Patient leaflet - Benzylpenicillin Sodium 1200 mg powder for injection
1. WHAT BENZYLPENICILLIN INJECTION IS AND WHAT IT IS USED FOR
Benzylpenicillin sodium 600mg and 1200mg Powder for Injection is referred to as “Benzylpenicillin Injection”
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:
- ear
- nose
- throat
chest
- heart
- bones
- skin.
It may also be used to treat:
some sexually
transmitted infections
(gonorrhoea and
syphilis)
- meningitis
- brain abscesses
gangrene (decay and
death of tissue due to
lack of blood supply)
- blood infections
anthrax (an infection
from animals)
- tetanus
diphtheria (acute
infections/disease of the
respiratory tract)
- listeria (a type of food poisoning)
leptospirosis (an
infection from animals)
- pasteurellosis (an infections following animals bites)
- severe Lyme disease (an infection from tick bites)
- actinomycosis (an infection caused by trauma/surgery)
- some infections cause by rat bites.
Benzylpenicillin sodium is also used for the prevention
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:
•
the joints, especially the big toe)
- methotrexate for the treatment of certain cancers •
- 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 Penicillins can interfere with the results of certain urine and blood tests. Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Sodium Content
600mg benzylpenicillin contains 38.7mg (1.68mmol) sodium (main component of cooking/table salt) in each dosage unit. This is equivalent to 1.93% of the recommended maximum daily dietary intake of sodium for an adult. 1200mg benzylpenicillin contains 77.4mg (3.36 mmol) of sodium (main component of cooking/table salt) in each dosage unit.
This is equivalent to 3.86% of the recommended maximum daily dietary intake of sodium for an adult. Talk to your doctor or pharmacist if you need 5 or more dosage units of 1200mg benzylpenicillin (or 10 or more dosage units of 600mg benzylpenicillin) for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.
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.,
Adults
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 used.
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Technical Leaflet
Consideration should be given to official local guidance
Patients with renal insufficiency
(or 10 dosage units of 600mg benzylpenicillin) reflects taking this medicine.
- Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist.
- 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 pharmacist.
Read all of this leaflet carefully before you start
situation, even if Clostridium difficile is only suspected,
In this leaflet:
in this leaflet. It contains benzylpenicillin sodium, also
of infection in newborn babies (specifically group B
probenecid for the treatment of gout (inflammation of
allopurinol or sulfinpyrazone - treatments for gout
Please read the back of this leaflet. 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.
Effects on ability to drive and use machines
None
Undesirable effects
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). Diarrhoea.
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%-0.1%)
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 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
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
Excessive blood levels of benzylpenicillin sodium can be corrected by haemodialysis.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: Beta-lactamase sensitive penicillins.
ATC code: J01 CE01.
General Properties:
Benzylpenicillin 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 benzylpenicillin 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 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 micro organisms will be susceptible to benzylpenicillin sodium or not.
Susceptible and intermediately susceptible micro-organisms
Type of
Micro-organism Micro-organism Range of required
resistance
Aerobic
Gram-positive
micro-organisms
- 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
micro-organisms
- Neisseria gonorrhoeae 9-10%*
- Neisseria meningitidis 18%*
- Pasteurella multocida 0%***
Anaerobic
micro-organisms • 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
micro-organisms • 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 micro-organisms
Type of
Micro-organism Micro-organism Range of
acquired resistance
Aerobic
Gram-positive
micro-organisms
Coagulase negative
Staphylococcus 71-81%*
- Enterococcus Spp Resistant
- Staphylococcus aureus 79-87%*
Aerobic
Gram-negative
micro-organisms
- Acinetobacter Resistant
Bordetella pertussis Generally
resistant
- Brucella spp. Resistant
Enterobacteriaceae
(including Escherichia
coli, Salmonella, Shigella,
Enterobacter, Klebsiella,
Proteus,Citrobacter).
Generally resistant
- Resistant
- Pseudomonas Resistant
Anaerobic
micro-organisms • 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
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 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
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 SmPC.
PHARMACEUTICAL PARTICULARS
List of excipients
None
Incompatibilities
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, methylprednisolone, or promethazine since it is incompatible with these drugs.
Shelf-life
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 and plastic containing 600 mg and 1.2 g of powder in boxes containing 10 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
Genus Pharmaceuticals,
MARKETING AUTHORISATION NUMBERS
PL 06831/0213
PL 06831/0284
DATE OF FIRST AUTHORISATION/ RENEWAL OF AUTHORISATION
3 July 2008
DATE OF (PARTIAL) REVISION OF THE TEXT
January 2026
Suspected Meningitis:
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. Meningitis:
The usual dose is 2,400mg every four hours for adults. Prevention of infection during labour:
If Benzylpenicillin is administered during labour
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 delivered. 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.
Children
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 given. 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). Meningitis:
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
have been seen in patients when very high doses of Benzylpenicillin Injection have been given by mistake, in particular to patients with poor kidney function.
4. POSSIBLE SIDE-EFFECTS
Like all medicines, Benzylpenicillin Injection can cause side-effects, although not everybody gets them. Tell your doctor immediately if you get any of the following side-effects:
- skin rash or itchy skin
•
•
- swelling or redness of the tongue
- fever
- 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:
- 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
•
- 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
•
Other side effects (it is not known how frequently these side effects may occur):
- AGEP – Acute Generalized Exanthematous Pustulosis with symptoms such as severe drug skin reactions with or without reddening of the skin, fever, pustules •
- rash morbilliform (rash that looks like measles),
- itching
•
- angioedema (swelling of the skin, mucosa and subcutaneous tissue, generally located on the face, mouth or tongue)
- thrombocytopenia (reduced blood levels of platelets)
- anaemia (reduced blood levels of red blood cells)
- metabolic encephalopathy (neurological disorders with convulsions and loss of consciousness). Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
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 sodium.
What Benzylpenicillin Injection looks like and the contents of the pack
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 10. The 1,200mg vial is available in packs of 10.
PL 06831/0213 Benzylpenicillin Injection 600mg PL 06831/0284 Benzylpenicillin Injection 1200mg Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
HD7 5QH, UK.
Manufacturers:
Sandoz GmbH, A-6250 Kundl, Tirol, Austria.
HD7 5QH, UK.
POM
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