INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo PAXICAL INJECTION 5 mg/2 mL

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

PAXICAL INJECTION 5 mg/2 mL

COMPOSITION:
Each mL of Paxical Injection contains 2,5 mg of
Droperidol.

PHARMACOLOGICAL CLASSIFICATION:
A2.6.5 Central Nervous System depressants. Miscellaneous structures.

PHARMACOLOGICAL ACTION:
Paxical Injection (droperidol) is a derivative of butyrophenone and has neuroleptic activity. It reduces anxiety and motor activity, provides calmness and indifference in the patient, while allowing the patient to respond to verbal command.
Paxical Injection (droperidol) also has adrenergic blocking effects, is anti-emetic, anti-fibrillatory and anti-convulsant and enhances the effect of other Central Nervous System depressants.
Paxical Injection (droperidol) has an initial plasma half-life of 10 minutes and a terminal plasma half-life of 2 hours. It is extensively plasma protein bound. The duration of action is from about 2 to 4 hours, to as long as 6 hours. Alteration of consciousness may last 12 hours or longer.

INDICATIONS:
A pre-medicant given pre-operatively for sedation or tranquillization. Neurolept analgesia in combination with an opioid analgesic during which a variety of diagnostic or minor surgical procedures can be accomplished. Postoperatively as a tranquillizer and for its anti-emetic effects.

CONTRA-INDICATIONS:
Sensitivity to Paxical Injection (droperidol) or any related substance.
The safety of Paxical Injection (droperidol) in pregnancy, lactation and its use in children under the age of 2, has not been established.
Parkinson's s Disease, impaired liver, kidney or respiratory function, patients receiving other Central Nervous System depressant drugs where Central Nervous System depression may be potentiated, pre-existing Central Nervous System depression or coma.
Use in patients with bone-marrow depression should be avoided.

WARNINGS:
Paxical Injection (droperidol) should be used in reduced doses in the elderly.
Caution should be exerted when Paxical Injection (droperidol) is administered to patients with myasthenia gravis due to its interference with neuromuscular transmission.
Administer with caution to patients in whom a sudden drop in blood pressure is undesirable, in phaeochromocytoma and cardiovascular disorders. Care is necessary in epileptic patients. Paxical Injection (droperidol) may lower the seizure threshold.

DOSAGE AND DIRECTIONS FOR USE:
Pre-medication: 2,5 to 10 mg (1,0 to 4,0 mL) intramuscularly, given 30 to 60 minutes pre-operatively according to age and physical status of the patient.

Adjunct to general anaesthesia: 5 to 15 mg (2 to 6 mL) intravenously, followed by 1,25 to 2,5 mg (0,5 to 1,0 mL) if required for maintenance.

Prevention of post-operative nausea and vomiting: 5 mg intramuscularly or intravenously.

Usual children's dosage in anaesthesia:
1,0 to 1,5 mg (0,4 to 0,6 mL) per 10 kg body mass intravenously.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Antimuscarinic effects such as dry mouth, constipation, urinary retention, and mydriasis, as well as agitation, insomnia, depression, convulsions, nasal congestion, tachycardia, electrocardiographic changes, postural hypotension, miosis; blurred vision, and inhibition of ejaculation.
Allergic reactions include urticaria, exfoliative dermatitis, and contact sensitivity. Jaundice, probably allergic in origin, and photosensitivity reactions have occurred.
Haematological disorders include potentially fatal agranulocytosis. Sore throat or fever should be watched for and white cell counts instituted, should the aforementioned symptoms appear.
Extrapyramidal dysfunction due to central dopaminergic transmission is produced, resulting in acute dystonia, a parkinsonism-like syndrome, akathisia, the neuroleptic malignant syndrome, tardive dyskinesia and perioral tremors.
Due to the alteration of endocrine and metabolic function, patients have experienced amenorrhoea, galactorrhoea, gynaecomastia, mass gain, hyperglycaemia and altered glucose tolerance, and increased serum-cholesterol concentrations. Body temperature regulation is impaired and may result in both hypo- or hyperthermia.
Pain and irritation at the injection site have been reported.

Precautions:
Paxical Injection (droperidol) has a longer duration of action than opioid analgesics e.g. fentanyl, therefore during concurrent use, repeat doses of Paxical Injection (droperidol) must not be given when only the opioid analgesic is required, since this will lead to accumulation of Paxical Injection (droperidol) and overdose.
Paxical Injection (droperidol) is not suitable as an anaesthetic for out patients due to its lengthy duration of action.
Other Central Nervous System depressants used by the patient, whose actions overlap with that of droperidol, should be reduced in dosage due to their additive or potentiating effect of each other.
Care should be exercised when Paxical Injection (droperidol) is given with other drugs that produce postural hypotension. Dosage adjustments may be necessary. It may also reduce the antihypertensive activity of guanethidine and other adrenergic neurone blockers.
Care should be taken in administration in patients with parkinsonism or diabetes. The effect on the vomiting centre may mask the symptoms of overdose of other agents or of disorders such as gastro-intestinal obstruction.

KNOWN SYMPTOMS OF OVERDOSE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions"
Treatment is supportive and symptomatic.

IDENTIFICATION:
A clear, colourless solution in 2 mL amber ampoules.

PRESENTATION:
2 mL ampoules in packs of 10.

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

REGISTRATION NUMBER:
Y/2.6.5/121

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (Pty) Ltd.
6 Gibaud Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 1991 12-291/6-93
  Davbar Dbn.

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