Skip to Content

UK Edition. Click here for US version.

ISOKET 1 MG/ML CONCENTRATE FOR SOLUTION FOR INJECTION OR INFUSION

Active substance(s): ISOSORBIDE DINITRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
isoket

®

1mg/ml
concentrate for
solution for injection
or infusion
Isosorbide Dinitrate
50 ml bottle

isoket

®

1mg/ml
concentrate for
solution for injection
or infusion

4009256_MU8 10/345 1368

Isosorbide Dinitrate
10 ml ampoule

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 1 mg/ml
concentrate for solution for injection or
infusion 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.

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

4009256_MU8_GI_MON_ISOKET_GBR.indd 1

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

®

1mg/ml
concentrate for
solution for injection
or infusion
Isosorbide Dinitrate
50 ml bottle

isoket

®

1mg/ml
concentrate for
solution for injection
or infusion
Isosorbide Dinitrate
10 ml ampoule

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
Adults, including the elderly
Intravenous route
A dose of between 2 mg and 12 mg per
hour is usually satisfactory. However,
dosages up to 20 mg per hour
administered should be adjusted to the
patient response.
Intra-coronary Route
The usual dose is 1 mg given as a bolus
injection prior to balloon inflation. Further
doses maybe given not exceeding 5 mg
within a 30 minute period.
Children
The safety and efficacy of Isoket has not
yet been established in children.

4009256_MU8 10/345 1368

Patient Information Leaflet

Administration:
Isoket is a concentrated solution and must
be diluted prior use. The diluted solution
should never be injected directly in the
form of a bolus except via the
intracoronary route prior to balloon
inflation.
A dilution of 50% is advocated for
intracoronary administration.

Isoket can be administered as an
intravenous admixture with a suitable
vehicle, see below.
Prepared Isoket admixtures should be
given by intravenous infusion or with the
aid of a syringe pump incorporating a glass
or rigid plastic syringe. During
administration the patient’s blood pressure
and pulse should be closely monitored.
Once diluted chemical and physical in-use
stability for 24 hours at 2-8°C has been
demonstrated. From a microbiological
point of view, the product must be used
immediately once opened/diluted. If not
used immediately, in-use storage times and
conditions prior to use are the responsibility
of the user and would normally not be
longer than 24 hours at 2-8°C, unless
reconstitution/dilution has taken place in
controlled and validated aseptic conditions.
Open ampoules or bottles should be used
immediately and any unused drug discarded.
Incompatabilities
Isoket contains isosorbide dinitrate in
isotonic solution and is compatible with
commonly employed infusion fluids, such
as sodium chloride solution, 5-30% 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 (PE), polypropylene (PP) or
polytetrafluoroethylene (PTFE).

11.06.15 13:46

R

Isoket may be infused slowly using a
syringe pump with glass or plastic syringe.
Polyvinyl chloride (PVC) or polyurethane
(PU) giving sets and containers should not
be used since significant losses of the
active ingredient by adsorption occur and
it has not been verified how the dose can
be adjusted to suit the patient’s needs to
account for this adsorption.

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.

Example of admixture preparation
To obtain a dose of 6 mg per hour, add
50 ml of Isoket 1 mg/ml to 450 ml of a
suitable vehicle, under aseptic conditions.
The resultant admixture (500ml) contains
100 µg/ml (1mg/10ml) isosorbide dinitrate.
An infusion rate of 60ml per hour
(equivalent to 60 paediatric microdrops
per minute or 20 standard drops per
minute) will deliver the required dose of
6mg per hour.
Should it be necessary to reduce fluid
intake, 100ml of Isoket 0.1% may be
diluted to 500ml using a suitable vehicle.
The resultant solution now contains 200
µg/ml (2mg/10ml) isosorbide dinitrate. An
infusion rate of 30ml per hour (equivalent
to 30 paediatric microdrops per minute or
10 standard drops per minute), will deliver
the required dose of 6 mg per hour.
A dilution of 50% is advocated to produce
a solution containing 0.5 mg/ml where fluid
intake is strictly limited.
Rev. November 2013

Warnings about the ingredients in
Isoket
Isoket 1 mg/ml contains 3.54 mg/ml of
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.

Important:

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.

Your doctor will choose the dose that
is right for you. If you have any
questions ask your doctor.
Isoket is a concentrate for intravenous
infusion (injected into a vein) and
intracoronary injection (injected directly
into the artery serving the heart).
Isoket is a concentrate and must be diluted
before use. Your doctor or nurse will
dilute Isoket with either saline (salt water)
or glucose solution before it is given to
you.

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 heart
beat, 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.

3. How to use Isoket

4009256_MU8 10/345 1368

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.

4009256_MU8_GI_MON_ISOKET_GBR.indd 2

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
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 when it is unopened.
Once opened the product should be used
immediately.

Medicines should not be disposed of via
wastewater or household waste. Return
any medicine you no longer need to your
pharmacist.
6. Further information
What Isoket contains
The active substance is isosorbide
dinitrate. Isoket 1 mg/ml contains 1 mg 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 concentrate for solution for
infusion and injection. It is a clear solution.
In Ireland
Isoket 1 mg/ml comes in 10 ml glass
am­poules and 50 ml glass bottles.
Each ampoule contains 10 mg of isosorbide
dinitrate in 10 ml of solution.
Each bottle contains 50 mg of isosorbide
dinitrate in 50 ml of solution.
In the UK
Isoket 1 mg/ml comes in 10 ml glass
ampoules and 50 ml & 100 ml glass
bottles.
Each ampoule contains 10 mg of isosorbide
dinitrate in 10 ml of solution.
The bottles contain either 50 mg of
isosorbide dinitrate in 50 ml of solution or
100 mg isosorbide dinitrate in 100 ml of

solution. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
UCB Pharma Limited
208 Bath Road
Slough
Berkshire
SL1 3WE
United Kingdom
Manufacturer
Aesica Pharmaceuticals GmbH,
Alfred-Nobel-Straße 10,
40789 Monheim, Germany
This leaflet was last updated June
2015
If this leaflet is difficult to see or read
or you would like it in a different
format, please contact
UCB Pharma Limited
208 Bath Road
Slough
Berkshire
SL1 3WE
United Kingdom

4009256_MU8 10/345 1368

11.06.15 13:46

V

Expand view ⇕

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.

Hide