Generic
Bupivacaine + Dextrose
9 brands available in the market
At a glance
Bupivacaine + Dextrose is an intraspinal injection used for intrathecal (subarachnoid, spinal) anesthesia for surgical and obstetrical procedures, including lower abdominal surgery (Caesarean section), urological, and lower limb surgery lasting 1.5 to 3 hours.
Description
Bupivacaine + Dextrose is a combination intraspinal injection used for intrathecal (subarachnoid, spinal) anesthesia for surgical and obstetrical procedures. Each 4 mL injection contains Bupivacaine Hydrochloride USP 20 mg and Dextrose Anhydrous USP 320 mg.
Bupivacaine is a long-acting amide-type local anesthetic. Bupivacaine spinal 5 mg/mL is a sterile non-glucose-containing solution with rapid onset of action. The duration of analgesia is 3-5 hours in the lower thoracic and lumbar segments, making it especially suitable for long-lasting lower limb procedures. Muscular relaxation of the lower limbs is profound and lasts 3-4 hours.
Indications
- Lower abdominal surgery (including Caesarean section)
- Urological surgery
- Lower limb and hip surgery (lasting 1.5-3 hours)
- Intrathecal (subarachnoid, spinal) anesthesia
- Surgical and obstetrical procedures
Therapeutic class
Regional anesthesia
Pharmacological class
Long-acting Amide-type Local Anesthetic + Hyperbaric Solution
Pharmacology
Bupivacaine is a long-acting amide-type local anesthetic that works by blocking sodium channels in neuronal cell membranes. It reduces neuronal membrane permeability to Na⁺ ions, inhibiting depolarization and blocking both the initiation and conduction of nerve impulses. Dextrose is a monosaccharide used as a source of calories and water for hydration, reducing loss of body protein and nitrogen, and promoting glycogen deposition in the liver.
Mechanism of action
Bupivacaine blocks sodium channels in nerve cell membranes, preventing Na⁺ influx, which inhibits depolarization and blocks pain signal transmission. Dextrose increases solution density, creating a hyperbaric solution that controls drug distribution in the subarachnoid space.
Dosage
Adults (Spinal anesthesia): 2-4 mL (10-20 mg Bupivacaine hydrochloride). Use the lowest dose required for adequate anesthesia, considering patient's physical status and concomitant medication. Reduce dose in elderly and late-stage pregnancy patients.
Children: Higher dose/kg required due to relatively high CSF volume in infants and neonates:
<5 kg: 0.40-0.50 mg/kg
5-15 kg: 0.30-0.40 mg/kg
15-40 kg: 0.25-0.30 mg/kg
Duration: Motor blockade of abdominal muscles lasts 1.5-2 hours; analgesia duration is 3-5 hours.
Note: Ampoules are for single use only; discard unused portions. Use solution immediately after opening. Do not use discolored solutions.
Administration
For intrathecal (intraspinal) administration only. Administered by healthcare professional. Patient should not self-administer.
Missed dose
Hospital-only medicine. Administered by doctor or anesthesiologist. Missed dose concept does not apply (procedure-related administration).
Side effects
CNS effects: Excitation (restlessness, dizziness, tinnitus, tremors) may be followed by depression (seizures, respiratory arrest).
Cardiovascular: Hypotension, bradycardia, arrhythmias, cardiac arrest.
Other: Methemoglobinemia, hypersensitivity reactions, prolonged block, edema, headache, hypoventilation, nausea, nervousness, palpitations, respiratory arrest, tachycardia, vomiting.
Potentially Fatal: Cardiac and sudden respiratory arrest.
Precautions & warnings
- For use by trained healthcare professionals only.
- Caution in hepatic disease, cardiovascular disease, children <12 years, pregnancy, elderly, and debilitated patients.
- Local anesthetics react with certain metals, releasing ions that may cause severe local irritation.
- Ampoules are for single use only; discard unused portions.
- Use solution immediately after opening. Do not use discolored solutions.
- Caution/contraindicated in active spinal diseases, recent trauma, meningitis, tumors, poliomyelitis, cranial hemorrhage, demyelinating disease, raised intracranial pressure, spinal stenosis.
Contraindications
- Allergy or hypersensitivity to amide-type local anesthetics
- Acute active diseases of the cerebrospinal system (meningitis, tumors, poliomyelitis, subacute combined degeneration, cranial hemorrhage, demyelinating disease, raised intracranial pressure)
- Spinal stenosis and active disease or recent trauma in the vertebral column
- IV regional anesthesia
- Paracervical block in obstetrics
- Spinal anesthesia in patients <18 years
- Lactation
- Solutions containing preservatives for caudal or epidural block
Drug interactions
- Other local anesthetics or agents structurally related to amide-type (lidocaine, mexiletine): Additive systemic toxic effects.
- Antiarrhythmic drugs: Increased risk of myocardial depression.
- Hyaluronidase: Enhanced adverse effects.
- Cimetidine and ranitidine: Decreased clearance and increased plasma concentrations.
- Beta-blockers and calcium channel blockers: Increased risk of adverse effects.
- Phenothiazines and butyrophenones: May reduce or reverse the pressor effect of epinephrine.
Food interactions
No food-related restrictions (parenteral administration).
Use in pregnancy
May be unsafe during pregnancy (Category C). Reduce dose in late-stage pregnancy. Many pregnant women have received this drug; no specific disturbances to the reproductive process (e.g., increased malformations) have been reported.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Limited data available. At recommended doses, bupivacaine enters breast milk in such small quantities that there is generally no risk to the breastfed child. With maternal serum levels up to 0.45 µg/mL during epidural use for vaginal delivery, bupivacaine was not detected in breast milk during the first 24 hours after delivery (detection limit 0.02 µg/mL).
Pediatric use
Can be used in children (see dosage section). Infants and neonates require relatively higher dose/kg due to higher CSF volume compared to adults.
Geriatric use
Reduce dose in elderly patients.
Renal / hepatic impairment
Caution in patients with hepatic and renal disease (drug metabolism and elimination may be affected).
Overdose effects
Systemic toxicity: Extremely unlikely with spinal anesthesia doses (20% or less of epidural doses); no reports. Accidental intravascular injection: toxic effects within 1-3 minutes. Overdose: peak plasma concentrations at 20-30 minutes; delayed toxic signs. Toxic reactions mainly involve CNS and cardiovascular systems.
Storage conditions
Store below 30°C in a dry place, protected from light.
Chemical structure
Bupivacaine Hydrochloride 20 mg + Dextrose Anhydrous 320 mg (per 4 mL injection)