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warnings
WARNINGS: For topical use only. Excessive dosage, or short intervals between doses, can result in high plasma levels and serious adverse effects. Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines. Lidocaine Ointment 5% should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application, since under such conditions there is the potential for rapid systemic absorption. When using this product, • Avoid contact with eyes • Do not exceed recommended dosage unless directed by a doctor Stop use and ask a doctor or pharmacist if, • Allergic reaction occurs • Redness, irritation, swelling, pain or other symptoms begin or increase • Taking other medicines - cimetidine for stomach problems, propranolol for high blood pressure, anxiety or heart problems. Keep out of reach of children, If swallowed, get medical help or contact a Poison Control Center right away Pregnancy and breast-feeding, If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking any medicine. Driving and using machines, Lidocaine Ointment may cause drowsiness if it enters your blood stream. If affected, DO NOT drive or operate machinery.
ADVERSE REACTIONS: To report SUSPECTED ADVERSE REACTIONS, contact Medicap Laboratories LLC. at 1-800-494-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. • Adverse effects are very rare and dose-related, mostly result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. • The following types are those most commonly reported: Central nervous system - CNS manifestations are excitatory and/or depressant and may be characterized by light-headedness, drowsiness, nervousness, apprehension, euphoria, confusion, dizziness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. • Drowsiness is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. • Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. • An allergic reaction may occur (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives). This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.