The detection of sensitivity by skin testing is of doubtful value. The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic administration.
At the first sign of change, oxygen should be administered. The first step in the management of convulsions consists of immediate attention to the maintenance of a patent airway and assisted or controlled ventilation with oxygen and a delivery system capable of permitting immediate positive airway pressure by mask.
Immediately after the institution of these ventilatory measures, the adequacy of the circulation should be evaluated, keeping in mind that drugs used to treat convulsions sometimes depress the circulation when administered intravenously. Should convulsions persist despite adequate respiratory support, and if the status of the circulation permits, small increments of an ultra-short acting barbiturate such as thiopental or thiamylal or a benzodiazepine such as diazepam may be administered intravenously.
The clinician should be familiar, prior to use of local anesthetics, with these anticonvulsant drugs. Supportive treatment of circulatory depression may require administration of intravenous fluids and, when appropriate, a vasopressor as directed by the clinical situation e. If not treated immediately, both convulsions and cardiovascular depression can result in hypoxia, acidosis, bradycardia, arrhythmias and cardiac arrest.
If cardiac arrest should occur, standard cardiopulmonary resuscitative measures should be instituted. This is roughly equivalent to squeezing a six 6 inch length of ointment from the tube.
In a 70 kg adult this dose equals 3. No more than one-half tube, approximately 17 g to 20 g of ointment or mg to mg lidocaine base, should be administered in any one day. It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight.
For children less than ten years who have a normal lean body mass and a normal lean body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas e. For example a child of five years weighing 50 lbs. In any case, the maximum amount of lidocaine administered should not exceed 4. For medical use, apply topically for adequate control of symptoms. The use of a sterile gauze pad is suggested for application to broken skin tissue.
Apply to the tube prior to intubation. In dentistry, apply to previously dried oral mucosa. Subsequent removal of excess saliva with cotton rolls or saliva ejector minimizes dilution of the ointment, permits maximum penetration, and minimizes the possibility of swallowing the topical ointment. For use in connection with the insertion of new dentures, apply to all denture surfaces contacting mucosa.
Pharmacist: If dispensed to a consumer, provide child resistant package for dispensing. Hemodynamics Excessive blood levels may cause changes in cardiac output, total peripheral resistance, and mean arterial pressure. Pharmacokinetics and metabolism Lidocaine may be absorbed following topical administration to mucous membranes, its rate and extent of absorption depending upon the specific site of application, duration of exposure, concentration, and total dosage.
Lidocaine crosses the blood-brain and placental barriers, presumably by passive diffusion. Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Information for Patients When topical anesthetics are used in the mouth, the patient should be aware that the production of topical anesthesia may impair swallowing and thus enhance the danger of aspiration. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies of lidocaine in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted.
Use in Pregnancy Teratogenic Effects. Labor and Delivery Lidocaine is not contraindicated in labor and delivery. Nursing Mothers It is not known whether this drug is excreted in human milk. Pediatric Use Dosage in children should be reduced, commensurate with age, body weight and physical condition.
Cardiovascular system Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. Allergic Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Management of local anesthetic emergencies The first consideration is prevention, best accomplished by careful and constant monitoring of cardiovascular and respiratory vital signs and the patient's state of consciousness after each local anesthetic administration.
Impairment of Fertility. Teratogenic Effects. Pregnancy Category B. There are, however, no adequate and well-controlled studies in pregnant women. Lidocaine is not contraindicated in labor and delivery. Lidocaine is excreted in human milk, and the milk:plasma ratio of lidocaine is 0. Safety and effectiveness in pediatric patients have not been established.
Application Site Reactions. These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours. Allergic and anaphylactoid reactions associated with lidocaine, although rare, can occur.
They are characterized by angioedema, bronchospasm, dermatitis, dyspnea, hypersensitivity, laryngospasm, pruritus, shock, and urticaria. If they occur, they should be managed by conventional means.
The detection of sensitivity by skin testing is of doubtful value. Due to the nature and limitation of spontaneous reports in postmarketing 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. 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. Lidocaine overdose from cutaneous absorption is rare, but could occur. The management of overdose includes close monitoring, supportive care, and symptomatic treatment. Dialysis is of negligible value in the treatment of acute overdose with lidocaine.
In the absence of massive topical overdose or oral ingestion, evaluation of symptoms of toxicity should include consideration of other etiologies for the clinical effects, or overdosage from other sources of lidocaine or other local anesthetics.
Apply the prescribed number of patches maximum of 3 , only once for up to 12 hours within a hour period. Clothing may be worn over the area of application. Smaller areas of treatment are recommended in a debilitated patient, or a patient with impaired elimination. If irritation or a burning sensation occurs during application, remove the patch es and do not reapply until the irritation subsides.
Avoid contact with water, such as bathing, swimming, or showering. Do not store patch outside the sealed envelope. Apply immediately after removal from the protective envelope. Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Carton of 30 patches NDC packaged in individual child-resistant envelopes.
For more information, call Rhodes Pharmaceuticals L. Marketed by: Rhodes Pharmaceuticals L. DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed. DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use.
If you are using the prescription lidocaine 1. If the lidocaine 1. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. This medication is usually used as needed. If your doctor has told you to use lidocaine patches or topical systems regularly, apply the missed patch or topical system as soon as you remember it.
However, if it is almost time for the next dose, skip the missed patch and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.
Lidocaine transdermal may cause other side effects. Call your doctor if you have any unusual problems while using this medication. Keep this medication in the container it came in, tightly closed, and out of reach of children.
Store it at room temperature and away from excess heat and moisture not in the bathroom. Do not store patches and topical systems outside the sealed envelope. Fold used patches or topical systems so that the adhesive side sticks to itself and then safely discard into trash and where children and pets cannot get to them.
It is important to keep all medication out of sight and reach of children as many containers such as weekly pill minders and those for eye drops, creams, patches, and inhalers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location — one that is up and away and out of their sight and reach.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program.
If you wear too many lidocaine transdermal patches or topical systems or wear them for too long, too much lidocaine may be absorbed into your blood. In that case, you may experience symptoms of an overdose. In case of overdose, call the poison control helpline at If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at Do not let anyone else use your medication.
Ask your pharmacist any questions you have about refilling your prescription. It is important for you to keep a written list of all of the prescription and nonprescription over-the-counter medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements.
You should bring this list with you each time you visit a doctor or if you are admitted to a hospital.
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