LMX 4 (Topical application)

Lidocaine topical jelly or ointment is applied to different areas of the body to create numbness or loss of feeling for patients undergoing certain medical procedures. It is also used to ease pain and itching from conditions like sunburn, other minor burns, insect bites or stings, poison ivy, poison oak, poison sumac, minor cuts, or scratches. Xylocaine® jelly treats painful urethritis (inflammation of the urethra) and helps prevent and control pain during 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 used to treat a sore mouth or throat and to help reduce gagging during X-ray procedures and dental impressions.

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

Lidocaine is part of a group of medicines called local anesthetics. This medicine stops pain by blocking signals at the nerve endings in the skin. It does not cause unconsciousness like general anesthetics do when used for surgery.

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

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

If your symptoms do not improve within a few days or if they get worse, contact your doctor.

This medicine may cause a rare but serious blood problem called methemoglobinemia. The risk may be higher in children under 6 months of age, elderly patients, or patients with certain genetic defects. It is more likely to happen if patients take too much of the medicine, but it can also occur with small amounts. Keep this medicine out of reach of children. Call your doctor immediately 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.

Contact 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 your child's skin, watch them closely to ensure they do not get any of the medicine in their eyes or mouth. Lidocaine can cause serious side effects, especially in children, if it enters the mouth and is swallowed.

If you are using the viscous topical solution in the mouth or throat, be aware of signs of toxicity. If you or your child experiences unusual drowsiness, dullness, tiredness, weakness, feeling sluggish, shallow breathing, or seizures after using this medicine, seek immediate medical help 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. This medicine may cause problems with swallowing and choking. Do not chew gum or food while your mouth or throat feels numb after using this medicine, as you may accidentally bite your tongue or the inside of your cheeks.

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

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

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

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. Here are some important points to consider:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, like to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

This medicine can be toxic, so it should be used very carefully in children younger than 3 years old, and only if other medicines have not worked. Do not exceed the recommended doses, and watch the patient closely during treatment. Do not give lidocaine viscous topical solution for teething pain.

There have not been proper studies on how age affects the use of lidocaine jelly or skin patches in children. Safety and effectiveness have not been proven.

Geriatric

Studies have not shown any specific problems in elderly patients that would limit the use of Ztlido® skin patch. However, older adults are more likely to have age-related liver, kidney, or heart issues, which may require caution and possibly a dose adjustment for patients using this medicine.

There is no information on how age affects the use of lidocaine topical in elderly patients. Because of this medicine's toxicity, it should be used with caution, after considering or finding other medicines ineffective. Do not exceed the recommended doses, and monitor the patient closely during treatment.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these cases, your doctor might need to adjust the dose or take other precautions. When using this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been highlighted based on their potential significance and are not all-inclusive.

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

• Dihydroergotamine
• Dronedarone
• Saquinavir
• Vernakalant

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed, your doctor may change the dose or frequency of use for one or both 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 increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or frequency of use for one or both medicines.

• Cimetidine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating or with certain foods, as interactions may happen. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine works. Be sure to inform your doctor if you have any other medical issues, 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 the risk of developing methemoglobinemia.

• Heart block or
• Severe shock—Use with caution.

• Infection at or near the application site or
• Large sores, broken skin, or severe injury at the application area or
• Severe liver disease or
• Sepsis or
• Severe traumatized mucosa—Use with caution. The risk of side effects may be increased.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, 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.

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:

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

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Amide

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.