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BENZYLPENICILLIN POTASSIUM 625 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): BENZYLPENICILLIN POTASSIUM / BENZYLPENICILLIN POTASSIUM / BENZYLPENICILLIN POTASSIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Benzylpenicillin Potassium 625 mg powder for solution for injection or infusion
Benzylpenicillin Potassium 1250 mg powder for solution for injection or infusion
Benzylpenicillin Potassium
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any
side-effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Benzylpenicillin Potassium is and what it is used for
2. What you need to know before you use Benzylpenicillin Potassium
3. How to use Benzylpenicillin Potassium
4. Possible side effects
5. How to store Benzylpenicillin Potassium
6. Contents of the pack and other information

1 What Benzylpenicillin Potassium is and
what it is used for
This medicine contains benzylpenicillin
potassium, which is one of a group of
medicines known as penicillins (‘antibiotics’).
Antibiotics are used to kill the bacteria
(germs) which cause infections.
Benzylpenicillin Potassium is used to treat
infections of the ear, nose, throat, chest,
heart, bones and skin.
Benzylpenicillin Potassium is also used for the
prevention of infection in newborn babies.
2 What you need to know before you use
Benzylpenicillin Potassium
Do not use Benzylpenicillin Potassium if
you:
• are allergic to benzylpenicillin potassium, or
any other antibiotics (in particular other
penicillins, cephalosporins or beta-lactams).
Warnings and precautions
Talk to your doctor, pharmacist or nurse
before using Benzylpenicillin Potassium:
• if you suffer from other allergies, especially
an allergy to medicines
• if you are pregnant, breast-feeding or think
you could be pregnant
• if you have kidney problems
• if you have liver problems
• if you have any heart problems
• if you are diabetic
Other medicines and Benzylpenicillin
Potassium
Tell your doctor or pharmacist if you are
taking, have recently taken or might take any
other medicines, particularly any of the
following medicines:
• oral contraceptives as this medicine may
make oral contraceptives less effective,
resulting in unplanned pregnancy
• probenecid for the treatment of gout
(inflammation of the joints, especially the
big toe). Probenecid may make the effects
of this injection last for longer
• methotrexate for the treatment of certain
cancers. This medicine may make it more
likely to get side-effects from methotrexate
• medicines which contain potassium or may
increase potassium levels (e.g. potassium
supplements, potassium-containing salt
substitutes or potassium-sparing medicines
such as certain diuretics [amiloride,
triamterene, spironolactone] or heparin)
Penicillins can interfere with the results of
certain urine and blood tests.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think
you may be pregnant or planning to have a
baby, ask your doctor for advice before taking
this medicine.
Driving and using machines
Benzylpenicillin Potassium is not known to
have any affect on your ability to drive or
operate machinery.
Benzylpenicillin Potassium contains
potassium:
Each vial of Benzylpenicillin Potassium
625 mg contains 65.3 mg (1.67 mmol) of
potassium.
Each vial of Benzylpenicillin Potassium
1250 mg contains 131 mg (3.35 mmol) of
potassium.
3 How to use Benzylpenicillin Potassium
Always use this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not
sure.
Your doctor or nurse will prepare your
injection. They will inject this into a muscle
(intramuscularly) or into a vein (intravenously).
Repeated injections will be given at different
sites.
Infants and diabetics will normally receive the
injection into a vein.
Adults
The usual dose is 625 mg to 3,750 mg daily.
For severe infections such as meningitis and
gangrene, higher daily doses of up to
15,000 mg and 45,000 mg respectively may
be used.
Suspected Meningitis
This medicine is sometimes given as a single
injection in cases of suspected meningitis.
The usual dose is 1,250 mg for adults and
children over 10 years.
Meningitis
The usual dose is 2,500 mg every four hours
for adults.
Prevention of infection during labour
If the injection is administered during labour
for the prevention of infection in newborn
babies (specifically group B streptococcal
infection), 3,125 mg should be given to the
mother followed by 1,550 mg every four
hours until the baby is delivered.

The following information is intended for medical or healthcare professionals only
Posology
The following dosages apply to both intramuscular and
intravenous injection.
Alternate sites should be used for repeated injections.
Adults
625 to 3,750 mg (1 to 6 mega units) daily, divided into 4 to 6
doses, depending on the indication. Higher doses (up to
15 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, 7.5 to 12.5 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 45 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
1.250 g (2 mega units) being given slowly, taking at least
one minute for each 312.5 mg (0.5 mega unit) to avoid high
levels causing irritation of the central nervous system
and/or electrolyte imbalance.
High doses of Benzylpenicillin Potassium can result in
serious and even fatal electrolyte disturbances, i.e.
hyperkalaemia and hyponatraemia when given intravenously in large doses, the potassium content should be
taken into account during administration.
Paediatric patients
Pediatric doses are generally determined on a weight basis
and should be calculated for each patient individually.
Children aged 1 month to 12 years
105 mg/kg/day in 4 divided doses; not exceeding
4.15 g/day.

Meningococcal disease
Children 1 month to 12 years:
Infants 1-4 weeks:
Newborn infants:
Adults and children over
12 years:

190-312 mg/kg/day in
4-6 divided doses, not
exceeding 12.5 g/day.
155 mg/kg/day in
3 divided doses.
105 mg/kg/day in
2 divided doses.
2.5 g every 4 hours.

Suspected meningococcal disease
If meningococcal disease is suspected general practitioners
should give a single dose of Benzylpenicillin Potassium,
before transferring the patient to hospital, as follows:
Adults and children over 10 years: 1,250 mg (2 mega units)
IV (or IM).
Children 1 - 9 years:
625 mg (1 mega unit) IV
(or IM).
Children under 1 year:
312 mg (0.5 mega units)
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.
For the prevention of Group B Streptococcal disease of the
newborn, a 3.125 g (5 mega units) loading dose should be
given to the mother initially, followed by 1.55 g (2.5 mega
units) every 4 hours until delivery.
Special populations
Patient with renal impairment
For doses of 0.625-1.250 g (1-2 mega units) the dosing
interval should be no more frequent than every 8-10 hours.

Infants 1-4 weeks
83 mg/kg/day in 3 divided doses.
Newborn Infants
56 mg/kg/day in 2 divided doses.

For high doses e.g. 15 g (24 mega units) required for the
treatment of serious infections such as meningitis, the
dosage and dose interval of Benzylpenicillin Potassium
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

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

3

8

PAGE 2 - IBI Benzylpenicillin Potassium 625 mg and 1250 mg Injection

Adults with kidney problems
Your doctor will carry out some tests to check
this. You may then be given a lower dose of
this 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 56 mg
per kg of their body weight per day.
For infants (1 to 4 weeks old), the usual dose
is 83 mg per kg of their body weight per day.
The usual dose for children is 105 mg per kg
of their body weight per day although higher
doses of up to 4,150 mg 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 190-312 mg per kg per day
(up to 12.5 g per day) for children up to 12
years old, 155 mg per kg per day for infants
(1 to 4 weeks old) and 105 mg 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 Potassium
than you should
Irritation of the brain and shaking fits
(convulsions) have been seen in patients
when very high doses of this medicine have
been given by mistake, in particular to
patients with poor kidney function.
If you forget a dose of Benzylpenicillin
Potassium
If you think you have not been given a dose
of Benzylpenicillin Potassium, tell your doctor
or other healthcare professional immediately.
If you have any further questions on the use
of this product, ask your doctor or other
healthcare professional.
4 Possible side effects
Like all medicines, this medicine 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
• difficulty in breathing or tightness of the
chest
• puffiness of the eyelids, face or lips
• swelling or redness of the tongue
• fever
• joint pains
• swollen lymph nodes.
Very common (may affect more than 1 in 10
people):
Skin irritation, fever, headache, sore throat,
sore muscles and fast heartbeat particularly
in patients being treated for syphilis (a
sexually transmitted disease).

Not known (cannot be estimated from the
available data):
Diarrhoea, colitis.
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:
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 Potassium
Keep this medicine out of the sight and reach
of children.
This medicine does not require any special
storage conditions.
Once the contents of the vial have been
mixed with an injection solution, it should be
used immediately.
Do not use this medicine after the expiry date
which is stated on the carton and label after
‘Exp’. The expiry date refers to the last day of
that month.
Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you longer use. These measures will help
protect the environment.
6 Contents of the pack and other
information
What Benzylpenicillin Potassium contains
The active substance is benzylpenicillin
potassium 625 mg equivalent to 560 mg of
benzylpenicillin (1 mega unit).
The active substance is benzylpenicillin
potassium 1250 mg equivalent to 1120 mg of
benzylpenicillin (2 mega units).
What Benzylpenicillin Potassium looks like
and contents of the pack
Benzylpenicillin Potassium is a white,
crystalline powder supplied in two strengths
(625 mg in 10 ml vial and 1250 mg in 20 ml
vial) in a rubber stoppered glass vial.
Pack sizes: 10 vials.
Marketing Authorisation Holder
Ibigen S.r.l.
Via Fossignano 2
04011 – Aprilia (LT)
Italy
Manufacturer:
Istituto Biochimico Italiano G. Lorenzini S.p.A.
Via Fossignano 2
04011 – Aprilia (LT)
Italy
This leaflet was last revised in October 2016

Common (may affect up to 1 in 10 people):
Hypersensitivity to penicillin in the form of
rashes (all types), fever, and serum sickness
may occur.
Rare (may affect up to 1 in 1,000 people):
Anaphylactic reactions, reduction in blood cell
count and anaemia, which might make you
feel tired or dizzy; reduction blood cell count
(agranulocytosis, leucopenia and
thrombocytopenia); fits (convulsions);
inflammation of the kidney.

The dose in the above table should be further reduced to
312.5 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 312.5 mg
(0.5 mega units) should be given 6 hourly during the
procedure.
This drug is known to be substantially excreted by the
kidney, and the risk of toxic reactions to this drug may be
greater in patients with impaired renal function. Because
elderly patients are more likely to have decreased renal
function, care should be taken in dose selection, and it may
be useful to monitor renal function.
Older people
Elimination may be delayed in elderly patients and dose
reduction may be necessary.
The geriatric population may respond with a blunted
natriuresis to salt loading. This may be clinically important
with regard to such diseases as congestive heart failure.
Preparation of solutions:
Only freshly prepared solutions should be used.
Reconstituted solutions of Benzylpenicillin Potassium are
intended for immediate administration.
Any unused product or waste material should be disposed
of in accordance with local requirements.
625 mg vial

1,250 mg vial

Intramuscular injection

Dissolve in 1.6 to 2.0 ml of Water for
Injections

Intravenous Injection

Dissolve in 4 to 10 ml of Water for
Injections or Sodium Chloride
Injection 0.9%

Dissolve in at least 8 ml of Water for
Injections or Sodium Chloride
Injection 0.9%

Intravenous Infusion

Dissolve in at least 10 ml of Water for
Injections or Sodium Chloride
Injection 0.9%

Dissolve in at least 20 ml of Water for
Injections or Sodium Chloride
Injection 0.9%

Displacement volume:
approx. 0.4 ml

Displacement volume:
approx. 0.9 ml

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.
Incompatibilities
In the absence of compatibility studies, this medicinal
product must not be mixed with other medicinal products.
Benzylpenicillin Potassium and solutions that contain metal
ions should be administered separately.
Benzylpenicillin potassium 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.

-

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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.

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