Components:
Benzylpenicillin
Method of action:
Bactericidal
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Medically reviewed by Militian Inessa Mesropovna, PharmD Last updated on 2019.07.17

Name of the medicinal product

Pen 30

Qualitative and quantitative composition

Benzylpenicillin

Therapeutic indications

The information provided in Therapeutic indications of Pen 30 is based on data of another medicine with exactly the same composition as the Pen 30 of the medicine (Benzylpenicillin). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Pen 30 directly from the package or from the pharmacist at the pharmacy.
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Powder for solution for injection; Powder for solution for injection and topical application; Powder for solution for intramuscular and subcutaneous administration; Powder for solution for intramuscular injection; Substance-powder
Powder for solution for intravenous and intramuscular administration

Benzylpenicillin is indicated for most wound infections, pyogenic infections of the skin, soft tissue infections and infections of the nose, throat, nasal sinuses, respiratory tract and middle ear, etc.

It is also indicated for the following infections caused by penicillin-sensitive microorganisms: Generalised infections, septicaemia and pyaemia from susceptible bacteria. Acute and chronic osteomyelitis, sub-acute bacterial endocarditis and meningitis caused by susceptible organisms. Suspected meningococcal disease. Gas gangrene, tetanus, actinomycosis, anthrax, leptospirosis, rat-bite fever, listeriosis, severe Lyme disease, and prevention of neonatal group B streptococcal infections. Complications secondary to gonorrhoea and syphilis (e.g. gonococcal arthritis or endocarditis, congenital syphilis and neurosyphilis). Diphtheria, brain abscesses and pasteurellosis.

Consideration should be given to official local guidance (e.g. national recommendations) on the appropriate use of antibacterial agents.

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

Pen 30 is indicated for most wound infections, pyogenic infections of the skin, soft tissue infections and infections of the nose, throat, nasal sinuses, respiratory tract and middle ear, etc.

It is also indicated for the following infections caused by penicillin-sensitive microorganisms: Generalised infections, septicaemia and pyaemia from susceptible bacteria. Acute and chronic osteomyelitis, sub-acute bacterial endocarditis and meningitis caused by susceptible organisms. Suspected meningococcal disease. Gas gangrene, tetanus, actinomycosis, anthrax, leptospirosis, rat-bite fever, listeriosis, severe Lyme disease, and prevention of neonatal group B streptococcal infections. Complications secondary to gonorrhoea and syphilis (e.g. gonococcal arthritis or endocarditis, congenital syphilis and neurosyphilis). Diphtheria, brain abscesses and pasteurellosis.

Consideration should be given to official local guidance (e.g. national recommendations) on the appropriate use of antibacterial agents.

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

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Pen 30 is based on data of another medicine with exactly the same composition as the Pen 30 of the medicine (Benzylpenicillin). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Pen 30 directly from the package or from the pharmacist at the pharmacy.
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Powder for solution for injection; Powder for solution for injection and topical application; Powder for solution for intramuscular and subcutaneous administration; Powder for solution for intramuscular injection; Substance-powder
Powder for solution for intravenous and intramuscular administration

Route of administration:

Intramuscular, intravenous.

Preparation of solutions:

Pharmaceutical preparation

Only freshly prepared solutions should be used. Reconstituted solutions of Pen 30 are intended for immediate administration.

1200 mg vials

Intravenous Injection: 1200 mg (2 mega units) dissolved in at least 8 ml of Sodium Chloride Injection BP or Water for Injections BP.

Intravenous Infusion: It is recommended that 1200 mg (2 mega units) should be dissolved in at least 20 ml of Sodium Chloride Injection BP or Water for Injections BP.

Sodium overload and/or heart failure may occur if Pen 30 is administered in sodium-containing solvents to patients who suffer from renal failure and/or heart failure. Therefore, for such patients, Pen 30 should not be reconstituted in sodium-containing liquids such as Sodium Chloride Injection BP or Ringer's solution.

Dosage and administration:

The following dosages apply to both intramuscular and intravenous injection.

Alternate sites should be used for repeated injections.

Adults

600 to 3,600 mg (1 to 6 mega units) daily, divided into 4 to 6 doses, depending on the indication. Higher doses (up to 14.4 g/day (24 mega units) in divided doses) may be given in serious infections such as adult meningitis by the intravenous route.

In bacterial endocarditis, 7.2 to 12 g (12 to 20 mega units) or more may be given daily in divided doses by the intravenous route, often by infusion.

Doses up to 43.2 g (72 mega units) per day may be necessary for patients with rapidly spreading gas gangrene.

High doses should be administered by intravenous injection or infusion, with intravenous doses in excess of 1.2g (2 mega units) being given slowly, taking at least one minute for each 300 mg (0.5 mega unit) to avoid high levels causing irritation of the central nervous system and/or electrolyte imbalance.

High dosage of Pen 30 may result in hypernatraemia and hypokalaemia unless the sodium content is taken into account.

For the prevention of Group B Streptococcal disease of the newborn, a 3 g (5 mega units) loading dose should be given to the mother initially, followed by 1.5 g (2.5 mega units) every 4 hours until delivery.

Children aged 1 month to 12 years

100 mg/kg/day in 4 divided doses; not exceeding 4 g/day.

Infants 1-4 weeks

75 mg/kg/day in 3 divided doses.

Newborn Infants

50 mg/kg/day in 2 divided doses.

Meningococcal disease

Children 1 month to 12 years:

180-300 mg/kg/day in 4-6 divided doses, not exceeding 12 g/day.

Infants 1-4 weeks:

150 mg/kg/day in 3 divided doses.

Newborn infants:

100 mg/kg/day in 2 divided doses.

Adults and children over 12 years:

2.4 g every 4 hours

Suspected meningococcal disease

If meningococcal disease is suspected general practitioners should give a single dose of Pen 30, before transferring the patient to hospital, as follows:

Adults and children over 10 years:

1,200 mg IV (or IM)

Children 1-9 years:

600 mg IV (or IM)

Children under 1 year:

300 mg IV (or IM)

Premature babies and neonates

Dosing should not be more frequent than every 8 or 12 hours in this age group, since renal clearance is reduced at this age and the mean half-life of benzylpenicillin may be as long as 3 hours.

Since infants have been found to develop severe local reactions to intramuscular injections, intravenous treatment should preferably be used.

Patients with renal insufficiency

For doses of 0.6-1.2 g (1-2 mega units) the dosing interval should be no more frequent than every 8-10 hours.

For high doses e.g. 14.4 g (24 mega units) required for the treatment of serious infections such as meningitis, the dosage and dose interval of Pen 30 should be adjusted in accordance with the following schedule:

Creatinine clearance (ml per minute)

Dose

(g)

Dose

(mega units)

Dosing interval

(hours)

125

1.2

or

1.8

2

or

3

2

3

60

1.2

2

4

40

0.9

1.5

4

20

0.6

1.0

4

10

0.6

1.0

6

Nil

0.3

or

0.6

0.5

or

1.0

6

8

The dose in the above table should be further reduced to 300 mg (0.5 mega units) 8 hourly if advanced liver disease is associated with severe renal failure.

If haemodialysis is required, an additional dose of 300 mg (0.5 mega units) should be given 6 hourly during the procedure.

Elderly Patients

Elimination may be delayed in elderly patients and dose reduction may be necessary.

Route of administration:

Intramuscular, intravenous.

Preparation of solutions:

Pharmaceutical preparation

Only freshly prepared solutions should be used. Reconstituted solutions of Pen 30 sodium are intended for immediate administration.

1200 mg vials

Intravenous Injection: 1200 mg (2 mega units) dissolved in at least 8 ml of Sodium Chloride Injection BP or Water for Injections BP.

Intravenous Infusion: It is recommended that 1200 mg (2 mega units) should be dissolved in at least 20 ml of Sodium Chloride Injection BP or Water for Injections BP.

Sodium overload and/or heart failure may occur if Pen 30 sodium is administered in sodium-containing solvents to patients who suffer from renal failure and/or heart failure. Therefore, for such patients, Pen 30 sodium should not be reconstituted in sodium-containing liquids such as Sodium Chloride Injection BP or Ringer's solution.

Dosage and administration:

The following dosages apply to both intramuscular and intravenous injection.

Alternate sites should be used for repeated injections.

Adults

600 to 3,600 mg (1 to 6 mega units) daily, divided into 4 to 6 doses, depending on the indication. Higher doses (up to 14.4 g/day (24 mega units) in divided doses) may be given in serious infections such as adult meningitis by the intravenous route.

In bacterial endocarditis, 7.2 to 12 g (12 to 20 mega units) or more may be given daily in divided doses by the intravenous route, often by infusion.

Doses up to 43.2 g (72 mega units) per day may be necessary for patients with rapidly spreading gas gangrene.

High doses should be administered by intravenous injection or infusion, with intravenous doses in excess of 1.2g (2 mega units) being given slowly, taking at least one minute for each 300 mg (0.5 mega unit) to avoid high levels causing irritation of the central nervous system and/or electrolyte imbalance.

High dosage of Pen 30 sodium may result in hypernatraemia and hypokalaemia unless the sodium content is taken into account.

For the prevention of Group B Streptococcal disease of the newborn, a 3 g (5 mega units) loading dose should be given to the mother initially, followed by 1.5 g (2.5 mega units) every 4 hours until delivery.

Children aged 1 month to 12 years

100 mg/kg/day in 4 divided doses; not exceeding 4 g/day.

Infants 1-4 weeks

75 mg/kg/day in 3 divided doses.

Newborn Infants

50 mg/kg/day in 2 divided doses.

Meningococcal disease

Children 1 month to 12 years:

180-300 mg/kg/day in 4-6 divided doses, not exceeding 12 g/day.

Infants 1-4 weeks:

150 mg/kg/day in 3 divided doses.

Newborn infants:

100 mg/kg/day in 2 divided doses.

Adults and children over 12 years:

2.4 g every 4 hours

Suspected meningococcal disease

If meningococcal disease is suspected general practitioners should give a single dose of Pen 30 sodium, before transferring the patient to hospital, as follows:

Adults and children over 10 years:

1,200 mg IV (or IM)

Children 1-9 years:

600 mg IV (or IM)

Children under 1 year:

300 mg IV (or IM)

Premature babies and neonates

Dosing should not be more frequent than every 8 or 12 hours in this age group, since renal clearance is reduced at this age and the mean half-life of Pen 30 may be as long as 3 hours.

Since infants have been found to develop severe local reactions to intramuscular injections, intravenous treatment should preferably be used.

Patients with renal insufficiency

For doses of 0.6-1.2 g (1-2 mega units) the dosing interval should be no more frequent than every 8-10 hours.

For high doses e.g. 14.4 g (24 mega units) required for the treatment of serious infections such as meningitis, the dosage and dose interval of Pen 30 sodium should be adjusted in accordance with the following schedule:

Creatinine clearance (ml per minute)

Dose

(g)

Dose

(mega units)

Dosing interval

(hours)

125

1.2

or

1.8

2

or

3

2

3

60

1.2

2

4

40

0.9

1.5

4

20

0.6

1.0

4

10

0.6

1.0

6

Nil

0.3

or

0.6

0.5

or

1.0

6

8

The dose in the above table should be further reduced to 300 mg (0.5 mega units) 8 hourly if advanced liver disease is associated with severe renal failure.

If haemodialysis is required, an additional dose of 300 mg (0.5 mega units) should be given 6 hourly during the procedure.

Elderly Patients

Elimination may be delayed in elderly patients and dose reduction may be necessary.

Contraindications

The information provided in Contraindications of Pen 30 is based on data of another medicine with exactly the same composition as the Pen 30 of the medicine (Benzylpenicillin). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Pen 30 directly from the package or from the pharmacist at the pharmacy.
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Allergy to penicillins. Hypersensitivity to any ingredient of the preparation.

Cross allergy to other beta-lactams such as cephalosporins should be taken into account.

Special warnings and precautions for use

The information provided in Special warnings and precautions for use of Pen 30 is based on data of another medicine with exactly the same composition as the Pen 30 of the medicine (Benzylpenicillin). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Pen 30 directly from the package or from the pharmacist at the pharmacy.
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Powder for solution for injection; Powder for solution for injection and topical application; Powder for solution for intramuscular and subcutaneous administration; Powder for solution for intramuscular injection; Substance-powder
Powder for solution for intravenous and intramuscular administration

600 mg benzylpenicillin contains 1.68 mmol of sodium. Massive doses of Pen 30 can cause hypokalaemia and sometimes hypernatraemia. Use of a potassium-sparing diuretic may be helpful. In patients undergoing high-dose treatment for more than 5 days, electrolyte balance, blood counts and renal functions should be monitored.

In the presence of impaired renal function, large doses of penicillin can cause cerebral irritation, convulsions and coma.

Skin sensitisation may occur in persons handling the antibiotic and care should be taken to avoid contact with the substance.

It should be recognised that any patient with a history of allergy, especially to drugs, is more likely to develop a hypersensitivity reaction to penicillin. Patients should be observed for 30 minutes after administration and if an allergic reaction occurs the drug should be withdrawn and appropriate treatment given.

Delayed absorption from the intramuscular depot may occur in diabetics.

Prolonged use of benzylpenicillin may occasionally result in an overgrowth of non-susceptible organisms or yeast and patients should be observed carefully for superinfections.

Pseudomembranous colitis should be considered in patients who develop severe and persistent diarrhoea during or after receiving benzylpenicillin. In this situation, even if Clostridium difficile is only suspected, administration of benzylpenicillin should be discontinued and appropriate treatment given.

600 mg Pen 30 contains 1.68 mmol of sodium. Massive doses of Pen 30 Sodium can cause hypokalaemia and sometimes hypernatraemia. Use of a potassium-sparing diuretic may be helpful. In patients undergoing high-dose treatment for more than 5 days, electrolyte balance, blood counts and renal functions should be monitored.

In the presence of impaired renal function, large doses of penicillin can cause cerebral irritation, convulsions and coma.

Skin sensitisation may occur in persons handling the antibiotic and care should be taken to avoid contact with the substance.

It should be recognised that any patient with a history of allergy, especially to drugs, is more likely to develop a hypersensitivity reaction to penicillin. Patients should be observed for 30 minutes after administration and if an allergic reaction occurs the drug should be withdrawn and appropriate treatment given.

Delayed absorption from the intramuscular depot may occur in diabetics.

Prolonged use of Pen 30 may occasionally result in an overgrowth of non-susceptible organisms or yeast and patients should be observed carefully for superinfections.

Pseudomembranous colitis should be considered in patients who develop severe and persistent diarrhoea during or after receiving Pen 30. In this situation, even if Clostridium difficile is only suspected, administration of Pen 30 should be discontinued and appropriate treatment given.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Pen 30 is based on data of another medicine with exactly the same composition as the Pen 30 of the medicine (Benzylpenicillin). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Pen 30 directly from the package or from the pharmacist at the pharmacy.
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None

Undesirable effects

The information provided in Undesirable effects of Pen 30 is based on data of another medicine with exactly the same composition as the Pen 30 of the medicine (Benzylpenicillin). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Pen 30 directly from the package or from the pharmacist at the pharmacy.
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Powder for solution for injection; Powder for solution for injection and topical application; Powder for solution for intramuscular and subcutaneous administration; Powder for solution for intramuscular injection; Substance-powder
Powder for solution for intravenous and intramuscular administration

Blood and Lymphatic System Disorders

Rare (0.01% - 0.1%)

Haemolytic anaemia and granulocytopenia (neutropenia), agranulocytosis, leucopenia and thrombocytopenia, have been reported in patients receiving prolonged high doses of Pen 30 (eg. Subacute bacterial endocarditis).

Immune System Disorders

Very Common (>10%)

Patients undergoing treatment for syphilis or neurosyphilis with benzylpenicillin may develop a Jarisch-Herxheimer reaction.

Common (1-10%)

Hypersensitivity to penicillin in the form of rashes (all types), fever, and serum sickness may occur (1-10% treated patients). These may be treated with antihistamine drugs.

Rare (0.01%-0.1%)

More rarely, anaphylactic reactions have been reported (<0.05% treated patients).

Nervous System Disorders

Rare (0.01%-.01%)

Central nervous system toxicity, including convulsions, has been reported with massive doses over 60 g per day and in patients with severe renal impairment.

Renal and Urinary Disorders

Rare (0.01%-0.1%)

Interstitial nephritis has been reported after intravenous Pen 30 at doses of more than 12 g per day.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Blood and Lymphatic System Disorders

Rare (0.01% - 0.1%)

Haemolytic anaemia and granulocytopenia (neutropenia), agranulocytosis, leucopenia and thrombocytopenia, have been reported in patients receiving prolonged high doses of Pen 30 sodium (eg. Subacute bacterial endocarditis).

Immune System Disorders

Very Common (>10%)

Patients undergoing treatment for syphilis or neurosyphilis with Pen 30 may develop a Jarisch-Herxheimer reaction.

Common (1-10%)

Hypersensitivity to penicillin in the form of rashes (all types), fever, and serum sickness may occur (1-10% treated patients). These may be treated with antihistamine drugs.

Rare (0.01%-0.1%)

More rarely, anaphylactic reactions have been reported (<0.05% treated patients).

Nervous System Disorders

Rare (0.01%-.01%)

Central nervous system toxicity, including convulsions, has been reported with massive doses over 60 g per day and in patients with severe renal impairment.

Renal and Urinary Disorders

Rare (0.01%-0.1%)

Interstitial nephritis has been reported after intravenous Pen 30 sodium at doses of more than 12 g per day.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Overdose

The information provided in Overdose of Pen 30 is based on data of another medicine with exactly the same composition as the Pen 30 of the medicine (Benzylpenicillin). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Pen 30 directly from the package or from the pharmacist at the pharmacy.
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Powder for solution for injection; Powder for solution for injection and topical application; Powder for solution for intramuscular and subcutaneous administration; Powder for solution for intramuscular injection; Substance-powder
Powder for solution for intravenous and intramuscular administration

Excessive blood levels of Pen 30 can be corrected by haemodialysis.

Excessive blood levels of Pen 30 sodium can be corrected by haemodialysis.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Pen 30 is based on data of another medicine with exactly the same composition as the Pen 30 of the medicine (Benzylpenicillin). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Pen 30 directly from the package or from the pharmacist at the pharmacy.
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Powder for solution for intravenous and intramuscular administration

Pharmacotherapeutic group: Beta-lactamase sensitive penicillins.

ATC code: J01 CE01.

General Properties:

Pen 30 is a beta-lactam antibiotic. It is bacteriocidal by inhibiting bacterial cell wall biosynthesis.

Breakpoints:

The tentative breakpoints (British Society for Antimicrobial Chemotherapy, BSAC) for Pen 30 are as follows:

Organism

S ≤ (mg/L)

I (mg/L)

R > (mg/L)

Streptococcus pneumoniae

Neisseria gonorrhoeae

0.06

0.12-1.0

2.0

Neisseria meningitides

0.06

0.12

Haemolytic streptococci

Staphylococci

Moraxella catarrhalis

Haemophilus influenzae

0.12

0.25

Rapidly growing anaerobes

1.0

2.0

S = Susceptible, I = Intermediate susceptibility, R = Resistant

Susceptibility:

The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. The following table gives only approximate guidance on probabilities whether microorganisms will be susceptible to Pen 30 or not.

Susceptible and intermediately susceptible microorganisms

Type of Microorganism

Microorganism

Range of acquired resistance

Aerobic Gram-positive microorganisms

- Bacillus anthracis

0%**

- Corynebacterium diphtheriae

0%*

- Haemolytic streptococci (including Streptococcus pyogenes)

0%*-3%**

- Listeria monocytogenes

0%**

- Streptococcus pneumoniae

4%*-40%**

- Streptococcus viridans

3-32%*

Aerobic Gram-negative microorganisms

- Neisseria gonorrhoeae

9-10%*

- Neisseria meningitidis

18%*

- Pasteurella multocida

0%***

Anaerobic microorganisms

- Actinomyces israelii

8%**

- Fusobacterium nucleatum and Fusobacterium necrophorum

Usually sensitive

- Gram-positive sporing bacilli (including Clostridium tetani and Clostridium perfringens (welchii))

14%**

- Gram-positive cocci (including peptostreptococcus)

7%*

Other microorganisms

- Borrelia bugdorferi

Usually sensitive

- Capnocytophaga canimorosus

Usually sensitive

- Leptospirae

Usually sensitive

- Streptobacillus moniliformis and spirrillum minus

Usually sensitive

- Treponema pallidum

0%***

* UK data; ** European data, ***Global data

Insusceptible microorganisms

Type of Microorganism

Microorganism

Range of acquired resistance

Aerobic Gram-positive microorganisms

- Coagulase negative Staphylococcus

71-81%*

- Enterococcus Spp

Resistant

- Staphylococcus aureus

79-87%*

Aerobic Gram-negative microorganisms

- Acinetobacter

Resistant

- Bordetella pertussis

Generally resistant

- Brucella spp.

Resistant

- Enterobacteriaceae (including Escherichia coli, Salmonella, Shigella, Enterobacter, Klebsiella, Proteus, Citrobacter).

Generally resistant

- Haemophilus influenzae

Resistant

- Pseudomonas

Resistant

Anaerobic microorganisms

- Bacteroides fragilis

100%***

* UK data; ** European data, *** Global data

Other Information:

Known Resistance Mechanisms and Cross-resistance

Penicillin resistance can be mediated by alteration of penicillin binding proteins or development of beta-lactamases.

Resistance to penicillin may be associated with cross-resistance to a variety of other beta lactam antibiotics either due to a shared target site that is altered, or due to a beta-lactamase with a broad range of substrate molecules. In addition to this, cross resistance to unrelated antibiotics can develop due to more than one resistance gene being present on a mobile section of DNA (e.g. plasmid, transposon etc) resulting in two or more resistance mechanisms being transferred to a new organism at the same time.

Pharmacotherapeutic group: Beta-lactamase sensitive penicillins.

ATC code: J01 CE01.

General Properties:

Pen 30 sodium is a beta-lactam antibiotic. It is bacteriocidal by inhibiting bacterial cell wall biosynthesis.

Breakpoints:

The tentative breakpoints (British Society for Antimicrobial Chemotherapy, BSAC) for Pen 30 sodium are as follows:

Organism

S ≤ (mg/L)

I (mg/L)

R > (mg/L)

Streptococcus pneumoniae

Neisseria gonorrhoeae

0.06

0.12-1.0

2.0

Neisseria meningitides

0.06

0.12

Haemolytic streptococci

Staphylococci

Moraxella catarrhalis

Haemophilus influenzae

0.12

0.25

Rapidly growing anaerobes

1.0

2.0

S = Susceptible, I = Intermediate susceptibility, R = Resistant

Susceptibility:

The prevalence of resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. The following table gives only approximate guidance on probabilities whether microorganisms will be susceptible to Pen 30 sodium or not.

Susceptible and intermediately susceptible microorganisms

Type of Microorganism

Microorganism

Range of acquired resistance

Aerobic Gram-positive microorganisms

- Bacillus anthracis

0%**

- Corynebacterium diphtheriae

0%*

- Haemolytic streptococci (including Streptococcus pyogenes)

0%*-3%**

- Listeria monocytogenes

0%**

- Streptococcus pneumoniae

4%*-40%**

- Streptococcus viridans

3-32%*

Aerobic Gram-negative microorganisms

- Neisseria gonorrhoeae

9-10%*

- Neisseria meningitidis

18%*

- Pasteurella multocida

0%***

Anaerobic microorganisms

- Actinomyces israelii

8%**

- Fusobacterium nucleatum and Fusobacterium necrophorum

Usually sensitive

- Gram-positive sporing bacilli (including Clostridium tetani and Clostridium perfringens (welchii))

14%**

- Gram-positive cocci (including peptostreptococcus)

7%*

Other microorganisms

- Borrelia bugdorferi

Usually sensitive

- Capnocytophaga canimorosus

Usually sensitive

- Leptospirae

Usually sensitive

- Streptobacillus moniliformis and spirrillum minus

Usually sensitive

- Treponema pallidum

0%***

* UK data; ** European data, ***Global data

Insusceptible microorganisms

Type of Microorganism

Microorganism

Range of acquired resistance

Aerobic Gram-positive microorganisms

- Coagulase negative Staphylococcus

71-81%*

- Enterococcus Spp

Resistant

- Staphylococcus aureus

79-87%*

Aerobic Gram-negative microorganisms

- Acinetobacter

Resistant

- Bordetella pertussis

Generally resistant

- Brucella spp.

Resistant

- Enterobacteriaceae (including Escherichia coli, Salmonella, Shigella, Enterobacter, Klebsiella, Proteus, Citrobacter).

Generally resistant

- Haemophilus influenzae

Resistant

- Pseudomonas

Resistant

Anaerobic microorganisms

- Bacteroides fragilis

100%***

* UK data; ** European data, *** Global data

Other Information:

Known Resistance Mechanisms and Cross-resistance

Penicillin resistance can be mediated by alteration of penicillin binding proteins or development of beta-lactamases.

Resistance to penicillin may be associated with cross-resistance to a variety of other beta lactam antibiotics either due to a shared target site that is altered, or due to a beta-lactamase with a broad range of substrate molecules. In addition to this, cross resistance to unrelated antibiotics can develop due to more than one resistance gene being present on a mobile section of DNA (e.g. plasmid, transposon etc) resulting in two or more resistance mechanisms being transferred to a new organism at the same time.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Pen 30 is based on data of another medicine with exactly the same composition as the Pen 30 of the medicine (Benzylpenicillin). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Pen 30 directly from the package or from the pharmacist at the pharmacy.
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Powder for solution for intravenous and intramuscular administration

Pen 30 rapidly appears in the blood following intramuscular injection of water-soluble salts and maximum concentrations are usually reached in 15-30 minutes. Peak plasma concentrations of about 12 mcg/ml have been reported after doses of 600 mg with therapeutic plasma concentrations for most susceptible organisms detectable for about 5 hours. Approximately 60% of the dose injected is reversibly bound to plasma protein.

In adults with normal renal function the plasma half-life is about 30 minutes. Most of the dose (60-90%) undergoes renal elimination, 10% by glomerular filtration and 90% by tubular secretion. Tubular secretion is inhibited by probenecid, which is sometimes given to increase plasma penicillin concentrations. Biliary elimination of Pen 30 accounts for only a minor fraction of the dose.

Pen 30 sodium rapidly appears in the blood following intramuscular injection of water-soluble salts and maximum concentrations are usually reached in 15-30 minutes. Peak plasma concentrations of about 12 mcg/ml have been reported after doses of 600 mg with therapeutic plasma concentrations for most susceptible organisms detectable for about 5 hours. Approximately 60% of the dose injected is reversibly bound to plasma protein.

In adults with normal renal function the plasma half-life is about 30 minutes. Most of the dose (60-90%) undergoes renal elimination, 10% by glomerular filtration and 90% by tubular secretion. Tubular secretion is inhibited by probenecid, which is sometimes given to increase plasma penicillin concentrations. Biliary elimination of Pen 30 sodium accounts for only a minor fraction of the dose.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Pen 30 is based on data of another medicine with exactly the same composition as the Pen 30 of the medicine (Benzylpenicillin). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Pen 30 directly from the package or from the pharmacist at the pharmacy.
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Beta-lactamase sensitive penicillins.

Preclinical safety data

The information provided in Preclinical safety data of Pen 30 is based on data of another medicine with exactly the same composition as the Pen 30 of the medicine (Benzylpenicillin). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Pen 30 directly from the package or from the pharmacist at the pharmacy.
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There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.

Incompatibilities

The information provided in Incompatibilities of Pen 30 is based on data of another medicine with exactly the same composition as the Pen 30 of the medicine (Benzylpenicillin). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Pen 30 directly from the package or from the pharmacist at the pharmacy.
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Powder for solution for injection; Powder for solution for injection and topical application; Powder for solution for intramuscular and subcutaneous administration; Powder for solution for intramuscular injection; Substance-powder
Powder for solution for intravenous and intramuscular administration

Pen 30 and solutions that contain metal ions should be administered separately.

Pen 30 should not be administered in the same syringe / giving set as amphotericin B, cimetidine, cytarabine, flucloxacillin, hydroxyzine, methylprednisolone, or promethazine since it is incompatible with these drugs.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products

Pen 30 sodium and solutions that contain metal ions should be administered separately.

Pen 30 sodium should not be administered in the same syringe / giving set as amphotericin B, cimetidine, cytarabine, flucloxacillin, hydroxyzine, methylprednisolone, or promethazine since it is incompatible with these drugs.

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Pen 30 is based on data of another medicine with exactly the same composition as the Pen 30 of the medicine (Benzylpenicillin). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Pen 30 directly from the package or from the pharmacist at the pharmacy.
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After contact with skin, wash immediately with water. In case of contact with eyes, rinse immediately with plenty of water and seek medical advice if discomfort persists.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.