Thiopental Sodium 500 mg powder for solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Thiopental sodium

Available from:

Kyowa Kirin Holdings B.V.

ATC code:

N01AF; N01AF03

INN (International Name):

Thiopental sodium

Dosage:

500 milligram(s)

Pharmaceutical form:

Powder for solution for injection

Therapeutic area:

Barbiturates, plain; thiopental

Authorization status:

Marketed

Authorization date:

1992-06-09

Summary of Product characteristics

Health Products Regulatory Authority
04 March 2019
CRN008QW9
Page 1 of 8
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 am