AMPICILLIN 500MG VIALS FOR INJECTION

Active substance: AMPICILLIN SODIUM

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Ampicillin 500 mg

Vials for Injection

Ampicillin Sodium EP for Injection

70/L/t/4

Content
Ampicillin is available as vials containing the equivalent of 500 mg ampicillin presented as Ampicillin
Sodium EP as a powder for reconstitution.
Therapeutic Indications
Ampicillin is a broad-spectrum penicillin indicated for the treatment of a wide range of bacterial
infections caused by ampicillin-sensitive organisms. Typical indications include: ear, nose and throat
infections, bronchitis, pneumonia, urinary tract infections, gonorrhoea, gynaecological infections,
gastrointestinal infections, enteric fever, peritonitis, septicaemia, endocarditis, meningitis.
Extraperitoneal application of ampicillin to wounds can be used to prevent infection following abdominal
surgery. Parenteral usage is indicated where oral dosage is inappropriate.
Routes of administration: intramuscular, intravenous, intraperitoneal, intrapleural, intra-articular,
extraperitoneal.
Posology and Method of Administration
Usual adult dosage (including elderly patients):
Septicaemia, endocarditis, osteomyelitis:

500 mg four to six times a day IM or IV for one to six weeks.

Peritonitis, intra-abdominal sepsis:

500 mg four times a day IM or IV.

Meningitis:

Adult dosage: 2 g six-hourly IV.
Children’s dosage: 150 mg/kg daily IV in divided doses.

Ampicillin may also be administered by other routes in conjunction with systemic therapy.
Intraperitoneal:
500 mg daily in up to 10 ml Water for Injections BP.
Intrapleural:
500 mg daily in 5-10 ml Water for Injections BP.
Intra-articular:
500 mg daily, in up to 5 ml Water for Injections BP or sterile
0.5% procaine hydrochloride solution.
Local use in abdominal surgery: 1 g sterile powder sprinkled into the wound extraperitoneally or into
muscle layers to prevent wound infection post-operatively.
Usual children's dosage (under 10 years):
Half 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 case of dialysis, an additional dose should be
administered after the procedure.
Administration:
Intramuscular:
Add 1.5 ml Water for Injections BP to 500 mg vial contents.
Intravenous:
Dissolve 500 mg in 10 ml Water for Injections BP. 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).
Special warnings and 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).
Sodium Content: one vial contains 33.7 mg sodium. This sodium content should be included in the daily
allowance of patients on sodium restricted 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.
Bacteriostatic 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.

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 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.
Effects on ability to drive and use machines
Adverse effects on the ability to drive or operate machinery have not been observed.
Undesirable effects
Hypersensitivity reactions: If any hypersensitivity reaction occurs, the treatment should be
discontinued.
Skin rash, pruritis and urticaria have been reported occasionally. The incidence is higher in patients
suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura has
also been reported. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson
syndrome, and toxic epidermal necrolysis have been reported.
As with other antibiotics, anaphylaxis (see Special warnings section) has been reported rarely.
Renal effects: Interstitial nephritis can occur rarely.
Gastrointestinal reactions: Effects include nausea, vomiting and diarrhoea.
Pseudomembraneous colitis and haemorrhagic colitis has been reported rarely.
Hepatic effects: As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been
reported rarely. As with most other antibiotics, a moderate and transient increase in transaminases has
been reported.
Haematological effects: As with other beta-lactams, haematological effects including transient
leucopenia, transient thrombocytopenia and haemolytic anaemia have been reported rarely.
Prolongation of bleeding time and prothrombin time have also been reported rarely.
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.
Pharmacological Properties
Pharmacodynamic properties: Ampicillin is a broad spectrum penicillin, indicated for the
treatment of a wide range of bacterial infection caused by ampicillin sensitive organisms.
Pharmacokinetic properties: Ampicillin is excreted mainly in the bile and urine with a plasma
half life of one to two hours.
Preclinical safety data: No further information of relevance.
Directions for use
Ampicillin vials are not suitable for multidose use. Any residual Ampicillin solution
should be discarded.
Stability and Compatibility
Ampicillin solutions for injection should be used immediately.
The stability of Ampicillin is improved in dilute solutions such as those commonly prepared for
intravenous infusion and the drug can be added to most intravenous fluids. Preparation of Ampicillin
infusion solutions must be carried out under appropriate aseptic conditions if these extended storage
periods are required. Reconstituted solutions of Ampicillin should be stored in a refrigerator at 2-8°C.
Refrigerated solutions should be restored to ambient temperature before use.
Intravenous fluids
Sodium chloride 0.9% with glucose 5% (dextrose saline), 5% glucose, 10% dextran 40 in 5% glucose
M/6 sodium lactate, 1.4% sodium bicarbonate,10% dextran 40 in normal saline
Water for Injections BP, sodium chloride 0.9% (normal saline), Ringer’s solution
Ampicillin has been shown to be compatible with heparin sodium in intravenous infusions and these
agents may be administered concurrently in normal saline.
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.
Storage

Ampicillin vials should not be stored above 25°C.

Availability

Strength
500 mg

Legal category

POM

Product Licence Holder

Chemidex Pharma Ltd., trading as Essential Generics,
7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB

Packs
10

Product Licence
PL 17736/0070

Leaflet prepared July 2012

70/L/t/4

Patient Information Leaflet

3. How to use

Ampicillin
500 mg Vials for Injection
Ampicillin

70/L/t/4

Read all of this leaflet carefully before you start using 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.
In this leaflet:
1. What this medicine is and what
it is used for
2. Before you use
3. How to use
4. Possible side effects
5. How to store
6. Further information

1. What this medicine is
and what it is used for
Ampicillin vials contain ampicillin
which belongs to the penicillin group
of antibiotics.
Ampicillin works by killing bacteria
that cause infections, such as:
ear, nose and throat infections
bronchitis, pneumonia, chest
infections
urinary tract infections
sexually transmitted infections
skin and soft tissue infections
gastrointestinal infections
blood poisoning.

2. Before you use
Do NOT use Ampicillin vials for
injection if you:
are allergic to ampicillin, other
antibiotics called beta-lactams
(e.g. penicillin or cephalosporin)
or any of the other ingredients
(see Section 6).
If this applies to you, speak to your
doctor or pharmacist.
Take special care with Ampicillin
vials for injection
Before treatment with the injection,
tell your doctor if you:
have ever had a skin rash or
swelling of the face or neck
when taking any antibiotic
are already being treated with
another antibiotic
have glandular fever or low
immune system
leukaemia
have kidney problems.

Taking 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, and herbal preparations.
Some medicines may be affected by
Ampicillin or they may affect how well
Ampicillin will work.
Tell your doctor or pharmacist if you
are taking:
any other antibiotics
allopurinol or probenecid for
conditions such as gout
oral contraceptives (the pill). You
will need an additional method of
contraception, such as condoms.
Speak to your doctor or
pharmacist about how long you
need to take extra precautions
for.
Urine tests: Tell the doctor if you are
having urine tests for glucose, as
your medicine may affect the results.
Pregnancy and breast-feeding
Ampicillin will not harm your unborn
baby. Small quantities of the medicine
may be present in breast milk.
Ask your doctor for advice before
taking any medicine.
Driving and using machines
Ampicillin vials for injection is unlikely
to affect your ability to operate
machinery or to drive.
Important information about some
of the ingredients of Ampicillin
vials for injection
sodium
Each vial of Ampicillin injection
contains 33.7 mg of sodium.
This should be taken into
consideration by patients on a
controlled sodium diet.

You will most likely receive Ampicillin
injection from a doctor or nurse. Your
doctor will decide on the appropriate
dose to suit your condition. Ask your
doctor or pharmacist if you are not
sure.
Your doctor or nurse will usually
inject Ampicillin into your muscles
or veins.
Ampicillin injection can also be
used in other ways depending on
your condition.
Doses
Adults and children over
10 years: the usual dose is
500 mg four to six times a day.
Children under 10 years: half
the adult dose.
In severe infections the above
doses may be increased by your
doctor.
Patients with kidney problems:
if your kidneys are not working
very well, your doctor may
change the dose.
Your doctor will give you special
instructions if you are on kidney
dialysis.
If you use more than you should
Having too much Ampicillin is unlikely
as the injection will be given to you by
a doctor or nurse. However, if you are
given too much Ampicillin, you may
experience nausea, vomiting and
diarrhoea. Ask your doctor or nurse if
you have any concerns.
If you forget to use
If you think you have missed an
injection, speak to your doctor or
nurse.
If you stop using
Do not stop just because you feel
better. If you stop too soon, the
infection may come back. Keep
having the injection until the
prescribed course is finished.
If you have any further questions on
the use of this product, ask your
doctor or pharmacist.

4. Possible side effects
Like all medicines, Ampicillin can
cause side effects, although not
everybody gets them. Do not be
alarmed by this list of possible side
effects. You may not experience any
of them.
Tell you doctor or nurse
immediately if you have any of the
following allergic reactions:
difficulty breathing or swallowing,
swelling of the face, lips, tongue
or throat
severe itching of the skin, with a
red rash or raised lumps
blistering of the mouth, eyes, or
genital region, patchy areas of
rash, peeling skin.
Seek immediate medical attention
if you have any of the following
symptoms:
severe stomach cramps, watery
and severe diarrhoea which may
be bloody, fever

Continued over page

70/L/t/4

yellowing of your skin or eyes,
pale faeces and dark urine,
unexplained persistent nausea,
stomach problems, loss of
appetite or unusual tiredness
unusual bleeding or bruising
fever, sore throat, mouth ulcers,
repeated infections or infections
that will not go away
feeling tired, breathless, and
looking pale
fever, rash, nausea, aches and
pains, passing more or less
urine than usual or passing
urine at night.
Some of these reactions may
happen several weeks after
finishing the treatment.
The following side effects usually
settle without changing the dose:
upset stomach, nausea or
diarrhoea.
Blood tests: tell your doctor if you
are having blood tests as your
medicine can cause short-term
changes in blood cell counts.
If any of the side effects get
troublesome, or if you notice any
side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5. How to store
Keep out of the reach and sight of
children.
Do not use after the expiry date
which is stated on the vial label
and on the carton. The expiry date
refers to the last day of that month.
Do not store above 25ºC.
Store prepared solutions for
injection in a refrigerator (2°C - 8°C)
for up to 24 hours.
Do not throw it away with your
household waste or in water.
Return all the unwanted medicine
to your pharmacist. This will help
to protect the environment.

6. Further information
What Ampicillin vial for injection
contains
The active ingredient is ampicillin
(500 mg) as ampicillin sodium.
(See end of Section 2 for further
information on sodium).
There are no other ingredients.
What Ampicillin vial for injection
looks like and contents of the
pack
Ampicillin is a white powder which is
made up into a solution before it is
given to you.
It is supplied to doctors in packs of
10 vials.
Marketing Authorisation Holder
Chemidex Pharma Ltd, trading as
Essential Generics, 7 Egham
Business Village, Crabtree Road,
Egham, Surrey TW20 8RB.
Manufacturer
Laboratorio Reig Jofre, S.A.
C/ Jarama 111, Polígono Industrial
Toledo, 45007 Toledo (Spain)
This leaflet was last revised in
July 2012

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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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