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Indications & Uses
Bupivacaine Hydrochloride + Dextrose intraspinal injection is used for lower abdominal surgery (including Caesarean section), urological and lower limb surgery, including hip surgery, lasting 1.5 to 3 hours. It is given as intrathecal (subarachnoid, spinal) anesthesia for surgical and obstetrical procedures. Vaspine intraspinal injection is indicated for the same uses: lower abdominal surgery (including Caesarean section), urological and lower limb, including hip surgery, lasting 1.5 to 3 hours, and intrathecal (subarachnoid, spinal) anesthesia for surgical and obstetrical procedures. Bupivacaine Hydrochloride + Dextrose produces motor blockade of the abdominal muscles, and this makes the solution suitable for abdominal surgery lasting 1.5 to 2 hours. The motor blockade does not last longer than the analgesia.
Pharmacology
Bupivacaine is a long acting local anesthetic of the amide type. Bupivacaine spinal 5 mg/ml is a sterile solution that contains no glucose. It starts working quickly, and the analgesia lasts 3 to 5 hours in the lower thoracic and lumbar segments. That makes Bupivacaine spinal especially suitable for long procedures on the lower limbs.
The muscle relaxation in the lower limbs is profound. It lasts 3 to 4 hours, which is somewhat shorter than the sensory blockade. The effects on the circulation are similar to those of other spinal agents, or less. Every tissue it comes in contact with tolerates it well.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The following doses are a guide for the average adult. For spinal anaesthesia for surgery, the dose of Bupivacaine Hydrochloride with dextrose is 2 to 4 ml (10 to 20 mg Bupivacaine hydrochloride). The patient's physical status and any other medicine they are taking should be considered when the dose is decided, and the lowest dose that gives adequate anaesthesia should be used. Duration varies with the dose. The segmental spread can be hard 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. Infants and neonates have a relatively high CSF volume compared with adults, so they need a relatively larger dose per kg to reach the same level of block. The doses are 0.40 to 0.50 mg/kg for children under 5 kg, 0.30 to 0.40 mg/kg for 5 to 15 kg, and 0.25 to 0.30 mg/kg for 15 to 40 kg.
Side Effects
Bupivacaine given into the spinal fluid (intrathecally) causes side effects much like those of other long acting local anesthetics given the same way. It's hard to tell which reactions come from the drug itself and which come from other things. These include the normal physiological effects of the nerve block, such as a fall in blood pressure, a slow heart rate (bradycardia) and temporary urinary retention. They also include injury caused directly by the needle, for example nerve trauma, or indirectly by the needle puncture, for example epidural abscess. Events linked to leakage of cerebrospinal fluid can add to the picture as well.
Cautions & Contraindications
Warnings & Precautions
Local anesthetics can react with certain metals and release metal ions, and if these are injected they may cause severe local irritation. The Bupivacaine Hydrochloride + Dextrose ampoules are for single use only, so throw away any solution that is left over. Use the solution straight after opening the ampoule. If the solution has changed colour, don't use it.
Contraindications
With Bupivacaine Hydrochloride + Dextrose, the general contraindications for intrathecal anesthesia should be taken into account. The absolute contraindications are allergy or hypersensitivity to amide type local anesthetics. Skin testing to detect suspected sensitivity is of limited value. Acute active diseases of the cerebrospinal system are also absolute contraindications. These include meningitis, tumours (primary or secondary), poliomyelitis, subacute combined degeneration of the spinal cord, cranial haemorrhage, demyelinating disease and raised intracranial pressure. Spinal stenosis, and active disease or recent trauma in the vertebral column, fall in the same group. Relative contraindications are arthritis and other diseases of the vertebral column, because they make a spinal injection technically difficult to perform.
Pregnancy & Breastfeeding
It's reasonable to assume that a large number of pregnant women, and women of child-bearing age, have been given Bupivacaine. No specific disturbances to the reproductive process have been reported so far, for example no increased incidence of malformations. The dose should be reduced in patients in the late stages of pregnancy. At the recommended doses, Bupivacaine enters breast milk in such small quantities that there is generally no risk of affecting the breast-fed child. When epidural use for vaginal delivery produced maternal serum levels of up to 0.45 g/mL, none could be detected in breast milk during the first 24 hours after delivery (detection limit 0.02 g/mL).
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
Emergencies from local anesthetics are usually linked to high plasma levels of the drug. The dose needed for spinal anesthesia with bupivacaine hydrochloride and dextrose is very small (20% or less of what epidural anesthesia needs), so acute systemic toxicity is extremely unlikely and has not been reported. If a local anesthetic is injected into a blood vessel by accident, the toxic effects show up clearly within 1 to 3 minutes. With an overdose it is different. Peak plasma concentrations may not be reached for 20 to 30 minutes, depending on the site of injection, and the toxic signs are delayed. The toxic reactions mainly affect the central nervous system and the cardiovascular system.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Keep Bupivacaine Hydrochloride + Dextrose in a dry place, at a temperature not above 30ºC. Protect it from light.
Drug Interactions
Common questions about Sivicaine Heavy 0.5%+8%
What is Sivicaine Heavy 0.5%+8% Intraspinal Injection?
Sivicaine Heavy 0.5%+8% Intraspinal Injection is a medicine that contains Bupivacaine Hydrochloride + Dextrose. It is made by Renata PLC. It belongs to the Regional anesthesia group of medicines.
What is Sivicaine Heavy used for?
Bupivacaine Hydrochloride + Dextrose intraspinal injection is used for lower abdominal surgery (including Caesarean section), urological and lower limb surgery, including hip surgery, lasting 1.5 to 3 hours. It is given as intrathecal (subarachnoid, spinal) anesthesia for surgical and obstetrical procedures.
What are the side effects of Sivicaine Heavy?
Bupivacaine given into the spinal fluid (intrathecally) causes side effects much like those of other long acting local anesthetics given the same way. It's hard to tell which reactions come from the drug itself and which come from other things.
Can I take Sivicaine Heavy during pregnancy or while breastfeeding?
It's reasonable to assume that a large number of pregnant women, and women of child-bearing age, have been given Bupivacaine. No specific disturbances to the reproductive process have been reported so far, for example no increased incidence of malformations. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Sivicaine Heavy?
Emergencies from local anesthetics are usually linked to high plasma levels of the drug. The dose needed for spinal anesthesia with bupivacaine hydrochloride and dextrose is very small (20% or less of what epidural anesthesia needs), so acute systemic toxicity is extremely unlikely and has not been reported. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Sivicaine Heavy?
Keep Bupivacaine Hydrochloride + Dextrose in a dry place, at a temperature not above 30ºC. Protect it from light.
Can I take other medicines with Sivicaine Heavy?
Some medicines can interact with Bupivacaine Hydrochloride + Dextrose, for example: Adrenaline. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Sivicaine Heavy?
Sivicaine Heavy is a prescription (Rx) medicine. Take it as your doctor advises.