Lidoderm Topical application

In the U.S.

• Anestacon
• Burnamycin
• Burn-O-Jel
• Lida Mantle
• Lidoderm
• LidoRx
• LMX 4
• LMX 5
• Senatec
• Solarcaine Cool Aloe
• Topicaine
• Xylocaine

In Canada

• Solarcaine First Aid Lidocaine Spray
• Solarcaine Lidocaine First Aid Spray

Available Dosage Forms:

• Foam
• Dressing
• Cream
• Pad
• Patch, Extended Release
• Ointment
• Lotion
• Gel/Jelly
• Spray
• Solution
• Powder
• Aerosol Liquid

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Amide

Lidocaine topical jelly or ointment is used on different parts of the body to cause numbness or loss of feeling for patients having certain medical procedures. It is also used to relieve pain and itching caused by conditions such as sunburn or other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, minor cuts, or scratches.

Lidocaine viscous topical solution is also used to treat sore mouth or throat and also reduce gagging during the taking of X-ray pictures and dental impressions.

Lidocaine skin patch is used to relieve pain caused by shingles (postherpetic neuralgia).

Lidocaine belongs to the family of medicines called local anesthetics. This medicine prevents pain by blocking the signals at the nerve endings in the skin. This medicine does not cause unconsciousness as general anesthetics do when used for surgery.

This medicine is available only with your doctor's prescription.

Along with its needed effects, a medicine 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:

• 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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Get emergency medical help if you have any of these signs of an allergic reaction to Lidoderm: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Lidoderm and call your doctor at once if you have any of these serious side effects:

• uneven heartbeats;

• drowsiness, confusion;

• tremors, seizure (convulsions); or

• blurred vision.

Less serious Lidoderm side effects include:

• mild irritation, redness, or swelling where the medication is applied;

• numbness in places where the medicine is accidentally applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 Lidoderm) 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

Applies to lidocaine topical: intradermal device, mucous membrane solution, mucous membrane spray, topical cream, topical film, topical gel, topical gel with applicator, topical kit, topical liquid, topical lotion, topical ointment, topical solution, topical spray, topical stick

General

The most common adverse events were administration site reactions: burning, dermatitis, erythema, pruritus, rash, skin irritation, and vesicles.[Ref]

Dermatologic

Very common (10% or more): Erythema (up to 67.3%), petechiae (up to 46.4%)
Common (1% to 10%): Pruritus, rash
Uncommon (0.1% to 1%): Skin lesion, skin injury
Frequency not reported: Flushing, cutaneous lesions, urticaria, dermatitis[Ref]

Local

Very common (10% or more): Administration site reactions
Common (1% to 10%): Irritation, redness, itching, application site erythema, application site burning, application site pain, application site pruritus, edema
Uncommon (0.1% to 1%): Venipuncture site hemorrhage, burning sensation
Frequency not reported: Locus of abnormal sensation, paleness (pallor or blanching), alteration in temperature sensation, blisters, bruising, depigmentation, dermatitis, discoloration, exfoliation, papules, petechiae, vesicles, application site dermatitis, application site vesicles, skin irritation[Ref]

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness
Frequency not reported: Lightheadedness, nervousness, apprehension, euphoria, confusion, drowsiness, tinnitus, nystagmus, headache, nausea, vomiting, sensations of heat, cold or numbness, twitching, tremors, paraesthesia, convulsions, unconsciousness, respiratory depression and arrest, pain and/or dysesthesia in the buttocks or legs, unconsciousness
Postmarketing reports: Headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, somnolence, taste alteration[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting[Ref]

Immunologic

Common (1% to 10%): Nasopharyngitis[Ref]

Hypersensitivity

Very rare (less than 0.01%): Anaphylactic reaction, hypersensitivity
Frequency not reported: Anaphylactoid reactions, anaphylactic shock, angioedema, bronchospasm, shock, dyspnea, laryngospasm[Ref]

Cardiovascular

Frequency not reported: Bradycardia, hypotension, arrhythmia, cardiovascular collapse, cardiac arrest, AV block, myocardial depression[Ref]

Hematologic

Frequency not reported: Methemoglobinemia[Ref]

Ocular

Frequency not reported: Corneal irritation, blurred or double vision
Postmarketing reports: Visual disturbances[Ref]

Respiratory

Rare (less than 0.1%): Endotracheal tube occlusion
Frequency not reported: Sore throat, hoarseness, loss of voice[Ref]

Psychiatric

Frequency not reported: Confusion, psychosis, disorientation, dizziness[Ref]

Other

Postmarketing reports: Open wound, asthenia, pain exacerbated[Ref]

Some side effects of Lidoderm may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.