BUCAIN SPINAL Injection

Bupivacaine 5 mg / ml

Category:

COMPOSITIONS :

Bucain® Spinal Heavy Injection, each ml contains : Bupivacaine HCl monohydrate equivalent to Bupivacaine HCl 5 mg and Dextrose anhydrate 80 mg.

 

DESCRIPTIONS :

Bucain® Spinal Heavy Injection contains Bupivacaine HCl monohydrate (equivalent to Bupivacaine HCl) and Dextrose anhydrate as an active ingredient is available in 5 mg/ml injection.

 

INDICATIONS :

Spinal anaesthetic for urological and lower limb surgery lasting 2 – 3 hours, abdominal surgery lasting 45 – 60 minutes.

 

DOSAGE AND ADMINISTRATIONS :

For Spinal/Intrathecal Use :

  • Spinal injection 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 is detected by aspiration.
  • Failure of spinal anaesthesia has been reported in 1 – 5% of the patients. One reason for failure could be an intrathecal maldistribution of the local anaesthetic e.g. entrapment in the caudal end of the dural sack or within a “pocket” with restricted communication to the major CSF space. In such cases a better spread, i.e. a sufficient block, may be achieved after temporary change(s) in the patient’s position. If a supplementary block is necessary, it should be performed at a different level and with a reduced volume of the local anaesthetic. Only one extra attempt should be made.
  • The following dosage recommendation should be regarded as a guide for use in the average adult. The effects of spinal administration of Bupivacaine exceeding 20 mg have not been reported.
  • The use of spinal anaesthesia in children requires a thorough knowledge of difference between adults and children to enable the administration of adequate doses of the drug used. A relatively a high CSF volume is found in infants and neonates. They therefore require a relatively larger dose/kg to produce the same level of block.
  • In small children the nerves are less myelinated, allowing easier diffusion and a more rapid onset of anaesthesia.
  • The hypotension usually seen after spinal blocks in adults is uncommon in children under the age of 8. Bucain® Spinal Heavy may be used in children. The following doses are recommended :
    1. 40 – 0.50 mg/kg for infants up to 5 kg.
    2. 30 – 0.40 mg/kg for children weighing between 5 and 15 kg.
    3. 25 – 0.30 mg/kg for children weighing more than 15 kg.

The onset of anaesthesia is slower than for Lidocaine and the duration is 60 – 120 minutes.

  • Dosage recommendation for Bucain® Spinal Heavy :

The dosage in the table are those thought to be necessary for the production of a successfull 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 anaesthesia % Site of injection Position of patient Dosage Onset minute Duration hours Indication
ml mg
Bupivacaine HCl Spinal Heavy 5 mg/ml, L1 0.5 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 minutes 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 solution should be used immediately after opening the ampoules and any remaining solution should be discarded.

 

OVERDOSAGE :

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use or to underventilation (and perhaps apnea) secondary to upward extension of spinal anesthesia. Hypotension is commonly encountered during the conduct of spinal anesthesia due to relaxation of sympathetic tone and sometimes, contributory mechanical obstruction of venous return.

Management of local anesthetic emergencies :

  • The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient’s state of consciousness after each local anesthetic injection. At the first sign of change, oxygen should be administered.
  • The first step in the management of systemic toxic reactions, as well as underventilation or apnea due to a high or total spinal, consists of immediate attention to the establishment and maintenance of a patent airway and effective assisted or controlled ventilation with 100% oxygen with a delivery system capable of permitting immediate positive airway pressure by mask. This may prevent convulsions if they have not already occurred.
  • If necessary, use drugs to control the convulsions. A 50 mg – 100 mg bolus IV injection of Succinylcholine will paralyze the patient without depressing the central nervous or cardiovascular systems and facilitate ventilation. A bolus IV dose of 5 mg – 10 mg of Diazepam or 50 mg – 100 mg of Thiopental will permit ventilation and counteract central nervous system stimulation, but these drugs also depress central nervous system, respiratory and cardiac function, add to postictal depression and may result in apnea. Intravenous barbiturates, anticonvulsant agents or muscle relaxants should only be administered by those familiar with their use. Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated. Supportive treatment of circulatory depression may require administration of intravenous fluids and when appropriate, a vasopressor dictated by the clinical situation (such as Ephedrine or Epinephrine to enhance myocardial contractile force).
  • Hypotension due to sympathetic relaxation may be managed by giving intravenous fluids (such as isotonic saline or lactated Ringer’s solution), in an attempt to relieve mechanical obstruction of venous return or by using vasopressors (such as ephedrine which increases the force of myocardial contractions) and if indicated, by giving plasma expanders or whole blood.
  • Endotracheal intubation, employing drugs and techniques familiar to the clinician, may be indicated after initial administration of oxygen by mask if difficulty is encountered in the maintenance of a patent airway or if prolonged ventilatory support (assisted or controlled) is indicated.
  • Recent clinical data from patients experiencing local anesthetic-induced convulsions demonstrated rapid development of hypoxia, hypercarbia and acidosis with Bupivacaine within a minute of the onset of convulsions. These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen which may avoid cardiac arrest. If not treated immediately, convulsions with simultaneous hypoxia, hypercarbia and acidosis plus myocardial depression from the direct effects of the local anesthetic may result in cardiac arrhythmias, bradycardia, asystole, ventricular fibrillation or cardiac arrest. Respiratory abnormalities, including apnea, may occur. Underventilation or apnea due to a high or total spinal may produce these same signs and also lead to cardiac arrest if ventilatory support is not instituted. If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted and maintained for a prolonged period if necessary. Recovery has been reported after prolonged resuscitative efforts.
  • The supine position is dangerous in pregnant women at term because of aortocaval compression by the gravid uterus. Therefore during treatment of systemic toxicity, maternal hypotension or fetal bradycardia following regional block, the parturient should be maintained in the left lateral decubitus position if possible or manual displacement of the uterus off the great vessels be accomplished.

 

CONTRAINDICATIONS :

  • Known hypersensitivity to local anaesthetics of the amide type.
  • Acute active disease of the central nervous system, such as meningitis, tumours, poliomyelitis and cranial haemorrhage. The presence of active tuberculosis or metastatic lesions in the vertebral column is also a contraindication.
  • Septicaemia
  • Pernicious anaemia with subacute combined degeneration of the spinal cord.
  • Pyrogenic infection of the skin at or adjacent to the site of puncture.
  • Cardiogenic or hypovolemic shock.
  • Coagulation disorders or ongoing anticoagulant treatment.
  • Severe hemorrhage, severe hypotension or shock and arrhythmias, such as complete heart block, which severely restrict cardiac output.

 

WARNINGS AND PRECAUTIONS :

  • Spinal anaesthesia should only be undertaken by or under the supervision of clinicians with the necessary knowledge and experience. Spinal anaesthesia should only be given in a fully equipped operating suite where all the necessary resuscitative equipment and drugs are immediately available. The anaesthetist must remain in constant attendance until the operation is finished and must supervise the recovery until the anaesthesia has worn off. Intravenous access, e.g. and IV infusion, should be in place before starting the spinal anaesthesia.
  • Regardless of the local anaesthetic used hypotension and bradycardia may occur. This should be prevented either by pre-loading the circulation with crystalloidal or colloidal solutions or by injecting a vasopressor, such as Ephedrine 20 – 40 mg IM, or treated promptly with, for example, Ephedrine 5 – 10 mg intravenously and repeated as necessary.
  • Hypotension is common in patients with hypovolemia due to haemorrhage or dehydration and in those with aortocaval occlusion due to abdominal tumours or the pregnant uterus in late pregnancy. Hypotension is poorly tolerated by patients with coronary or cerebrovascular disease.
  • Spinal anaesthesia can be unpredictable and very high blockades are sometimes encountered with paralysis of the intercostals muscles and even the diaphragm, especially in pregnancy. On rare occasions it will be necessary to assist or control ventilation.
  • Chronic neurological disorders, such as multiple sclerosis, old hemiplegia due to stroke etc., are not thought to be adversely affected by spinal anaesthesia, but call for caution.

Nb : Because spinal anaesthesia may be preferable to general anaesthesia in some high-risk patients, attempts should be made to optimise their general condition preoperatively when time allows.

  • Spinal anesthetics should not be injected during uterine contractions, because spinal fluid current may carry the drug further cephalad than desired.
  • Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use.
  • The lowest dosage of local anesthetic that results in effective anaesthesia should be used.
  • Aspiration for blood should be performed before injection and injection should be made slowly.
  • Elderly patients, acutely ill patients, debilitated patients and patients with cardiac and/or liver disease may required reduced doses.
  • Monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient’s state of consciousness after local anesthetic injection.
  • Caution in patients with severe disturbances of cardiac rhythm, shock or heart block.
  • Caution in patients with severe hepatic disease.
  • Caution in patients with impaired cardiovascular function.
  • The following conditions may preclude the use of spinal anesthesia, depending upon the physician’s evaluation of the situation and ability to deal with the complications or complaints which may occur :
    1. Pre-existing diseases of the central nervous system, such as those attributable to pernicious anemia, poliomyelitis, syphilis or tumor.
    2. Hematological disorders predisposing to coagulopathies or patients on anticoagulant therapy. Trauma to a blood vessel during the conduct of spinal anesthesia may, in some instances, result in uncontrollable central nervous system hemorrhage or soft tissue hemorrhage.
    3. Chronic backache and preoperative headache.
    4. Hypotension and hypertension.
    5. Technical problems (persistent paresthesias, persistent bloody tap).
    6. Arthritis or spinal deformity.
    7. Extremes of age.
    8. Physicosis or other causes of poor cooperation by the patient.
  • Pregnancy category C : Bupivacaine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. This does not exclude the use of Bupivacaine hydrochloride at term for obstetrical anesthesia. (See labor and delivery).
  • Labor and delivery : Spinal anesthesia has a recognized use during labor and delivery. Bupivacaine hydrochloride, when administered properly, via the epidural route in doses 10 – 12 times the amount used in spinal anesthesia has been used for obstetrical analgesia and anesthesia without evidence of adverse effects on the fetus.
  • Nursing mother : Bupivacaine has been reported to be excreted in human milk suggesting that the nursing infant could be theoretically exposed to a dose of the drug. Because of the potential for serious adverse reactions in nursing infants from Bupivacaine, a decision should be made whether to discontinue nursing or not administer Bupivacaine, taking into account the importance of the drug to the mother.
  • Pediatric use : Until further experience is gained in patients younger than 18 years, administration of Bupivacaine hydrochloride in this age group is not recommended.
  • Geriatric use : Patients over 65 years, particularly those with hypertension, may be at increased risk for developing hypotension while undergoing spinal anesthesia with Bupivacaine hydrochloride. Elderly patients may require lower doses of Bupivacaine hydrochloride.
  • This product is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.

 

PRESENTATION :

Bucain® Spinal Heavy Injection            Box, 5 ampoules @ 4 ml      Reg. No. DKL0402335643A1

 

STORAGE :

STORE BELOW 30°C, PROTECT FROM LIGHT

 

ON MEDICAL PRESCRIPTION ONLY

 

Manufactured by :

PT. BERNOFARM

Sidoarjo – Indonesia

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