Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
Application Site Reactions During or immediately after treatment with Lidothol Gel, the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation.
These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours.
Other Adverse Events Due to the nature and limitation of spontaneous reports in post marketing surveillance, causality has not been established for additional reported adverse events including: Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor.
Systemic (Dose-Related) Reactions Systemic adverse reactions following appropriate use of Lidothol Gel are unlikely, due to the small dose absorbed (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
Systemic adverse effects of lidocaine is similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest).
Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness.
Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.
Sensitivity reactions associated with the use of mentholated products have been reported.
Use of mentholated nasal drops in infants has evidently caused isolated cases of spasm of the larynx, and a few cases of nervous or digestive system disturbance have been associated with excessive inhalation or oral exposure to menthol
Medicines intended to be applied to the skin should not be swallowed.
Lidothol Gel is flammable.
Keep away from open flame.
You should never heat, microwave, or add the medicine to hot water.
Risk of Methemoglobinemia Cases of methemoglobinemia have been reported in association with lidocaine use.
Like all medications, Lidothol Gel can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: