Bupivacaine hydrochloride.
Each mL Regivell injection contains Bupivacaine Hydrochloride 5 mg.
Pharmacology: Bupivacaine is a local anesthetic of the amide type which has a long duration of action. It appears to block conduction of nerves impulses through all nerve fibers by decreasing permeability of the nerve cell membrane to sodium ions.
Toxicology: Acute systemic toxicity: Like all local anesthetic drugs, Bupivacaine may have acute toxic effects on the central nervous and cardiovascular systems, if given high doses. This is especially the case if the injection is made intravascular. However, the dose required for spinal anesthesia is so small (20 % or less than required for epidural anesthesia) that acute systemic toxicity is extremely unlikely and has not been reported.
Spinal anesthesia for surgery (urological and lower limb surgery lasting 2-3 hours, abdominal surgery lasting 45-60 minutes).
Spinal injections should be made after the subarachnoid space has been clearly identified by lumbar puncture. No drug should be injected until clear cerebrospinal fluid (CSF) is seem to escape from the spinal needle.
The following dosage recommendations should be regarded as a guide for use in the average adult and may be varied in each patient. (See table.)
Click on icon to see table/diagram/image
The recommended injection site should be below L3.
The effects of spinal administration of Bupivacaine exceeding 20 mg have not been reported.
Known hypersensitivity to local anesthetics of amide type.
Septicemia.
Serious disease of the central nervous system, such as meningitis, poliomyelitis and cranial haemorrhage.
Pyrogenic infection of the skin at or adjacent to the site of puncture.
Severe shock.
Coagulation disorders or ongoing anticoagulant treatment.
Spinal anesthesia should only be undertaken by or under the supervision of clinicians with the necessary knowledge and experience. Resuscitative equipment and drugs must be immediately available whenever the drugs are used. The anesthetist must remain in constant attendance until the operation is finished and must supervise the recovery until the anesthesia has worn off.
Regardless of the local anesthetic used hypotension and bradycardia may occur. This should be prevented by pre-loading the circulation with crystalloidal or colloidal solutions, or treated promptly with for example, ephedrine 5-10 mg IV, and repeated as necessary.
Spinal anesthesia can be unpredictable and very high blockades are sometimes encountered with paralysis of intercostals muscles, especially in pregnancy.
Pregnancy: No specific disturbances to the reproductive process have so far been reported, e.g. no incidence of malformations, so there should be careful consideration in using the drug in pregnancy.
Lactation: Bupivacaine enters the mother's milk; however there is generally no risk of this affecting the neonate at the therapeutic dose.
The most common acute adverse reactions are related to the CNS and cardiovascular systems. These are generally dose-related and may result from overdose, rapid absorption from the injection site, diminished tolerance, or unintentional intravascular injection.
Cardiovascular: Myocardial depression, hypotension, decreased cardiac output, bradycardia, ventricular arrhythmias, etc.
CNS: Restlessness, anxiety, dizziness, drowsiness merging into unconsciousness and respiratory arrest.
Gl: Nausea, vomiting.
Hypersensitivity.
Respiratory: Respiratory impairment or paralysis.
Miscellaneous: High or total spinal block, paralysis of the lower extremities, headache and backache, persistent motor, sensory, or autonomic deficit, etc.
Intercurrent use: Exercise caution regarding toxic equivalence when mixtures of local anesthetics are employed.
CNS depressants: Use reduced doses when Local anesthetics are used in combination with CNS depressants.
CYP450: Dosage adjustment may be warranted when levobupivacaine is concurrently administered with enzyme inhibitors like CYP3A4 inhibitors (azole antimycotic such as ketoconazole, certain protease inhibitors such as ritonavir, macrolide antibiotics such as erythromycin, calcium channel antagonists such as verapamil) and CYP1A2 inhibitors (furafylline, clarithromycin), as systemic levobupivacaine levels may rise, resulting in toxicity.
N01BB01 - bupivacaine ; Belongs to the class of amides. Used as local anesthetics.
Regivell inj 5 mg/mL
4 mL x 5 × 1's
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