AMPICILLIN 500MG POWDER FOR SOLUTION FOR INJECTION

Active substance: AMPICILLIN SODIUM

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Ampicillin 500 mg Powder
for Solution for Injection
Please read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions please ask your
doctor or your pharmacist.
• This medicine has been prescribed for you
personally and you should 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
In this leaflet:
1. What Ampicillin 500 mg Powder for Solution for
Injection is and what it is used for
2. Before you take Ampicillin 500 mg Powder for
Solution for Injection
3. How to take Ampicillin 500 mg Powder for Solution
for Injection
4. Possible side effects
5. How to store Ampicillin 500 mg Powder for
Solution for Injection
6. Further information

1. What Ampicillin 500 mg Powder for
Solution for Injection is and what it is
used for
Ampicillin 500 mg Powder for Solution for Injection
contains one active ingredient called ampicillin. Each
vial contains 500 mg of ampicillin (as ampicillin
sodium).
Ampicillin is an antibiotic medicine. It belongs to a
group of antibiotics called penicillins and it works by
killing bacteria that cause infections. Ampicillin can
be used for the treatment of a wide range of bacterial
infections which result in conditions not amenable to
oral therapy such as:
− Ear, nose and throat infections
− Respiratory tract infections such as bronchitis and
pneumonia
− Urinary tract infections
− Gonorrhoea (a sexually transmitted infection)
− Female reproductive system infections
− Stomach or intestinal infections such as enteric
fever or peritonitis
− Heart infections such as endocarditis
− Infections of the membranes of the brain such as
meningitis.

2. Before you take Ampicillin 500 mg
Powder for Solution for Injection
Do not take Ampicillin
• If you know you are allergic to ampicillin, penicillin,
cephalosporin (or any other antibiotic).
• If you have glandular fever.
• If you have a blood disease called acute lymphatic
leukaemia
Take special care with Ampicillin
• If you have ever had a skin rash or swelling of the
face or neck when taking any antibiotic. You should
let your doctor or nurse know before you receive
ampicillin.
• If you are being treated for kidney problems. The
doctor may need to adjust the dose depending on
how your kidneys work.

• If you need a urine test for glucose. Ampicillin may
give falsely high results unless the correct method
is used.
• This medicinal product contains 31.3mg of sodium
per dose which needs to be taken into
consideration by patients on a controlled sodium
diet.
Taking Ampicillin with 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. Make sure
to tell your doctor or pharmacist if you are taking any
of these medications before taking ampicillin:
− Allopurinol (for gout): When taken with ampicillin,
the risk of allergic skin rashes is increased.
− Probenecid (for gout): This medicine can increase
the amount of ampicillin in your blood
− Other antibiotics can interfere with the effect of
ampicillin making it ineffective.
− Methotrexate (for cancer or arthritis): this medicine
can reduce the amount of ampicillin that is
excreted.
− Oral contraceptives: If you are taking birth control
pills, ampicillin may reduce its efficacy. Please let
your doctor or pharmacist know as you may need
to use alternative contraceptive methods.
Ask your doctor or pharmacist for advice before
taking any medicine.
Pregnancy and breastfeeding:
There is no evidence that ampicillin will harm your
baby if you are pregnant. However, if you are
pregnant, think you may be pregnant or are trying for
a baby you should let your doctor know.
Very small quantities of ampicillin can be detected in
breast milk but adverse effects on the nursing baby
appear to be rare. It is possible that these small
quantities may affect the baby’s normal bowel flora
(the normal bacteria in the gut), may provoke allergy
or sensitisation, or may interfere with the results of
blood cultures should your baby require them if
she/he becomes sick. If you are breast feeding you
should tell your doctor or nurse before you receive
this medication.
Driving and using machines
Ampicillin is not expected to impair your ability to
drive or to operate machinery.

3. How to take Ampicillin 500 mg Powder
for Solution for Injection
You will never give yourself this medicine. This
medicine will be given to you by a qualified person
such as a doctor, pharmacist or nurse via injection or
infusion into a vein (intravenous) or a muscle
(intramuscular).
Your doctor will decide how much you need each day
and how often the injections should be given. The
doctor, nurse or pharmacist will make up the injection
before use using an appropriate fluid (such as Water
for Injections or an injection/infusion fluid)
The usual dose for treating infections are:
• Adults, the elderly and children over 10 years:
500mg four to six times a day.
• Children under 10 years usually receive half the
above adult dose.
• Infections of the heart (endocarditis): 500 mg four
to six times a day by intramuscular or intravenous
injection for one to six weeks.
• Infections of the stomach and/or gut (peritonitis):
500 mg four times a day by intramuscular or
intravenous injection.

TRIAL

PATIENT INFORMATION LEAFLET

• Infections of the membranes of the brain (meningitis):
Adult dosage: 2 g every six hours by intravenous
injection. Children’s dosage: 150 mg/kg daily in divided
doses by intravenous injection.
All of these doses can be increased in serious infections.
If your kidneys are not working very well, your doctor
may reduce the dose you take, if appropriate. Your
doctor will give you special instructions if you are on
kidney dialysis.
If you take more Ampicillin than you should
Since Ampicillin will be administered to you it is unlikely
that you will take more than you should. However if you
think you have, you should tell your doctor or
pharmacist.
If you forget to take Ampicillin
If you think you have missed an injection, speak to your
doctor or nurse.
If you stop taking Ampicillin
It is important that you complete your treatment with
ampicillin as recommended by your doctor. If the
treatment is stopped too early the infection may not be
resolved and your symptoms will come back.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. Possible side effects
Like many medicines, Ampicillin for Injection may
occasionally cause side effects in some patients.
The side effects listed below have been experienced by
people taking this medicine and they are listed
according to frequency.
Common (affects less than 1 in 10 but more than 1 in
100 patients):
− Skin rash
− Itching (pruritus)
− Raised itchy bumps/hives (urticaria)
− Red/purple discoloration of the skin (purpura)
− Feeling sick (nausea)
− Vomiting
− Diarrhoea
The above affects are often mild and may disappear
during treatment. If they are severe or last for more than
a few days, tell your doctor.
You are unlikely to experience any of the following side
effects but if you do - see your doctor as soon as
possible
Uncommon (affects less than 1 in 100 patients but
more than 1 in 1000 patients):
− Fever
− General ill feeling
− Joint aches
− Skin lesions
− Skin peeling
− An increase or decrease in urine output
− Blood in the urine or stools
− Weight gain from fluid retention
− Abdominal cramps or urges to have bowel movement
− Loss of appetite
− Yellowing of the skin or whites of eyes (jaundice)
− Darkening of the urine
− Faeces becoming paler
− Increased feeling of tiredness
− Shortness of breath
− Abnormally heavy and prolonged menstrual periods
Rare (affects less than 1 in 1000 patients but more
than 1 in 10,000 patients):
- Allergic reactions (hypersensitivity) - signs include

runny nose, sneezing, swelling of the face, neck, lips,
tongue or throat, difficulty in breathing, blistering or
peeling of the skin, with or without ulceration in the
mouth, sore eyes or sore genitals, joint pain, fever, rapid
heart beat or loss of consciousness may be signs of an
allergic reaction. If any of these symptoms occur, STOP
taking Ampicillin for Injection and seek immediate
medical attention as you may require hospitalisation.
If any of the side effects gets serious, or if you notice
any other side effects not mentioned in this leaflet,
please tell your doctor or pharmacist.

5. How to store Ampicillin 500 mg Powder
for Solution for Injection
• Ampicillin for Injection should not be stored above
25° C prior to use.
• After reconstitution, Ampicillin solutions for injection
can be stored at 2-8°C in a refrigerator.
• Chemical and physical compatibility of Ampicillin
powder for solution for injection have been
demonstrated with the following intravenous fluids for
the periods and temperatures stated:
Intravenous fluids
Stability time
0.5 % Procaine Hydrochloride
at ambient temperature.......................................Use Immediately
Water for Injection at
ambient temperature ...........................................Use Immediately
Sodium Chloride 0.9 % Solution at 25 ˚C ......................... 4 hours
Ringers Solution at 25 ˚C................................................... 3 hours
Compound Sodium Lactate Solution at 25 ˚C .................. 3 hours
5 % Glucose Solution at 2-8˚C............................Use Immediately
Sodium Chloride 0.9 % Solution at 2-8˚C ....................... 10 hours
Ringers Solution at 2-8˚C ................................................ 10 hours
Compound Sodium Lactate Solution at 2-8˚C .................. 9 hours
1.4 % Sodium Bicarbonate at 2-8˚C ................................. 3 hours
• There is an expiry date on the label, the doctor or
nurse will check that this date has not passed before
giving you the medicine.
• Keep out of the reach and sight of children.
• Ampicillin vials are not suitable for multidose use.
• Any unused product or waste material should be
disposed of in accordance with local requirements.

6. Further information
What Ampicillin 500 mg Powder for Solution for
Injection contains
Ampicillin for Injection contains one active ingredient
called ampicillin. Ampicillin for Injection contains no
other ingredients.
What Ampicillin 500 mg Powder for Solution for
Injection looks like and contents of the pack
Ampicillin for Injection is a white powder that is made
up into a solution for injection. Each vial contains 500
mg of ampicillin as Ampicillin Sodium. The vials are
supplied to doctors in packs of 10.
Marketing Authorisation Holder and Manufacturer
Norbrook Laboratories Limited,
Newry, Co. Down, Northern Ireland
For any information about this medicinal product,
please contact the local representative of the
Marketing Authorisation Holder:
Norbrook Laboratories Limited,
The Green, Great Corby, Cumbria,
CA4 8LR, Carlisle, England.
Leaflet prepared:
10/2011

Ampicillin 500 mg Powder
for Solution for Injection
The following information is intended for medical or
healthcare professionals only
CONTENT
Ampicillin 500 mg Powder for Solution for Injection is available in vials
containing the equivalent of 500 mg ampicillin presented as Ampicillin
Sodium as a powder for reconstitution for injection.
THERAPEUTIC INDICATIONS
Ampicillin 500 mg Powder for Solution for Injection is indicated for the
treatment of a wide range of bacterial infections caused by
ampicillin-sensitive organisms which result in conditions not amenable
to oral therapy such as:
-

Ear, nose and throat infections
Respiratory tract infections such as bronchitis and pneumonia
Urinary tract infections
Gonorrhoea
Gynaecological infections
Enteric fever
Peritonitis
Septicaemia
Endocarditis
Meningitis.

Susceptibility of the causative organism to the treatment should be
tested (if possible), although therapy may be initiated before the results
are available.
Consideration should be given to official local guidance on the
appropriate use of antibacterial agents.
POSOLOGY AND METHOD OF ADMINISTRATION
Ampicillin 500 mg Powder for Solution for Injection is indicated for
intramuscular or intravenous administration at the following dosages:
Usual dosage for Adults, the elderly and children over 10 years:
500 mg four to six times a day
The intravenous dose is given by slow injection (3-4 minutes) but may
also be added to infusion fluids or be injected, suitably diluted, into the
drip tube over 3-4 minutes.
Endocarditis:
Peritonitis:
Meningitis:

500 mg four to six times a day IM or IV for one to six weeks
500 mg four times a day IM or IV
Adult dosage: 2 g six-hourly IV
Children’s dosage: 150 mg/kg daily IV in divided doses

Usual children’s dosage (under 10 years):
Half the adult routine dosage.
All recommended dosages are a guide only. In severe infections the
above dosages may be increased.
Renal Impairment
In the presence of severe renal impairment (creatinine clearance < 10
ml/min) a reduction in dose or extension of dose interval should be
considered. In cases of dialysis, an additional dose should be
administered after the procedure.
Administration:
Intramuscular: Dissolve 500mg in 1.5ml Water for Injections
Intravenous: Dissolve 500 mg in 10 ml Water for Injections. Administer
by slow injection (three to four minutes). Ampicillin may also be added
to infusion fluids or injected, suitably diluted, into the drip tube over a
period of three to four minutes.
CONTRA-INDICATIONS
Ampicillin is a penicillin and should not be given to patients with a
history of hypersensitivity to beta-lactam antibiotics (e.g. ampicillin,
penicillins, cephalosporins).
It should not be given to patients with glandular fever or acute lymphatic
leukaemia.
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Before initiating therapy with ampicillin, careful enquiry should be made
concerning previous hypersensitivity reactions to beta-lactam
antibiotics.
Serious and occasionally fatal hypersensitivity reactions (anaphylaxis)
have been reported in patients receiving beta-lactam antibiotics.
Although anaphylaxis is more frequent following parenteral therapy, it
has occurred in patients on oral penicillins. These reactions are more
likely to occur in individuals with a history of beta-lactam
hypersensitivity.
Ampicillin should be avoided if infectious mononucleosis and/or acute or
chronic leukaemia of lymphoid origin are suspected. The occurrence of
a skin rash has been associated with these conditions following the
administration of ampicillin.
Prolonged use may occasionally result in overgrowth of non-susceptible
organisms.

Dosage should be adjusted in patients with renal impairment (see
dosage section).
This medicinal product contains 31.3mg of sodium per dose which
needs to be taken into consideration by patients on a controlled sodium
diet.
INTERACTION WITH OTHER MEDICAMENTS AND OTHER FORMS
OF INTERACTION
If ampicillin is prescribed concurrently with an aminoglycoside, the
antibiotics should not be mixed in the syringe, intravenous fluid
container or giving set because loss of activity of the aminoglycoside
can occur under these conditions.
Bateriostatic drugs may interfere with the bactericidal action of
ampicillin.
In common with other oral broad-spectrum antibiotics, ampicillin may
reduce the efficacy of oral contraceptives and patients should be
warned accordingly.
Probenecid decreases the renal tubular secretion of ampicillin.
Concurrent use with ampicillin may result in increased and prolonged
blood levels of ampicillin.
Concurrent administration of allopurinol during treatment with ampicillin
can increase the likelihood of allergic skin reactions.
It is recommended that when testing for the presence of glucose in urine
during ampicillin treatment, enzymatic glucose oxidase methods should
be used. Due to the high urinary concentrations of ampicillin, false
positive readings are common with chemical methods.
Methotrexate excretion is reduced by penicillins.
PREGNANCY AND LACTATION
Pregnancy:
Animal studies with ampicillin have shown no teratogenic effects. The
product has been in extensive clinical use since 1961 and its use in
human pregnancy has been well documented in clinical studies. When
antibiotic therapy is required during pregnancy Ampicillin for Injection
may be considered appropriate.
Lactation:
During lactation, trace quantities of penicillins can be detected in breast
milk. Adequate human and animal data on use of Ampicillin during
lactation are not available. While adverse effects are apparently rare,
three potential problems exist for the nursing infant:
• modification of bowel flora.
• direct effects on the infant such as allergy/sensitisation.
• interference with interpretation of culture results when a pyrexia of
unknown origin occurs.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Adverse effects on the ability to drive or operate machinery have not
been observed.
UNDESIRABLE EFFECTS
The following convention has been used for the classification of
undesirable effects in terms of frequency
Very Common:
Common:
Uncommon:
Rare:
Very Rare:

≥ 1/10
≥ 1/100 and < 1/10
≥ 1/1000 and < 1/100
≥ 1/10,000 and < 1/1000
< 1/10,000

Skin and subcutaneous tissue disorders
Common: skin rash, pruritus and urticaria. The incidence is higher in
patients suffering from infectious mononucleosis and acute or chronic
leukaemia of lymphoid origin. Purpura has also been reported.
Uncommon: skin reactions such as erythema multiforme
(Stevens-Johnson syndrome), and toxic epidermal necrolysis have been
reported.
Rare: anaphylaxis
Renal and urinary disorders
Uncommon: Interstitial nephritis
Gastrointestinal disorders
Common: nausea, vomiting and diarrhoea.
Uncommon: pseudomembraneous colitis and haemorrhagic colitis.
Hepatobiliary disorders
Common: a moderate and transient increase in transaminases
Uncommon: hepatitis and cholestatic jaundice
Blood and lymphatic system disorders
Uncommon: as with other beta-lactams, haematological effects
including transient leucopenia, transient thrombocytopenia and
haemolytic anaemia. Prolongation of bleeding time and prothrombin.
OVERDOSAGE
Gastrointestinal effects such as nausea, vomiting and diarrhoea may be
evident and should be treated symptomatically.
Ampicillin may be removed from the circulation by haemodialysis.

TRIAL

TECHNICAL INFORMATION LEAFLET

PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group: Beta-lactam antibacterials, penicillins
ATC-Code: J01CA01
Mode of action
Ampicillin is an aminopenicillin that has a bactericidal action due to its
inhibition of the synthesis of the bacterial cell wall.
Mechanism of resistance
Bacteria may be resistant to ampicillin due to production of
beta-lactamases which hydrolyse aminopenicillins, due to alteration in
penicillin-binding proteins, due to impermeability to the drug, or due to
drug efflux pumps. One or more of these mechanisms may co-exist in the
same organism, leading to variable and unpredictable cross-resistance to
other beta-lactams and to antibacterial drugs of other classes.
Breakpoints
The MIC breakpoints for susceptible organisms vary according to species.
Susceptibility:
The prevalence of acquired resistance may vary geographically and with
time for selected species and local information on resistance is desirable,
particularly when treating severe infections. As necessary, expert advice
should be sought when the local prevalence of resistance is such that the
utility of the agent in at least some types of infections is questionable.
Commonly susceptible species
Gram positive aerobes
Listeria monocytogenes
Streptococcus agalactiae
Streptococcus pyogenes
Gram negative aerobes
Neisseria meningitidis
Anaerobes
Bacteroides spp
Clostridium spp
Fusobacterium spp
Peptostreptococci
Species for which acquired resistance may be a problem
Gram positive aerobes
Enterococcus faecalis
Staphylococcus aureus
Streptococcus pneumoniae
Gram negative aerobes
Escherichia coli
Haemophilus influenzae
Haemophilus parainfluenzae
Moraxella catarrhalis
Neisseria gonorrhoeae
Proteus spp.
Salmonella spp
Shigella spp
Inherently resistant organisms
Gram negative aerobes
Acinetobacter spp
Citrobacter spp
Enterobacter spp
Klebsiella spp
Pseudomonas spp
Serratia spp
Other
Chlamydia
Mycoplasma
Legionella
Pharmacokinetic properties
Following the intramuscular administration of 500 mg, ampicillin reaches
peak plasma concentrations within about 1 hour which are reported to
range from 7 to 14 µg/ml.
Ampicillin is widely distributed and therapeutic concentrations can be
achieved in ascitic, pleural and joint fluids.
Ampicillin is around 20% bound to plasma proteins and the plasma half-life
is about 1 to 1½ hours.
Ampicillin is metabolised to some extent to penicilloic acid which is
excreted in the urine.
Renal clearance of ampicillin occurs partly by glomerular filtration and
partly by tubular secretion; it is retarded by the concomitant administration
of probenecid. Following parenteral administration, about 60 to 80% is
excreted in the urine within 6 hours. Ampicillin is removed by
haemodialysis. High concentrations are reached in bile, it undergoes
enterohepatic recycling and some is excreted in the faeces.
Preclinical safety data
No further information of relevance.
DIRECTIONS FOR USE
Preparation of injections:

Intramuscular: Dissolve 500 mg in 1.5 ml Water for Injections.
Intravenous:
Dissolve 500 mg in 10 ml Water for Injections.
Shake to dissolve.
Ampicillin solutions for injection should be used immediately.
Chemical and physical compatibility of Ampicillin powder for solution for
injection have been demonstrated with the following intravenous fluids for
the periods and temperatures stated (when reconstituted at 5 % w/v
nominal):
Intravenous fluids
Stability time
0.5 % Procaine Hydrochloride at ambient temperature .......... Use Immediately
Water for Injection at ambient temperature ............................. Use Immediately
Sodium Chloride 0.9 % Solution at 25 ˚C............................................... 4 hours
Ringers Solution at 25 ˚C ........................................................................ 3 hours
Compound Sodium Lactate Solution at 25 ˚C........................................ 3 hours
5 % Glucose Solution at 2-8˚C ................................................ Use Immediately
Sodium Chloride 0.9 % Solution at 2-8˚C ............................................ 10 hours
Ringers Solution at 2-8˚C...................................................................... 10 hours
Compound Sodium Lactate Solution at 2-8˚C ....................................... 9 hours
1.4 % Sodium Bicarbonate at 2-8˚C ...................................................... 3 hours
DISPOSAL
Ampicillin vials are not suitable for multidose use.
Any remaining solution should be discarded. Any unused product or waste
material should be disposed of in accordance with local requirements.
INCOMPATABILITIES
If Ampicillin is prescribed concurrently with an aminoglycoside, the
antibiotics should not be mixed in the syringe, intravenous fluid container or
giving set; because loss of activity of the aminoglycoside can occur under
these conditions.
Ampicillin should not be mixed with blood products or other proteinaceous
fluids (e.g. protein hydrolysates) or with intravenous lipid emulsions.
SHELF-LIFE AND STORAGE
UNOPENED VIAL

AFTER RECONSTITUTION

AVAILABILITY

Strength
500 mg

LEGAL CATEGORY

Do not store above 25°C.
Do not use this product after the expiry
date which is stated on the label. The
expiry date refers to the last day of that
month.
From a microbiological point of view, the
reconstituted product should be used
immediately, unless reconstitution has
taken place in controlled and validated
aseptic conditions. If not used
immediately, in-use storage times and
conditions prior to use are the
responsibility of the user and would
normally not be longer than 24 hours at
2-8°C.
Packs
10

Product licence
PL 02000/0001

POM

MANUFACTURER AND PRODUCT LICENSE HOLDER
Norbrook Laboratories Limited,
Newry, Co. Down, Northern Ireland.
Leaflet prepared: 10/2011

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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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