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Logo MACAINE® HCl 0,5% Spinal Injection

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

MACAINE® HCl 0,5% Spinal Injection

COMPOSITION:
Each mL contains:
Bupivacaine hydrochloride 5 mg.

PHARMACOLOGICAL CLASSIFICATION:
A. 4 Local anaesthetics

PHARMACOLOGICAL ACTION:
Bupivacaine is a long acting local anaesthetic of the amide type. MACAINE®HCl 0,5% Spinal Injection is a sterile glucose-free solution with an onset of action of 10 –15 minutes. The duration of analgesia is 2 - 3 hours in the lower thoracic and lumbar segments. Muscular relaxation of the lower limbs is profound although shorter than the duration of the sensory blockade.

INDICATIONS:
Spinal anaesthesia for surgery (e.g. lower limb surgery lasting 2 - 3 hours, where profound muscle relaxation is required).

CONTRA-INDICATIONS:
Bupivacaine hydrochloride is contra-indicated in patients with a known hypersensitivity to local anaesthetics of the amide type.
Safety in pregnancy, other than in labour has not yet been established.
Bupivacaine HCI is not recommended for use in paracervical block in obstetrics.

DOSAGE AND DIRECTIONS FOR USE:
The following dose should be regarded as a guide for use in the average adult:
2- 4 mL (10 - 20 mg bupivacaine hydrochloride).
The spread of anaesthesia obtained with MACAINE®HCl 0,5% Spinal Injection is dependent upon several factors, the most important being volume of solution injected, and the age and positioning of the patient.
The difference in spread between a 10 mg and 20 mg dose is approximately two segments. The larger dose gives a half to 1 hour longer duration of anaesthesia in the lumbar segments and a longer lasting motor blockade.
When injected into the sub-arachnoid space via the L
3/L4 interspace with the patient in a sitting position, 3 mL of MACAINE®HCl 0,5% Spinal Injection spreads to between the T4 and T5 segments.
If the patient is in the supine horizontal position the blockade spreads to between the T5 and T7 segment.
Before administration of the drug make sure that resuscitative equipment, such as equipment to maintain a free airway, oxygenation and circulation, is immediately available.
The effects of spinal administration of a dose of MACAINE®HCl 0,5% Spinal Injection exceeding 20 mg have not yet been studied and such volume can therefore not be recommended.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects of MACAINE® HCl 0,5% Spinal Injection include central nervous system toxicity, manifesting as drowsiness merging into unconsciousness and respiratory arrest. Cardiovascular reactions are depressant and may be characterised by hypotension, myocardial depression, bradycardia and possibly cardiac arrest.
Severe systemic side-effects may occur after accidental intravascular injection and are characterised bynausea, vertigo and numbness of the tongue, light-headedness, dizziness, blurred vision and tremor followed by drowsiness, convulsions, unconsciousness and possibly respiratory arrest.
Spinal anaesthetics should be used with caution in patients with impaired cardiovascular function such as severe disturbances of cardiac rhythm, shock, heart block or congestive heart failure. There should be careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness after local anaesthetic injection.
In addition, dose-related convulsions and cardiovascular collapse may result from diminished tolerance and rapid absorption from the injection site.
Neurologic effects following spinal anaesthesia may include impaired perineal sensation and sexual function, persistent anaesthesia, paraesthesia, weakness and paralysis of the lower extremities, and loss of sphincter control, (from which there may be slow, incomplete, or no recovery), hypotension, high or total spinal block, urinary retention, headache, backache, septic meningitis, meningismus, arachnoiditis, slowing of labour, increased incidence of forceps delivery; shivering; cranial nerve palsies due to traction on nerves (from loss of cerebrospinal fluid), and faecal and urinary incontinence. Allergic type reactions may occur as a result of sensitivity to local anaesthetics.
Spinal headache may occur as a sequel to sub-arachnoid injection.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment of extensive spinal blockade consists of assuring and maintaining a patient airway and supporting ventilation using oxygen, if necessary by assisted or controlled ventilation.
Should circulatory depression occur, symptomatic support is needed.
In the case of inadvertent intravascular injection resulting in convulsions, this should be treated rapidly by intravenous injection e.g. thiopentone 100 mg - 200 mg or diazepam 5 mg - 10 mg.

IDENTIFICATION:
A clear colourless solution.

PRESENTATION:
4 mL ampoules in packs of 10.

STORAGE INSTRUCTIONS:
Store below 25°C. The solution must not be stored in such a way that it can be influenced by metals, e.g. needles or metal parts of syringes, as dissolved metal ions may cause swelling at the site of the injection.
Caution:
The solution should be used immediately after opening of the ampoule. Any remaining solution should be discarded.
Keep out of reach of children.

REGISTRATION NUMBER:
U/4/55

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:
March 1990
® Registered Trade Mark

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

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