Penicillin G sodium salt (Powder) Instructions for Use

Marketing Authorization Holder

Biochemie GmbH (Austria)

ATC Code

J01CE01 (Benzylpenicillin)

Active Substance

Benzylpenicillin (Rec.INN registered by WHO)

Dosage Form

Penicillin G sodium salt

Powder for solution for injection 1 million IU: fl. 100 pcs.

Dosage Form, Packaging, and Composition

Vials (100) – cardboard boxes.

Clinical-Pharmacological Group

Penicillin antibiotic, destroyed by penicillinase

Pharmacotherapeutic Group

Antibiotic, penicillin

Pharmacological Action

An antibiotic from the group of biosynthetic penicillins. It exerts a bactericidal effect by inhibiting the synthesis of the microorganism’s cell wall.

It is active against gram-positive bacteria: Staphylococcus spp., Streptococcus spp. (including Streptococcus pneumoniae), Corynebacterium diphtheriae, Bacillus anthracis; gram-negative bacteria: Neisseria gonorrhoeae, Neisseria meningitidis; anaerobic spore-forming rods; as well as Actinomyces spp., Spirochaetaceae.

Strains of Staphylococcus spp. that produce penicillinase are resistant to the action of benzylpenicillin. It is destroyed in an acidic environment.

The procaine salt of benzylpenicillin is characterized by a longer duration of action compared to the potassium and sodium salts.

Pharmacokinetics

After intramuscular administration, it is rapidly absorbed from the injection site. It is widely distributed in body tissues and fluids. Benzylpenicillin penetrates well through the placental barrier and the blood-brain barrier when the meninges are inflamed.

T_1/2 is 30 minutes. It is excreted in the urine.

Indications

Treatment of diseases caused by microorganisms sensitive to benzylpenicillin: lobar and focal pneumonia, pleural empyema, sepsis, septicemia, pyemia, acute and subacute septic endocarditis, meningitis, acute and chronic osteomyelitis, infections of the urinary and biliary tracts, tonsillitis, purulent infections of the skin, soft tissues and mucous membranes, erysipelas, diphtheria, scarlet fever, anthrax, actinomycosis, treatment of purulent-inflammatory diseases in obstetric and gynecological practice, ENT diseases, eye diseases, gonorrhea, blennorrhea, syphilis.

ICD codes

Dosage Regimen

Individual. It is administered intramuscularly, intravenously, subcutaneously, endolumbally.

For intramuscular and intravenous administration in adults, the daily dose ranges from 250,000 to 60 million IU. The daily dose for children under 1 year of age is 50,000-100,000 IU/kg, over 1 year – 50,000 IU/kg; if necessary, the daily dose can be increased to 200,000-300,000 IU/kg, for vital indications – up to 500,000 IU/kg. The frequency of administration is 4-6 times/day.

For endolumbar administration, depending on the disease and severity of the course, adults are given 5,000-10,000 IU, children – 2,000-5,000 IU. The drug is diluted in sterile water for injection or in 0.9% sodium chloride solution at the rate of 1 thousand IU/ml. Before injection (depending on the level of intracranial pressure), 5-10 ml of cerebrospinal fluid is withdrawn and added to the antibiotic solution in an equal ratio.

Subcutaneously, Benzylpenicillin is used for infiltrate injections (100,000-200,000 IU in 1 ml of 0.25%-0.5% procaine solution).

Benzylpenicillin potassium salt is used only intramuscularly and subcutaneously, in the same doses as benzylpenicillin sodium salt.

Benzylpenicillin procaine salt is used only intramuscularly. The average therapeutic dose for adults: single – 300,000 IU, daily – 600,000 IU. For children under 1 year of age – 50,000-100,000 IU/kg/day, over 1 year – 50,000 IU/kg/day. The frequency of administration is 3-4 times/day.

The duration of treatment with benzylpenicillin, depending on the form and severity of the disease, can range from 7-10 days to 2 months or more.

Adverse Reactions

From the digestive system diarrhea, nausea, vomiting.

Effects due to chemotherapeutic action vaginal candidiasis, oral candidiasis.

From the central nervous system when using benzylpenicillin in high doses, especially with endolumbar administration, neurotoxic reactions may develop: nausea, vomiting, increased reflex excitability, meningism symptoms, convulsions, coma.

Allergic reactions increased body temperature, urticaria, skin rash, rash on mucous membranes, joint pain, eosinophilia, angioedema. Cases of anaphylactic shock with fatal outcome have been described.

Contraindications

Hypersensitivity to benzylpenicillin and other drugs from the group of penicillins and cephalosporins. Endolumbar administration is contraindicated in patients suffering from epilepsy.

Use in Pregnancy and Lactation

Use during pregnancy is possible only if the intended therapeutic benefit for the mother outweighs the potential risk to the fetus.

If use during lactation is necessary, the issue of discontinuing breastfeeding should be decided.

Use in Renal Impairment

Use with caution in patients with impaired renal function.

Pediatric Use

Can be used in children according to indications.

Special Precautions

Use with caution in patients with impaired renal function, heart failure, predisposition to allergic reactions (especially drug allergy), and with hypersensitivity to cephalosporins (due to the possibility of cross-allergy).

If no effect is observed 3-5 days after the start of use, a switch to other antibiotics or combination therapy should be made.

Due to the possibility of fungal superinfection, it is advisable to prescribe antifungal drugs during treatment with benzylpenicillin.

It must be taken into account that the use of benzylpenicillin in subtherapeutic doses or premature discontinuation of treatment often leads to the emergence of resistant strains of pathogens.

Drug Interactions

Probenecid reduces the tubular secretion of benzylpenicillin, resulting in an increase in its plasma concentration and an increase in the half-life.

With simultaneous use with antibiotics that have a bacteriostatic effect (tetracycline), the bactericidal effect of benzylpenicillin is reduced.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.