Indications:

Benzylpenicillin is indicated for the treatment of the following infections in adults, adolescents, children, newborn infants and pre-term infants, caused by penicillin-sensitive pathogens:

- skin and wound infections

- diphtheria (in addition to antitoxin)

- community acquired pneumonia

- empyema

- erysipelas

- bacterial endocarditis

- peritonitis

- meningitis

- brain abscesses

- osteomyelitis

- infections of the genital tract caused by fusobacteria

Benzylpenicillin is also used for the treatment of the following specific infections:

- anthrax

- tetanus

- gas gangrene

- listeriosis

- pasteurellosis

- rat bite fever

- fusospirochaetosis

- actinomycosis

Furthermore, Benzylpenicillin is also used for complications in gonorrhoea and syphilis (e.g. gonorrhoeal endocarditis or arthritis, congenital syphilis), provided that the isolate of Neisseria gonorrhea is documented to have sensitivity to penicillin .   However, in uncomplicated cases, preference should be given to depot penicillins.   Benzylpenicillin is not indicated for the treatment of syphilis during pregnancy.

Benzylpenicillin is also used in Lyme borreliosis from the second stage of the disease onwards (meningopolyneuritis Garin-Bujadoux-Bannwarth, acrodermatitis chronica atrophicans, Lyme arthritis, Lyme carditis) if oral penicillin therapy is no longer indicated.   During pregnancy, high-dose parenteral Benzylpenicillin administration is recommended from the second stage of Lyme disease onwards to prevent diaplacental infections.

Dosage and administration：

Adults and adolescents (aged 12 years and older):

Normal dosage (intramuscular or intravenous): 18 mg/kg/day, equivalent to approximately 600-3000 mg per day, divided into 4 - 6 doses

Infants (aged one month and older) and children (up to 12 years of age):

Normal dosage (intramuscular or intravenous): 18-60 mg/kg/day, divided into 4-6 doses

Newborn infants (2-4 weeks of age):

Normal dosage (intramuscular or intravenous): 18-60 mg/kg/day, in 3-4 single doses

Pre-term and newborn infants (up to 2 weeks of age):

Normal dosage (intramuscular or intravenous): 18-60 mg/kg/day, in 2 single doses

Elderly:

Elimination processes may be delayed with advanced age. The dosage must therefore be adjusted to renal function in each individual case.

Contraindications:

• Hypersensitivity to the active substance

• History of hypersensitivity to penicillin

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

Precautions:

- allergic diathesis (urticaria or hay fever) or asthma (increased risk of hypersensitivity reactions)

- severe heart conditions or severe electrolyte disturbances of any other origin (attention should be paid to electrolyte intake in this patient group, especially potassium intake);

- renal insufficiency

- liver damage

- epilepsy, cerebral oedema or meningitis (increased risk of seizures, especially with high-dose administration (12000 mg ) of Benzylpenicillin)

- existing mononucleosis (increased risk of skin rash)

- when treating co-infections in patients with acute lymphatic leukaemia (increased risk of skin reactions)

- dermatomycoses (para-allergic reactions are possible, as there may be common antigenicity between penicillins and metabolic products of dermatophytes)

Drug interactions:

Based on the general principle not to combine bactericidal and bacteriostatic antibiotics, Benzylpenicillin should not be combined with bacteriostatic antibiotics.

Caution is required when co-administering with:

Probenecid

Anti-inflammatories, antirheumatics and antipyretics

Digoxin

Methotrexate

Oral anticoagulants

Synergism between antibiotics:

Benzylpenicillin should only be given in combination with other antibiotics if a synergistic or at least an additive effect is anticipated.

If duly indicated, it should, in particular, be remembered that Benzylpenicillin can be combined with the following bactericidal antibiotics:

- isoxazolyl penicillins (e.g. flucloxacillin and other narrow-spectrum beta-lactams)

- aminopenicillins

- aminoglycosides

Storage:

Do not store above 25°C