THIOPENTAL SODIUM 500 Milligram Pdr for Soln for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

THIOPENTAL SODIUM

Available from:

Archimedes Pharma UK Limited

ATC code:

N01AF03

INN (International Name):

THIOPENTAL SODIUM

Dosage:

500 Milligram

Pharmaceutical form:

Pdr for Soln for Injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Barbiturates, plain

Authorization status:

Authorised

Authorization date:

1997-06-09

Patient Information leaflet

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
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
–
Please keep this leaflet. You may need to read it again.
–
If you have any further questions, ask the doctor or nurse.
–
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What Thiopental injection is and what it is used for
2.
What you need to know before Thiopental injection is given
3.
How Thiopental injection is given
4.
Possible side effects
5.
How to store Thiopental injection
6.
Contents of the pack and other 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.
WHAT YOU NEED TO KNOW BEFORE THIOPENTAL INJECTION IS GIVEN
YOU MUST NOT BE GIVEN THIOPENTAL INJECTION 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 (including difficulty in
breathing), such as an obstruction
in your lungs or in the tubes leading to them
•
have ACUTE ASTHMA (short term asthma)
•
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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Thiopental Sodium 500 mg Powder for Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg thiopental sodium (as thiopental sodium and
sodium carbonate).
Contains 53.5mg sodium per vial
For full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Powder for solution for injection (Powder for Injection)
Yellow-white freeze dried powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Thiopental sodium is given intravenously to induce short duration
general anaesthesia. It is also indicated as an
induction agent, and for the control of convulsive disorders. It may
be used rectally to produce basal anaesthesia.
Thiopental sodium may be used to reduce the intracranial pressure in
patients with increased intracranial pressure, if
controlled ventilation is provided.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Thiopental sodium is administered normally as a 2.5% w/v (500mg in
20ml) solution. On occasions it may be
administered as a 5% solution (500mg in 10ml).
A test dose of 25mg to 75mg can precede the main administration.
Use in anaesthesia
Normal dosage for the induction of anaesthesia is 100mg to 150mg
injected over 10 to 15 seconds. If necessary a repeat
dose of 100mg to 150mg may be given after one minute. No fixed dosage
recommendations for the intravenous
injection can be given, since the dosage will need to be carefully
adjusted according to the patient’s response. Factors
such as age, sex, weight of the patient should be taken into
consideration. Thiopental sodium reaches effective
concentrations in the brain within 30 seconds and anaesthesia is
normally produced within one minute of an
intravenous dose.
_Adult_
100 mg to 150 mg intravenously over 10 to 15 seconds, normally as a
2.5% w/v solution. A repeat dose of 100 mg to
150 mg may be given after one minute.
The intravenous injection should be given slowly and the amounts given
titrated against the patient’s response to
minimise the ris