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CIDOMYCIN 80MG/2ML SOLUTION FOR INJECTION

Active substance(s): GENTAMICIN SULPHATE

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Cidomycin® 80mg/2ml
Solution for Injection
Gentamicin



Technical Leaflet- Cidomycin Injection
The following information is extracted from the SPC.
Technical information for the preparation and
administration of Cidomycin.
1. TRADE NAME OF THE MEDICINAL PRODUCT
Cidomycin® 80mg/2ml Solution for Injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule or vial (2ml) contains Gentamicin Sulphate
Ph Eur equivalent to 80mg Gentamicin base.
Also contains
Sodium chloride: 12.84 mg/2ml ampoule or vial
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Solution for Injection.
Clear, colourless solution.
4.2. Posology and method of administration
ADULTS :
Serious infections : If renal function is not impaired,
5mg/kg/daily in divided doses at six or eight hourly
intervals. The total daily dose may be subsequently
increased or decreased as clinically indicated.
Systemic infections : If renal function is not impaired,
3-5mg/kg/day in divided doses according to severity of
infection, adjusting according to clinical response and
body weight.
Urinary tract infections : As “Systemic infections”. Or, if renal
function is not impaired, 160mg once daily may be used.
PAEDIATRIC PATIENTS :
The daily dose recommended in children aged 1 year and
above and adolescents with normal renal function, is
3-6mg/kg body weight per day as 1 (preferred) or up to 2
single dose(s).
The daily dose in infants after the first month of life is
4.5-7.5mg/kg body weight per day as 1 (preferred) or up
to 2 single dose(s).
The daily dose in neonates and pre-term infants (aged 0-4
weeks old) is 4-7mg/kg body weight per day. Due to the
longer half-life, newborns are given the required daily
dose in 1 single dose.

(mg/100ml)
< 40

(mmol/l)
6-7

(ml/min)
> 70

40 - 100

6 - 17

30 - 70

100 - 200
> 200

17 - 34
> 34

10 - 30
5 - 10

Twice weekly intermittent
haemodialysis

<5

80mg*
8 hourly
80mg*
12 hourly
80mg* daily
80mg* every
48 hours
80mg* after
dialysis

*60mg if body weight <60kg. Frequency of dosage in
hours may also be approximated as serum creatinine
(mg%) x eight or in si units, as serum creatinine (µmol/l)
divided by 11. If these dosage guides are used peak serum
levels must be measured. Peak levels of gentamicin occur
approximately one hour after intramuscular injection and
intravenous injection. Trough levels are measured just prior
to the next injection. Assay of peak serum levels gives
confirmation of adequacy of dosage and also serves to
detect levels above 10mg/l, at which the possibility of
ototoxicity should be considered. One hour concentrations
of gentamicin should not exceed 10mg/l (but should reach
4mg/l), while the pre-dose trough concentration should be
less than 2mg/l.

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This is because your doctor will need to
keep a careful eye on you during your
treatment, to prevent damage to your ears.
He may check your hearing, your balance,
how your kidneys are working and the
amount of gentamicin in your blood.
If you are not sure if any of the above apply
to you, talk to your doctor or pharmacist
before having Cidomycin.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Cidomycin® 80mg/2ml
Solution for Injection

Gentamicin

Is this leaflet hard to
see or read?
Phone 0845 372 7101
for help
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 gets serious, or if
you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Cidomycin is and what it is used for
2. Before you take Cidomycin
3. How to take Cidomycin
4. Possible side effects
5. How to store Cidomycin
6. Further information
1. What Cidomycin is and what it is
used for

THE ELDERLY :
There is some evidence that elderly patients may be more
susceptible to aminoglycoside toxicity whether secondary
to previous eighth nerve impairment or borderline renal
dysfunction. Accordingly, therapy should be closely
monitored by frequent determination of gentamicin serum
levels, assessment of renal function and signs of ototoxicity.
RENAL IMPAIRMENT :
In impaired renal function, the recommended daily dose
has to be decreased and adjusted to the renal function.
Gentamicin is excreted by simple glomerular filtration
and therefore reduced dosage is necessary where renal
function is impaired. Nomograms are available for the
calculation of dose, which depends on the patient’s age,
weight and renal function. The following table may be
useful when treating adults.
Creatinine
Dose &
Blood Urea
clearance
frequency of
(GFR)
administration

i

The name of your medicine is Cidomycin
80mg/2ml Solution for Injection (called
Cidomycin throughout this leaflet). It contains
a medicine called gentamicin. This belongs to a
group of antibiotics called ‘aminoglycosides’.
Cidomycin is used to treat infections caused
by bacteria. This includes infections of the:
• Urinary tract (including your kidneys or
bladder)
• Chest (including your lungs)
• Blood – this is sometimes called
‘bacteraemia’ or ‘septicaemia’.
2. Before you have Cidomycin
Do not have this medicine if:
 You have Myasthenia Gravis. This is a
disease that causes muscle weakness.
 You are allergic (hypersensitive) to
gentamicin, any other antibiotics or to any
of the other ingredients of this medicine
(see Section 6: Further Information).
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling
of your lips, face, throat and tongue.
Do not have this medicine if any of the above
apply to you. If you are not sure, talk to your
doctor or pharmacist before having Cidomycin.
Take special care with Cidomycin
Check with your doctor or pharmacist
before having this medicine if:
 You are pregnant, might become pregnant,
or think you may be pregnant.
 You are breast-feeding (see ‘Pregnancy and
breast-feeding’ section below)
 You have any muscle weakness problems
 You are extremely overweight
 You have kidney problems, are over 65 years
of age or the patient is less than 1 year old.

Taking other medicines
Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines. This includes medicines you buy
without a prescription, including herbal
medicines. This is because Cidomycin can affect
the way some other medicines work. Also some
medicines can affect the way Cidomycin works.
In particular, tell your doctor if you are taking
any of the following:
• Medicines to thin the blood such as warfarin
• Water tablets or injections (diuretics) such as
furosemide or etacrynic acid
• Amphotericin B (used to treat fungal infections)
• Cephalosporin antibiotics such as cephaloridine
• Ciclosporin (used in organ transplants or for
severe skin problems)
• Neostigmine or pyridostigmine (used to treat
Myasthenia Gravis)
• Muscle relaxants - sometimes used during
operations which need an anaesthesic
• Indometacin (used to treat pain or swelling)
• Bisphosphonates (used to treat osteoporosis)
• Cisplatin (used to treat some cancers)
• Botulinum toxin – used to lower the activity
of overactive muscles. This is also sometimes
used in cosmetic procedures.
These medicines may increase certain side
effects (see Section 4: Possible side effects).
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine
if you are pregnant, might become pregnant,
or think you may be pregnant. Cidomycin
should not normally be used during pregnancy.
If you are breast-feeding or planning to
breast-feed, talk to your doctor or pharmacist
before taking any medicine.
Important information about some of the
ingredients of Cidomycin
Cidomycin contains very little sodium. It
contains less than 1 mmol sodium (23 mg)
per ampoule or vial.
3. How to have Cidomycin
Cidomycin is always given to you by a doctor
or nurse. This is because it needs to be given
as an injection.
Having this medicine
Your doctor will decide how much to give you,
depending on your weight. The correct dose
also depends on the type of infection and any
other illnesses you may have. Blood samples
will be taken by your doctor or nurse to check
the dose is right for you.
Adults:
• The usual daily dose in adults is 3-5mg for
each kg of body weight
• This is split into doses given every 6-8 hours
• This dose may be increased or decreased
by your doctor depending on your illness
Children (aged 1 year and above):
• The usual daily dose is 3-6mg for each kg of
body weight
• This is given either as 1 single dose
Turn
(preferred) or split into 2 separate
Over
doses
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The recommended dose and precautions for
intramuscular and intravenous administration are
identical. Gentamicin when given intravenously should
be injected directly into a vein or into the drip set tubing
over no less than three minutes. If administered by
infusion, this should be over no longer than 20 minutes
and in no greater volume of fluid than 100ml.
Monitoring Advice
Serum concentration monitoring of gentamicin is
recommended, especially in elderly, in newborns and in
patients with impaired renal function.
Samples are taken at the end of a dosing interval (trough
level). Trough levels should not exceed 2µg/ml
administering gentamicin twice daily and 1µg/ml for
once daily dose.
4.4 Special Warnings and precautions for use
To avoid adverse events, continuous monitoring (before,
during and after) of renal function (serum creatinin,
creatinin clearance), control of function of vestibule and
cochlea as well as hepatic and laboratory parameters is
recommended.
Ototoxicity has been recorded following the use of
gentamicin. Groups at special risk include patients with
impaired renal function, infants and possibly the elderly.
Consequently, renal, auditory and vestibular functions
should be monitored in these patients and serum levels
determined so as to avoid peak concentrations above
10mg/l and troughs above 2mg/l when administering
Gentamicin twice daily and 1mg/l for a once daily dose.
As there is some evidence that risk of both ototoxicity and
nephrotoxicity is related to the level of total exposure,
duration of therapy should be the shortest possible
compatible with clinical recovery. In some patients with
impaired renal function there has been a transient rise in
blood-urea-nitrogen which has usually reverted to
normal during or following cessation of therapy. It is
important to adjust the frequency of dosage according to
the degree of renal function.
Gentamicin should only be used in pregnancy if
considered essential by the physician (see section 4.6
Pregnancy and Lactation.)
Gentamicin should be used with care in conditions
characterised by muscular weakness.
In cases of significant obesity gentamicin serum
concentrations should be closely monitored and a
reduction in dose should be considered.

PHARMACEUTICAL PARTICULARS
6.1 List of Excipients
Sodium Chloride
Water for Injections
2N Sodium Hydroxide (for pH adjustment)
2N Sulphuric Acid (for pH adjustment)
6.2 Incompatabilities
In general, gentamicin injection should not be mixed. In
particular the following are incompatible in mixed solution
with gentamicin injection : penicillins, cephalosporins,
erythromycin, heparins, sodium bicarbonate.
* Dilution in the body will obviate the danger of physical
and chemical incompatibility and enable gentamicin to be
given concurrently with the drugs listed above either as a
bolus injection into the drip tubing, with adequate
flushing, or at separate sites. In the case of carbenicillin,
administration should only be at a separate site.
* Carbon dioxide may be liberated on addition of the two
solutions. Normally this will dissolve in the solution but
under some circumstances small bubbles may form.
6.3 Shelf-life
3 years
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze.
6.5 Nature and contents of container
Cidomycin is supplied in in packs of 5 x 2ml colourless
glass ampoules (Type I) with an OPC (one point cut) break
system and red and green rings or in packs of 5 x 2ml
colourless glass vials (Type I) closed with a chlorobutyl
rubber stopper sealed with an aluminium capsule type
flip-off.
6.6 Instructions for use/handling
Not applicable.
9. FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
July 2011
10. DATE OF REVISION
June 2013

Babies (aged 4 weeks to 1 year):
• The usual daily dose is 4.5-7.5mg for each kg
of body weight
• This is given either as 1 single dose
(preferred) or split into 2 separate doses
Premature babies or new born babies (up
to 4 weeks)
• The usual daily dose is 4-7mg for each kg of
body weight
• This is given in 1 single dose
If you have more Cidomycin than you should
It is most unlikely that you will be given too
much medicine by the doctor or nurse. Your
doctor or nurse will be checking your progress
and checking the medicine that you are given.
Ask if you are not sure why you are getting a
dose of medicine.
If you forget to have Cidomycin
Your doctor or nurse have instructions about
when to give you your medicine. It is most
unlikely that you will not be given the
medicine as it has been prescribed. If you
think that you may have missed a dose then
talk to your nurse or doctor.
If you stop having Cidomycin
It is important that the course of treatment your
doctor has prescribed is finished. You may start
to feel better but it is important to continue
your treatment until the doctor advises. If you
stop, your infection may get worse again.

• Feeling confused
• Depression
• Strange visions or sounds (hallucinations)
and memory loss
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.

4. Possible side effects
Like all medicines, Cidomycin can cause side
effects, although not everybody gets them.
Tell your doctor or nurse as soon as possible
if any of the following side effects happen:
Ear problems: these may happen because
Cidomycin can sometimes damage the ear,
especially if your kidneys do not work very
well. The side effects are:
• Difficulty keeping your balance
• Feeling dizzy
• Poor hearing.
Kidney problems: if you notice anything
unusual when you pass water, such as:
• If you see any sign of blood in your water
(urine)
• If you find you are passing less water than
is normal for you.
Nerve or muscle problems:
• If you have unusual difficulty in moving
which has not happened before
• If you have a feeling of weakness or
unusual tiredness
• If you have any breathing difficulties that
have not happened before
• Numbness, weakness and pain in the
arms and legs (peripheral neuropathy)
If you are not sure if you have any of the above,
talk to your doctor or nurse as soon as possible.
Tell your doctor or nurse if any of the
following side effects get serious or last
longer than a few days. Also tell them if you
notice any side effects not listed in this leaflet
• Allergic (also called hypersensitivity) reactions,
such as nettle rash or difficulty breathing
• Headache
• Feeling tired
• Purplish or reddish-brown skin colouring
• Mouth ulcers
• Feeling or being sick (nausea or vomiting)
• Rash
• Bloody diarrhoea
• Fits or convulsions

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5. How to store Cidomycin
• Keep out of the reach and sight of children
• You will not be asked to store your
medicine. It will be brought to you ready to
be taken straight away.
• Do not store this medicine above 25°C.
It should not be kept in a fridge or freezer
• Do not have Cidomycin after the expiry date.
This is stated in month and year on the
carton and on the label after “Exp”. The
expiry date refers to the last day of that
month. If you are not sure when this is,
check with your doctor or pharmacist.
• Ask your pharmacist how to dispose of
medicines no longer needed. Do not dispose
of medicines by flushing down the toilet or a
sink or by throwing out with your normal
household rubbish. This will help to protect
the environment.
6. Further information
What Cidomycin contains
• The active substance is gentamicin sulphate
equivalent to 80mg of gentamicin.
• The other ingredients are sulphuric acid and
sodium hydroxide for pH adjustment,
sodium chloride and water for injections
What Cidomycin looks like and content of
the pack
The medicine is a clear, colourless solution for
injection in 2ml ampoules or vials. Cidomycin
is available in packs of 5 glass ampoules with
an OPC (one point cut) break system and red
and green rings or in packs of 5 glass vials
closed with a chlorobutyl rubber stopper
sealed with an aluminium capsule type
flip-off. Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com
Manufacturer
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.
Avda. Leganés, 62
Alcorcón 28923 (Madrid) Spain
This leaflet does not contain all the
information about your medicine. If you have
any questions or are not sure about anything,
ask your doctor or pharmacist.
This leaflet was last revised in 01/2015
© Sanofi, 1973 - 2015
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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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