Ultracaine Heavy0.5%+8%

Bupivacaine hydrochloride in dextrose injection (a "heavy" or hyperbaric solution) is indicated in adults for subarachnoid (intrathecal) injection to produce spinal anaesthesia for surgical procedures, including:

• Lower extremity and perineal procedures
• Lower abdominal procedures
• Urological and lower limb surgery, including hip surgery
• Caesarean section and other obstetric procedures

This medicine is administered only by, or under the direct supervision of, clinicians experienced in spinal anaesthesia, in a setting equipped to manage the acute complications that can arise from this procedure.

Contains bupivacaine hydrochloride and dextrose as active ingredients in a sterile solution for spinal (intrathecal) injection, commonly available as 15 mg bupivacaine hydrochloride with 165 mg dextrose per 2 mL ampoule (0.75% bupivacaine with 8.25% dextrose), among other available strengths and volumes. The dextrose content makes the solution denser (hyperbaric or "heavy") than cerebrospinal fluid, causing it to settle and spread predictably within the spinal canal according to the patient's positioning.

Bupivacaine with dextrose is a specialized local anaesthetic solution used specifically for spinal anaesthesia, injected directly into the fluid-filled space around the spinal cord to numb the lower body for surgery. The added dextrose makes the solution denser than the surrounding spinal fluid ("heavy" or hyperbaric), which allows the anaesthetist to control how far the numbing effect spreads by adjusting the patient's position immediately after injection. This is a specialized procedure performed only by trained anaesthesia personnel, given the significant risks of local anaesthetic toxicity and profound physiological effects (such as a sharp drop in blood pressure) that can accompany spinal anaesthesia.

Therapeutic Class: Local Anaesthetic (for Spinal Anaesthesia)

The dextrose content (8.25%) makes this solution significantly denser than cerebrospinal fluid, so once injected into the spinal fluid, it spreads according to gravity and the patient's position - for example, spreading to a higher spinal level if the patient is tilted head-down shortly after injection. The extent and duration of the resulting spinal block depend on the dose, the injection level, the patient's position during and shortly after injection, and individual patient factors, and can be difficult to predict precisely even in experienced hands.

• Administered only by, or under the direct supervision of, clinicians experienced in the technique of spinal anaesthesia and in the management of dose-related toxicity and other emergencies that may arise
• Given by subarachnoid (intrathecal) injection into the spinal fluid, at a specific vertebral level chosen by the anaesthetist
• Visually inspect the solution before use; do not administer if it is discoloured or contains visible particles
• Patient positioning immediately after injection is used to help control the spread and level of the resulting block, given the hyperbaric nature of the solution
• Mixing with any other local anaesthetic is not recommended, given insufficient data on such combinations
• Discard any unused portion after opening - this is a single-dose product
• Continuous monitoring of blood pressure, heart rate, and respiratory status is essential during and after administration

The following should be assessed and managed by the administering anaesthesia team:

• Other local anaesthetics given concurrently or recently: increases the risk of additive systemic toxicity; total cumulative local anaesthetic dose from all sources should be considered.
• Antiarrhythmic drugs with local anaesthetic properties (such as lidocaine used elsewhere, or class I antiarrhythmics): may have additive cardiac effects if significant systemic bupivacaine absorption occurs.
• Drugs that lower seizure threshold: may increase the risk of central nervous system toxicity if significant systemic bupivacaine levels occur.
• Vasopressors used to manage the low blood pressure commonly associated with spinal anaesthesia: are used as part of routine management by the anaesthesia team.

Expected effects of spinal anaesthesia

• Temporary loss of sensation and motor function in the lower body, including the inability to move the legs, which is the intended effect and resolves as the block wears off
• Low blood pressure (a common, expected physiological response to the sympathetic nerve block, managed by the anaesthesia team with fluids and/or medication)
• Bladder dysfunction requiring temporary catheterization

Common side effects

• Nausea, vomiting
• Headache (including post-dural-puncture headache)
• Shivering
• Backache at the injection site

Serious side effects (require prompt medical attention)

• Local anaesthetic systemic toxicity (LAST): if significant systemic absorption occurs, symptoms can include numbness around the mouth, metallic taste, ringing in the ears, visual disturbances, muscle twitching, seizures, and, in severe cases, cardiac arrhythmias or cardiac arrest; this requires immediate specialized emergency treatment.
• Cardiac arrest with epidural (not spinal) use of higher-concentration bupivacaine has been specifically reported in obstetric anaesthesia in the past, which is part of why appropriate concentration selection and technique matter significantly.
• High or total spinal block: if the anaesthetic spreads higher than intended, this can cause difficulty breathing, very low blood pressure, or loss of consciousness, requiring immediate resuscitation and respiratory support.
• Methemoglobinemia (rare): pale, gray, or blue-coloured skin, headache, rapid heart rate, shortness of breath, dizziness, or fatigue - a serious condition requiring prompt medical attention.
• Persistent numbness, weakness, or neurological symptoms beyond the expected duration of the block should be reported promptly.

Pregnancy

This formulation is specifically used for certain obstetric procedures, including Caesarean section, under the direct supervision of an experienced anaesthetist; doses are generally reduced in late pregnancy given increased sensitivity to local anaesthetics and altered spread within the spinal canal at this stage. A paracervical block technique using bupivacaine is specifically avoided given the risk of fetal bradycardia.

Breastfeeding

Bupivacaine used for a single spinal anaesthesia procedure is generally considered compatible with breastfeeding once the mother has recovered from the procedure and any sedating effects, given limited systemic absorption from correctly performed spinal anaesthesia; discuss timing with your care team if you plan to breastfeed shortly after the procedure.

• Must be administered only by clinicians experienced in spinal anaesthesia, in a setting equipped to manage acute complications, including local anaesthetic systemic toxicity, high spinal block, and severe hypotension.
• Use reduced doses in patients with impaired cardiovascular function (such as hypotension, heart block, or valvular abnormalities), given their reduced ability to compensate for the physiological changes associated with spinal anaesthesia.
• Use reduced doses in the elderly and in late pregnancy, given altered spread and increased sensitivity.
• Continuous monitoring of vital signs is essential throughout the procedure and recovery period.
• Do not mix with other local anaesthetics, given insufficient data on the safety of such combinations.
• Discuss with patients in advance that temporary loss of sensation and movement in the lower body is an expected part of the procedure.

Excessive dose, unintended intravascular injection, or unusually rapid systemic absorption can cause local anaesthetic systemic toxicity (LAST), with early signs including numbness around the mouth, metallic taste, tinnitus, and visual disturbances, potentially progressing to seizures, cardiac arrhythmias, and cardiac arrest. This is a medical emergency requiring immediate specialized treatment, including airway management, seizure control, and, for cardiac toxicity, specific management including intravenous lipid emulsion therapy, following established local anaesthetic systemic toxicity protocols, provided by the anaesthesia and resuscitation team.

Store at controlled room temperature, protected from light and freezing, as directed on the product label. Discard any unused portion after opening, since this is a single-dose, preservative-free product.

• Elderly: Require reduced doses, given altered spread of the hyperbaric solution and increased sensitivity to local anaesthetics and their cardiovascular effects.
• Late pregnancy: Require reduced doses, given altered anatomy and physiology affecting local anaesthetic spread and sensitivity at this stage.
• Patients with cardiovascular impairment: Require reduced doses and closer monitoring, given a reduced ability to compensate for the sympathetic blockade and blood pressure changes associated with spinal anaesthesia.
• Children: Used for spinal anaesthesia in some settings, per specific pediatric anaesthesia protocols and weight-based dosing.

This is a single-dose injection used for the duration of a specific surgical procedure; the resulting spinal block typically provides anaesthesia for approximately 1.5 to 3 hours depending on the dose and procedure, after which sensation and movement gradually return. It is not used for ongoing or repeated dosing in the way that a systemic medicine would be.

Drug Class: Amide-type local anaesthetic, hyperbaric (dextrose-containing) formulation

Bupivacaine works by reversibly blocking voltage-gated sodium channels in nerve cell membranes, which prevents the generation and conduction of nerve impulses. When injected into the spinal fluid, it blocks nerve signal transmission at the level of the spinal nerve roots, producing a temporary loss of sensation and, depending on the dose and level achieved, temporary loss of motor function in the areas of the body served by the blocked nerves - typically the lower half of the body for spinal anaesthesia.

This formulation is used for spinal anaesthesia in children of all ages in some clinical settings, with dosing determined by a pediatric anaesthesia specialist based on the child's weight, the specific procedure, and individual clinical factors.