INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
TANYL® INJECTION 500 µg/10 mL
TANYL® INJECTION 100 µg/2 mL

SCHEDULING STATUS:
S7

PROPRIETARY NAME
(and dosage form):

TANYL^® INJECTION 500 µg/10 mL
TANYL^® INJECTION 100 µg/2 mL

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:
Tanyl^® (Fentanyl) is a narcotic analgesic of the phenylpiperidine class. Following intravenous injection the effect begins almost immediately although maximum analgesia may not occur for several minutes, and the average duration of action is 30 to 60 minutes.
Tanyl^® (Fentanyl) acts as an agonist, binding with stereospecific and saturable sites in the brain and other tissues. These binding sites are widely but unevenly distributed throughout the central nervous system with the highest concentration in the limbic system, thalamus, striatum, hypothalamus, midbrain and spinal cord.

INDICATIONS:
Tanyl^® (Fentanyl) is a narcotic analgesic, which is indicated for use in anaesthesia in combination with the following agents:

a)	neuroleptic agents such as droperidol
b)	inhalation narcotics, such as nitrous oxygen
c)	agents such as diazepam and/or atropine.

Tanyl^® (Fentanyl) is also indicated for the relief of pain during epidural anaesthesia and postoperative pain.

CONTRA-INDICATIONS:
Tanyl^® (Fentanyl) is contra-indicated in patients with the following conditions:

i)	respiratory depression, especially in the presence of cyanosis and excessive bronchial secretion,
ii)	after biliary tract operations,
iii)	acute alcoholism,
iv)	head injuries and conditions in which intracranial pressure is raised,
v)	an attack of bronchial asthma,
vi)	heart failure secondary to chronic lung disease,
vii)	patients taking mono-amine oxidase inhibitors or within 14 days of stopping such treatment, and
viii)	pre-operative use in babies less than one year of age.

WARNING:
A morphine type drug dependence can occur after prolonged use of Tanyl^® (Fentanyl).

DOSAGE AND DIRECTIONS FOR USE:
Epidural anaesthesia: 100 µg Tanyl^® (Fentanyl) diluted with 8 mL of sodium chloride injection, administered through an epidural catheter.
Postoperative pain: 50 to 100 µg of Tanyl^® (Fentanyl) may be given intramuscularly, repeated after 1 to 2 hours if necessary.
In anaesthesia where spontaneous respiration is maintained, an initial intravenous dose of the equivalent of 50 to 200 µg of Tanyl^® (Fentanyl) is given, with supplementary doses of 50 µg. The initial dose in children is 3 to 5 µg per kg body-mass. In anaesthesia with controlled respiration, the initial dose is 300 to 3500 µg Tanyl^® (Fentanyl) 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 controlled respiration.
When Tanyl^® (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. Neuroleptanalgesia can be converted to neurolept anaesthesia by the concurrent administration of 65% nitrous oxide in oxygen. Droperidol and Tanyl^® (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 Tanyl^® (Fentanyl) exerts its analgesic effect for only 30 to 60 minutes. Following induction of neurolept anaesthesia, supplementary doses of Tanyl^® (Fentanyl) alone (1 µg/kg) may be injected at intervals of approximately 20 minutes.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects of Tanyl^® (Fentanyl) include nausea, vomiting, constipation, drowsiness and confusion. Micturition may be difficult and there may be ureteric 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.
Respiratory depression, mild decreases in blood pressure, some delay in awakening, and an appreciable incidence of postoperative nausea or vomiting accompany the use of opioid analgesics.
A parasympathomimetic effect of Tanyl^® (Fentanyl) accounts for bradycardia. Administration of atropine will prevent this. The pre-operative use of atropine can help to reduce this effect.
Care should be taken when Tanyl^® (Fentanyl) is given to patients with myasthenia gravis.
Muscle rigidity may occur. It has been reported that it can be alleviated by muscle relaxants.
The depressant effects of Tanyl^® (Fentanyl) are enhanced by central nervous system depressants such as alcohol, anaesthetics, hypnotics, sedatives, phenothiazines and meprobamate.
The administration of Tanyl^® (Fentanyl) during labour may cause respiratory depression in neonates.
Tanyl^® (Fentanyl) should be given with caution or in reduced doses to patients with hypothyroidism, adrenocortical insufficiency; impaired liver function, prostatic hypertrophy or shock, elderly or debilitated patients. It should be used with caution in patients with inflammatory or obstructive bowel disorders.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage produces respiratory depression and hypotension, with circulatory failure and deepening coma. Death may occur from respiratory failure. Toxic doses vary considerably between individuals whilst addicts may tolerate doses well above the average. Pulmonary oedema sometimes associated with opioid overdosage may be countered by positive-pressure respiration.

Treatment:
In addition, the specific antagonist, naloxone hydrochloride is used to counteract, very rapidly, the severe respiratory depression and coma. A dose of 400 µg is given intravenously, subcutaneously or intramuscularly, repeated at intervals of 2 to 3 minutes if necessary. In children, a dose of 5 to 10 µg per kg body-mass may be given, while in neonates a dose of 10 µg per kg may be given. Repeated doses may be necessary.

IDENTIFICATION
Clear colourless solution in amber glass ampoules.

PRESENTATION:
10 mL Amber ampoules in containers of 5.
2 mL Amber ampoules in containers of 10.

STORAGE INSTRUCTIONS:
Protect from light.
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBERS:
Tanyl^® Injection 500 µg/10 mL : X/2.7/260
Tanyl^® Injection 100 µg/2 mL : W/2.7/123

NAME AND BUSINESS ADDRESS OF APPLICANT:
Intramed (Pty) Ltd
6 Gibaud Road
Port Elizabeth
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

December 1989

12-021/8-94

KOHLER C&P P.E.
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