Laryng-O-Jet

Lidocaine is a prescription medication used to prevent pain before procedures or to relieve pain due to certain conditions. Lidocaine belongs to a group of drugs called local anesthetics. These stop nerves from sending pain signals to the brain.

This medication comes in several topical forms, including a patch to be applied to the skin (transdermal), ointment, cream, and oral solution. Lidocaine is an ingredient in some over-the-counter topical pain relievers. This page refers to the prescription forms of lidocaine.

This medication is also available in an injectable form to be given directly into a vein (IV) or for infiltration and nerve block by a healthcare professional.

Common side effects of topical lidocaine include irritation at site of application. Common side effects of injectable lidocaine include confusion, nervousness, and numbness. Lidocaine may also cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how this medication affects you. 

Serious side effects have been reported with lidocaine. See the “Lidocaine Precautions” section.

Topical:

Common side effects of topical lidocaine include irritation at site of application, including burning, blisters, bruising, redness, or swelling at the site of application. Lidocaine ointment, gel, and cream, as well as the oral solution, may also cause vomiting, seizures, ringing in the ears, and irregular heartbeat. Lidocaine ophthalmic gel may cause headache or bloodshot eyes.

Lidocaine may also cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how this medication affects you. 

Injectable:

Common side effects of injectable lidocaine include confusion, nervousness, numbness, blurred vision, irregular heartbeat, vomiting, seizures, ringing in the ears, headache, and shivering.

This is not a complete list of lidocaine side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. The dose and frequency of use of lidocaine will depend on the condition being treated or the procedure you will undergo.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

Do not use topical forms of lidocaine on broken or blistered skin.

Do not swallow the oral solution of lidocaine. Swish and/or gargle in your mouth and/or throat and spit out the solution.

Rx Only

Lidocaine HCI Topical Solution, 4% is indicated for the production of topical anesthesia of the mucous membranes of the respiratory tract.

General:

The safety and effectiveness of lidocaine depend on proper dosage, correct technique, adequate precautions, and readiness for emergencies. Resuscitative equipment, oxygen and other resuscitative drugs should be available for immediate use. (See “WARNINGS” and “ADVERSE REACTIONS”.) The lowest dosage that results in effective anesthesia should be used to avoid high plasma levels and serious adverse effects. Repeated doses of lidocaine may cause significant increases in blood levels with each repeated dose because of slow accumulation of the drug or its metabolites. Tolerance to elevated blood levels varies with the status of the patient. Debilitated, elderly patients, acutely ill patients, and children should be given reduced doses commensurate with their age and physical status. Lidocaine should also be used with caution in patients with severe shock or heart block.
    Careful and constant monitoring of cardiovascular and respiratory (adequacy of ventilation) vital signs and the patient’s state of consciousness should be accomplished after each local anesthetic injection. It should be kept in mind at such times that restlessness, anxiety, tinnitus, dizziness, blurred vision, tremors, depression or drowsiness may be early warning signs of central nervous system toxicity.
Since amide-type local anesthetics are metabolized by the liver, Lidocaine HCI Topical Solution should be used with caution in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. Lidocaine HCI Topical Solution should also be used with caution in patients with impaired cardiovascular function since they may be less able to compensate for functional changes associated with the prolongation of A-V conduction produced by these drugs.
    Many drugs used during the conduct of anesthesia are considered potential triggering agents for familial malignant hyperthermia. Since it is not known whether amide-type local anesthetics may trigger this reaction and since the need for supplemental general anesthesia cannot be predicted in advance, it is suggested that a standard protocol for management should be available. Early unexplained signs of tachycardia, tachypnea, labile blood pressure and metabolic acidosis may precede temperature elevation. Successful outcome is dependent on early diagnosis, prompt discontinuance of the suspect triggering agent(s) and institution of treatment, including oxygen therapy, indicated supportive measures and dantrolene (consult dantrolene sodium intravenous package insert before using).
    Lidocaine should be used with caution in persons with known drug sensitivities. Patients allergic to para-amino-benzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross     sensitivity to lidocaine.

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. For this reason, food should not be ingested for 60 minutes following use of local anesthetic preparations in the mouth or throat area. This is particularly important in children because of their frequency of eating.
    Numbness of the tongue or buccal mucosa may enhance the danger of unintentional biting trauma. Food and chewing gum should not be used while the mouth or throat area is anesthetized.

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: Pregnancy Category B

Reproduction studies have been performed in rats at doses up to 6.6 times the human dose and have revealed no evidence of harm to the fetus caused by lidocaine. There are, however, no adequate and well-controlled studies in pregnant women. Animal reproduction studies are not always predictive of human response. General consideration should be given to this fact before administering lidocaine to women of childbearing potential, especially during early pregnancy when maximum organogenesis takes place.
    Labor and delivery: Lidocaine is not contraindicated in labor and delivery. Should Lidocaine HCI Topical Solution be used concomitantly with other products containing lidocaine, the total dose contributed by all formulations must be kept in mind.
    Nursing mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when lidocaine is administered to a nursing woman.
    Pediatric use: Dosages in children should be reduced, commensurate with age and body weight. See “DOSAGE AND ADMINISTRATION.”

Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may 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. Serious adverse experiences are generally systemic in nature.
The following types are those most commonly reported:
Central Nervous System: CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, 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. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest.
Drowsiness following the administration of lidocaine is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption.
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. Allergic reactions as a result of sensitivity to lidocaine are extremely rare and, if they occur, should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value.
Neurologic: The incidences of adverse reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration and the physicalstatus of the patient.

Applies to lidocaine topical: topical application aerosol liquid, topical application cream, topical application dressing, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment, topical application pad, topical application patch extended release, topical application powder, topical application solution, topical application spray

Along with its needed effects, lidocaine topical (the active ingredient contained in Laryng-O-Jet Spray) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lidocaine topical:

• Blistering, crusting, irritation, itching, or reddening of the skin
• cough
• cracked, dry, or scaly skin
• fast heartbeat
• fever
• hives or welts, itching, or skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy breathing
• swelling of the eyelids, face, lips, hands, or feet
• tightness in the chest
• troubled breathing or swallowing

• Blistering, bruising, burning, discoloration, itching, redness, or swelling at the application site
• blurred vision
• chest pain or discomfort
• cold, clammy, or pale skin
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness or dizziness
• false or unusual sense of well-being
• fear or nervousness
• irregular, fast or slow, or shallow breathing
• lethargy
• no blood pressure or pulse
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• shakiness in the legs, arms, hands, or feet
• slow heart rate
• slow or irregular heartbeat
• stopping of heart
• trembling or shaking of the hands or feet
• twitching
• unconsciousness
• unusual tiredness or weakness
• weakness

Some side effects of lidocaine topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bad, unusual, or unpleasant (after) taste
• change in taste
• cold or numbness
• confusion about identity, place, and time
• continuing ringing or buzzing or other unexplained noise in the ears
• double vision
• headache
• hearing loss
• heat sensation
• lack or loss of strength
• metallic taste
• sleepiness or unusual drowsiness