Indications

1.For the treatment of: erysipelas; syphilis: early syphilis (primary and secondary); latent syphilis (except for neurosyphilis and presence of pathological CSF findings); yaws; pinta

2.For the prophylaxis of: rheumatic fever (chorea, rheumatic carditis);  poststreptococcal glomerulonephritis; erysipelas

Dosage and Administration

Usage:The preparation is strictly for intramuscular injection

The injection must not be administered into tissue with reduced perfusion

Dosage:

Adults and adolescents: 1.2 Million I.U.

Note: In streptococcal diseases, a 10-day minimum course of treatment should be observed to avoid secondary diseases. This is generally ensured with a single injection of 0.6 Million I.U., 1.2 Million I.U. or 2.4 Million I.U..

Precautions & Warning:

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

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

3.Beta-lactams are associated with a risk of encephalopathy (confusion, altered levels of consciousness, epilepsy or movement abnormalities), particularly in cases of over-dose or impaired renal function.

4.When treating syphilis, a Jarisch-Herxheimer reaction may occur as a result of the bactericidal action of penicillin on pathogens. Within 2 to 12 hours after administration headaches, fever, sweating, shivering, myalgia, arthralgia, nausea, tachycardia, increased blood pressure followed by hypotension may occur.

5.Antibiotic-associated colitis has been reported with nearly all antibacterial agents including benzylpenicillin benzathine and may range in severity from mild to life threatening

6.Painful induration may occur in the event of accidental subcutaneous administration. Ice packs help in such cases.

7.In the event of inadvertent intravascular injection, Hoigné syndrome may occur (symptoms of shock with mortal fear, confusion, hallucinations, possibly cyanosis, tachycardia and motor disorders, although no circulatory collapse),

8.A positive direct Coombs' test often develops (≥ 1% to < 10%) in patients receiving 10 million IU (equivalent to 6 g) benzylpenicillin or more per day.

Contraindications:

1.Hypersensitivity to penicillins or any of the excipients.

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

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

Adverse Reactions:

1.The most frequent and common adverse reactions related to benzylpenicillin benzathine are candidiasis, diarrhoea, nausea and laboratory investigation changes.

2.When treating syphilis, a Jarisch-Herxheimer reaction may occur as a result of bacteriolysis, characterised by fever, chills, general and focal symptoms. In patients with dermatomycosis, para-allergic reactions may occur, as common antigenicity may exist between penicillins and dermatophyte metabolites.

In infants, local reactions are possible.

It cannot be excluded that, in very rare cases and due to the povidone content, povidone may accumulate in the reticuloendothelial system (RES) or local deposits and foreign body granuloma may occur, which may be confused with tumours.

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.

Storage instructions:

This medicinal product does not require any special storage conditions.