Reactions to levobupivacaine are characteristic of those associated with other amide-type anesthetics. A major cause of the adverse reactions to this group of drugs is associated with excessive plasma levels, or high dermatomal levels, which may be due to overdose, unintentional intravascular injection, or slow metabolic degradation. Systems involved may include the central nervous system, the cardiovascular system, and the respiratory system (see Precautions).
Adverse events that occurred in levobupivacaine-treated patients are: Hypotension, nausea, postoperative pain, fever, vomiting, anemia, pruritus, pain, headache, constipation, dizziness, fetal distress, backpain, delayed delivery, abnormal ECG, enlarged abdomen, albuminemia, rigors, diplopia, hypoesthesia, flatulence, abdominal pain, hypothermia, bradycardia, dyspepsia, hematuria, hemorrhage in pregnancy, paresthesia, tachycardia, abnormal urine, purpura, increased wound drainage, coughing, leukocytosis, somnolence, urinary incontinence, local anesthesia, anxiety, breast pain (female), hypertension, decreased urine flow, urinary tract infection, diarrhea.
The following adverse events were also reported and were considered clinically relevant: See Table 2.
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The incidence of adverse neurological reactions associated with the use of local anesthetics may be related to the total dose of anesthetic administered and are also dependent upon the particular drug used, the route of administration, and the physical status of the patient. Many of these effects may be related to local anesthetic techniques, with or without contribution from the drug.
Allergic-type reactions are rare and may occur as a result of sensitivity to the local anesthetic. These reactions are characterized by signs such as urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and possibly, anaphylactoid-like symptomatology (including severe hypotension). Cross sensitivity among members of the amide-type local anesthetic group have been reported. Anaphylaxis has been reported. Very rare reports of convulsions have occurred following accidental intravenous administration. There have been reports of prolonged weakness or sensory disturbance, some of which may have been permanent, in association with levobupivacaine therapy. It is difficult to determine whether the long-term effects were the result of medication toxicity or unrecognized trauma during surgery or other mechanical factors, such as catheter insertion and manipulation.
Reports have been received of cauda equina syndrome or signs and symptoms of potential injury to the base of the spinal cord or spinal nerve roots (including lower extremity paresthesias, weakness or paralysis, loss of bowel control and/or bladder control and priapism) associated with levobupivacaine administration. These events were more severe and in some cases did not resolve when levobupivacaine was administered for greater than 24 hours (see Precautions). However, it cannot be determined whether these events are due to an effect of levobupivacaine, mechanical trauma to the spinal cord or spinal nerve roots, or blood collection at the base of spine.
There have also been reports of transient Homer's syndrome (ptosis, miosis, enophthalmus, unilateral sweating and/or flushing) in association with the use of regional anesthetics, including levobupivacaine. This event resolves with discontinuation of therapy.