Bupivacaine Hydrochloride & Dextrose is indicated for- Bupivacaine is indicated for lower abdominal surgery (including Caesarean section), urological and lower limb, including hip surgery, lasting 1.5 to 3 hours. Bupivacaine are indicated for intrathecal (subarachnoid, spinal) anesthesia for surgical and obstetrical procedures. Bupivacaine produces motor blockade of the abdominal muscles makes the solution suitable for performance of abdominal surgery lasting 1.5-2 hours. The duration of motor blockade does not exceed the duration of analgesia.
Bupivacaine is a long acting local anesthetic of the amide type. Bupivacaine spinal 5 mg/ml is a sterile non-glucose containing solution. Bupivacaine spinal has a rapid onset of action. The duration of analgesia is 3-5 hours in the lower thoracic and lumbar segments, which makes Bupivacaine spinal especially suitable for long lasting procedures in the lower limbs. The muscular relaxation of the lower limbs is profound, and lasts 3-4 hours, being somewhat shorter than the duration of the sensory blockade. The circulatory effects of Bupivacaine spinal are similar or less than those seen with other spinal agents. Bupivacaine spinal is well tolerated by all tissues with which it comes in contact.
The doses recommended below should be regarded as a guide for use in the average adult Spinal anaesthesia for surgery: 2-4 ml (10-20 mg Bupivacaine hydrochloride). The spread of anaesthesia obtained with Bupivacaine depends on several factors including the volume of the solutions and the position if the patients during and following the injection. When injected in the L3-L4 intervertebral space with the patient in the sitting position, 3 ml of Bupivacaine spreads to the T7- T10 spinal segments. With the patient receiving the injection in the horizontal position and then turned supine, the blockade spine spreads to T4-T7 spinal segments. It should be understood that the level of spinal anaesthetic can be unpredictable in a given patient.
Bupivacaine should be used with care in patients receiving antiarrhythmic drugs with local anaesthetic activity, as their toxic effects may be additive. Phenothiazines and Butyrophenones may reduce or reverse the pressor effect of epinephrine.
Bupivacaine in Dextrose is contraindicated in patients with a known hypersensitivity to it or to any local anaesthetic agent of the amide type. The following conditions preclude the use of spinal anaesthesia: Severe hemorrhage, severe hypotension or shock and arrhythmias, such as complete heart block, which severely restrict cardiac output,Local infection at the site of proposed lumbar puncture ,Septicemia. Bupivacaine should be given cautiously to the elderly, the debilitated patients and to children, to patients with epilepsy, respiratory impairment, impaired cardiac conduction, bradycardia, severe shock; porphyria; myasthenia gravis. Myocardial depression may be more severe and more resistant to treatment.
The adverse reaction profile for Bupivacaine is similar to those for other long acting local anesthetics administered intrathecally. Adverse reactions caused by the drug are difficult to distinguish from the physiological effects of the nerve block (e.g. decrease in blood pressure, bradycardia, temporary urinary retention), events caused directly (e.g. nerve trauma) or indirectly (e.g. epidural abscess) by the needle puncture or events associated to cerebrospinal leakage (eg. postdural puncture headache).
It is reasonable to assume that a large number of pregnant women and women of child-bearing age have been given Bupivacaine. No specific disturbances to the reproductive process have so far been reported, e.g. no increased incidence of malformations. It should be noted that the dose should be reduced in patients in the late stages of pregnancy With recommended doses, Bupivacaine enters breast milk in such small quantities that there is generally no risk of affecting the breast feed child. At maternal serum levels of up to 0.45 ?g/ml produced by the epidural use of Bupivacaine for vaginal delivery, Bupivacaine could not be detected in breast milk during the first 24 hours after delivery (detection limit 0.02 ?g/ml).
Acute emergencies associated with the use of local anesthetics are generally related to high plasma levels. Since the dose required for spinal anesthesia is so small (20% or less than that required for epidural anesthesia), acute systemic toxicity is extremely unlikely and has not been reported. With accidental intravascular injections of local anesthetics, the toxic effects will be obvious within 1-3 minutes. With over dosage, peak plasma concentrations may not be reached for 20-30 minutes, depending on the site of injection and toxic signs will be delayed. Toxic reactions mainly involve the central nervous and cardiovascular systems.
Store at temperature not exceeding 30ºC in a dry place. Protect from light.
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