Lidocream

Lidocaine is a local anesthetic (numbing medication). It works by blocking nerve signals in your body.

Lidocream (for use on the skin) is used to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches, or burns. This medicine is also used to treat rectal discomfort caused by hemorrhoids.

Lidocream may also be used for purposes not listed in this medication guide.

An overdose of numbing medicine can cause fatal side effects if too much of the medicine is absorbed through your skin.

Do not use large amounts of Lidocream, or cover treated skin areas with a bandage or plastic wrap without medical advice.

Keep both used and unused lidocaine skin patches out of the reach of children or pets. The amount of lidocaine in the skin patches could be harmful to a child or pet who accidentally sucks on or swallows the patch.

You should not use Lidocream if you are allergic to any type of numbing medicine.

Fatal overdoses have occurred when numbing medicines were used without the advice of a medical doctor (such as during a cosmetic procedure like laser hair removal). However, overdose has also occurred in women treated with a numbing medicine before having a mammography.

Be aware that many cosmetic procedures are performed without a medical doctor present.

To make sure Lidocream is safe for you, tell your doctor if you have:

• liver disease; or

• if you take a heart rhythm medicine.

Lidocream is not expected to harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether Lidocream passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Since Lidocream is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe burning, stinging, or irritation where the medicine was applied;

• swelling or redness;

• sudden dizziness or drowsiness after medicine is applied;

• confusion, blurred vision, ringing in your ears; or

• unusual sensations of temperature.

Common side effects include:

• mild irritation where the medication is applied; or

• 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 Lidocream) 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, 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
• loss of consciousness
• 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 the heart
• trembling or shaking of the hands or feet
• twitching
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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

For Healthcare Professionals

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]