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Logo CURON-B INJECTION 4 mg/2 mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CURON-B INJECTION 4 mg/2 mL

COMPOSITION:
Each 2 mL ampoule contains:
Pancuronium Bromide 4 mg
Benzyl Alcohol 1% v/v

PHARMACOLOGICAL CLASSIFICATION:
A17.1 Peripherally acting muscle relaxants.

PHARMACOLOGICAL ACTION:
Curon-B (pancuronium bromide) is a synthetic bis-quaternary ammonium steroids. It is a competitive neuromuscular blocking agent interrupting neuromuscular transmission by competing with acetylcholine for receptor sites on the motor endplate. Curon-B (pancuronium bromide) does not cross the blood-brain barrier.
Curon-B (pancuronium bromide) is partially hydroxylated in the liver. It is adequately absorbed intramuscularly. After intravenous injection it has a residual effect for 2 to 4 hours or more. Subsequent doses within 24 hours should be decreased. It has a half life of 2,3 hours and is only slightly plasma protein bound.

INDICATIONS:
As an adjunct to anaesthesia when adequate skeletal muscle relaxation is needed.

CONTRA-INDICATIONS:
Patients who are sensitive to Curon-B (pancuronium bromide) or any related neuromuscular blocking agent.

DOSAGE AND DIRECTIONS FOR USE:
Efficient respiratory exchange must be maintained.
Upon intravenous administration, the muscle relaxant effect of Curon-B (pancuronium bromide) commences within 1 to 3 minutes and lasts for about 45 minutes. The anaesthetic technique, the duration of the procedure, possible interactions with other medication during or post operatively as well as the general condition of the patient should be considered prior to calculation of the required dose of Curon-B (pancuronium bromide).

Adult dosage
Initial dose is usually: 40 to 100 µg/kg body mass
Supplementary dose: 10 to 20 µg/kg body mass

Childrens' dosage
Children may be given similar doses as above

Neonate dosage
Initial dosage: 30 - 40 µg/kg body mass
Supplementary dosage: up to 20 µg/kg body mass

The standard dose of Curon-B (pancuronium bromide) Injection must be reduced when given with a potent inhalation anaesthetic which can potentiate its neuromuscular blocking action (eg. halothane, methoxyflurane, isoflurane and enflurane).

A reduction of dosage is also recommended when Curon-B (        pancuronium bromide) is given following administration of suxamethonium. Initial doses of 20 to 60 µg/kg body mass have been suggested.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Slightly elevated blood pressure or sometimes hypotension. Tachycardia or bradycardia.
Reduction in gastro-intestinal motility and tone.
Allergic response: at site of injection and bronchospasm, pulmonary oedema, cyanosis and hypoxaemia.
Prolonged apnoea and respiratory paralysis.

Special Precautions:
Caution should be taken in patients with raised catecholamine concentrations including those receiving tri-cyclic antidepressants in whom it may result in cardiovascular side effects, particularly when given in association with halothane.

Great care should be taken in patients with myasthenia gravis in respiratory insufficiency or pulmonary disease and in the dehydrated or severely ill patient; patients with a history of asthma or allergy in the presence of renal impairment or when pancuronium bromide has been given to a patient on two occasions within 24 hours. Patients with hepatic impairment may be relatively resistant to the effects of Curon-B (pancuronium bromide). The effects may be increased by acidosis and hypokalaemia.

Competitive neuromuscular blockade may be enhanced by raised body temperature and reduced in the presence of hypothermia. The effects are also enhanced by inhalation anaesthetics, kanamycin, gentamicin, aminoglycosides, tetracyclines, peptides, clindamycin and lincomycin, beta-blockers, magnesium salts, potassium-depleting diuretics, opioid analgesics and quinidine.

Administration of Curon-B (pancuronium bromide) with or before a depolarising neuromuscular blocker may cause a muscle relaxation which is irreversible by neostigmine.

Latent myasthenia gravis, myasthenic syndrome and malignant hyperthermia may induce apnoea.

Curon-B (pancuronium bromide) should be given with caution to patients with liver, kidney or biliary disease as it is excreted via these organs.

Dosage should be reduced in premature neonates.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "side-effects and special precautions". In the event of overdosage, treatment is symptomatic and supportive.

IDENTIFICATION:
Clear colourless solution in 2 mL clear glass ampoules.

PRESENTATION:
Boxes of 2 mL clear glass ampoules packed in 10's.

STORAGE INSTRUCTIONS:
Store between 2°C and 8°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Y/2.10/407

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
April 1992 12-123/10-93
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