Bupivacaine is indicated for the production of local or regional anaesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures. The routes of administration and indicated Bupivacaine concentrations are: Local infiltration: 0.25% Peripheral nerve block: 0.25%, 0.5% Sympathetic block: 0.25% Lumbar epidural: 0.25%, 0.5% and 0.75% (non-obstetrical) Caudal: 0.25%, 0.5%
Bupivacaine Hydrochloride is a local anaesthetic of the amide type and has a relatively slow onset and a long duration of action about 8 hours; it can provide significant sensory anaesthesia and motor blockade. Local anaesthetics act by preventing the generation and transmission of impulses along nerve fibres and at nerve endings; depolarization and ion-exchange are inhibited. The effects are reversible. Bupivacaine is about 95% bound to plasma proteins. Half-lives in adults are 1.5 to 5.5 hours and about 8 hours in neonates.
Percutaneous infiltration anesthesia For prolonged action: 9 mg with adrenaline (1 in 200,000), may repeat 2-10 mins later if needed. Max: 90 mg per dental sitting. Peripheral nerve block: 12.5 mg (as 0.25% solution) or 25 mg (as 0.5% solution). Max: 150 mg/dose. Sympathetic nerve block: As 0.25% solution: 50-125 mg. Retrobulbar block: As 0.75% solution: 15-30 mg. Caudal block In surgery: 37.5-75 mg (as 0.25% solution) or 75-150 mg (as 0.5% solution). Lumbar epidural block In surgery: 25-50 mg (as 0.25% solution) and 50-100 mg (as 0.5% solution).
Bupivacaine should be used with caution in patients receiving other local anaesthetics or agents structurally related to amide‐type local anaesthetics, e.g. certain anti‐arrhythmics, such as lidocaine and mexiletine, since the systemic toxic effects are additive.Specific interaction studies with Bupivacaine and anti arrhythmic drugs class III (e.g. amiodarone) have not been performed, but caution should be advised.
Hypersensitivity to Bupivacaine, other amide type local anaesthetics or other components of these preparations; Intravenous regional anaesthesia; obstetrical paracervical block anaesthesia. Readiness for emergencies.The lowest dosage that gives effective anaesthesia should be used in order to avoid high plasma levels and serious systemic side effects. Injection of repeated doses of Bupivacaine Hydrocholoride may cause significant increase in blood levels with each additional dose, due to accumulation of the drug or its metabolites or due to slow metabolic degradation. Tolerance varies with the status of the patient. Debilitated, elderly patients and acutely ill patients should be given reduced doses commensurate with age and physical condition. Caution is advised in administration of repeat doses of Bupivacaine Hydrocholoride to patients with severe liver disease.Local anaesthetic procedures should be used with caution when there is inflammation and/or sepsis in the region of the proposed injection.
Central Nervous System and Neurological: Restlessness, excitement, nervousness, dizziness, tinnitus, blurred vision, miosis, nausea, vomiting, numbness of the tongue and perioral region, chills, tremors, muscle twitching, convulsions. Cardiovascular System Reactions: Myocardial depression and peripheral vasodilatation resulting hypotension and bradycardia, ventricular arrhythmia, cardiac arrest. Hypersensitivity: urticaria, pruritus, erythema, angioneurotic edema ,tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly, anaphylactoid reactions.
There are no adequate and well?controlled studies in pregnant women of the effect of bupivacaine hydrochloride on the developing fetus. Bupivacaine should not therefore be given in early pregnancy only if the potential benefit justifies the potential risk to the fetus. Bupivacaine enters the mother's milk, but in such small quantities that there is no risk of affecting the child at therapeutic dose levels.
Keep in a cool & dry place, protected from light. Keep out of the reach of children.
.png&w=384&q=75)