THIOPENTAL SODIUM 500 MG POWDER FOR SOLUTION FOR INJECTION

Active substance: THIOPENTAL SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

THIOPENTAL SODIUM 500 mg
Powder for Solution for Injection

Read all of this leaflet carefully before receiving
this medicine.
– Please keep this leaflet. You may need to read it
again.
– If you have any further questions, ask the doctor
or nurse.
– If you suffer from any side effect that gets serious,
or if you notice any side effects not listed in this
leaflet, please tell the doctor or nurse.
In this leaflet:
1. What Thiopental injection is and what it is used for
2. Before Thiopental injection is given
3. How Thiopental injection is given
4. Possible side effects
5. How to store Thiopental injection
6. Further information

1. WHAT THIOPENTAL INJECTION IS AND
WHAT IT IS USED FOR
Thiopental injection contains the active ingredient
thiopental sodium which is also known as
thiopentone sodium. It is an anaesthetic agent,
which may be given:
as a general anaesthetic or to make you sleepy
before using another anaesthetic agent
before using agents to prevent pain or to relax
muscles
to control fits
to reduce intracranial pressure.
This injection is usually given to you by a doctor
directly into a vein.






2. BEFORE THIOPENTAL INJECTION
IS GIVEN








You MUST NOT be given Thiopental if you:
are allergic to thiopental sodium or have had
reactions to thiopental or to other barbiturates
(such as some anaesthetics)
have any respiratory abnormalities (difficulty in
breathing), such as an obstruction in your lungs or
in the tubes leading to them
have acute asthma (short term)
are in severe shock
have myotonic dystrophy - a muscular disease
have the condition known as porphyria - a
metabolic disorder.
If any of these apply to you; tell the doctor or nurse,
they will usually decide to use another medicine
instead.
Take special care with Thiopental injection
Tell your doctor, before you are given Thiopental if
you have any of the following, as your dose may
need to be adjusted:
heart disease or circulatory problems, as these
can suddenly be made more severe by Thiopental
severe anaemia, blood pressure problems
(high blood pressure or low blood pressure),
raised blood potassium, increased blood urea,
bacterial infection in the blood, severe bleeding
liver or kidney disease
increased pressure in the brain
muscle weakness or degeneration (such as
myasthenia gravis or muscular dystrophies)
thyroid gland problems
diabetes
dehydration, malnutrition or wasting
underproduction of steroid hormones by the
adrenal gland (even when controlled by cortisone)
a metabolic disorder caused by an underactive
thyroid gland (a reduced dose may be required)




















asthma
burns
shock
hypovolaemia – a low level of fluids in the body
are elderly (a reduced dose may be required)
are taking opioid analgesics - strong pain
relievers.
are on a sodium controlled diet as this product
contains 53.5mg sodium per vial.

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
The following medicines can affect, or be affected
by, this injection and may need to be adjusted
before or after receiving this injection:
antibiotics (used to treat infections), such
as vancomycin, isoniazid and sulfonamides
sulphafurazole (an antibiotic) - smaller doses of
thiopental given more frequently may be required
antihypertensives (used to treat high blood
pressure or heart problems), such as ACE
inhibitors, angiotensin-II receptor antagonists,
alpha blockers, beta-blockers, calcium
antagonists, diuretics, vasodilating antihypertensives, alpha adrenergic neurone blockers
nitrates (used to treat angina)
antidepressants (used to treat depression), such
as monoamine oxidase inhibitors (MAOIs) and
tricyclic antidepressants
benzodiazepines, such as midazolam, to treat
anxiety
lithium (used to treat mania, manic depressive
illness or depression)
analgesics (used to treat pain) such as aspirin
opioid analgesics (strong pain relievers) such as
morphine, fentanyl and pethidine
phenothiazines (used to treat psychosis and
nausea) such as promethazine
drugs that have an effect on the gastrointestinal
tract (gut), such as metoclopramide or droperidol
drugs that have an effect on the central nervous
system (CNS)
cyclizine (used to treat dizziness, nausea and
vomiting)
drugs to treat high blood pressure, such as
diazoxide, methyldopa, moxonidine, hydralazine,
minoxidil and nitroprusside
probenecid (used to treat gout and high uric acid
in the blood)
oral anticoagulants (to thin your blood)
oestrogens (oral contraceptives or hormone
replacement therapy)
herbal medicines, such as valerian and
St John’s Wort.




















Thiopental sodium with alcohol
The effect of alcohol may be increased in the period
after treatment with thiopental sodium (at least the
first 24 hours).
Pregnancy and breast-feeding
If you are pregnant, planning to become pregnant
or breast-feeding, your doctor will consider the risks
and benefits of giving Thiopental to you.
Driving and using machines
You may experience dizziness (vertigo),
disorientation and sedation; these will wear off quite
quickly. Do not drive or operate machinery, especially
during the first 24 to 36 hours after the injection.

3. HOW THIOPENTAL INJECTION IS GIVEN
This injection is usually given to you directly into a vein
by a doctor, but can be given via a drip into a vein.

If thiopental is accidentally injected into an artery
instead of a vein, it can cause damage to your
tissues. Your doctor should treat these effects (a
similar problem can occur if thiopental leaks from
the vein into surrounding tissue). If you feel severe
pain near where the drug was injected tell the
doctor or nurse immediately so that treatment can
be started quickly.
Dose
The sterile powder is made into a solution and
must not be mixed with other acidic injections.
This solution should be discarded after 7 hours.
The dosage will be adjusted according to your age,
sex, and weight as well as your response to the
drug.
Anaesthesia:
Adults: 100mg - 150mg, injected over 10 to 15
seconds.
Elderly: as for adults, although smaller doses may
be required.
Children: the calculated dose will usually be 2 to
7mg/kg.
You will normally feel the effects within 30 seconds
and be asleep within one minute. Further small
doses will be given to you as necessary (you will
normally be asleep during this process).
Convulsions (fits):
75mg to 125mg, given as soon as possible after
the convulsion begins. Further doses may be
required and your doctor will decide the best dose
to give.
Neurological patients with raised intracranial
pressure: Intermittent injections of 1.5 to 3mg/kg.






Reduced doses may be needed if you have:
liver disease (including jaundice), shock,
dehydration, severe anaemia, high blood level of
potassium, infection in your blood
myxoedema (a metabolic disorder caused by an
underactive thyroid gland).
received morphine or similar medicines before
you are given Thiopental
received a medicine called sulfafurazole – your
doctor may need to give you smaller and more
frequent doses of Thiopental.




Increased doses may be needed if you:
are a heavy and frequent drinker of alcohol
regularly take non-prescribed drugs.
The dose of Thiopental may need to be increased
or given with another medicine to increase its
effect.
If you are given more Thiopental than you
should
This product will be given to you under medical
supervision, it is therefore unlikely that you will be
given too much. However, if you feel unwell you
should tell your doctor immediately. Symptoms
could be: rapid shallow breathing or feeling faint or
dizzy.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Thiopental can cause side
effects, although not everybody gets them.
Seek medical help immediately if you have any
of the following allergic reactions:
difficulty breathing or swallowing, swelling of the
face, lips, tongue or throat
skin rashes and other allergic reactions, such as
itching.




When it is injected, Thiopental can cause the
following:







coughing, sneezing or spasm of the airways;
difficulty in breathing
fall in blood pressure - often seen when thiopental is
first given
drowsiness, nausea with or without vomiting,
anorexia (poor appetite), malaise (general sense of
unwellness), fatigue, dizziness, headache
delirium (sudden severe confusion) - may occur in
elderly patients
shivering, low body temperature and severely
reduced brain function can occur with excessive
doses of thiopental.






Other effects include:
confusion, amnesia (loss or disruption of memory)
reduced pumping action of the heart or irregular
heartbeats
low blood pressure or other circulatory effects
tissue damage if the injection leaks into
surrounding tissue. If you experience severe
pain at the site of injection, inform your doctor
immediately.
If any of these side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor.

5. HOW TO STORE THIOPENTAL
INJECTION
Keep out of the sight and reach of children.
Before reconstitution:
The vials should be kept in the outer carton and not
stored above 25°C.
After reconstitution:
This product contains no preservatives and should
be used immediately. If the solution is stored, keep
it upright and store between 2°C and 8°C. The
reconstituted solution must be used within 7 hours.
If the solution is discoloured it must not be used.
Thiopental should not be used after the expiry
date printed on each vial and the pack. The expiry
date refers to the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Your healthcare professional
will dispose of this medicine once no longer
required. These measures will help to protect the
environment.

6. FURTHER INFORMATION
What Thiopental Injection contains
Each vial contains 500mg of the active substance
Thiopental Sodium (as Thiopental Sodium and
Sodium Carbonate Ph. Eur.)
What Thiopental injection looks like and contents
of the pack
The product is a dry, yellow-white powder contained
in 20ml glass vials with rubber closures. Each vial
contains 500mg thiopental sodium. This powder
needs to be dissolved in Water for Injections before
use.
Thiopental injection is packed in 25 x 20ml glass
vials.
Marketing Authorisation Holder
Archimedes Pharma UK Ltd, 250 South Oak Way,
Green Park, Reading, UK. RG2 6UG.
Manufacturer
Inresa Arzneimittel GmbH, Obere Hardtstraβe 18,
79114 Freiburg, Germany.
PL 12406/0014 PA 0757/004/001
This leaflet was revised: 10/2013

01193507

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
(web2)