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Sensorcaine-MPF Spinal Side Effects

Generic Name: bupivacaine

Note: This document contains side effect information about bupivacaine. Some of the dosage forms listed on this page may not apply to the brand name Sensorcaine-MPF Spinal.

For the Consumer

Applies to bupivacaine: injection injectable, injection kit, injection solution

Along with its needed effects, bupivacaine (the active ingredient contained in Sensorcaine-MPF Spinal) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking bupivacaine:

Incidence not known
  • Anxiety
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • cold, clammy, pale skin
  • confusion
  • cough
  • difficulty swallowing
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • excitement
  • fast or irregular heartbeat
  • feeling sad or empty
  • general feeling of illness
  • hives, itching, skin rash
  • inability to breathe without assistance
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • nausea
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • restlessness
  • seizures
  • severe headache
  • shivering
  • slow heart rate
  • slowing of labor
  • stiff neck or back
  • sweating
  • tightness in the chest
  • trouble concentrating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
  • weakness of the muscles in your face

Some side effects of bupivacaine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Abnormal ejaculation
  • continuing ringing or buzzing or other unexplained noise in the ears
  • decrease in frequency and amount of urine
  • decreased sexual performance or desire
  • difficulty in passing urine [dribbling]
  • hearing loss
  • no sensation in the legs
  • numbness
  • painful urination
  • unable to move the legs

For Healthcare Professionals

Applies to bupivacaine: compounding powder, injectable kit, injectable solution, intrathecal solution, intravenous solution

General

The most frequently reported side effects are acute adverse experiences which demand immediate countermeasures are related to the central nervous system and the cardiovascular system. A major cause of adverse reactions is excessive plasma levels, which may be due to overdose, unintentional intravascular injection, or slow metabolic degradation. It is also difficult to distinguish adverse reactions caused by the drug per se from the physiological effects of the nerve block (e.g. decrease in blood pressure, bradycardia, temporary urinary retention), events caused directly (e.g. spinal hematoma) or indirectly (e.g. meningitis, epidural abscess) by needle puncture or events associated to cerebrospinal leakage (e.g. postdural puncture headache).[Ref]

Cardiovascular

Very common (10% or more): Hypotension, bradycardia
Common (1% to 10%): Hypertension
Rare (less than 0.1%): Cardiac arrest, cardiac arrhythmia
Frequency not reported: Cardiac output decreased, heart block, ventricular tachycardia, ventricular fibrillation, myocardium depression, cardiovascular collapse, maternal hypotension[Ref]

Nervous system

Common (1% to 10%): Paresthesia, postdural puncture headache, dizziness
Uncommon (0.1% to 1%): Paresis, dysesthesia, convulsion, circumoral paresthesia, unconsciousness, tremor, lightheadedness, dysarthria
Rare (less than 0.1%): Paraplegia, paralysis, neuropathy, arachnoiditis, total unintentional spinal block, peripheral nerve injury
Frequency not reported: Loss of sphincter control, meningismus, cranial nerve palsies, syncope, high/total spinal block, slurred speech, drowsiness, spinal hematoma[Ref]

Gastrointestinal

Very common (10% or more): Nausea
Common (1% to 10%): Vomiting
Frequency not reported: Fecal incontinence, swallowing difficult, numbness of tongue[Ref]

Local

Frequency not reported: Persistent anesthesia[Ref]

Genitourinary

Common (1% to 10%): Urinary retention, urinary incontinence
Frequency not reported: Loss of perineal sensation, loss of sexual function[Ref]

Respiratory

Rare (less than 0.1%): Respiratory depression
Frequency not reported: Respiratory arrest, laryngeal edema, sneezing, respiratory paralysis, hypoxia, hypercarbia[Ref]

Other

Uncommon (0.1% to 1%): Hyperacusis, tinnitus
Frequency not reported: Alkaline phosphatase increased, bilirubin increased, chills, weakness, septic meningitis, labor delayed, temperature elevated, forceps delivery increased, sensation of heat, cold/numbness[Ref]

Immunologic

Rare (less than 0.1%): Allergic reaction, anaphylactic shock
Frequency not reported: Anaphylaxis[Ref]

Ocular

Uncommon (0.1% to 1%): Vision disturbed
Rare (less than 0.1%): Diplopia
Frequency not reported: Blurred vision, pupils constricted[Ref]

Psychiatric

Frequency not reported: Restlessness, anxiety, depression, agitation, nervousness, apprehension, euphoria, confusion[Ref]

Hepatic

Frequency not reported: Hepatic dysfunction, ALT increased, AST increased[Ref]

Dermatologic

Frequency not reported: Urticaria, pruritus, erythema, angioedema, excessive sweating, cutaneous lesion[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Muscle weakness, back pain, muscle twitching
Frequency not reported: Joint pain, stiffness, loss of motion
Postmarketing reports: Chondrolysis[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Marcaine HCl (bupivacaine)." Hospira Inc, Lake Forest, IL.

4. "Product Information. Bupivacaine Hydrochloride, Spinal (bupivacaine)." Claris Lifesciences Inc, North Brunswick, NJ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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