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

Logo CARBOCAINE* 3% DENTAL

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

CARBOCAINE* 3% DENTAL
Injection

COMPOSITION:
Each 1,8 mL contains
mepivacainehydrochloride 54 mg.

PHARMACOLOGICAL CLASSIFICATION:
A. 4 Local Anaesthetics

PHARMACOLOGICAL ACTION:
Mepivacaine is a local anaesthetic of the amide type. It has a rapid onset and intermediate duration of action.

INDICATIONS:
For the production of local anaesthesia for conservative and surgical interventions in the oral region (especially for dental work).

CONTRA-INDICATIONS:
CARBOCAINE* 3% DENTAL Injection is contra-indicated in patients with a known hypersensitivity to the amide type of local anaesthetic.

WARNINGS:
DO NOT AUTOCLAVE.

DOSAGE AND DIRECTIONS FOR USE:
The dose varies and depends on the area to be anaesthetized, vascularity of the tissues, number of neuronal segments to be blocked, individual tolerances and the technique of anaesthesia. The lowest dose needed to provide effective anaesthesia should be administered.
The average dose of one dental cartridge will usually suffice. This dose may be doubled if necessary to effect anaesthesia. The maximum adult dose should not exceed 400 mg mepivacaine hydrochloride, (approximately 7 mg/kg) at any one time and the total dose should not exceed 1 g in any twenty-four hour period.
Any unused portion of a dental cartridge should be discarded.

RESUSCITATIVE EQUIPMENT AND EMERGENCY MEDICINES SHOULD BE IMMEDIATELY AVAILABLE WHEN ANY ANAESTHETIC IS USED.

DISINFECTION OF CARBOCAINE* 3% DENTAL Injection cartridges:
The diaphragm should be disinfected before needle puncture. Immerse only the metal cap in undiluted isopropyl alcohol or 70% ethyl alcohol for at least fifteen minutes. Only enough cartridges for one day's use should be stored in the alcohol.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Systemic toxicity of local anaesthetics mainly involves the central nervous system and the cardiovascular system. Excitation of the central nervous system may be manifested by yawning, restlessness, excitement, nervousness, dizziness, tinnitus, nystagmus, blurred vision, nausea and vomiting, muscle twitching and tremors, and convulsions. Numbness of the tongue and perioral region is an early sign of systemic toxicity. Excitation may be transient and followed by depression with drowsiness, respiratory failure and coma. There may be simultaneous effects on the cardiovascular system with myocardial depression and peripheral vasodilation resulting in hypotension and bradycardia, arrhythmias and cardiac arrest may occur.
Methaemoglobinaemia may occur.
Safe use of CARBOCAINE* 3% DENTAL Injection during pregnancy has not been established with respect to foetal development.
The effect of mepivacaine hydrochloride may be reduced if the injection is made into an inflamed or infected area with a low tissue pH.
Mepivacaine hydrochloride should be given with caution to patients with epilepsy, impaired cardiac conduction, impaired respiratory function, or with liver damage. Patients with myasthenia gravis are particularly susceptible to the effects of local anaesthetics. Doses should be reduced in elderly and debilitated patients and children.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage correspond to the side-effects. Cardiorespiratory arrest and convulsions as well as somnolence may occur. Treatment is symptomatic and supportive. Resuscitative equipment and emergency medicines should always be immediately available, as symptomatic treatment is recommended.

IDENTIFICATION:
Clear, colourless solution for injection.

PRESENTATION:
Available in 1,8 mL dental cartridges in cans of 100 cartridges.

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

REFERENCE NUMBER:
G 2753 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext 77
Private Bag X69
Bryanston 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
18 August 1988

* Registered trademark

New addition to this site: April 2004
Source: Pharmaceutical Industry

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