Drugs List

Therapeutic Indications

Uses

Anthrax: treatment
Bacterial endocarditis
Bacterial meningitis
Infections sensitive to penicillin
Meningococcal disease
Neonatal group B streptococcal infections (intrapartum): prophylaxis
Suspected meningococcal disease or meningitis

Treatment of most wound infections, pyogenic infections of the skin, soft tissue infections and infections of the nose, throat, nasal sinuses, respiratory tract and middle ear.

It is effective against many streptococcal (including pneumococcal), gonococcal and meningococcal infections.

It is also indicated for treating the following infections caused by penicillin-sensitive organisms:
Generalised infections
Pneumonia
Septicaemia
Pyaemia
Osteomyelitis (acute and chronic)
Bacterial endocarditis (sub-acute)
Meningitis
Suspected meningococcal disease or meningitis
Gas gangrene
Tetanus
Actinomycosis
Anthrax
Leptospirosis
Rat-bite fever
Listeriosis
Severe Lyme disease
Diphtheria
Brain abscesses
Pasteurellosis
Complications secondary to gonorrhoea and syphilis (e.g. gonococcal arthritis or endocarditis, and neurosyphilis)

Prophylaxis of neonatal group B streptococcal infections (intrapartum)

Treatment of congenital syphilis and neurosyphilis

Administration

For intramuscular injection or intravenous injection or infusion.

Only freshly prepared solutions should be used. Once reconstituted, solutions of benzylpenicillin sodium should be used immediately.

Intravenous treatment is preferable in infants. This is because there is an increased risk of severe local reactions to intramuscular injections in these patients.

For repeated injections, alternative sites should be used.

Higher doses should be administered intravenously. Intravenous doses in excess of 1.2 grams should be given slowly, taking at least one minute for each 300 mg to avoid high levels causing irritation of the central nervous system and/or electrolyte imbalance.

Take into account the sodium content of the injection as high doses of benzylpenicillin sodium may result in hypernatraemia and hypokalaemia.

Benzylpenicillin should not be reconstituted in sodium-containing liquids (such as Sodium Chloride Injection BP or Ringer's solution) for patients with renal impairment or cardiac failure. This is because the excess sodium may lead to sodium overload or cardiac failure in these patients.

Contraindications

None known

Precautions and Warnings

Allergic disposition
Restricted sodium intake
Asthma
Diabetes mellitus
Eczema
Renal impairment
Severe hepato-renal syndrome

Contains more than 1 mmol (23 mg) sodium per dose
Reduce dose and/or alter dose interval in patients with renal impairment
Before initiating therapy enquire about previous hypersensitivity reactions
Consult national/regional policy on the use of anti-infectives
Avoid contact with skin or eyes
Consider pseudomembranous colitis if patient presents with severe diarrhoea
Monitor electrolyte balance when treatment exceeds 5 days
Monitor for signs of superinfection with non-susceptible organisms
Monitor haematological parameters when treatment exceeds 5 days
Monitor patient for 30 minutes after administration
Monitor renal function when treatment exceeds 5 days
Prolonged use may result in superinfection with non-susceptible organisms
May affect results of some laboratory tests
Discontinue if drug-related rash or other hypersensitivity reactions occur
Discontinue if severe and persistent diarrhoea develops

Diabetic patients may experience delayed absorption following intramuscular injection.

600 mg of benzylpenicillin sodium contains 1.68 mmol of sodium. Take into account the sodium content of the injection as high doses of benzylpenicillin sodium may result in hypernatraemia and hypokalaemia.
Potassium-sparing diuretics may be beneficial. Where high doses are administered for more than 5 days, electrolyte balances, renal function and blood counts should be monitored.

Pregnancy and Lactation

Pregnancy

Benzylpenicillin sodium is considered safe for use during pregnancy.

Benzylpenicillin sodium has been taken by a large number of pregnant women and women of childbearing age without an increase in malformations or other direct or indirect harmful effects on the foetus having been observed.

Reproduction studies in mice, rats and rabbits revealed no evidence of impaired fertility or foetal harm.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Benzylpenicillin sodium is considered safe for use in breastfeeding.

Administration during breastfeeding is not known to be harmful, but Briggs suggests the following problems may exist for the nursing infant, modification of bowel flora, allergic response and interference with the interpretation of culture results if fever workup is required.

It is not known whether benzylpenicillin sodium is excreted in human breast milk. However, it has been present in the milk of animals and trace amounts of other penicillins have been detected in human breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Agranulocytosis
Anaphylaxis
Angioedema
Antibiotic-associated colitis
CNS toxicity
Coagulation disorders
Convulsions
Diarrhoea
Fever
Granulocytopenia
Haemolytic anaemia
Hypernatraemia
Hypersensitivity reactions
Hypokalaemia
Interstitial nephritis
Jarisch-Herxheimer reaction
Joint pain
Leucopenia
Neutropenia
Overgrowth by non-susceptible organisms
Pseudomembranous colitis
Rash
Serum sickness-like reactions
Thrombocytopenia
Urticaria

Presentation

Powder for solution for injection containing benzylpenicillin sodium

Drugs List

Therapeutic Indications

Uses

Anthrax: treatment
Bacterial endocarditis
Bacterial meningitis
Infections sensitive to penicillin
Meningococcal disease
Neonatal group B streptococcal infections (intrapartum): prophylaxis
Suspected meningococcal disease or meningitis

Treatment of most wound infections, pyogenic infections of the skin, soft tissue infections and infections of the nose, throat, nasal sinuses, respiratory tract and middle ear.

It is effective against many streptococcal (including pneumococcal), gonococcal and meningococcal infections.

It is also indicated for treating the following infections caused by penicillin-sensitive organisms:
Generalised infections
Pneumonia
Septicaemia
Pyaemia
Osteomyelitis (acute and chronic)
Bacterial endocarditis (sub-acute)
Meningitis
Suspected meningococcal disease or meningitis
Gas gangrene
Tetanus
Actinomycosis
Anthrax
Leptospirosis
Rat-bite fever
Listeriosis
Severe Lyme disease
Diphtheria
Brain abscesses
Pasteurellosis
Complications secondary to gonorrhoea and syphilis (e.g. gonococcal arthritis or endocarditis, and neurosyphilis)

Prophylaxis of neonatal group B streptococcal infections (intrapartum)

Treatment of congenital syphilis and neurosyphilis

Dosage

Susceptibility of the causative organism to the treatment should be tested, if possible, although therapy may be initiated before the results are available.

Adults

Elderly

Children

Neonates

Patients with Renal Impairment

Patients with Hepatic Impairment

Administration

For intramuscular injection or intravenous injection or infusion.

Only freshly prepared solutions should be used. Once reconstituted, solutions of benzylpenicillin sodium should be used immediately.

Intravenous treatment is preferable in infants. This is because there is an increased risk of severe local reactions to intramuscular injections in these patients.

For repeated injections, alternative sites should be used.

Higher doses should be administered intravenously. Intravenous doses in excess of 1.2 grams should be given slowly, taking at least one minute for each 300 mg to avoid high levels causing irritation of the central nervous system and/or electrolyte imbalance.

Take into account the sodium content of the injection as high doses of benzylpenicillin sodium may result in hypernatraemia and hypokalaemia.

Benzylpenicillin should not be reconstituted in sodium-containing liquids (such as Sodium Chloride Injection BP or Ringer's solution) for patients with renal impairment or cardiac failure. This is because the excess sodium may lead to sodium overload or cardiac failure in these patients.

Contraindications

None known

Precautions and Warnings

Allergic disposition
Restricted sodium intake
Asthma
Diabetes mellitus
Eczema
Renal impairment
Severe hepato-renal syndrome

Contains more than 1 mmol (23 mg) sodium per dose
Reduce dose and/or alter dose interval in patients with renal impairment
Before initiating therapy enquire about previous hypersensitivity reactions
Consult national/regional policy on the use of anti-infectives
Avoid contact with skin or eyes
Consider pseudomembranous colitis if patient presents with severe diarrhoea
Monitor electrolyte balance when treatment exceeds 5 days
Monitor for signs of superinfection with non-susceptible organisms
Monitor haematological parameters when treatment exceeds 5 days
Monitor patient for 30 minutes after administration
Monitor renal function when treatment exceeds 5 days
Prolonged use may result in superinfection with non-susceptible organisms
May affect results of some laboratory tests
Discontinue if drug-related rash or other hypersensitivity reactions occur
Discontinue if severe and persistent diarrhoea develops

Diabetic patients may experience delayed absorption following intramuscular injection.

600 mg of benzylpenicillin sodium contains 1.68 mmol of sodium. Take into account the sodium content of the injection as high doses of benzylpenicillin sodium may result in hypernatraemia and hypokalaemia.
Potassium-sparing diuretics may be beneficial. Where high doses are administered for more than 5 days, electrolyte balances, renal function and blood counts should be monitored.

Pregnancy and Lactation

Pregnancy

Benzylpenicillin sodium is considered safe for use during pregnancy.

Benzylpenicillin sodium has been taken by a large number of pregnant women and women of childbearing age without an increase in malformations or other direct or indirect harmful effects on the foetus having been observed.

Reproduction studies in mice, rats and rabbits revealed no evidence of impaired fertility or foetal harm.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Benzylpenicillin sodium is considered safe for use in breastfeeding.

Administration during breastfeeding is not known to be harmful, but Briggs suggests the following problems may exist for the nursing infant, modification of bowel flora, allergic response and interference with the interpretation of culture results if fever workup is required.

It is not known whether benzylpenicillin sodium is excreted in human breast milk. However, it has been present in the milk of animals and trace amounts of other penicillins have been detected in human breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Agranulocytosis
Anaphylaxis
Angioedema
Antibiotic-associated colitis
CNS toxicity
Coagulation disorders
Convulsions
Diarrhoea
Fever
Granulocytopenia
Haemolytic anaemia
Hypernatraemia
Hypersensitivity reactions
Hypokalaemia
Interstitial nephritis
Jarisch-Herxheimer reaction
Joint pain
Leucopenia
Neutropenia
Overgrowth by non-susceptible organisms
Pseudomembranous colitis
Rash
Serum sickness-like reactions
Thrombocytopenia
Urticaria

Effects on Laboratory Tests

Benzylpenicillin administration may interfere with the following tests:
Urinary glucose tests (false positive results if testing for reducing substances)
Coomb's test
Urinary or serum protein tests
Tests that use bacteria (e.g. Guthrie test)

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: October 2014

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press [Accessed on 9 October, 2014].

Summary of Product Characteristics: Benzylpenicillin sodium powder for injection. Genus Pharmaceuticals. Revised June 2014.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications [Accessed on 9 October, 2014].