be excluded before intramuscular injection of benzylpenicillin benzathine.

Drug interactions:

Concomitant administration of benzylpenicillin benzathine is not recommended with:

- bacteriostatic antibiotics: based on the general principle not to combine bactericidal and bacteriostatic antibiotics.

Caution should be exercised when co-administering the following:

- probenecid

- methotrexate

- anticoagulants

Storage instructions:

Do not store above 25°C.

Following reconstitution, benzylpenicillin benzathine should be used immediately.