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Benzylpenicillin sodium 600mg Powder for Injection Vial x25

Benzylpenicillin sodium 600mg Powder for Injection Vial x25

Misc (Generics)

Prescription-only systemic antibacterial (parenteral antibiotic)
  • UK Licensed medicinal product containing benzylpenicillin sodium as active ingredient, authorised by the Medicines and Healthcare products Regulatory Agency (MHRA).
  • Active substance benzylpenicillin sodium is described in the European Pharmacopoeia and manufactured in compliance with Good Manufacturing Practice (GMP).
  • Finished product manufactured and controlled according to EU/UK Good Manufacturing Practice for medicinal products.
  • Subject to routine pharmacovigilance, quality control and batch release testing as per regulatory requirements.
  • Supplied as a Prescription Only Medicine (POM) with approved SmPC and PIL available via recognised medicines information services.
Beta-lactam penicillin (benzylpenicillin / penicillin G sodium) powder for injection

Description

Benzylpenicillin sodium 600mg Powder for Injection is a prescription-only sterile powder containing benzylpenicillin (penicillin G) as the sodium salt, intended for reconstitution to form a solution for injection or infusion. Each vial contains 600 mg benzylpenicillin sodium (approximately 1 mega unit). The product appears as a white crystalline, water-soluble powder supplied in glass vials sealed with bromobutyl rubber stoppers and aluminium or plastic flip-off caps. It is indicated for the treatment of a wide range of infections caused by penicillin-sensitive organisms, including skin and wound infections, respiratory tract infections, meningitis, septicaemia, osteomyelitis, endocarditis and specific conditions such as suspected meningococcal disease, gas gangrene, tetanus, anthrax, leptospirosis, listeriosis, severe Lyme disease and complications of gonorrhoea and syphilis. The pack configuration supplied by Williams Medical Supplies contains 25 vials of 600 mg powder for injection.

Bnefits

  • Broad-spectrum activity against many Gram-positive and some Gram-negative organisms sensitive to benzylpenicillin.
  • Well-established first-line therapy for many serious systemic infections when organisms are known or suspected to be penicillin-sensitive.
  • Multiple parenteral routes (intravenous, intramuscular, and, where appropriate, infusion) allow flexible dosing in hospital and emergency settings.
  • White crystalline, water-soluble sterile powder allows straightforward reconstitution with standard diluents (e.g. Water for Injections or 0.9% sodium chloride).
  • Extensive clinical experience and inclusion in national/international treatment guidelines for conditions such as meningitis, meningococcal disease and syphilis.
  • Availability in 600 mg (1 mega unit) vials facilitates dosing across adults, children, neonates and pre-term infants with weight-based regimens.
  • High sodium content is clearly stated, allowing appropriate use in patients requiring sodium restriction.
  • Supplied in multi-vial packs (e.g. 25-vial box) convenient for practices and hospitals requiring stock for acute and emergency use.

Indications

  • Most wound infections and pyogenic infections of the skin and soft tissues caused by benzylpenicillin-sensitive organisms.
  • Infections of the nose, throat, nasal sinuses, respiratory tract and middle ear due to susceptible bacteria (e.g. streptococcal infections).
  • Generalised infections including septicaemia and pyaemia caused by susceptible organisms.
  • Central nervous system infections such as bacterial meningitis and brain abscesses due to penicillin-sensitive pathogens.
  • Acute and chronic osteomyelitis caused by susceptible bacteria.
  • Sub-acute bacterial endocarditis and other forms of bacterial endocarditis due to susceptible organisms.
  • Suspected or confirmed meningococcal disease (e.g. meningococcal meningitis or septicaemia) as part of emergency and definitive therapy.
  • Specific serious infections such as gas gangrene (clostridial myonecrosis), tetanus (as part of combination therapy), actinomycosis, anthrax, leptospirosis, rat-bite fever, listeriosis and severe Lyme disease (later stages).
  • Prevention of neonatal group B streptococcal infections in appropriate obstetric and neonatal settings according to local guidelines.
  • Complications secondary to gonorrhoea and syphilis (e.g. gonococcal arthritis or endocarditis, congenital syphilis and neurosyphilis) where the causative organisms are confirmed penicillin-sensitive and regimen follows current guidance.
  • Diphtheria (as adjunct to antitoxin therapy), brain abscesses and infections due to Pasteurella species, where organisms are susceptible.
  • Other infections caused by penicillin-sensitive microorganisms in accordance with official local guidance and susceptibility testing results.

Composition

  • Active ingredient: Benzylpenicillin sodium 600 mg per vial (equivalent to approximately 1 mega unit of benzylpenicillin).
  • Sodium content: Each 600 mg vial contains approximately 38–39 mg sodium (about 1.68 mmol), contributing to the patient’s total daily sodium intake.
  • Excipients: Many licensed benzylpenicillin sodium 600 mg powder for injection products contain benzylpenicillin sodium as the sole component, with no additional excipients; refer to the specific SmPC/PIL for confirmation for each marketed pack.
  • The reconstituted solution is clear and colourless to pale yellow when prepared with appropriate diluents (e.g. Water for Injections or 0.9% sodium chloride).

Formulation

  • Pharmaceutical form: Powder for solution for injection/infusion.
  • Appearance: White or almost white crystalline, water-soluble sterile powder.
  • After reconstitution: Clear solution suitable for intravenous injection, intravenous infusion or intramuscular injection, depending on the diluent volume and route chosen.
  • Supplied strength: 600 mg benzylpenicillin sodium per vial (approximately 1 mega unit).
  • Vials are aseptically filled and stoppered under sterile conditions.

Packaging

  • Tubular type III glass vials containing 600 mg benzylpenicillin sodium powder.
  • Vials sealed with bromobutyl rubber stoppers and oversealed with aluminium caps or plastic flip-top caps.
  • Pack sizes: Boxes containing 10, 25, 50 or 100 vials, with Williams Medical Supplies specifically offering a 25-vial pack (Vial x25).
  • Outer carton labelled with product name, strength, batch number, expiry date, storage conditions, legal category and marketing authorisation details.
  • Each pack is supplied with a Patient Information Leaflet (PIL) and the prescribing information is detailed in the Summary of Product Characteristics (SmPC).

Usage

  • For parenteral use only. Administration routes typically include intravenous injection, intravenous infusion or intramuscular injection, depending on the clinical situation and local prescribing information.
  • Reconstitution: The powder must be reconstituted with an appropriate sterile diluent such as Water for Injections BP or 0.9% Sodium Chloride Injection BP. Typical reconstitution guidance (may vary by product) includes dissolving 600 mg in 1.6–2 ml for intramuscular injection or in 4–10 ml for intravenous injection; larger volumes may be used for infusion. Always follow the specific SmPC/PIL for the product supplied.
  • Dosage: The dose, route and frequency depend on the type and severity of infection, the susceptibility of the pathogen, and the patient’s age, weight and renal function. High doses may be required for severe infections such as meningitis or endocarditis. Dosing in neonates, infants, children, elderly patients and those with renal impairment should follow the SmPC and local dosing guidelines.
  • Administration: Solutions should be inspected visually for particulate matter and discolouration prior to administration. Only clear solutions should be used. Reconstituted solutions should be used immediately when possible.
  • Duration of therapy: Treatment should continue for at least 48–72 hours after the patient’s temperature has returned to normal and/or there is evidence of bacterial eradication. Total duration will vary according to the infection (e.g. longer courses for endocarditis, osteomyelitis, meningitis and neurosyphilis).
  • Compatibility: When used for infusion, benzylpenicillin should be diluted only with compatible fluids as specified in the product information (commonly 0.9% sodium chloride or 5% glucose). Solutions should not be mixed with other drugs in the same syringe or infusion container unless compatibility is established.
  • Monitoring: Clinical response, renal function, liver function and haematological parameters should be monitored in prolonged therapy or high-dose treatment. Adjust dose as needed for renal impairment and in patients receiving concomitant nephrotoxic drugs.
  • Microbiological guidance: Therapy should be guided by susceptibility testing where possible. Empirical use should be reviewed once culture and sensitivity results are available, in line with local antimicrobial stewardship policies.

Contraindications

  • Known hypersensitivity to benzylpenicillin, any other penicillin, or any component of the formulation.
  • History of severe immediate hypersensitivity reactions (e.g. anaphylaxis) to beta-lactam antibiotics such as cephalosporins, carbapenems or monobactams, due to the risk of cross-reactivity.
  • Previous serious skin reactions (e.g. Stevens–Johnson syndrome, toxic epidermal necrolysis) associated with penicillin therapy.
  • In patients with known severe allergy to penicillins, alternative non-beta-lactam therapy should be considered, unless no suitable alternatives exist and treatment is given under strict specialist supervision.
  • Intrathecal administration is contraindicated unless specifically detailed in the product information for that formulation (many benzylpenicillin sodium powder for injection products are not licensed for intrathecal use).
  • Other contraindications or restrictions specified in the current SmPC for the specific marketed product.

Adverse Effects

  • Hypersensitivity reactions ranging from rash, urticaria and pruritus to severe anaphylactic shock; angioedema and bronchospasm may occur.
  • Serum sickness-like reactions, fever, arthralgia and eosinophilia.
  • Gastrointestinal disturbances such as nausea, vomiting, diarrhoea and abdominal discomfort.
  • Clostridioides difficile-associated diarrhoea and colitis (CDAD), including pseudomembranous colitis, may occur with broad-spectrum antibiotic use.
  • Local injection site reactions including pain, inflammation, induration, phlebitis or thrombophlebitis (particularly with intravenous use).
  • Haematological effects such as haemolytic anaemia, thrombocytopenia, leukopenia, neutropenia or eosinophilia, especially with prolonged or high-dose therapy.
  • Neurological effects such as convulsions or encephalopathy, particularly with very high doses, intravascular overdose, or in patients with renal impairment or meningitis.
  • Renal effects including interstitial nephritis or renal impairment, usually reversible after discontinuation.
  • Electrolyte disturbances related to sodium load, particularly in patients on sodium-restricted diets or with heart failure, hypertension or renal impairment.
  • Jarisch–Herxheimer reaction during treatment of spirochaetal infections such as syphilis or Lyme disease (acute febrile reaction with headache, myalgia and other symptoms shortly after starting therapy).
  • Other adverse reactions listed in the current SmPC, including rare or very rare events such as severe cutaneous adverse reactions (SCARs), should also be considered.

Storage Conditions

  • Store below 25°C in the original package to protect from moisture and light.
  • Shelf life of unopened vials is typically 36 months from the date of manufacture (check the expiry date on the carton and vial label).
  • From a microbiological point of view, reconstituted solutions should be used immediately whenever possible.
  • If not used immediately, in-use storage of reconstituted solution should not normally exceed 24 hours at 2–8°C, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions as stated in local guidelines and product information.
  • Do not freeze reconstituted solutions. Discard any unused solution after the recommended in-use period.
  • Keep out of the sight and reach of children.

Duration

Treatment duration is determined by the type and severity of infection and the patient\u2019s clinical response. Many uncomplicated infections are treated for around 7\u201310 days, whereas serious infections such as endocarditis, osteomyelitis, meningitis, neurosyphilis or severe Lyme disease may require prolonged courses (often several weeks). Therapy should usually continue for at least 48\u201372 hours after clinical signs and symptoms have resolved and/or there is evidence of bacterial eradication, in line with the SmPC and local antimicrobial guidelines.

Onset

Bactericidal activity begins soon after adequate plasma concentrations are achieved following injection, with clinical improvement commonly observed within the first few days of appropriate therapy in susceptible infections. The exact onset of symptom relief depends on the infection site, pathogen, bacterial load, and patient factors.

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