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IOPAMIDOL 340MG IODINE/ML INJECTION

Active substance(s): IOPAMIDOL

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Information for the Doctor

Iopamidol 340mg Iodine/ml Injection
Summary of Product Characteristics
1.

Trade Name of the Medicinal Product

* Dose dependent on body size and age.
** Repeat as necessary.
*** For severe renal failure patients use up to 1.5ml/kg.

Iopamidol 340mg Iodine/ml Injection.

2.

Qualitative and Quantitative Composition

Elderly:
No special dosage requirements. However, the lowest
effective dose to be used.

Contains 694.0mg iopamidol, equivalent to 340mg iodine/ml.

3.

Pharmaceutical Form

Once the vial is opened use immediately and discard any
remaining solution after use.

Solution for injection.

4.

Clinical Particulars

4.1 Therapeutic indications
Iopamidol 340mg Iodine/ml Injection, an X-ray contrast
media is indicated for the following procedures:











peripheral arteriography
angiocardiography and left ventriculography
coronary arteriography
aortography
selective renal arteriography
selective visceral angiography
digital subtraction angiography
computer tomography enhancement
intravenous urography
arthrography.

4.2 Posology and method of administration
Dosage and administration:
Adults and children:
Dosage (ml)

Procedure
Peripheral arteriography
Angiocardiography and left
ventriculography
Coronary arteriography
Aortography (retrograde)
Selective renal arteriography
Selective visceral angiography:
Hepatic
Coeliac
Superior Mesenteric
Inferior Mesenteric
Digital subtraction angiography:
Intra-venous injection
Left ventriculography
Selective coronary arteriography
by intra-arterial DSA
Computer tomography enhancement:
Brain scanning
Whole body scanning
Intravenous urography
Arthrography

Adults
20-50**
30-80

4.3 Contra-indications
Known or suspected hypersensitivity to iodine containing
preparations or to any of the excipients detailed under
section 6.1.
4.4 Special warnings and precautions for use
As with other contrast media there is the possibility that this
product may provoke anaphylactoid reactions or other
signs of allergy with nausea, vomiting, dyspnoea,
erythema, urticaria and hypotension. Extra caution to be
taken with patients known to have a positive history of
allergy, asthma or have reacted during previous similar
investigations, hence the benefits must be assessed
against the risks. Appropriate resuscitation procedures
must be available immediately. Patients must be kept under
close observation for 15 minutes following the last injection
as the majority of severe reactions occur during this time.
Patients should remain in the hospital environment (but not
necessarily in the radiology department) for 1 hour after
the last injection is administered. Patients should be
advised to return to the radiology department if any
symptoms develop.

Children
*
*

Patients who have been administered the media
intrathecally should rest with the head and thorax elevated
for at least 1 hour followed by subsequent ambulation or
bed rest with the head elevated to 6 hours post procedure.

4-8
Not recommended
(per artery)**
30-80
Not recommended
5-10
*
30-70
40-70
25-70
5-30

Not recommended
Not recommended
Not recommended
Not recommended

30-50
25
2-5

0.5-0.75ml/kg*
1.0-1.5ml/kg*
Not recommended

The dose of iopamidol must be adjusted in patients with
moderate to severe impaired renal function or in patients
known to be diabetic. In patients taking metformin for renal
impairment the use of contrast media may precipitate lactic
acidosis. Hence, this drug should be stopped 48 hours
prior to the administration of the contrast media and
restarted after control of renal function has been regained.
Such patients must be maintained hydrated through the
procedure and renal function monitored after the
procedure.
In patients suffering from severe hepato-renal impairment
no procedure should be conducted unless absolutely
required, with re-examination delayed for 5-7 days.
Investigation of the right heart can be conducted, but in
patients with pulmonary hypertension, the pulmonary
artery examination should not be conducted unless
absolutely required. During intracardiac and/or
coronary arteriography, ventricular arrhythmias may
infrequently occur.

50-100 Not recommended
40-100 Not recommended
40-80***
1-2.5ml/kg*
1-10
Not recommended

Care to be taken when conducting the procedure in
patients with severe functional impairment of the liver or
myocardium and severe systemic disease, especially in
myelomatosis where patients should be well hydrated.
Abnormalities of fluid or electrolyte balance should be
corrected prior to the administration of the contrast media.
In patients suffering from or with known history of epilepsy,
anticonvulsant therapy should be maintained before and
following myelographic procedures, with therapy increased
for 48 hours before the procedure in some patients.
Caution must be taken in patients with hyperthyroidism and
those previously suffering from Graves’ disease. Hyperthyroidism may recur in patients previously treated for
Graves’ disease.
Rarely, serious thromboembolic complications have
occurred after the use of contrast media. To minimise the
risk of clotting, non-ionic media should not be permitted to
remain in contact with blood in the syringe and
intravascular catheters should be flushed frequently.
4.5 Interactions with other medicaments and other forms
of interaction
No other drugs should be mixed with this contrast media.
As a precautionary measure, metformin should be stopped
48 hours prior to administration of this contrast media and
only restarted after renal control has been regained.
Iopamidol may interfere with tests for thyroid function.
4.6 Pregnancy and lactation
Limited data are available on the use of iopamidol during
pregnancy and lactation. Caution should therefore be
exercised because of the risk of X-rays associated with this
product, by balancing the potential benefits of treatment
against any possible hazard. Hence, administration and
investigational procedures should be conducted in the preovulation phase in women.
4.7 Effects on ability to drive and use machines
None known. However, because of the risk of early
reactions driving or operating machinery is not advisable
for 1 hour following the time of injection. Driving or
operating machinery is not advisable for 6 hours following
intrathecal administration of the media (see section 4.4).
4.8 Undesirable effects
This medicine may cause headache, nausea, vomiting,
dizziness, heat sensation, skin rashes (e.g. erythema),
dyspnoea and hypotension as seen with other contrast
media. Iopamidol will irritate the gastrointestinal tract to
cause nausea, vomiting and diarrhoea with heartburn.
In addition, for myelography procedures rare cases of
seizures, transient confusion or transient motor or sensory
dysfunction may occur. Menigism or meningitis have also
been reported, the possibility of an infective meningitis
should be considered.


Information for the Patient

Iopamidol 340mg Iodine/ml Injection
Please read this leaflet carefully. This leaflet does not contain the
complete information about your medicine. If you have any questions
or are not sure about anything, ask your doctor.

About your medicine

Before starting your treatment



Iopamidol 340mg Iodine/ml Injection is a clear, colourless to
pale yellow solution which contains 694.0mg of the active
ingredient iopamidol. The iopamidol is equivalent to 340mg
iodine/ml.

If the answer to any of the following questions is yes, tell the
doctor before your treatment begins.


Have you ever had an allergic reaction to iopamidol, iodine
or any of the ingredients listed above?



Each vial also contains tromethamine, sodium calcium
edetate, Water for Injections, sodium hydroxide or
hydrochloric acid.



Have you ever had an uncomfortable reaction during
previous similar investigations?



It comes in 20ml, 50ml, 100ml and 200ml vials.



Are you asthmatic or have a history of allergies?



Iopamidol is a non-ionic X-ray contrast media, allowing the
different tissues of the body to be visible under X-ray
inspection.



Do you suffer from liver, heart or kidney disease?



Do you have any other disease affecting any part of your
body?



Have you experienced dehydration, especially as a result of
cancer?

Genus Pharmaceuticals, Park View House, 65 London Road,
Newbury, Berkshire RG14 1JN, UK.



Do you suffer from epilepsy, diabetes, problems with your
thyroid or Graves’ disease?

Manufacturer



N.P.B.I., Runde ZZ41, 7881 HM Emmer-Compascuum, The
Netherlands.

Are you pregnant, think that you may be pregnant or
planning a family?

If the procedure involved you being given injections of iopamidol
into the spinal cord area of your back, the medical staff will
ensure that you rest with your head and upper body kept upright
for at least 1 hour. You will then also be told to rest with your
head supported for 6 hours after the last injection of iopamidol
was given to you.



Are you taking metformin, blood thinning medicines (anticoagulants) or any other drugs?

What unwanted effects can this medicine have?

Marketing Authorisation holder

Uses for your medicine
This medicine is used to help the doctor examine the following:

No other drugs should be mixed with this contrast media.
Do not drive or operate any tools/machines for at least 6
hours following a procedure during which iopamidol was
injected into the spinal cord area of your back. For other
procedures the time you should allow before driving or
operating any tools/machines should be at least 1 hour
following the last injection of iopamidol.

If too much iopamidol is given it can be quickly removed from
your body by increasing the amount of fluids into your body or if
necessary by haemodialysis (artificial kidney).
At the end of the procedure the medical staff caring for you will
observe you closely for 15 minutes. This is in case you develop
side-effects to iopamidol that might require immediate
treatment. The medical staff are also likely to request that you
stay on the hospital premises for 1 hour after the last injection of
iopamidol given to you. If during this time you develop any of the
side-effects listed in the next section (‘What unwanted effects
can this medicine have?’) you should return to the department
where you had your procedure (radiology department) and tell
the medical staff your symptoms.

This medicine, like most other medicines, may cause sideeffects in some people.
Occasionally, kidney problems may occur which rarely may
result in kidney failure. Your doctor will ensure that you have
adequate fluids in order for this to be avoided.



peripheral arteriography - the blood vessels situated away
from the main body organs



angiocardiography and left ventriculography - the heart



coronary arteriography - the arteries around the heart



aortography - the main artery leaving the heart, the aorta



selective renal arteriography - the arteries in the kidney

How is Iopamidol Injection given?

The following side-effects may occur; headache, nausea,
vomiting, dizziness, hot flush, skin rashes, difficulty breathing
and low blood pressure. The side-effects will go away after
treatment is stopped.



selective visceral angiography - any large organ in the body
cavity, especially the abdomen

The doctor will decide the most suitable dose for the procedure
to be undertaken.

Examination of your heart may result in an abnormal or irregular
heart beat.



digital subtraction angiography - blood vessels in the body



computer tomography enhancement - for brain and whole
body scanning

The dose administered to adults will differ for children, the dose
for children is according to body size and age.

Occasionally, reactions such as itching and rashes of the skin
can occur some time after iopamidol has been given to you.
Severe, life-threatening, allergic reactions (swelling of the



intravenous urography - the urinary tract from the bladder



arthrography - joints in the body.

The Iopamidol Injection will be given by injecting the solution
into an artery, vein or the back around the spinal cord
depending on the diagnostic purpose.

There is minimum protein binding, it is distributed between
the circulating blood volume and other extracellular fluid
with no disposition in tissues. It does not appear to cross
the blood brain barrier following intravascular
administration. The volume of distribution at steady state is
approximately 16.8 litres, equivalent to the extracellular
fluid volume.

Renal impairment developing during treatment usually
responds to rehydration of the patient, therefore the patient
should not be exposed to dehydration.
During intracardiac and/or coronary arteriography,
ventricular arrhythmias may infrequently occur.
Anaphylactoid reactions and cardiac arrest may occur
following use of contrast media including iopamidol.
Fatalities have been reported. There have also been
isolated reports of acute pulmonary oedema.
Resuscitation procedures should be immediately available
in order to overcome more severe reactions involving the
cardiovascular system.

Excretion occurs primarily through the kidneys with
minimum amount detected in the faeces. The elimination
half-life has been determined as approximately 2.5 hours
(T1_), this would increase in renal impairment.
2

Subacute toxicity studies have been performed in rats,
dogs and rabbits. In rats and dogs, intravenous studies for
up to four weeks showed some histological alterations of
the thyroid gland only at high doses, though the weight of
the thyroid gland increased at all dose levels.

In blood it may dehydrate erythrocytes resulting in a
decreased ability for circulation, combined with an
inhibiting effect on platelet aggregation and coagulation.
Adverse cardiac effects of contrast media are related to the
osmolality of the product, the presence of calcium
chelating compounds, and anionic and cationic
composition. Iopamidol is a non-ionic contrast media, low
osmolality, low sodium content and low calcium chelating
activity, hence exhibits a reduced evidence of adverse
effect to the cardiovascular system.
As the preparation contains iodine, there is a small amount
of free iodide that has the potential to induce a clinically
significant hyperthyroidism in susceptible patients.
5.2 Pharmacokinetic properties
Peak iodine levels occur immediately following rapid
intravascular injection of iopamidol. It is rapidly absorbed
into the bloodstream from the cerebrospinal fluid following
administration into the subarachnoid space, with
appearance in plasma within 1 hour and virtually all
reaching the systemic circulation within 24 hours.

8.

Marketing Authorisation Number
PL 06831/0065

9.

Date of First Authorisation/Renewal of Authorisation
23 November 1999.

10. Date of (Partial) Revision of Text
December 2007.

No effect on fertility was observed in rats and no
teratogenic potential in rats and mice. No mutagenic
potential was detected in mice.

Pharmacological Properties

5.1 Pharmacodynamic properties
As contrast medias are administered for diagnostic
purposes they have minimal pharmacodynamic effect.

Marketing Authorisation Holder
Genus Pharmaceuticals Limited
Park View House
65 London Road
Newbury
Berkshire
RG14 1JN
UK

5.3 Pre-clinical safety data
Acute toxicity is very low in mice, rats, rabbits and dogs.

4.9 Overdose
Iopamidol undergoes minimal metabolism, deiodination or
biotransformation in vivo. Majority of dose is excreted in the
urine unchanged, therefore increase intake of fluid.

5.

7.

Iopamidol undergoes minimal metabolism, deiodination or
biotransformation, and no metabolites have been detected
in urine.

Delayed reactions may occur occasionally with pruritus and
urticaria being the most common reactions.
Rarely, serious thromboembolic complications have
occurred after the use of contrast media.

6.6 Instructions for use/handling
See 4.2 Posology and method of administration.
Discard the solution if particulate matter present.
Discard any unused solution at the end of the procedure.
For immediate and single patient use only.

6.

Pharmaceutical Particulars

POM

6.1 List of excipients
Tromethamine
Sodium calcium edetate
Water for Injections
Sodium hydroxide*
Hydrochloric acid*
*Added if required, to adjust pH of the solution.
6.2 Incompatibilities
Many radiopaque contrast agents are incompatible in vitro
with some antihistamines and many other drugs; therefore,
no other pharmaceuticals should be admixed with contrast
agents.
6.3 Shelf-life
36 months, unopened.
6.4 Special precautions for storage
Do not store above 25°C. Keep container in outer carton.
6.5 Nature and contents of container
Colourless glass Type I vial, closed with rubber stopper
and aluminium flip cap.
Pack sizes: Single vial, x5 vials or x10 vials in 20ml, 50ml
100ml or 200ml volumes.

* Trademark


tongue, lips, face and extremities, breathlessness, fluid in the
lungs, low blood pressure, fainting and possible collapse), heart
attacks and, rarely, blood vessel obstructions have also been
reported following the use of contrast media.
Rarely, other side-effects affect the nervous system, including
seizures, temporary confusion or the “shakes”. Meningitis has
also been reported.
If you experience any of the above effects or any other
undesirable effects, tell your doctor immediately. Your doctor will
give you advice.

How should this medicine be stored?

Keep all medicines out of the reach and sight of children

Do not use this medicine after the expiry date indicated on the
vial and pack.

Remember: This medicine has been prescribed for you. Do not
give it to others. It may harm them even if their symptoms
appear to be the same as yours.

Normally, your doctor or the pharmacist will store this medicine.
Do not store above 25°C. Keep the container in the outer carton
to protect from light. Once the vial has been opened, the
solution should be used immediately and any remaining solution
discarded.
If the solution is cloudy do not use.

Leaflet prepared: December 2007.

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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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