Anesthetic, local (topical application, dental, buccal mucosa route, gargle)


    Description

    Dental anesthetics are used in the mouth to relieve pain or irritation caused by many conditions. Examples include toothache, teething, and sores in or around the mouth, such as cold sores, canker sores, and fever blisters. Also, some of these medicines are used to relieve pain or irritation caused by dentures or other dental appliances, including braces. However, if you have an infection or a lot of large sores in your mouth, check with your medical doctor or dentist before using a dental anesthetic because other kinds of treatment may be needed. Also, the chance of side effects is increased.

    One form of lidocaine is also used to relieve pain caused by certain throat conditions. Some forms of benzocaine, benzocaine and menthol combination, and dyclonine are also used to relieve sore throat pain.

    Some of these medicines are available only with your medical doctor's or dentist's prescription. Others are available without a prescription; however, your medical doctor or dentist may have special instructions on the proper use and dose for your medical problem. Some nonprescription (over-the-counter [OTC]) aerosols, gels, liquids, or ointments that contain a local anesthetic are not meant to be used in or around the mouth. If you have any questions about which product to use, check with your pharmacist.


    Before Using

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

    Children may be especially sensitive to the effects of dental anesthetics. This may increase the chance of unwanted effects, some of which can be serious, during treatment. When using a dental anesthetic for a child, be very careful not to use more of the medicine than directed on the label, unless otherwise directed by your health care professional. Teething medicines that contain benzocaine may be used in babies 4 months of age and older. One product that contains benzocaine (Orabase-B with Benzocaine) may be used in children 6 years of age and older. Most of the other nonprescription (over-the-counter [OTC]) medicines that contain a dental anesthetic may be used in children 2 years of age and older. However, these other nonprescription products should not be used in infants or children younger than 2 years of age unless prescribed by a health care professional.

    Geriatric

    Elderly people are especially sensitive to the effects of many local anesthetics. This may increase the chance of side effects during treatment, especially with lidocaine. Nonprescription (over-the-counter [OTC]) products containing local anesthetics are not likely to cause problems. However, elderly people should be especially careful not to use more medicine than directed on the package label, unless otherwise directed by a medical doctor or a dentist.

    Pregnancy

    Dental anesthetics have not been reported to cause birth defects or other problems in humans.

    Breastfeeding

    Dental anesthetics have not been reported to cause problems in nursing babies.

    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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

    • Dronedarone
    • Saquinavir
    • Vernakalant

    Using medicines in this class 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.

    • Acecainide
    • Alcuronium
    • Amifampridine
    • Amiodarone
    • Amprenavir
    • Arbutamine
    • Articaine
    • Atracurium
    • Benoxinate
    • Benzocaine
    • Benzyl Alcohol
    • Bretylium
    • Bupivacaine Liposome
    • Bupropion
    • Chloroprocaine
    • Cisatracurium
    • Cobicistat
    • Cocaine
    • Darunavir
    • Dasabuvir
    • Delavirdine
    • Dibucaine
    • Disopyramide
    • Dofetilide
    • Donepezil
    • Doxacurium
    • Dronedarone
    • Dyclonine
    • Encainide
    • Ethyl Chloride
    • Etidocaine
    • Etravirine
    • Fazadinium
    • Flecainide
    • Fosamprenavir
    • Fosphenytoin
    • Gallamine
    • Hexafluorenium
    • Hyaluronidase
    • Ibutilide

    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.


    Proper Use

    For safe and effective use of this medicine:

    • Follow your medical doctor's or dentist's instructions if this medicine was prescribed.
    • Follow the manufacturer's package directions if you are treating yourself.
    • Do not use more of this medicine, do not use it more often, and do not use it for a longer time than directed. To do so may increase the chance of absorption into the body and the risk of side effects. This is particularly important for young children and elderly patients, especially with lidocaine.
    • Dental anesthetics should be used only for conditions being treated by your medical doctor or dentist or for problems listed in the package directions. Do not use any of them for other problems without first checking with your medical doctor or dentist. These medicines should not be used if certain kinds of infections are present.

    To use the viscous (very thick) liquid form of lidocaine (e.g., Xylocaine Viscous):

    • This medicine may cause serious side effects if too much of it is swallowed. Be certain that you understand exactly how you are to use this medicine, and whether or not you are to swallow it. Follow your medical doctor's or dentist's directions very carefully. Also, be very careful to measure the exact amount of medicine that you are to use. Use a special measuring spoon to measure the amount; regular household teaspoons or soup spoons that you use at the table may not measure the amount correctly. These measures are especially important when this medicine is used for young children, who are especially sensitive to its effects.
    • If you are using this medicine for a problem in the mouth, you may apply it to the sore places with a cotton-tipped applicator. Or, you may swish the measured amount of medicine around in your mouth until you are certain that it has reached all of the sore places. Do not swallow the medicine unless your medical doctor or dentist has told you to do so.
    • If you are using this medicine for a problem in the throat, gargle with the measured amount of medicine as directed by your doctor. Do not swallow the medicine unless your doctor has told you to do so.

    To use benzocaine film-forming gel (e.g., Oratect Gel):

    • Children may find it difficult to apply this medicine correctly. They should be helped by an adult.
    • First, dry the area where the medicine is needed, using a swab included in the package.
    • Apply the gel to a second swab. Then roll the swab over the dried area.
    • Keep your mouth open and dry for about 30 to 60 seconds after applying the medicine. A film will form where you placed the medicine.
    • Do not remove the film. It will slowly disappear and should be gone about 6 hours after the medicine was applied.

    To use other gel or liquid forms of a dental anesthetic :

    • Apply the medicine to the sore places with a clean finger, a cotton-tipped applicator, or a piece of gauze.
    • When relieving pain caused by dentures or other dental appliances, do not apply this medicine directly to the appliance, and do not place the appliance in your mouth while the medicine is there, unless directed to do so by your dentist. Instead, apply the medicine to the sore areas in your mouth and wait until the pain is relieved. Then rinse your mouth with water before replacing the appliance.

    To use benzocaine dental paste (e.g., Orabase-B with Benzocaine):

    • Use a cotton-tipped applicator to dab small amounts of the medicine onto the sore places. Do not rub or try to spread the medicine with your finger while you are applying it, because the medicine will become crumbly and gritty.

    To use aerosol or spray forms of a dental anesthetic :

    • To help prevent unwanted effects, be very careful not to inhale (breathe in) the medicine. Also, do not spray the back of your mouth or throat with it unless your medical doctor or dentist directs you to do so.

    To use lozenge forms of benzocaine, benzocaine and menthol, or dyclonine:

    • These lozenges should be dissolved slowly in the mouth. Do not bite or chew them or swallow them whole. Before giving a lozenge to a young child, be sure that the child understands these directions and will follow them.

    Dosing

    The dose medicines in this class 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 these medicines. 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 benzocaine

    • For dental paste dosage form:
      • For sores in and around the mouth, sore gums, or pain caused by dental appliances:
        • Adults, teenagers, and children 6 years of age and older—Apply a small amount of the medicine to the painful areas.
        • Children up to 6 years of age—Use and dose must be determined by your health care professional.
    • For film-forming gel, liquid, and ointment dosage forms:
      • For sores in and around the mouth, toothache, sore gums, or pain caused by dental appliances:
        • Adults, teenagers, and children 2 years of age and older—Apply a small amount of medicine to the painful areas up to four times a day.
        • Children up to 2 years of age—Use and dose must be determined by your health care professional.
    • For gel dosage form:
      • For sores in and around the mouth, toothache, sore gums, or pain caused by dental appliances:
        • Adults, teenagers, and children 2 years of age and older—Apply a small amount of medicine to the painful areas up to four times a day.
        • Children up to 2 years of age—Use and dose must be determined by your health care professional.
      • For teething pain:
        • Children 2 years of age and older—Apply any strength of benzocaine gel to sore gums up to four times a day.
        • Infants and children 4 months to 2 years of age—Apply a small amount of the 7.5% or 10% benzocaine gel to sore gums up to four times a day.
        • Infants up to 4 months of age—Use and dose must be determined by your health care professional.
    • For lozenge dosage form:
      • For pain in the mouth or throat:
        • Adults and teenagers—One lozenge, dissolved slowly in the mouth every two hours as needed.
        • Children 2 years of age and older—One children's strength (5-milligram [mg]) lozenge, dissolved slowly in the mouth every two hours as needed.
        • Children up to 2 years of age—Use and dose must be determined by your health care professional.
    • For aerosol spray dosage form:
      • For pain in the mouth:
        • Adults and teenagers—One or 2 sprays, pointed at the sore places. Each spray should last about one second.
        • Children—Use and dose must be determined by your dentist.

    For benzocaine and menthol combination

    • For lozenge dosage form:
      • For pain in the mouth or throat:
        • Adults, teenagers, and children 2 years of age and older—One lozenge, dissolved slowly in the mouth every two hours as needed.
        • Children up to 2 years of age—Use and dose must be determined by your health care professional.

    For benzocaine and phenol combination

    • For gel dosage form:
      • For sores in and around the mouth, teething, toothache, sore gums, or pain caused by dental appliances:
        • Adults, teenagers, and children 2 years of age and older—Apply a small amount of medicine to the painful areas up to four times a day.
        • Children up to 2 years of age—Use and dose must be determined by your health care professional.
    • For liquid dosage form:
      • For sores in and around the mouth, toothache, sore gums, or pain caused by dental appliances:
        • Adults, teenagers, and children 2 years of age and older—Apply a small amount of medicine to the painful areas up to four times a day.
        • Children up to 2 years of age—Use and dose must be determined by your health care professional.

    For dyclonine

    • For lozenge dosage form:
      • For pain in the mouth or throat:
        • Adults and teenagers—One 2-milligram (mg) or 3-mg lozenge, dissolved slowly in the mouth every two hours as needed.
        • Children 2 years of age and older—One children's strength (1.2-mg) lozenge, dissolved slowly in the mouth every two hours as needed.
        • Children up to 2 years of age—Use and dose must be determined by your health care professional.

    For lidocaine

    • For dental liquid dosage form (e.g., Zilactin-L):
      • For sores on the lips and around the mouth:
        • Adults and teenagers—Apply to sores every one or two hours for the first three days. Then apply as needed.
        • Children—Dose must be determined by your health care professional.
    • For dental ointment dosage form:
      • For gum pain:
        • Adults—Apply a small amount of medicine to the sore places. Do not apply the ointment directly to dentures, braces, or other dental appliances, unless your dentist has directed you to do so.
        • Children—Use and dose must be determined by your health care professional.
    • For aerosol spray dosage form:
      • For pain in the mouth:
        • Adults and teenagers—Two sprays, pointed at the sore places. Do not use more than twenty sprays a day.
        • Children—Use and dose must be determined by your health care professional.
    • For viscous (very thick) solution dosage form (e.g., Xylocaine Viscous):
      • For pain in the mouth:
        • Adults and teenagers—One tablespoonful of medicine (or less), swished around in the mouth, then spit out. Or, apply a total of 1 tablespoonful (or less) to the sore places with a cotton-tipped applicator. This medicine should not be used more often than every three hours.
        • Children 3 years of age and older—Apply a small amount of medicine to the sore places with a cotton-tipped applicator. The largest amount that can be used must be determined by your health care professional.
        • Infants and children up to 3 years of age—Apply a total of one-fourth of a teaspoonful (or less) to the sore places with a cotton-tipped applicator. This medicine should not be used more often than every three hours.
      • For sore throat pain:
        • Adults and teenagers—One tablespoonful, used as a gargle. Swallow after gargling only if directed to do so by your doctor. Otherwise, spit out the medicine after gargling with it.
        • Children—Dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, take 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. Do not double doses.

    Storage

    Keep out of the reach of children.

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

    Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

    Do not keep outdated medicine or medicine no longer needed.


    Precautions

    Check with your medical doctor:

    • If you are using this medicine for a sore throat and your sore throat is severe or lasts for more than 2 days.
    • If other symptoms, such as fever, headache, skin rash, swelling, nausea, or vomiting, are also present.

    You may have a condition that needs other treatment.

    Check with your health care professional:

    • If you are using this medicine for pain or sores in or around the mouth and your condition does not get better within 7 days or gets worse.
    • If you notice other symptoms, such as swelling, rash, or fever.

    You may have a condition that needs other treatment

    Check with your dentist:

    • If you are using this medicine for a toothache. This medicine should not be used for a long time. It is meant to relieve toothache pain temporarily, until the problem causing the toothache can be corrected. Arrange for treatment as soon as possible.
    • If you are using this medicine to relieve pain caused by new dentures or other dental appliances. An adjustment to your appliance may be needed to prevent more soreness. Also, if your dentist has ordered you to apply this medicine to the appliance before inserting it or to keep the appliance in your mouth while using the medicine, he or she will want to make sure that the medicine is not causing any unwanted effects

    False test results may occur if benzocaine or lidocaine is present in your body when a certain laboratory test is done. This test uses a medicine called bentiromide (e.g., Chymex) to show how well your pancreas is working. You should not use any products containing benzocaine or lidocaine for about 72 hours (3 days) before this test is done.

    If you are using this medicine in the back of the mouth, or in the throat, do not eat or drink anything for one hour after using it. When this medicine is applied to these areas, it may interfere with swallowing and cause choking.

    Do not chew gum or food while your mouth or throat feels numb after you use this medicine. To do so may cause an injury. You may accidentally bite your tongue or the inside of your cheeks.


    Side Effects

    Check with your doctor immediately if any of the following side effects occur:

    Less common

    • Large swellings that look like hives on skin or in mouth or throat

    Signs and symptoms of too much medicine being absorbed by the body

    • Blurred or double vision
    • confusion
    • convulsions (seizures)
    • dizziness or lightheadedness
    • drowsiness
    • feeling hot, cold, or numb
    • headache
    • increased sweating
    • ringing or buzzing in the ears
    • shivering or trembling
    • slow or irregular heartbeat
    • troubled breathing
    • unusual anxiety, excitement, nervousness, or restlessness
    • unusual paleness
    • unusual tiredness or weakness

    Check with your doctor as soon as possible if any of the following side effects occur:

    Less common

    • Burning, stinging, swelling, or tenderness not present before treatment
    • skin rash, redness, itching, or hives in or around the mouth

    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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