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warnings and cautions
WARNINGS AND PRECAUTIONS Do not use on patients with a known sensitivity to benzocaine or p-aminobenzoate compounds. Do not use on children under the age of 2 without the consent of a doctor as safety and efficacy have not been confirmed. Keep out of reach of children. Methemoglobinemai Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase efficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobinemia levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Lolicaine Topical Anesthetic Gel/Liquid – 20% Benzocaine and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. DRUG INTERACTIONS Patients that are administered local anesthetics may be at increased risk of developing methemoglobinemia when concurrently exposed to the following oxidizing agents: Class Examples Nitrates/Nitrites Nitroglycerin, nitroprusside, nitric oxide, nitrous oxide Local anesthetics Benzocaine, lidocaine, bupivacaine, mepivacaine, tetracaine, prilocaine, procaine, articaine, ropivacaine Antineoplastic agents Cyclophosphamide, flutamide, rasburicase, ifosfamide, hydroxyurea Antibiotics Dapsone, sulfonamides, nitrofurantoin, paraaminosalicylic acid Antimalarials Chloroquinone, primaquine Anticonvulsants Phenytoin, sodium valproate, phenobarbital Other drugs Acetaminophen. Metoclopramide, sulfa drugs (i.e. sulfasalazine), quinine PATIENT COUNSELING INFORMATION Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis) ; headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.
ADVERSE REACTIONS All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with benzocaine gel. Seek medical attention right away if any of these SEVERE side effects occur: Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); mouth burning, irritation, redness, swelling, or tenderness; pale, gray or blue colored skin as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider.