Lidocaine (topical application route)


    Brand Name

    US Brand Name

    Anestacon

    Burnamycin

    Burn-O-Jel

    Lida Mantle

    Lidoderm

    LidoRx

    LMX 4

    LMX 5

    Senatec

    Solarcaine Cool Aloe

    Topicaine

    Xylocaine

    Canadian Brand Name

    Solarcaine First Aid Lidocaine Spray

    Solarcaine Lidocaine First Aid Spray


    Description

    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. Xylocaine® jelly is used to treat painful urethritis (inflammation of the urethra). It is also used to prevent and control pain in procedures involving the male and female urethra. Xylocaine® jelly is also used to lubricate the nose, mouth, and throat for intubation.

    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 nerve pain caused by herpes zoster or 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.

    This product is available in the following dosage forms:

    • Spray
    • Cream
    • Patch, Extended Release
    • Gel/Jelly
    • Ointment
    • Solution
    • Lotion
    • Pad
    • Swab
    • Powder

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Because of this medicine's toxicity, it should be used with extreme caution in children younger than 3 years of age, only after other medicines have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during treatment. Do not give lidocaine viscous topical solution for teething pain.

    Appropriate studies have not been performed on the relationship of age to the effects of lidocaine jelly or skin patch in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Ztlido® skin patch in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

    No information is available on the relationship of age to the effects of lidocaine topical in geriatric patients. However, because of this medicine's toxicity, it should be used with caution, after other medicines have been considered or found ineffective. Recommended doses should not be exceeded, and the patient should be carefully monitored during treatment.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Dronedarone
    • Saquinavir
    • Vernakalant

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Amifampridine
    • Amiodarone
    • Amprenavir
    • Arbutamine
    • Bupivacaine Liposome
    • Bupropion
    • Cobicistat
    • Darunavir
    • Dasabuvir
    • Delavirdine
    • Disopyramide
    • Donepezil
    • Encainide
    • Etravirine
    • Flecainide
    • Fosamprenavir
    • Fosphenytoin
    • Hyaluronidase
    • Lopinavir
    • Metoprolol
    • Mexiletine
    • Moricizine
    • Nadolol
    • Phenytoin
    • Procainamide
    • Propafenone
    • Quinidine
    • Sotalol
    • Succinylcholine
    • Telaprevir
    • Tocainide

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Cimetidine

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Glucose-6-phosphate dehydrogenase deficiency (G6PD) or
    • Heart problems or
    • Lung or breathing problems or
    • Methemoglobinemia (blood disorder), hereditary or idiopathic (unknown cause)—Use with caution. May increase risk of having methemoglobinemia.
    • Heart block or
    • Shock, severe—Use with caution.
    • Infection at or near the place of application or
    • Large sores, broken skin, or severe injury at the area of application or
    • Liver disease, severe or
    • Sepsis or
    • Traumatized mucosa, severe—Use with caution. The chance of side effects may be increased.

    Proper Use

    Use this medicine exactly as directed by your doctor. Do not use it for any other condition without first checking with your doctor. This medicine may cause unwanted effects if it is used too much, because more of it is absorbed into the body through the skin.

    This medicine should only be used for problems being treated by your doctor. Check with your doctor before using it for other problems, especially if you think that an infection may be present. This medicine should not be used to treat certain kinds of skin infections or serious problems, such as severe burns.

    This medicine should come with a patient information and instructions leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

    If you are using the topical jelly or ointment:

    • A nurse or other trained health care professional may give you this medicine before having a medical procedure.
    • Wash your hands with soap and water before and after using this medicine.
    • Unless otherwise directed by your doctor, do not apply this medicine to open wounds, burns, or broken or inflamed skin.
    • Be careful not to get any of the ointment in your eyes, because it can cause severe eye irritation. If any of the medicine does get into the eyes, wash the eyes with water for at least 15 minutes and check with your doctor right away.

    If you are using the viscous topical solution:

    • Wash your hands with soap and water before and after using this medicine.
    • Use an accurate measuring device to avoid using more than the prescribed amount of medicine.
    • If you are using this medicine in the mouth, swish the solution around inside the mouth and spit it out.
    • If you are using this medicine for the throat, gargle the undiluted solution. You may also swallow the solution.

    If you are using the skin patch:

    • Use this medicine exactly as directed by your doctor. It will work only if applied correctly.
    • This medicine should only be used on the skin. Do not get it into your eyes, nose, or mouth. If it does get on these areas, rinse it off with water or saline right away.
    • Wash your hands with soap and water before and after applying a patch.
    • Do not use the patch if it is damaged. Throw it away and get a new one.
    • Keep the patch in its protective envelope until you are ready to apply it. You may cut the patch into smaller sizes with scissors after removing the patch release liner.
    • Apply the patch to clean, dry, intact skin. Choose an area with little or no hair and free of scars, cuts, or irritation. Avoid putting the patch on areas where it could be rubbed off by tight clothing.
    • Put on a new patch if the old one has fallen off and cannot be reapplied.
    • Do not use the Lidoderm® patch when you take a bath, shower, or swim. Always keep the patch dry.
    • You may also use the Ztlido® patch during moderate exercise (eg, biking for 30 minutes).
    • Ztildo® patch may be worn in water (eg, showering for 10 minutes or bathing for 15 minutes). After exposure to water, you may pat the patch dry. Do not rub it.
    • You may apply up to 3 Ztlido® patches at a time. Do not wear the patch for longer than 12 hours in any 24-hour period.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For topical dosage form (ointment):
      • For pain and itching caused by minor skin conditions:
        • Adults—Apply to the affected area 3 or 4 times a day. The largest amount of ointment that should be used in a single application is 5 grams. If you use the 5% ointment, this is about 6 inches of ointment from the tube.
        • Children—Dose is based on body weight and must be determined by your doctor.
    • For topical dosage form (skin patch):
      • For pain caused by shingles:
        • Adults—Apply 1 to 3 patches to the painful area for up to 12 hours each day.
        • Children—Use and dose must be determined by your doctor.
    • For topical dosage form (solution):
      • For treatment of irritated or sore mouth or throat:
        • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 15 milliliters (mL) tablespoonful every 3 hours. Your doctor may adjust your dose as needed. Do not use more than 8 doses in a 24-hour period.
        • Children 3 years of age and older—Dose is based on body weight and must be determined by your doctor.
        • Children younger than 3 years of age—Dose is based on body weight and must be determined by your doctor. The dose should be no more than 1.2 mL applied to the immediate area with a cotton-tipped swab. Wait at least 3 hours between doses, and do not use more than 4 doses in a 12-hour period.

    Missed Dose

    If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

    If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.

    After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.


    Precautions

    It is very important that your doctor check you or your child's progress at regular visitsto make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

    If your symptoms do not improve within a few days or if they become worse, check with your doctor.

    This medicine may cause a rare, but serious blood problem called methemoglobinemia. The risk may be increased in children younger than 6 months of age, elderly patients, or patients with certain inborn defects. It is more likely to occur in patients receiving too much of the medicine, but can also occur with small amounts. Make sure you store this medicine out of reach of children. Call your doctor right away if you or your child has pale, gray, or blue-colored skin, lips, or nails, confusion, headache, lightheadedness, fast heartbeat, or unusual tiredness or weakness.

    Check with your doctor right away if you have a rash, burning, stinging, swelling, or irritation of your skin after using this medicine.

    After applying this medicine to the skin of your child, watch the child carefully to make sure that he or she does not get any of the medicine into their eyes or mouth. Lidocaine can cause serious side effects, especially in children, if it gets into the mouth and is swallowed.

    If you are using the viscous topical solution medicine in the mouth or throat, be aware of signs of toxicity. If you or your child experiences unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness, shallow breathing, or seizures after use of this medication, seek immediate medical attention and do not give any more doses.

    If you are using this medicine in the mouth or throat, do not eat or drink anything for at least 1 hour after using it. When this medicine is applied to these areas, it may cause swallowing and choking problems. Do not chew gum or food while your mouth or throat feels numb after you use this medicine. You may accidentally bite your tongue or the inside of your cheeks.

    Heat can cause the lidocaine in the patch to be absorbed into your body faster. This may increase the chance of serious side effects or an overdose. While you are using this medicine, do not use a heating pad, electric blanket, heat or tanning lamps, sauna, a sunlamp, or a heated water bed. Do not sunbathe. However, you may apply Ztlido® patch on the skin after exposure to moderate heat (eg, after 15 minutes of heating pad use on a medium setting).

    Do not use cosmetics or other skin care products on the treated skin areas.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    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:

    Rare

    • 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 genitals
    • noisy breathing
    • swelling of the eyelids, face, lips, hands, or feet
    • tightness in the chest
    • trouble breathing or swallowing

    Incidence not known

    • Blistering, bruising, burning, discoloration, itching, redness, or swelling at the application site
    • bluish-colored lips, fingernails, or palms
    • blurred vision
    • chest pain or discomfort
    • cold, clammy, or pale skin
    • confusion
    • dark urine
    • 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
    • headache
    • 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
    • rapid heart rate
    • seizures
    • shakiness in the legs, arms, hands, or feet
    • slow or irregular heartbeat
    • sore throat
    • stopping of the heart
    • trembling or shaking of the hands or feet
    • twitching
    • unusual bleeding or bruising
    • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

    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:

    Incidence not known

    • 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
    • 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.






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