LIDOSYNC (lidocaine/methyl salicylate/menthol)

There are 2 contraindications. Absolute contraindication.

Contraindication List
Large open wound
Methemoglobinemia

There are 6 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Burns
Glucose-6-phosphate dehydrogenase (g6Pd) deficiency
Heart block
Hemolytic anemia from pyruvate kinase and g6PD deficiencies
Sepsis
Shock

There are 3 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Disease of liver
Respiratory depression
Seizure disorder

There are 33 severe adverse reactions.

More Frequent	Less Frequent
None.	Dermatitis due to topical drug

Rare/Very Rare

Acidosis Acute respiratory failure Anaphylaxis Angioedema Bradycardia Bronchospastic pulmonary disease Burns Cardiac arrest Cardiac arrhythmia CNS depression CNS toxicity Cyanosis Dyspnea Excitement Eyelid edema Facial edema Headache disorder Heart block Hypersensitivity drug reaction Hypotension Hypoxia Methemoglobinemia Periorbital edema Pharyngeal edema Respiratory depression Seizure disorder Skin ulcer Superficial skin ulcer Syncope Throat constriction Unconsciousness Urticaria

There are 25 less severe adverse reactions.

More Frequent	Less Frequent
Stinging of skin Treatment site sequelae	Blanching of skin Dry skin Edema Erythema Pruritus of skin Skin irritation Skin rash Stinging of skin Urticaria

Rare/Very Rare
Acute cognitive impairment Apprehension Blurred vision Dizziness Drowsy Euphoria Muscle fasciculation Nervousness Pruritus of skin Sensation of cold Sensation of warmth Tinnitus Tremor Vomiting

Lidocaine 5% patch has not been studied in pregnancy. The limited human data with the 1.8% patch are insufficient to inform a drug-associated risk for major birth defects and miscarriage.

Animal reproductionstudies found that subcutaneous administration of the drug at doses higher than recommended human doses during the period of organogenesis resulted in lower fetal weights. Some manufacturers recommend that lidocaine patches should be used during pregnancy only if clearly needed. Lidoderm patches have not been studied and are contraindicated in labor and delivery. If lidocaine patches are used concomitantly with other productscontaining lidocaine, total doses contributed by all formulations must be considered.

Lidocaine is excreted into humanmilk in low concentrations following topical application. Caution should be exercised whenlidocaine is administered to a nursing woman, especially when administered with other local anesthetics.

Clinical studies of lidocaine 1.8% patch did not include sufficient number of patients >=65 years of age to determine whether they respond differently from younger patients. No differences in response have been identified in other clinical experience.