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

Logo PETERKAÏEN 2% m/v INJECTION 2 mL
PETERKAÏEN 2% m/v INJECTION 5 mL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

PETERKAÏEN 2% m/v INJECTION 2 mL
PETERKAÏEN 2% m/v INJECTION 5 mL

COMPOSITION
Each 2 mL ampoule contains 0,04 g
Lignocaine Hydrochloride Monohydrate
Each 5 mL ampoule contains 0,1 g Lignocaine Hydrochloride Monohydrate

PHARMACOLOGICAL CLASSIFICATION
A 4 Local anaesthetics

PHARMACOLOGICAL ACTION
Lignocaine has local anaesthetic action (it blocks conduction of nerve impulses by decreasing or preventing the large transient increase in permeability of the cell membrane to sodium ions) and antiarrhythmic properties, last mentioned, 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 after digoxin overdosage. As a local anaesthetic in infiltration, field block, nerve block, intravenous regional and spinal anaesthesia. As a local anaesthetic it has an action of intermediate duration (30 to 45 minutes).

CONTRA-INDICATIONS
Contra-indicated in patients that are hypersensitive to local anaesthetics. Lignocaine hydrochloride should not be given to patients with hypovolaemia, heartblock or other conduction disturbances, bradycardia, cardiac decompensation or hypotension.

WARNINGS
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 for Injections) 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.

As local anaesthetic:
1. Infiltration anaesthesia –0,5 to 1,0% is used
2. Field block anaesthesia –as for infiltration anaesthesia.
3. Nerve block anaesthesia –depending upon which nerves or plexuses, the type of fibres –a 1 to 2% solution is used.
4. Intravenous regional anaesthesia of upper extremities –1,5 mg/kg bodymass of 0,5% solution.
5. Spinal anaesthesia –The injected concentration should not exceed 5%. When high thoracic anaesthesia is sought 100 mg of lignocaine may be used.
6. Epidural anaesthesia – Determined by the segmental level of anaesthesia required. The volumes of local anaesthetic injected during epidural anaesthesia are determined principally by the type of nerve fibres to be blocked, what level of anaesthesia is required and the technique employed. The duration of anaesthesia is frequently prolonged by addition of adrenaline 1:200 000.

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 ampoules.

PRESENTATION
Ten ampoules of 2 mL or 5 mL containing a 2% solution.

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

REGISTRATION NUMBER
Peterkaïen 2% m/v Injection 2 mL: M/4/254
Peterkaïen 2% m/v Injection 5 mL: M/4/255

NAME AND BUSINESS ADDRESS OF APPLICANT
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH
6001
Marketed by: Intramed, Division of Pharmacare
6 Gibaud Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT
October 1988
                        12-306/4-98
                        KOHLER C&P P.E.

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