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TOBRAMYCIN INJECTION BP 40 MG/ML AND 80 MG/2ML

Active substance(s): TOBRAMYCIN

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Patient Information Leaflet

TOBRAMYCIN INJECTION BP
40 mg in 1 ml, 80 mg in 2 ml.
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, 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 Tobramycin is and what it is used for
2. Before you receive Tobramycin
3. How to receive Tobramycin
4. Possible side effects
5. How to store Tobramycin
6. Further information
1. What Tobramycin is and what it is
used for
Tobramycin is an aminoglycoside antibiotic,
effective against a number of different bacterium
species. Aminoglycosides kill bacteria which
cause infections in your body, by inhibiting the
protein synthesis of the bacteria.
Tobramycin injection is used if you are suffering
from an infectious disease such as:
• infections of the lower respiratory tract
(inflammation of the lungs, bronchitis,
pheumonia);
• infections of the skin, soft tissue, muscle and
bone infections, including complications of
burns;
• urogenital infections (causing inflammation of
the kidneys, bladder and genitals);
• infections of the stomach, the bowels and other
abdominal organs, including peritonitis;
• infections of the central nervous system (such
as meningitis) and blood poisoning, including
that in new-born infants;
• infections of the heart valve (endocarditis)
2. Before you recEIve tobramycin
Do not receive Tobramycin if you:
• are allergic (hypersensitive) to Tobramycin
or any other aminoglycoside antibiotics, or
ingredients in this medicine
• are to have this injection into your spinal canal
Take special care with Tobramycin
Tell your doctor before you are given medicine,
if you:
• have any kidney problem
• have any hearing problems
• have any balance / gait problems
• are pregnant or trying to get pregnant
• are breast-feeding
Patients with kidney problems, or those who
develop problems with their kidneys, hearing
or balance during treatment will be regularly
monitored and their dosage adjusted as
necessary.
Taking other medicines
If you take any other drugs at the same time as
Tobramycin, they may interfere with the effects
of the other. Therefore, during your treatment
with Tobramycin consult your doctor before
taking any other drugs. Tobramycin should
preferably not be given with the following drugs:
• other antibiotics having possible toxic effects
on the nervous system and the kidneys (e.g.
amikacin, streptomycin, neomycin, kanamycin,
gentamycin, paromomycin, amphotericin
B, cephaloridine, viomycin, polymyxin B,
vancomycin)
• diuretics (water tablets) (e.g. furosemide,
etacrinic acid)

• neuromuscular blockers (e.g. tubocurarine,
succinylcholine), used to treat myasthenia gravis
or Parkinson’s disease.
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
Pregnancy and breast-feeding
The administration of tobramycin should be
avoided in pregnant women unless the patient
suffers from a life-threatening infection which
cannot be treated with any other antibiotic. If a
pregnant woman is treated with tobramycin, the
drug may cause severe and permanent damage
to the unborn baby. Tobramycin should not be
administered to nursing mothers because it
passes into the breast milk.
Driving and using machines
Tobramycin may cause dizziness, if affected do
not drive or operate machinery.
Important information about some of the
ingredients of Tobramycin
This medicine contains sodium metabisulphite,
which may cause allergic reactions and breathing
problems. Tell your doctor if you know that you
are allergic to sodium metabisulphite, as you
should not be given this medicine.
3. How to receive Tobramycin
Tobramycin may be given on its own or
with other medicines. You will receive it by
intravenous or intramuscular injection, or in
infusion. Before the treatment is started, your
doctor may carry out some blood tests to find
out what’s causing your infection. In urgent
cases, your doctor may start your treatment
without this test.
The injection should always be given by a doctor
or nurse.
How much Tobramycin will you receive, how
often and how long?
This will depend on the severity of your disease,
your age, weight and your general medical
condition. Tobramycin will be given to you with
care as it may affect your kidneys and the inner
parts of your ears.
Your doctor may carry out blood tests while you
are being treated with this medicine, to make
sure you are getting the correct dose.
Adults:
Also refer to ‘recommendations for patient with
impaired (less effective) kidney function’
• The usual single dose for adults with normal
kidney function is 1.0 – 1.5 mg/kg, which may
be repeated depending on the severity of the
disease.
• In patients with cystic fibrosis, a dose up to 8 to
10 mg/kg/day in equally divided doses.
The dosage should be reduced as soon as your
doctor determines it is safe to do so.
Children:
• The recommended dose for children is 3 – 5 mg/
kg/day, given in 3 equal doses every 8 hours.
Premature and full-term new-born babies:
• The recommended dosage is 2 – 3 mg/kg/day,
in 2 – 3 equal portions.
• In new-born babies the dosage will be given
with caution because their kidney function is
not yet fully developed.
Overweight patients:
• In obese patients the ideal body weight and
40% of excess weight should be taken into
account when determining the correct dosage.

Elderly:
• Same as adults, but see recommendations for
patients with impaired (less effective) kidney
function, below.

If you believe you are suffering from any of these
side effects then do report them to your doctor
or nurse, who may confirm them by arranging for
a blood test to be performed.

For patients with impaired (less effective)
kidney function:
• Patients with reduced kidney function are prone
to the toxic effects of Tobramycin in the inner
ear and the kidneys. To prevent these patients
with kidney problems will be given either a
reduced single dose or normal doses given at
prolonged intervals.
• If you suffer from kidney failure, the effective
dose and the time between two consecutive
doses will be based on your blood test (e.g.
serum creatinine levels and creatinine clearance)
and the levels of Tobramycin in the blood.

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.

The recommended dose is 1 mg/kg/day, and
the time between two consecutive doses is
determined by your kidney function according to
the following table:
Serum
creatinine
mg %
< 1.3
1.4 – 1.9
2.0 – 2.8
2.9 – 3..7
3.8 – 5.3
5.4 – 7.2
> 7.2

µmol/l
< 110
110 – 168
176 -247
256 – 327
335 – 468
477 – 636
> 636

Creatinine Interval
clearance between the
ml/min
administration
in hours
> 80
40 – 80
25 – 40
15 – 25
10 – 15
5 – 10
<5

8
12
18
24
36
48
72

If you receive more Tobramycin than you
should or think you have missed a dose
• this medicine will be given to you in hospital.
If you have any concerns about the amount of
medicine you are given or how often you should
recieve it, please tell your doctor or nurse.
If you have any further questions on the use of
this product, ask your doctor or nurse.
4. Possible side effects
Tobramycin can cause side effects. You should
discuss them with your doctor, who will explain
the risks and benefits of your treatment.
Like all medicines Tobramycin can have side
effects.
Tell your doctor immediately if the following
happens:
• an allergic reaction causing a sudden itchy rash
(hives), swelling of the hands, feet, ankles, face,
lips, mouth or throat (which may cause difficulty
in swallowing or breathing).
This is a very rare but serious side effect.
You may need urgent medical attention.
The risk of toxic effects on your kidneys and ears
is low (less than 1 patient in 100) if you receive
tobramycin in the correct dose and correct time
period. The risks are low in patients with normal
kidney functions who do not receive tobramycin
in higher doses or for longer periods of time than
recommended.
Tobramycin may affect your hearing and sense of
balance, you may experience:
• impaired hearing – this may occur if you are
given high doses or over long periods of time.
• ringing in your ears
• dizziness
In rare cases:
• there could be an increase in liver enzyme levels
• a lower number of red blood cells (anaemia)
• a lower number of white blood cells
(leukopenia)
• a lower number of platelets (thrombocytopenia)
• a lowered calcium levels (hypocalcaemia)
• a lowered sodium levels (hyponatraemia)
• lowered potassium levels (hypokalaemia)
• fever
• rash
• urticaria (hives)
• vomiting
• headache
• lethargy

5. How to store Tobramycin
Keep out of the reach and sight of children.
The ampoules should be kept below 25oC
protected from light.
Do not use Tobramycin after the expiry date that
is stated on the outer packaging. The expiry date
refers to the last day of that month.
Medicines should not be disposed of via
wastewater or household waste. These measures
will help to protect the environment.
6. Further information
What Tobramycin Injection contain(s):
• The active ingredient is Toramycin as sulphate
salt
• The other ingredients are disodium edentate,
sodium metabisulphite and water for injection
as excipients.
What Tobramycin Injection look(s) like and
contents of the pack:
Tobramycin injections are available in two
strengths:
• Tobramycin injection BP 40 mg in 1 ml – each
ampoule contains 40 mg tobramycin as
sulphate salt.
• Tobramycin injection BP 80 mg in 2 ml – each
ampoule contains 80 mg tobramycin as
sulphate salt.
• Tobramycin injections are available in packs of
10 ampoules.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder:
Medimpex UK Limited, 127 Shirland Road,
London, W9 2EP England.
Manufacturer:
Teva Pharmaceutical Works Private Limited
Company, Gödöllő, Táncsics Mihály út 82,
Hungry
This leaflet was last revised: July 2011
Product Licence Nos. PL 05276/0008

Version 1
UT PIL

July 2008
RA;

Code:
ETF:

Actavis, Barnstaple, EX32 8NS, UK

MPXPL002

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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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