BENZYLPENICILLIN SODIUM 1200MG POWDER FOR INJECTION
Active substance(s): BENZYLPENICILLIN SODIUM
600mg and 1200mg
Powder for Injection
Qualitative and Quantitative Composition
Benzylpenicillin sodium available as 600 mg and 1200 mg vials.
White crystalline, water-soluble sterile powder for injection.
Intravenous Infusion: It is recommended that 600 mg (1 mega
unit) should be dissolved in at least 10 ml of Sodium Chloride
Injection BP or Water for Injections BP and 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 benzylpenicillin sodium is
administered in sodium-containing solvents to patients who
suffer from renal failure and/or heart failure. Therefore, for such
patients, benzylpenicillin sodium should not be reconstituted in
sodium-containing liquids such as Sodium Chloride Injection BP or
Dosage and administration:
The following dosages apply to both intramuscular and
Alternate sites should be used for repeated injections.
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.
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.
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
Susceptibility of the causative organism to the treatment should
be tested (if possible), although therapy may be initiated before
the results are available.
Posology and method of administration
Route of administration:
Preparation of solutions:
Only freshly prepared solutions should be used. Reconstituted
solutions of benzylpenicillin sodium are intended for
600 mg vial
Intramuscular injection: 600 mg (1 mega unit) is usually
dissolved in 1.6 to 2.0 ml of Water for Injections BP.
600 mg and 1200 mg vials
Intravenous Injection: A suitable concentration is 600 mg
(1 mega unit) dissolved in 4 to 10 ml of Water for Injections BP
or Sodium Chloride Injection BP and 1200 mg (2 mega units)
dissolved in at least 8 ml of Sodium Chloride Injection BP or Water
for Injections BP.
PACKAGE LEAFLET: INFORMATION FOR THE USER
600mg and 1200mg
Powder for Injection
Read all of this leaflet carefully before you start taking this
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
- This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.
- If any of the side-effects get serious, or if you notice any
side-effects not listed in this leaflet, please tell your doctor or
In this leaflet:
1. What Benzylpenicillin Injection is and what it is used for
2. Before you use Benzylpenicillin Injection
3. How to use Benzylpenicillin Injection
4. Possible side-effects
5. How to store Benzylpenicillin Injection
6. Further information
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.
Suspected meningococcal disease
If meningococcal disease is suspected general practitioners
should give a single dose of benzylpenicillin 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 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 benzylpenicillin sodium should be
adjusted in accordance with the following schedule:
(ml per minute)
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 benzylpenicillin 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
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.
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.
100 mg/kg/day in 2 divided doses.
Adults and children over 12 years:
2.4 g every 4 hours
1. WHAT BENZYLPENICILLIN INJECTION IS AND WHAT IT IS
Benzylpenicillin sodium 600mg and 1200mg Powder for Injection
is referred to as "Benzylpenicillin Injection" in this leaflet. It
contains benzylpenicillin sodium, also known as penicillin G.
Benzylpenicillin sodium is one of a group of medicines known as
penicillins, which are antibiotics. Antibiotics are used to kill the
bacteria (germs) which cause infections.
Benzylpenicillin sodium is used to treat infections of the:
It may also be used to treat:
• some sexually transmitted
infections (gonorrhoea and
• brain abscesses
• gangrene (decay and death
of tissue due to lack of
• blood infections
• anthrax (an infection from
• diphtheria (acute
infections/disease of the
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.
Elimination may be delayed in elderly patients and dose reduction
may be necessary.
50 mg/kg/day in 2 divided doses.
• listeria (a type of food
• leptospirosis (an infection
• pasteurellosis (an infection
following animal bites)
• severe Lyme disease (an
infection from tick bites)
• actinomycosis (an infection
caused by trauma/surgery)
• some infections caused by
Allergy to penicillins. Hypersensitivity to any ingredient of the
Cross allergy to other beta-lactams such as cephalosporins should
be taken into account.
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
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.
Interaction with other medicaments and other forms
The efficacy of oral contraceptives may be impaired under
concomitant administration of benzylpenicillin sodium, which
may result in unwanted pregnancy. Women taking oral
contraceptives should be aware of this and should be informed
about alternative methods of contraception.
There is reduced excretion of methotrexate (and therefore
increased risk of methotrexate toxicity) when used with
Probenecid inhibits tubular secretion of benzylpenicillin sodium
and so may be given to increase the plasma concentrations.
Penicillins may interfere with:
• Urinary glucose tests
• Coombs’ tests
• Tests for urinary or serum proteins
• Tests which use bacteria e.g. Guthrie test
Pregnancy and lactation
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.
Although it is not known if benzylpenicillin sodium may be
excreted into the breast milk of nursing mothers, it is actively
transported from the blood to milk in animals and trace amounts
of other penicillins in human milk have been detected.
Special warnings, special precautions
600 mg benzylpenicillin contains 1.68 mmol of sodium. Massive
doses of benzylpenicillin sodium can cause hypokalaemia and
sometimes hypernatraemia. Use of a potassium-sparing diuretic
Benzylpenicillin sodium is also used for the prevention of infection
in newborn babies (specifically group B streptococcal infection).
2. BEFORE YOU USE BENZYLPENICILLIN INJECTION
Do not use Benzylpenicillin Injection if you:
• are allergic (hypersensitive) to benzylpenicillin sodium, any
other antibiotics (in particular other penicillins,
cephalosporins or beta-lactams) or any of the other ingredients
(see section 6 - Further information).
Take special care with Benzylpenicillin Injection if you:
• suffer from other allergies, especially an allergy to medicines
• are pregnant, breast-feeding or think you could be pregnant
• have kidney problems
• have liver problems
• have any heart problems
• are diabetic.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Take care if you are taking any of the following medicines:
• oral contraceptives
• probenecid for the treatment of gout (inflammation of the
joints, especially the big toe)
• methotrexate for the treatment of certain cancers
• allopurinol or sulfinpyrazone - treatments for gout
• neomycin - an antibiotic
• anti-coagulants - medicines that prevent blood clots
• oral typhoid vaccine.
Probenecid may make the effects of Benzylpenicillin last for longer.
Benzylpenicillin can make it more likely to get side-effects from
methotrexate and can sometimes make oral contraceptives less
effective, resulting in unplanned pregnancy.
Penicillins can interfere with the results of certain urine and blood
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any
3. HOW TO USE BENZYLPENICILLIN INJECTION
Your doctor will mix the benzylpenicillin sodium powder with an
injection solution, which is usually water for injections or sodium
chloride, before injecting it. (Sodium chloride injection will not be
used if you have kidney or heart problems.)
Your medicine will be injected either intramuscularly (into the
muscle) or intravenously (into a vein). Repeated injections will be
given at different sites. Infants and diabetics will normally receive
Benzylpenicillin into a vein.
Please read the back of this leaflet.
Technical Leaflet (continued)
Effects on ability to drive and use machines
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
benzylpenicillin sodium (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.
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.
More rarely, anaphylactic reactions have been reported
(<0.05% treated patients).
Nervous System Disorders
Central nervous system toxicity, including convulsions, has been
reported with massive doses over 60 g per day and in patients
with severe renal impairment.
The tentative breakpoints (British Society for Antimicrobial
Chemotherapy, BSAC) for benzylpenicillin sodium are as
Rapidly growing anaerobes
S = Susceptible, I = Intermediate susceptibility, R = Resistant
Susceptible and intermediately susceptible micro-organisms
Type of Micro-organism
Range of required
• Bacillus anthracis
• Corynebacterium diphtheriae
• Haemolytic streptococci
(including Streptococcus pyogenes)
• Listeria monocytogenes
• Streptococcus pneumoniae
• Neisseria gonorrhoeae
• Neisseria meningitidis
• Pasteurella multocida
• Fusobacterium nucleatum and
• Gram-positive sporing bacilli
(including Clostridium tetani and
Clostridium perfringens (welchii))
• Gram-positive cocci
• Borrelia bugdorferi
• Capnocytophaga canimorosus
• Streptobacillus moniliformis and
• Treponema pallidum
Range of acquired
• Coagulase negative Staphylococcus
• Enterococcus Spp
• Staphylococcus aureus
• Bordetella pertussis
• Brucella spp.
• Enterobacteriaceae (including Escherichia
coli, Salmonella, Shigella, Enterobacter,
Klebsiella, Proteus, Citrobacter).
• Haemophilus influenzae
• Bacteroides fragilis
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
• Streptococcus viridans
• Actinomyces israelii
* UK data, ** European data, ***Global data
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 micro organisms will be susceptible to
benzylpenicillin sodium or not.
The usual dose is 600mg to 3,600mg daily.
For severe infections such as meningitis and gangrene, higher
daily doses of up to 14,400mg and 43,200mg respectively may be
Benzylpenicillin is sometimes given as a single dose in cases of
suspected meningitis. The usual dose is 1,200mg for adults and
children over 10 years.
The usual dose is 2,400mg every four hours for adults.
Prevention of infection during labour:
If Benzylpenicillin is administered during labour for the prevention
of infection (specifically group B streptococcal infection) in
newborn babies, 3,000mg of Benzylpenicillin should be given to
the mother followed by 1,500mg every four hours until the baby is
Adults with kidney problems
Your doctor will carry out some tests to check this. You may then
be given a lower dose of Benzylpenicillin Injection. Lower doses
may also be given to some elderly patients.
The dose for babies and children is based on their weight. The
usual dose for newborn babies is 50mg per kg body weight per
day and for infants (1 to 4 weeks old) is 75mg per kg body weight
per day. The usual dose for children is 100mg per kg body weight
per day although higher doses of up to 4,000mg per day may be
R >– (mg/L)
Excessive blood levels of benzylpenicillin sodium can be
corrected by haemodialysis.
Pharmacotherapeutic group: Beta-lactamase sensitive penicillins.
ATC code: J01 CE01.
benzylpenicillin sodium is a beta-lactam antibiotic. It is
bacteriocidal by inhibiting bacterial cell wall biosynthesis.
Renal and Urinary Disorders
Interstitial nephritis has been reported after intravenous
benzylpenicillin 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.
S <– (mg/L)
Type of Micro-organism
* UK data, ** European data, ***Global data
The daily dose may be divided into between two and six separate
injections. Higher doses for severe infections are usually given by
slow intravenous infusion (drip).
The usual dose is 180-300mg per kg per day (up to 12g per day)
for children up to 12 years old, 150mg per kg per day for infants
(1 to 4 weeks old) and 100mg per kg per day for newborn babies.
Premature babies and neonates
Lower doses may also be given to these groups.
If you take more Benzylpenicillin Injection than you should
Irritation of the brain and shaking fits (convulsion) have been seen
in patients when very high doses of Benzylpenicillin Injection have
been given by mistake, in particular to patients with poor kidney
4. POSSIBLE SIDE-EFFECTS
Like all medicines, Benzylpenicillin Injection can cause sideeffects, although not everybody gets them.
Tell your doctor immediately if you get any of the following sideeffects:
• skin rash or itchy skin
• difficulty in breathing or tightness of the chest
• puffiness of the eyelids, face or lips
• swelling or redness of the tongue
• joint pains
• swollen lymph nodes.
The following side-effects have also been reported after either
long-term use or with high doses of your medicine:
Benzylpenicillin 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
List of excipients
benzylpenicillin sodium and solutions that contain metal ions
should be administered separately.
Benzylpenicillin 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.
Unopened 36 months.
Reconstituted product should be used immediately.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Tubular type Ill glass vials sealed with bromobutyl rubber plugs with
aluminium overseals or plastic ‘flip-top’ caps. This product is
supplied in vials containing 600 mg and 1.2 g of powder in boxes
containing 25 vials and "GP pack" containing 2 vials of 600 mg.
Instructions for use/handling
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.
MARKETING AUTHORISATION HOLDER
Linthwaite, Huddersfield, HD7 5QH, UK.
MARKETING AUTHORISATION NUMBERS
DATE OF FIRST AUTHORISATION/ RENEWAL OF
3 July 2008
DATE OF (PARTIAL) REVISION OF THE TEXT
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 benzylpenicillin sodium accounts for only a
minor fraction of the dose.
Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which
are additional to that already included in other sections of the
• reduction in blood cell count and anaemias which might
make you feel tired or dizzy
• low levels of potassium in the blood
• high levels of sodium in the blood
• inflammation of the kidney
• skin irritation, fever, headache, sore throat, sore muscles and
fast heartbeat particularly in patients being treated for syphilis
(a sexually transmitted disease)
• diarrhoea, which may, rarely, have blood in it
• thrush or infections with other germs
• fits (convulsions).
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow Card Scheme at:
By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE BENZYLPENICILLIN INJECTION
Keep out of the sight and reach of children.
Benzylpenicillin Injection vials should be stored below 25°C. Once
the content of the vial has been mixed with an injection solution, it
should be used immediately.
They should not use a bottle after the expiry date printed on the
bottle label. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help protect the environment.
6. FURTHER INFORMATION
The active substance in Benzylpenicillin Injection is benzylpenicillin
What Benzylpenicillin Injection looks like and the contents of
Benzylpenicillin Injection is a white, crystalline powder, supplied in
two strengths (600mg and 1,200mg) as a lyophilised plug in a
rubber stoppered glass vial. The 600mg vial is available in packs of
2 (GP pack) and 25. The 1,200mg vial is available in packs of 25.
Benzylpenicillin Injection 600mg
Benzylpenicillin Injection 1200mg
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.
Sandoz GmbH, A-6250 Kundl, Tirol, Austria.
Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK.
This leaflet was last revised in April 2016
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.