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

Logo PETERKAÏEN 10% m/v INJECTION 5 mL
PETERKAÏEN 20% m/v INJECTION 5 mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PETERKAÏEN 10% m/v INJECTION 5 mL
PETERKAÏEN 20% m/v INJECTION 5 mL

COMPOSITION:
Contains
Lignocaine hydrochloride monohydrate 500 mg/5 mL (10% m/v)
Contains Lignocaine hydrochloride monohydrate 1,0 g/5 mL (20% m/v)

PHARMACOLOGICAL CLASSIFICATION:
A 6.2 Cardiac depressants.

PHARMACOLOGICAL ACTION:
Lignocaine has antiarrhythmic properties, as a result of its direct influence on the depolarising of the cardiac membrane. It increases the electrical stimulation threshold of the ventricle during diastole.

INDICATIONS:
Treatment of ventricular arrhythmias during open-heart surgery, acute myocardial infarction, and with digoxin overdosage.

CONTRA-INDICATIONS:
Contra-indicated in patients hypersensitive to local anaesthetics. Lignocaine hydrochloride should not be given to patients with hypovolaemia, heartblock or other conduction disturbances, bradycardia, cardiac decompensation or hypotension (not due to treatable tachyarrhythmias).

WARNING:
Intravenous injections should be given slowly over 2 minutes and infusion at a rate of 1 to 4 mg per minute.

DOSAGE AND DIRECTIONS FOR USE:
For the emergency treatment of acute myocardial infarction, doses of up to 300 mg may be given by intramuscular injection into the deltoid muscle, followed by a 0,1% to 0,2% intravenous infusion in Dextrose 5% in water at a rate of 1 to 4 mg per minute, in accordance with the needs of the patient. In the treatment of cardiac arrhythmias 50 to 100 mg may be administered by a slow intravenous injection over 2 minutes (0,5 mL to 1,0 mL of a 10% solution; 0,25 mL to 0,5 mL of a 20% solution).

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Caution should be exercised in the presence of hepatic insufficiency, other cardiac conditions, epilepsy, myasthenia gravis and impaired respiratory function. The plasma half-life of lignocaine hydrochloride may be prolonged in conditions which reduce hepatic blood flow such as cardiac and circulatory failure. The main systemic toxic effect is excitation of the central nervous system, manifested by yawning, restlessness, excitement, nervousness, dizziness, blurred vision, nausea, vomiting, muscle twitching and convulsions. Excitation of the central nervous system may be transient, and followed by depression, with drowsiness, respiratory failure and coma. There is simultaneous depression of the cardiovascular system, with pallor, sweating and hypotension. Arrhythmias, bradycardia and cardiac arrest may be precipitated. Allergic reactions of an anaphylactic nature may occur. Drowsiness, lassitude and amnesia have been reported with therapeutic doses of lignocaine hydrochloride. Numbness of the tongue and perioral region is an early sign of systemic toxicity. Methaemoglobinaemia has been reported. Foetal intoxication has occurred following the use of lignocaine hydrochloride in labour. Doses should be reduced in elderly and debilitated patients and in children.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See symptoms mentioned under Side-effects and special precautions. Treatment is symptomatic and supportive.

IDENTIFICATION:
A clear solution in clear glass ampoules.

PRESENTATION:
10 by 5 mL ampoules containing a 10% m/v solution lignocaine hydrochloride.
10 by 5 mL ampoules containing a 20% m/v solution of lignocaine hydrochloride.

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

REGISTRATION NUMBER:
PETERKAÏEN 10% m/v INJECTION 5 mL V/6.2/319
PETERKAÏEN 20% m/v INJECTION 5 mL V/6.2/320

NAME AND BUSINESS ADDRESS OF APPLICANT:
INTRAMED (PTY) LTD.
6 Gibaud Rd
Korsten
PORT ELIZABETH 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
October 1988 12-293/3-93
Qwaqwa Printers 3212

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