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IOPAMIDOL 300MG IODINE/ML INJECTION

Active substance(s): IOPAMIDOL

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Information for the Doctor

Iopamidol 300mg Iodine/ml Injection
Summary of Product Characteristics
1. Trade Name of the Medicinal Product
Iopamidol 300mg Iodine/ml Injection.

2. Qualitative and Quantitative Composition
Contains 612.4mg iopamidol, equivalent to 300mg
iodine/ml.

3. Pharmaceutical Form
Solution for injection.

4. Clinical Particulars
4.1 Therapeutic indications
Iopamidol 300mg Iodine/ml Injection, an X-ray contrast
media is indicated for the following procedures:









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.

lumbar myelography
thoraco-cervical myelography
cerebral angiography
peripheral arteriography
venography
computer tomography enhancement
intravenous urography
arthrography

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.
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.

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

Procedure
Lumbar myelography
Thoraco-cervical myelography
Cerebral angiography
Peripheral arteriography
Venography
Computer tomography enhancement:
Brain scanning
Whole body scanning
Intravenous urography
Arthrography

Adults
5-10
5-10
5-10**
20-50**
20-50

Children
Not recommended
Not recommended
5-7*
*
*

50-100
40-100
40-80***
1-10

Not recommended
Not recommended
1-2.5ml/kg*
Not recommended

In patients suffering from severe hepato-renal impairment
no procedure should be conducted unless absolutely
required, with re-examination delayed for 5-7 days.

* Dose dependent on body size and age.
** Repeat as necessary.
*** For severe renal failure patients use up to 1.5ml/kg.
Elderly:
No special dosage requirements. However, the lowest
effective dose to be used.

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.

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.

Renal impairment developing during treatment usually
responds to rehydration of the patient, therefore the patient
should not be exposed to dehydration.

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.

4.3 Contra-indications
Known or suspected hypersensitivity to iodine containing
preparations or to any of the excipients detailed under
section 6.1.

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.

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.

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.

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

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.

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.


Information for the Patient

Iopamidol 300mg 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







Iopamidol 300mg Iodine/ml Injection is a clear, colourless to
pale yellow solution which contains 612.4mg of the active
ingredient iopamidol. The iopamidol is equivalent to 300mg
iodine/ml.
Each vial also contains tromethamine, sodium calcium
edetate, Water for Injections, sodium hydroxide or
hydrochloric acid.
It comes in 20ml, 50ml, 100ml and 200ml vials.
Iopamidol is a non-ionic X-ray contrast media, allowing the
different tissues of the body to be visible under X-ray
inspection.

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








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

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

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









lumbar myelography - the backbone in the lower portion of
the back
thoraco-cervical myelography - the chest and neck regions
of the body
cerebral angiography - scanning the network of blood
vessels in the brain
peripheral arteriography - the blood vessels situated away
from the main body organs
venography - veins in the body
computer tomography enhancement - for brain and whole
body scanning
intravenous urography - the urinary tract from the bladder
arthrography - joints in the body.

Before starting your treatment




Have you ever had an allergic reaction to iopamidol, iodine
or any of the ingredients listed above?
Have you ever had an uncomfortable reaction during
previous similar investigations?
Are you asthmatic or have a history of allergies?
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?
Do you suffer from epilepsy, diabetes, problems with your
thyroid or Graves’ disease?
Are you pregnant, think that you may be pregnant or
planning a family?
Are you taking metformin, blood thinning medicines (anticoagulants) or any other drugs?

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.

How is Iopamidol Injection given?
The doctor will decide the most suitable dose for the procedure
to be undertaken.
The dose administered to adults will differ for children, the dose
for children is according to body size and age.
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.

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.
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.

What unwanted effects can this medicine have?
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.
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.
Examination of your heart may result in an abnormal or irregular
heart beat.

Delayed reactions may occur occasionally with pruritus and
urticaria being the most common reactions.

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.

Rarely, serious thromboembolic complications have
occurred after the use of contrast media.

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

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.

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.

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

2

5.3 Pre-clinical safety data
Acute toxicity is very low in mice, rats, rabbits and dogs.
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.
There is minimum protein binding, it is distributed between
the circulating blood volume and other extracellular fluid

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

6. Pharmaceutical Particulars
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.
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.

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

8. Marketing Authorisation Number
PL 06831/0064

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

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

POM

* Trademark


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
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.

solution should be used immediately and any remaining solution
discarded.

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

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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