0.5% HEAVY

Long acting local anaesthetic injection for spinal anaesthesia

Each ml injection contains:

Active ingredient:

Bupivacaine HCl monohydrate equivalent to Bupivacaine HCl anhydrous 5 mg in:

Dextrose monohydrate 80 mg

Bupivacaine is a long acting local anaesthetic agent of the amide type. Decain Spinal 0.5% Heavy has rapid onset of action and long duration. The duration of analgesia in the T10-T12 segments is 2-3 hours. Decain Spinal 0.5% Heavy produces a moderate muscular relaxation of the lower extremities lasting 2-2.5 hours. The motor blockade of the abdominal muscles makes the solution suitable for performance of abdominal surgery lasting for 45-60 minutes. The duration of motor blockade does not exceed the duration of analgesia.

Decain Spinal 0.5% Heavy is hyperbaric and its initial spread in the subarachnoid space is considerable affected by gravity. Moreover, it spreads cephalad more extensively than the isobaric solutions, even in the horizontal position when the effect of gravity is minimal. Due to the larger intrathecal distribution and the consequently lower mean concentration the duration of anaesthesia tends to be shorter. Thus the solution without added dextrose produce a lower level of block, but of longer duration, than the hyperbaric solution.

Bupivacaine, like other local anaesthetics, causes a reversible blockade of impulse propagation along nerve fibres by preventing the inward movement of sodium ions through the nerve membrane. Local anaesthetics of the amide type are thought to act within the sodium channels of the nerve membrane.

• Intrathecal (subarachnoid, spinal) anaesthesia for surgical.
  
  
• Abdominal surgery lasting 45-60 minutes (including Caesarean section).
  
  
• Urological and lower limb surgery lasting 2-3 hours (including hip surgery).
  

• Known hypersensitivity to local anaesthetics of the amide type.
  
  
• Acute active diseases of the central nervous system, such as meningitis, poliomyelitis, intracranial haemorrhage, and demyelinating, increased intracranial pressure, cerebral and spinal tumors.
  
  
• Spinal stenosis and active disease (e.g. Spondylitis, tumour) or recent trauma (e.g. fracture) in the vertebral column.
  
  
• Tuberculosis of the spine.
  
  
• Pyrogenic infection of the skin at or adjacent to the site of lumbar puncture.
  
  
• Septicaemia.
  
  
• Pernicious anemia with subacute combined degeneration of the spinal cord.
  
  
• Coagulation disorders or ongoing anti-coagulation treatment.
  
  
• Uncorrected hypotension, cardiogenic or hypovolaemic shock.
  
  
• Obstetric paracervical block, intravenous regional anaesthesia (Bier's block) and all intravenous infusions.

• The doses recommended below should be regarded as a guide for use in the average adult.

Spinal anaesthesia for surgery: 1.5 - 3 ml (7.5 – 15 mg bupivacaine hydrochloride).

• The dosage in the table are those thought to be necessary for the production of a successful block and should be regarded as guideline for use in the average adult. Regarding spread and duration times, there are wide individual variations and it is impossible to be precise.

  
  

  Upper level of	%	Site of	Position of	Dosage		Onset (min)	Duration (hours)	Indication
  				ml	mg
  Decain Spinal Heavy 5 mg/ml	0,5
  L1		L3/4/5	Sitting	1.5-3	7.5-15	5-8	2-3	Lower-limb, urological and perineal surgery. N.B. The patients should be laid horizontal 2-3 min after injection or if he/she complains of faintness
  T5		L2/3/4	Horizontal	3-4	15-20	5-8	1.5-2	Lower abdominal operations (include Caesarean section).

  
  
• The spread of anaesthesia is dependent of several factors including the volume of solution and the position of the patient during and following injection.
  
  When injected at the L3 – L4 intervertebral space, with the patient in the sitting position, 3 ml of Decain Spinal 0.5% Heavy spreads to the T7 – T10 spinal segments. With the patient receiving the injection in the horizontal position and then turned supine, the blockade spreads to T4 – T7 spinal segments. It should be understood that the level of spinal anaesthesia achieved with any local anaesthetic can be unpredictable in a given patient.
  
  
• Decain Spinal 0.5% Heavy may be used in children.
  One of the differences between small children and adults is a relatively high cerebrospinal fluid (CSF) volume in infants and neonates, requiring a relatively larger dose/kg to produce the same level of block as compared to adult.
  
  The following doses are recommended:
  0.40 – 0.50 mg/kg for infants up to 5 kg
  0.30 – 0.40 mg/kg for children weighing between 5 and 15 kg
  0.25 – 0.30 mg/kg for children weighing more than 15 kg
  
  
• Spinal injections should only be made after the subarachnoid space has been clearly identified by lumbar puncture. No drug should be injected until clear cerebrospinal fluid (CSF) is seen to escape from the spinal needle or it is detected by aspiration.
  
  
• The solution should be used immediately after opening the ampoule. Any remaining solution should be discarded.

• In general, almost all the side effects seen with spinal anaesthesia are due to the nerve blockade itself and not to the drug used. This effects include hypotension, bradycardia and post dural puncture headache.
  
  
• High or total spinal blockade. Severe adverse reactions following spinal anaesthesia are rare but may occur in connection with extensive 9total) spinal blockade. Total spinal blockade will result in cardiovascular and respiratory depression. The cardiovascular depression is caused by an extensive sympathetic blockade which may result in profound hypotension and bradycardia, or even cardiac arrest. Ventilatory depression is caused by blockade of the innervation of the respiratory muscles, including the diaphragm.
  
  
• Neurological reactions. Neurological damage is rare, though recognised, consequence of regional and particulary spinal anaethesia. It may be due to several causes, such as direct injury to the spinal cord or spinal nerves, anterior spinal artery syndrome, injection of an irritant substance, injection of a non-sterile solution or the development of a space occupying lesion (haematoma or abcess) within the spinal canal. These may result in localised areas of paraesthesia or anaesthesia, motor weakness, loss of sphincter control of paraplegia. Occasionally these are permanent. Neurological complications of this type have been reported with all local anaesthethics used for spinal anaesthesia.
  
  
• Allergic reactions. Allergy to amide type local anaesthetics is very rare but may be present as allergic dermatitis, bronchospasm or anaphylaxis.
  
  
• Acute systemic toxicity. Like all local anaesthetic drugs, bupivacaine may have acute toxic effects on the central nervous and cardiovascular systems, if given in high doses. The first manifestation of CNS toxicity is drowsiness merging into unconsciousness and respiratory arrest. The cardiovascular reactions are depressant and may be characterised by hypotension, myocardial depression, bradycardia and possibly cardiac arrest. In view of the low dosage employed, systemic adverse reactions are rarely associated with spinal anaesthesia, but may occur after accidental intravascular injection. Systemic adverse reactions are characterised by numbness of the tongue, light-headedness, dizziness and tremors, followed by convulsions and cardiovascular disorders.

• The safety and effectiveness of bupivacaine depend on proper dosage, correct technique and adequate precautions. Standard textbooks should be consulted for specific techniques and precautions for spinal anaesthetic procedures. If signs of acute systemic toxicity or total spinal block appear, injection of the local anaesthetic should be stopped immediately.
  
  
• Injection should always be made slowly with frequent aspirations to avoid inadvertent intravascular injection which can produce toxic effects.
  
  
• Bupivacaine should be used with caution in patients with cardiac block, impaired liver function and cardiovascular disturbances.
  
  
• Bupivacaine should be used with caution during pregnancy and lactation.
  
  
• Besides the direct anaesthetic effect, local anaesthetics may have a very mild effect on mental function and coordination even in the absence of overt CNS toxicity and may temporarily impair locomotion and alertness.
  
  
• When any local anaesthetic agent is used, resuscitative equipment and agents, including oxygen, should be immediately available in order to manage possible adverse reactions involving the cardiovascular, respiratory or central nervous systems.
  
  
• Spinal anaesthesia can cause intercostal paralysis and patients with pleural effusions may suffer respiratory embarrassment.
  
  
• Bupivacaine may react with certain metals causing the release of ions into solution. Prolonged contact with metal surfaces should be avoided including metal syringe components.
  
  
• The possibility of hypotension and bradycardia following epidural or subarachnoid blockade should be anticipated and appropriate precautions taken, including the prior establisment of an intravenous line and the availability of vasopressor agents and oxygen. Hypotension is common in patients with hypovolaemia due to haemorrhage or dehydration and in those with aortocaval occlusion due to abdominal tumors or the pregnant uterus in late pregnancy. Hypotension is poorly tolerated by patients with coronary or cerebrovascular disease.
  
  
• Bupivacaine should be use with caution in patients with genetic predisposition to malignant hyperthermia as the safety of amide local anaesthetic agents in these patients has not been fully established. A standard protocol for the management of malignant hyperthermia should be available.
  
  
• Spinal anaesthesia can be unpredictable and very high blocks are sometimes encountered with paralysis of the intercostal muscles, and even the diaphragm, especially in pregnancy. On rare occasions it will be necessary to assist or control ventilation.
  
  
• There is an increased risk for high or total spinal blockade in the elderly and in patients in the late stages of pregnancy. The dose shold therefore be reduced in these patients.

• Bupivacaine should be used with care in patients receiving antiarrhythmic drugs with local anaesthetic activity or other local anaesthetics, as their toxic effects may be additive.
  
  
• Increased risk of bupivacaine hydrochloride toxicity with propranolol.

Decain Spinal 0.5% Heavy used as recommended are not likely to cause blood levels high enough to cause systemic toxicity. However, if other local anaesthetics are concomitantly administered, toxic effects are additive and may cause systemic toxic reactions.

Acute emergencies associated with the use of bupivacaine are normally related to high plasma levels, or to unintended subarachnoid injection. Toxic symptoms may present following a seemingly normal dose as there is a wide variation in patient response to bupivacaine.

Systemic toxicity is initially manifested as CNS excitation e.g. Yawning, restlessness, excitement, nervousness, blurred vision, nausea and vomiting, muscle twitching and in more severe cases, convulsions. Excitation may be followed by CNS depression with drowsiness, respiratory failure, coma, cardiac arrhythmias and cardiac arrest.

Treatment of a patient with toxic manifestations consists of ensuring adequate ventilation and arresting convulsions. Assisted or controlled ventilation should be maintained with oxygen, if required.

If convulsions occur, intravenous diazepam should be administered incrementally. Sodium thiopentone (5 mg/kg) may be used if diazepam is unavailable or ineffective. If convulsions interfere with breathing and/or are not rapidly controlled by specific anticonvulsant medication, suxamethonium (1-2 mg/kg) may be used to paralyse the patient. Artificial ventilation must then be instituted.

If ventricular fibrillation or cardiac arrest occurs, effective vardiovascular resuscitation treatment must be instituted and maintained for a prolonged period if necessary.

Box, 5 ampoule @ 4 ml No. Reg. DKL0605040143A1