This combination intrathecal (intraspinal) injection is indicated for:

• Lower abdominal surgeries, including cesarean section
• Urological procedures
• Lower limb surgeries, including hip surgery, lasting approximately 1.5 to 3 hours

It is also used for spinal (subarachnoid) anesthesia in surgical and obstetrical procedures. This preparation produces effective motor blockade of the abdominal muscles, making it suitable for abdominal surgeries of about 1.5–2 hours duration. The duration of motor blockade generally does not exceed the duration of analgesia.

Each 4 mL injection contains:

• Bupivacaine Hydrochloride USP 20 mg
• Dextrose Anhydrous USP 320 mg

Bupivacaine is a long-acting amide-type local anesthetic. Bupivacaine spinal (5 mg/mL) is a sterile solution designed for spinal use. It has a relatively rapid onset of action and provides analgesia lasting approximately 3 to 5 hours in the lower thoracic and lumbar regions, making it suitable for prolonged procedures involving the lower limbs. It produces profound muscle relaxation in the lower limbs, lasting about 3 to 4 hours, which is slightly shorter than the duration of sensory blockade. The cardiovascular effects are similar to or less pronounced than other spinal anesthetics. Bupivacaine is generally well tolerated by tissues at the site of administration.

The following dosage recommendations should be regarded as a guide for use in the average adult:

Spinal anesthesia for surgery: 2-4 ml (10-20 mg Bupivacaine hydrochloride) The patient's physical status and concomitant medication should be considered when deciding the dose, and the lowest dose required for adequate anesthesia should be used. Duration varies with dose, while segmental spread may be difficult to predict, especially with the isobaric (plain) solution. The dose should be reduced in the elderly and in patients in the late stages of pregnancy.

Pediatrics: Bupivacaine may be used in children. One of the differences between small children and adults is a relatively high CSF volume in infants and neonates, requiring a relatively larger dose/kg to produce the same level of block as compared to adults.
▪ <5 kg: 0.40–0.50 mg/kg
▪ 5 to 15 kg: 0.30–0.40 mg/kg
▪ 15 to 40 kg: 0.25–0.30 mg/kg

Bupivacaine should be used with caution in patients receiving antiarrhythmic drugs that possess local anesthetic activity, as their toxic effects may be additive. Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine.

General contraindications associated with intrathecal anesthesia must always be considered. Known allergy or hypersensitivity to amide-type local anesthetics is a contraindication, and skin testing for suspected sensitivity has limited reliability.

• Conditions involving active disease of the cerebrospinal system—such as meningitis, primary or secondary tumors, poliomyelitis, subacute combined degeneration of the spinal cord, cranial hemorrhage, demyelinating disorders, or increased intracranial pressure—preclude its use.
• Spinal stenosis, as well as active disease or recent injury of the vertebral column, are also contraindications.

Relative: Arthritis and other vertebral column disorders may present technical challenges in administering spinal injection and are therefore considered relative contraindications.

The adverse effect profile is similar to other long-acting intrathecal local anesthetics. Adverse reactions may result from the drug itself or from the physiological effects of nerve blockade (e.g., hypotension, bradycardia, temporary urinary retention). They may also occur due to procedural complications such as nerve injury, epidural abscess, or cerebrospinal fluid leakage.

Bupivacaine has been widely used in pregnant women without evidence of increased risk of fetal abnormalities. Dose adjustment is recommended in late pregnancy. At recommended doses, only small amounts pass into breast milk, which are unlikely to affect the infant.

Local anesthetics may react with certain metals, releasing ions that can cause local irritation if injected. Ampoules are intended for single use only; any remaining solution should be discarded. The solution should be used immediately after opening, and any discolored solution must not be used.

Acute toxicity is usually associated with high plasma concentrations. However, since spinal doses are relatively small, systemic toxicity is rare. In cases of accidental intravascular injection, toxic symptoms may appear within 1–3 minutes. In overdose, peak plasma levels may be delayed (20–30 minutes), and toxic effects may involve the central nervous system and cardiovascular system.

Regional anesthesia

Store below 30°C in a dry place, protected from light.