THIOPENTAL INJECTION BP 1 G

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

THIOPENTAL SODIUM

Available from:

PHARMALOGIC LTD

ATC code:

N05CA19

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION

Composition:

THIOPENTAL SODIUM 1 G

Administration route:

I.V

Prescription type:

Required

Manufactured by:

PANPHARMA LABORATORIES, FRANCE

Therapeutic group:

THIOPENTAL

Therapeutic area:

THIOPENTAL

Therapeutic indications:

Anaesthesia of short duration without assisted ventilation. - Initiation of general Anaesthesia with OR without assisted ventilation. - It is also used as an adjunct For Control of convulsive disorders of various aetiology including those CAUSED BY local anaesthetics.

Authorization date:

2010-05-31

Summary of Product characteristics

THIOPENTAL INJECTION B.P.
COMPOSITION
Powder for Injection:
Vials containing sterile powder of thiopental sodium 0.5 gm for
extemporaneous preparation of 2.5% solution.
Vials containing sterile powder of thiopental sodium 1 gm for
extemporaneous preparation of 5% solution.
USES
Administered intravenously, Thiopental Injection B.P. produces general
anaesthesia of short duration. Thiopental Injection B.P. is
indicated for the induction of general anaesthesia of short duration;
it is also used as an adjunct for control of convulsive disorders
of various aetiology, including those caused by local anaesthetics.
Other Information:
Although bound to plasma proteins, it rapidly crosses the blood-brain
barrier and reaches maximum concentration in the brain within
30 seconds of injection. It is slowly metabolised by the liver. Only a
small proportion of the active drug is excreted in the urine.
PHARMACOTHERAPEUTIC GROUP
Barbiturates, Plain
ATC Code: N01AF
DOSAGE AND METHOD OF ADMINISTRATION
Thiopental Injection B.P. is administered intravenously as a 2.5% w/v
(500 mg in 20 ml) solution. On occasion it may be administered
as a 5% w/v solution (500 mg in 10 ml).
The obtained solution for intravenous injection should be used
immediately; any remaining portion of the content should be discarded.
Thiopental sodium injection is usually administered as a 2.5%
solution. The content of the vial should be dissolved in 20 ml Water
for injection.
USE IN ANAESTHESIA
Normal dosage for the induction of anaesthesia is 100 mg to 150 mg
injected intravenously over 10 to 15 seconds. If necessary
a repeated dose of 100 mg to 150 mg may be administered after one
minute. No fixed dosage recommendations for the intravenous
injection can be given, since the dosage should be carefully adjusted
according to the patient's response.
Factors such as age, sex and 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 minu