INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
Q-MED FENTANYL 500 µg/10 mL Injection
Q-MED FENTANYL 100 µg/2 mL Injection

SCHEDULING STATUS:
S7

PROPRIETARY NAME
(and dosage form):

Q-MED FENTANYL 500 µg/10 mL Injection
Q-MED FENTANYL 100 µg/2 mL Injection

COMPOSITION:
Each 10 mL contains the equivalent of 500 µg fentanyl base as fentanyl citrate.
Each 2 mL contains the equivalent of 100 µg fentanyl base as fentanyl citrate.

PHARMACOLOGICAL CLASSIFICATION:
A.2.7 (Narcotic Analgesics).

PHARMACOLOGICAL ACTION:
Fentanyl citrate is a synthetic opioid related to phenylpiperidines. It is primarily a µ agonist and is estimated to be 80 times as potent as morphine as an analgesic. Its duration of action is 1 to 2 hours after intramuscular injection. Following intravenous administration, the agent is rapidly distributed and the duration of action ± 30 minutes.
However, accumulation occurs on repeated doses or large doses acting to prolong duration of sedation and respiratory depression. Fentanyl is metabolised by the liver and is eliminated with a half life of ± 3½ hours.

INDICATIONS:
Fentanyl citrate is a narcotic analgesic, which is usually used for anaesthesia, but it can also be used for post operative analgesia. It is used in conjunction with:

a)	neuroleptics such as droperidol.
b)	inhalation anaesthetics, such as nitrous oxide.

CONTRA-INDICATIONS:
Fentanyl citrate is contra-indicated in patients with the following conditions:

i)	Hypersensitivity to fentanyl or its derivatives.
ii)	Children under 2 years of age as safety has not been established,
iii)	respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion,
iv)	acute alcoholism.
v)	head injuries and conditions in which intracranial pressure is raised,
vi)	an attack of bronchial asthma,
vii)	heart failure secondary to chronic lung disease,
viii)	patients taking mono-amine oxidase inhibitors or within 14 days of stopping such treatment.

WARNINGS:
Dependence of the morphine type can occur after prolonged use of fentanyl citrate, and therefore has the potential for abuse.
Patients who have received fentanyl should remain under appropriate surveillance. Resuscitation equipment and a narcotic antagonist should be readily available to manage apnoea. If fentanyl is administered with a tranquilliser such as droperidol, the user should be familiar with the special properties of each agent, particularly the difference in duration of action.

DOSAGE AND DIRECTIONS FOR USE:
Postoperative pain: 50 to 100 µg fentanyl may be given intramuscularly, repeated after 1 or 2 hours if necessary.
Anaesthesia in adults with spontaneous respiration: an initial intravenous dose of the equivalent of 50 to 200 µg of fentanyl is given, with supplementary doses of 50 µg.
The initial dose in children is 3 to 5 µg per kg body-mass.
Dosages as low as 2 to 3 µg per kg body-mass have been employed.
Anaesthesia in adults with assisted respiration: the initial dose is 300 to 3500 µg with supplementary doses of 100 to 200 µg.
The initial dose in children is 10 to 15 µg per kg body-mass in anaesthesia with assisted respiration.
When fentanyl is combined with a neuroleptic agent such as droperidol, a state of neurolept-analgesia is established, during which a variety of diagnostic or minor surgical procedures can be accomplished. Neurolept analgesia can be converted to neurolept anaesthesia by the concurrent administration of 65% nitrous oxide in oxygen. Droperidol and fentanyl may be used alone or together, the dose of each being adjusted individually.
Droperidol has a prolonged duration of action (3 to 6 hours) whereas fentanyl exerts its analgesic effect for only 30 to 60 minutes. Following indication of neurolept anaesthesia, supplementary doses of fentanyl alone (1 µg/kg), may be injected at intervals of approximately 20 minutes.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects of fentanyl are nausea, vomiting, constipation, drowsiness and confusion. Micturition may be difficult and there may be uretic or biliary spasm, there is also an antidiuretic effect. Dry mouth, sweating, facial flushing, vertigo, bradycardia, palpitations, orthostatic hypotension, hypothermia, restlessness, change of mood, and miosis also occur. Raised intracranial pressure occurs in some patients. These effects occur more commonly in ambulant patients than in those at rest in bed. Larger doses produce respiratory depression, hypotension with circulatory failure and deepening coma. Respiratory depression responds to naloxone. Atropine may be used to block the vagal effects of fentanyl such as bradycardia. Muscle rigidity may occur and in some instances may be associated with reduced pulmonary compliance and/or apnoea, laryngospasm and bronchospasm, which has been reported to be alleviated by muscle relaxants. It should be used with caution in patients with obstructive bowel and in patients with myasthenia gravis.
The depressant effects of fentanyl are enhanced by central nervous system depressants such as alcohol, anaesthetics, hypnotics, sedatives, phenothiazines and meprobamate.
The administration of fentanyl during labour may cause respiratory depression in the newborn infant. Fentanyl should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy or shock, elderly or debilitated patients.

KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT:
Overdosage produce respiratory depression and hypotension, with circulatory failure and deepening coma. Convulsions may occur especially in children. Rhabdomyolysis progressing to renal failure has been reported. Death may occur from respiratory failure.
Overdosage may be countered by positive-pressure respiration. In addition, the specific antagonist, naloxone hydrochloride is used to counteract, the severe respiratory depression and coma. A dose of 400 µg to 2 mg is given intravenously, subcutaneously or intramuscularly, repeated at intervals of 2 to 3 minutes, if necessary, up to 10 mg. In children, a dose of 5 to 10 µg per kg body-mass may be given intravenously, while in neonates a dose of 10 µg per kg body-mass may be given. Repeated doses may be necessary.

IDENTIFICATION:
A clear, colourless solution in amber glass ampoules.

PRESENTATION:
Amber 10 mL ampoules in boxes of 10.
Amber 2 mL ampoules in boxes of 10.

STORAGE INSTRUCTIONS:
Protect from light.
Store below 25°C.
Keep out of reach of children.

REGISTRATION NUMBER:
500 µg/10 mL : 29/2.7/0604
100 µg/2 mL : 29/2.7/0605

NAME AND BUSINESS ADDRESS OF APPLICANT:
Quatromed Limited
10 Lindley Street
BETHLEHEM
9700

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
September 1994
        PFE0031/8-95
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