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.

Each 30 ml contains 150 mg Bupivacaine Hydrochloride (anhydrous) USP.

The dose of any local anaesthetic administered varies with the anaesthetic procedure, the area to be anaesthetized, the vascularity of the tissues, the number of neuronal segments to be blocked. In recommended doses, Bupivacaine produces complete sensory block, but the effect on motor function differs among the three concentrations.

0.25% when used for caudal, epidural, or peripheral nerve block, produces incomplete motor block. Should be used for operations in which muscle relaxation is not important, or when another means of providing muscle relaxation is used concurrently. Onset of action may be slower than with the 0.5% or 0.75% solutions.

0.5% provides motor blockade for caudal, epidural, or nerve block, but muscle relaxation may be inadequate for operations in which complete muscle relaxation is essential.

Maximum dosage limit must be individualized in each case after evaluating the size and physical status of the patient, as well as the usual rate of systemic absorption from a particular injection site. Most experience to date is with single doses of Bupivacaine up to 175 mg. These doses may be repeated up to once every three hours. In clinical studies to date, total daily doses up to 400 mg have been reported. Until further experience is gained, this dose should not be exceeded in 24 hours.

The following dosages have generally proved satisfactory and are recommended as a guide for use in the average adult. These dosages should be reduced for young, elderly or debilitated patients.

• Local Infiltration: 0.25%: up to max (mg)
• Epidural: 0.5%: 50-100 mg
• Epidural: 0.25%: 25-50 mg
• Caudal: 0.5%: 75-150 mg
• Caudal: 0.25%: 37.5-75 mg
• Peripheral Nerves: 0.5%: 25 mg to max.
• Peripheral Nerves: 0.25%: 12.5 mg to max.
• Sympathetic 0.25%: 50-125 mg

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.

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.

Bupivacaine injection should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when administered during lactation.

Local anaesthetics should only be employed by clinicians who are well versed in diagnosis and management of dose-related toxicity and other acute emergencies which might arise from the block to be employed, and then only after ensuring the immediate availability of oxygen, other resuscitative drugs, cardiopulmonary resuscitative equipment, and the personal resources needed for proper management of toxic reactions and related emergencies.

Should be given cautiously to the elderly, the debilitated and to children, to patients with epilepsy, impaired cardiac conductions, shock, liver damage and myasthenia gravis.

The lowest dosage of local anaesthetic that results in effective anaesthesia should be used to avoid high plasma levels and serious adverse effects. The rapid injection of a large volume of local anaesthetic solution should be avoided and fractional (incremental) doses should be used when feasible.

Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient's state of consciousness should be performed after each local anaesthetic injection. Because of the risk of systemic adverse effects when local anaesthetics are absorbed too rapidly, they should not be injected into inflamed or infected tissues and should not be applied to damaged mucosa.

Use in Children: Administration to children under 12 years of age is not recommended until further experience is gained in this group.

Keep in a cool & dry place, protected from light. Keep out of the reach of children.