ISOKET 0.5 MG/ML SOLUTION FOR INFUSION OR INJECTION

Active substance: ISOSORBIDE DINITRATE

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®

0.5 mg/ml

solution for infusion or injection

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Isosorbide Dinitrate

Angina usually feels like a tight pain in
the chest, neck or arm area.
It is also used sometimes during surgical
procedures on the heart.
2. Before you use Isoket
Do not use Isoket if:
• You are allergic to isosorbide dinitrate,
other nitrates or any of the other
ingredients of Isoket (see section 6)
• You suffer from anaemia
(reduction in red blood cells which can
make the skin pale and cause weakness
or breathlessness)
You have had a brain haemorrhage

(bleeding)
• You have had a head injury (head
trauma) or raised intracranial pressure
(high pressure within your skull)
• You have a low blood volume
(hypovolaemia)
• You have very low blood pressure
• Your blood has stopped circulating
around your body properly
(circulatory failure)
• You have cardiogenic shock
(your heart is not delivering enough
oxygen around your body)
• You have constrictive pericarditis
(inflammation of the sack-like covering
of the heart)



You have cardiac tamponade or
hypertrophic obstructive
cardiomyopathy (conditions which affect
the ability of your heart to function as a
pump)
• You have aortic or mitral valve stenosis
(narrowing of the heart valves)
• You have an eye disease called glaucoma
• You take sildenafil (“Viagra”) or any
other phosphodiesterase inhibitor.
If any of the above applies to you talk to
your doctor or pharmacist.
Check with your doctor before using
Isoket if:
• You have hypothyroidism
(an underactive thyroid gland which can
cause tiredness or weight gain)
You are malnourished

(severely underfed)
• You have liver or kidney disease
• You suffer from hypothermia
(a very low body temperature)
• You have other heart problems or a
family history of heart problems
• You suffer from orthostatic syndrome,
(where you may have a rapid heart rate
and light-headedness on standing)

Taking other Medicines
• Do not take Isoket with
phosphodiesterase inhibitors such
as Sildenafil ("Viagra") used for
impotence . Using Isoket with
these medicines could cause your
blood pressure to fall to a
dangerously low level.
Tell your doctor if you are taking any
of the following medicines:
• Medicines to lower your blood pressure.
They could increase the effect of
Isoket and lower your blood pressure
too much.
Tricyclic antidepressants (used to treat

depression) and neuro-leptics (used to
treat anxiety). These may also increase
the effect of Isoket.
Dihydroergotamine (used to treat

migraine). This could increase your
blood pressure too much.
• Any other medicine, including medicines
obtained without a prescription.
If any of the above applies to you, talk to
your doctor or nurse.
Using Isoket with food and drink
Do not drink alcohol. It could increase the
effect of Isoket and lower your blood
pressure too much. If this happens, you may
feel dizzy or faint.

isoket

®

0.5 mg/ml

The following information is intended
for medical or healthcare
professionals only.
It supplements the information provided
above in section 3.
Posology and method of administration

solution for infusion or injection

Adults, including the elderly

Isosorbide Dinitrate

Intravenous route
Isoket 0.5 mg/ml is intended for intravenous administration by slow infusion via a
syringe pump.
A dose of between 2mg and 12mg per
hour is usually satisfactory. However,
dosages up to 20mg per hour may be
required. In all cases the dose
administered should be adjusted to the
patient response.
Intra-coronary Route
The usual dose is 1mg given as a bolus
injection prior to balloon inflation. Further
doses may be given not exceeding 5mg
within a 30 minute period.

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isoket

Patient Information Leaflet
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.
• In this leaflet, Isoket 0.5 mg/ml solution
for infusion or injection will be called
Isoket.
In this leaflet:
1. What Isoket is for
2. Before you use Isoket
3. How to use Isoket
4. Possible side effects
5. How to store Isoket
6. Further information.
1. What Isoket is for
Isoket belongs to a group of medicines
called organic nitrates. Organic nitrates
work by widening the blood vessels in your
heart to allow an increased amount of blood
to flow to areas which need it.
Isoket is used to treat heart failure (heart
problems that can cause shortness of breath
or ankle swelling) and angina pectoris.

Children
The safety and efficacy of Isoket has not
yet been established in children.
Admixtures are stable for approximately
24 hours at room temperature in the
recommended containers.
Open ampoules or bottles should be used
immediately and any unused drug discarded.

Incompatibilities
Isoket contains isosorbide dinitrate in
isotonic solution and is compatible with
commonly employed infusion fluids, such as
sodium chloride solution, glucose solution,
Ringer’s solution and solutions containing
albumin. No incompatibilities have so far
been demonstrated.
Isoket is compatible with glass infusion
bottles and infusion packs made from
polyethylene.
Isoket may be infused slowly using a syringe
pump with glass or plastic syringe. The use
of PVC giving sets and containers should be
avoided since significant losses of the
active ingredient by adsorption can occur.
Rev. June 2010

Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant
or breast-feeding, ask your doctor or pharmacist
for advice before taking Isoket. Your doctor will
decide whether you should take this medicine.

Driving and using machines
Isoket may give you a headache, or make
you feel dizzy or tired. If this happens to
you, do not drive or operate machinery.
Warnings about the ingredients in
Isoket
Isoket 0.5 mg/ml contains 3.54 mg/ml
sodium and may not be suitable for people
on a controlled sodium diet. Tell your
doctor or pharmacist before taking Isoket
if this applies to you.
3. How to use Isoket
Important:
Your doctor will choose the dose
that is right for you. If you have any
questions ask your doctor.
Isoket is for intravenous infusion (injected
into a vein) and intracoronary injection
(injected directly into the artery serving
the heart).
Your doctor or nurse may dilute Isoket with
saline (salt water) or glucose solution before
it is given to you.

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Adults
• When this medicine is given intravenously
(injected into a vein), the usual dose will
be between 2 mg and 12 mg per hour,
although sometimes as much as 20 mg
per hour is necessary.
• When used during surgical procedures
on the heart the usual dose is 1 mg
injected directly into the heart.
Further doses may be given if your
doctor thinks it necessary
As this medicine is used in hospital, your
heart beat (pulse) and blood pressure will
be carefully monitored whilst you are being
given Isoket. This is to make sure that your
medicine is working properly and that the
dose you are taking is right for you.
Children
This medicine is not suitable for children.
If you have any further questions about the
use of this medicine, ask your doctor or
pharmacist.
If you think you have been given too
much Isoket
As this medicine will be given to you by a
doctor or nurse, it is unlikely that you will
be given too much or too little.
An overdose of Isoket may cause your
blood pressure to be too low resulting in
paleness, sweating, weak pulse, fast
heartbeat, light-headedness on standing,

headache, weakness, dizziness, feeling sick,
being sick and diarrhoea. If you have any
concerns about this tell your doctor or
nurse.

Medicines should not be disposed of via
wastewater or household waste. Return
any medicine you no longer need to your
pharmacist.

4. Possible side effects
Like all medicines Isoket can cause side
effects, although not everybody gets them.
• headache
• feeling sick
• have a faster heart beat (tachycardia)
• A reduced blood flow to the brain and
heart, causing you to feel faint or dizzy.
• drowsiness
• weakness
• light-headedness on standing
• fainting.
• symptoms of angina (chest pain) may be
increased.
• skin rash or flushing,
• heartburn

6. Further information
What Isoket contains
The active substance is isosorbide dinitrate.
Isoket contains 0.5 milligrams of isosorbide
dinitrate in each ml of solution.
The other ingredients are sodium chloride,
water for injections and hydrochloric acid
and sodium hydroxide for pH adjustment.
What Isoket looks like
Isoket is a solution for infusion and
injection. It is a clear solution.
In Ireland
Isoket 0.5 mg/ml comes in glass bottles
containing 25 mg of isosorbide dinitrate in
50 ml of solution.
In the UK
Isoket 0.5 mg/ml comes in a glass bottle
or syringe. The bottles contain 25 mg of
isosorbide dinitrate in 50 ml of solution.
Each syringe contains 5 mg of isosorbide
dinitrate in 10 ml of solution.
Not all pack sizes may be marketed.

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.
5. How to store Isoket
Keep out of the reach and sight of children.
Do not use Isoket after the expiry date on
the carton. The expiry date refers to the
last day of that month.
This medicine does not require any special
storage conditions.

Marketing Authorisation Holder
Schwarz Pharma Ltd, 5 Hercules Way,
Leavesden Park, Watford, WD25 7GS, UK
Manufacturer
UCB Pharma GmbH,
Alfred Nobel Strasse 10, D-40789,
Monheim, Germany
This leaflet was last updated
June 2010

If this leaflet is difficult to see or
read or you would like it in a
different format, please contact
Schwarz Pharma Ltd, 5 Hercules
Way, Leavesden Park, Watford,
WD25 7GS, UK

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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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