Senatec Topical application

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 therapy. 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 skin patch in the pediatric population. Safety and efficacy have not been established.

Geriatric

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 therapy.

Interactions with Medicines

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 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.

• Amiodarone

Interactions with Food/Tobacco/Alcohol

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:

• 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—Use with caution. The chance of side effects may be increased.

This section provides information on the proper use of a number of products that contain lidocaine. It may not be specific to Senatec. Please read with care.

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.

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 in 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 of an accurate measuring device is recommended, to avoid using more than the prescribed amount of medicine.
• If you are using this medicine in the mouth, swish the solution around in the mouth and spit it out.
• If you are using this medicine in 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 in 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.
• Keep the patch in its protective envelope until you are ready to put it on. You may cut the patch into smaller sizes with scissors after removing the patch release liner.
• Apply the patch to a 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 patch when you take a bath, shower, or swim. Always keep the patch dry.

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 three or four 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.

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.