RAPIFEN 2 ml INJECTION

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Piramal Critical Care South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

INJECTION

Composition:

EACH 1 ml CONTAINS ALFENTANIL 0,5 mg

Authorization status:

Registered

Authorization date:

1989-08-02

Summary of Product characteristics

ZA - 62000000024376 R
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SCHEDULING STATUS
Schedule 6
PROPRIETARY NAME AND DOSAGE FORM
RAPIFEN
®
2 ml IV injection
COMPOSITION
Each ml contains alfentanil hydrochloride 0,544 mg (equivalent to
alfentanil
base 0,5 mg) and sodium chloride 9,0 mg in water for injection.
PHARMACOLOGICAL CLASSIFICATION
A.2.7 Central nervous system depressants. Narcotic analgesics.
PHARMACOLOGICAL ACTION
PHARMACODYNAMICS
Alfentanil
is
a
narcotic
analgesic
with
potent
analgesic
and
respiratory
depressant eff ects.
The onset of the action is rapid, the peak eff ect being reached
within 1 minute.
The duration of action is short, 11 minutes at twice and 17 minutes at
four
times the lowest ED
50
.
At high doses (> 120 μg/kg), alfentanil induces sleep.
Recovery after alfentanil administration is rapid and smooth.
All actions of alfentanil are immediately and completely reversed by
the specifi c
narcotic antagonist naloxone hydrochloride.
Alfentanil maintains cardiovascular stability. It has not been shown
to cause
histamine release (in doses used clinically).
PHARMACOKINETICS
Alfentanil is rapidly eliminated after intravenous administration.
Sequential
distribution half-lives of 0,4 – 2,2 min and 8 – 32 min and
terminal half-lives of
83 – 223 min have been reported. The low degree of ionisation (11 %
at pH = 7,4)
contributes to a rapid but limited tissue distribution. Reported
volumes of distri-
bution are 1,27 – 4,81 L (volume of distribution of the central
compartment)
and 12,1 – 98,2 L (volume of distribution at steady state). Plasma
protein
binding of Alfentanil is about 92 %. Alfentanil is mainly metabolised
in the
liver. Only 1 % of unchanged alfentanil is found in urine. Metabolites
are inactive
and 70 – 80 % of them are eliminated via the urine. The plasma
clearance in
young subjects averages 356 ml/min, and decreases with age.
Accumulation of alfentanil may occur under the following
circumstances: With
prolonged
continuous
infusion
or
with
repeated
administration
of
single
doses and in patients with reduced