Bupivacaine/ Dextrose

Registered South African indications:

• Spinal anaesthesia

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Intravenous administration

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Inexperienced clinician
• Hypovolaemia
• Massive ascites
• Large abdominal tumours
• Pleural effusion
• Partial or complete heart block

Forms avail. in SA and covered in this monograph: inj

Spinal anaesthesia 

Bupivacaine/ Dextrose monohydrate
20/320 (mg/4ml)

• Intrathecal: 1.5-4.0ml of the 0.5% solution

Spinal anaesthesia for subdiaphragmatic surgery

Bupivacaine/ Dextrose monohydrate
20/320 (mg/4ml)

• Intrathecal: 2.5-3.5ml of the 0.5% solution

Spinal anaesthesia for caesarean section

Bupivacaine/ Dextrose monohydrate
20/320 (mg/4ml)

• Intrathecal: 2.0-2.5ml of the 0.5% solution

Preservative-free solution should be used for all intrathecal injections

See additional prescribing points

Not indicated for use in children

Pregnancy

• Caution
• There is no evidence of untoward effects in human pregnancy. In large doses, there is evidence of decreased pup survival in rats and an embryological effect in rabbits if bupivacaine is administered in pregnancy. Bupivacaine should not, therefore, be given in early pregnancy unless the benefits are considered to outweigh the risks.  It should be noted that the dose should be reduced in patients in the late stages of pregnancy

Breastfeeding

• Caution
• Bupivacaine enters the mother's milk, but in such small quantities that there is no risk of affecting the child at therapeutic dose levels

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended
  Use with caution in the elderly; dose reduction may be required

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Post-dural puncture headache
• Paraesthesia
• Paresis
• Dysaesthesia
• Total spinal block
• Paraplegia
• Paralysis
• Neuropathy
• Arachnoiditis

Cardiovascular Disorders

• Hypotensin
• Bradycardia
• Cardiac arrest

Respiratory Disorders

• Respiratory arrest

Gastrointestinal Disorders

• Nausea and vomiting

Genitourinary Disorders

• Urinary retention
• Urinary incontinence

Musculoskeletal Disorders

• Muscle weakness
• Back pain

Immune, Blood and Lymphatic System Disorders

• Allergic reactions
• Anaphylaxis

• Antiarrhythmics (Class III)
• Local anaesthetic agents

• Vital signs
• Signs of central nervous system toxicity

Specific cases may require

• Cardiac monitoring

• Regional anaesthetic procedures should always be performed in a properly equipped and staffed area. Resuscitative equipment and drugs should be immediately available and the anaesthetist should remain in constant attendance
• Intravenous access should be in place before starting the intrathecal anaesthesia. The clinician responsible should take the necessary precautions to avoid intravascular injection and be appropriately trained and familiar with the diagnosis and treatment of side effects, systemic toxicity and other complications. If signs of acute systemic toxicity or total spinal block appear, injection of the local anaesthetic should be stopped immediately

Bupivacaine
Bupivacaine is a long acting local anaesthetic with both anaesthetic and analgesic effects. At high doses it produces surgical anaesthesia, while at lower doses it produces sensory block with less pronounced motor block. It causes reversible blockade of impulse propagation along nerve fibres by binding to sodium channels and preventing the inward movement of sodium ions through the cell membrane of the nerve fibres.

Dextrose
This ingredient has no pharmacological effect.

Injection (per ml) 5mg

• Macaine HCI 0.5% Spinal injection with Dextrose (Adcock)

Injection (per 4ml) 20mg

• Pharma-Q Bupivacaine Spinal with Dextrose (Pharma-Q)