DBL EPHEDRINE SULFATE INJECTION 30 mgml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

EPHEDRINE SULFATE

Available from:

PFIZER PRIVATE LIMITED

ATC code:

R03CA02

Dosage:

30 mg/ml

Pharmaceutical form:

INJECTION

Composition:

EPHEDRINE SULFATE 30 mg/ml

Administration route:

INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR

Prescription type:

Prescription Only

Manufactured by:

Siegfried Hameln GmbH

Authorization status:

ACTIVE

Authorization date:

1989-05-06

Summary of Product characteristics

DBL
™ EPHEDRINE SULFATE INJECTION
NAME OF THE MEDICINE
Ephedrine sulfate USP
The molecular formula of Ephedrine Sulfate is (C
10
H
15
NO)
2
H
2
SO
4
. Its molecular weight is
428.5. The CAS registry number of Ephedrine Sulfate is 134-72-5.
DESCRIPTION
DBL
™
Ephedrine Sulfate Injection is a sterile solution of Ephedrine Sulfate
in Water for
Injections. Each mL contains 30 mg of Ephedrine Sulfate and 3 mg of
Sodium Chloride in
Water for Injections.
PHARMACOLOGY
Ephedrine is a sympathomimetic which stimulates both alpha and beta
adrenergic receptors,
and also releases noradrenaline from storage site. The main effects of
therapeutic doses of
ephedrine are relaxation of bronchial smooth muscle, cardiac
stimulation and increased
systolic and usually diastolic blood pressure via an increase in
cardiac output and peripheral
vasoconstriction. Ephedrine also decreases intestinal tone and
motility, relaxes the bladder
wall, contracts the sphincter muscle, relaxes the detrusor muscle, and
decreases uterine
activity. Ephedrine also has central nervous system stimulant effects.
Tachyphylaxis to the
effects of ephedrine may also occur after use for a short while
possibly due to the depletion of
noradrenaline stores.
PHARMACOKINETICS
Ephedrine is rapidly absorbed after intramuscular or subcutaneous
administration. The onset
of action after intramuscular administration is 10 to 20 minutes, and
the duration of pressor
and cardiac responses to ephedrine is 1 hour after intravenous
administration of 10 to 25 mg
or
intramuscular
or
subcutaneous
administration
of
25
to
50
mg.
Small
quantities
of
ephedrine are metabolised in the liver, but the majority of ephedrine
is excreted unchanged in
the urine. The plasma half-life of ephedrine is 3 to 6 hours.
Elimination of ephedrine is
increased (and hence the half-life is decreased) with decreasing pH of
the urine. Ephedrine is
presumed to cross the placenta, and to be excreted into breast milk.
INDICATIONS
DBL
™
Ephedrine Sulfate Injection is indicated in the treatment of shock
unrespo