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USP DI Vol. II - ANESTHETICS (Dental)

ANESTHETICS (Dental)


Some commonly used brand names are:

In the U.S.?

  • Anbesol, Baby 1
  • Anbesol Maximum Strength Gel 1
  • Anbesol Maximum Strength Liquid 1
  • Anbesol Regular Strength Gel 3
  • Anbesol Regular Strength Liquid 3
  • Benzodent 1
  • Chloraseptic Lozenges 2
  • Chloraseptic Lozenges, Children's 1
  • Dentapaine 1
  • Dent-Zel-Ite 1
  • Hurricaine 1
  • Numzident 1
  • Num-Zit Gel 1
  • Num-Zit Lotion 1
  • Orabase, Baby 1
  • Orabase-B with Benzocaine 1
  • Orajel, Baby 1
  • Orajel Maximum Strength 1
  • Orajel Nighttime Formula, Baby 1
  • Oratect Gel 1
  • Rid-A-Pain 1
  • SensoGARD Canker Sore Relief 1
  • Spec-T Sore Throat Anesthetic 1
  • Sucrets, Children's 4
  • Sucrets Maximum Strength 4
  • Sucrets Regular Strength 4
  • Xylocaine 5
  • Xylocaine Viscous 5
  • Zilactin-L 5

In Canada?

  • Anbesol Baby Jel 1
  • Anbesol Gel 3
  • Anbesol Liquid 3
  • Anbesol Maximum Strength Liquid 3
  • Chloraseptic Lozenges Cherry Flavor 2
  • Dentocaine 1
  • Orajel, Baby 1
  • Orajel Extra Strength 1
  • Orajel Liquid 1
  • Topicaine 1
  • Xylocaine 5
  • Xylocaine Viscous 5

Other commonly used names are: dyclocaine ethyl aminobenzoate lignocaine

Note:

For quick reference, the following anesthetics are numbered to matchthe corresponding brand names.

This information applies to the following medicines:
1.Benzocaine (BEN-zoe-kane)
2.Benzocaine and Menthol (BEN-zoe-kane and MEN-thole)
3.Benzocaine and Phenol (BEN-zoe-kane and FEE-nole)
4.Dyclonine (DYE-kloe-neen)
5.Lidocaine (LYE-doe-kane)?
? Generic name product may be available in the U.S.

Category

  • Anesthetic (mucosal-local)?Benzocaine; Benzocaine and Menthol; Benzocaine and Phenol; Dyclonine; Lidocaine

Description

Dental anesthetics (an-ess-THET-iks)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, suchas cold sores, canker sores, and fever blisters. Also, some of these medicinesare used to relieve pain or irritation caused by dentures or other dentalappliances, including braces. However, if you have an infection or a lot oflarge sores in your mouth, check with your medical doctor or dentist beforeusing 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 throatconditions. 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 ordentist's prescription. Others are available without a prescription; however,your medical doctor or dentist may have special instructions on the properuse and dose for your medical problem. Some nonprescription (over-the-counter[OTC]) aerosols, gels, liquids, or ointments that contain a local anestheticare not meant to be used in or around the mouth. If you have any questionsabout which product to use, check with your pharmacist.

These medicines are available in the following dosage forms:

    Dental
  • Benzocaine
    • Aerosol spray (U.S.)
    • Dental paste (U.S.)
    • Film-forming gel (U.S.)
    • Gel (U.S. and Canada)
    • Lozenges (U.S.)
    • Ointment (U.S. and Canada)
    • Solution (liquid) (U.S. and Canada)
  • Benzocaine and Menthol
    • Lozenges (U.S. and Canada)
  • Benzocaine and Phenol
    • Gel (U.S. and Canada)
    • Solution (liquid) (U.S. and Canada)
  • Dyclonine
    • Lozenges (U.S.)
  • Lidocaine
    • Aerosol spray (U.S. and Canada)
    • Ointment (U.S. and Canada)
    • Solution (U.S. and Canada)
    • Viscous (very thick) solution (U.S. and Canada)


Before Using This Medicine

If you are taking this medicinewithout a prescription, carefully read and follow any precautions on the label.For dental anesthetics, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to a local anesthetic, especially one that was applied toany part of the body as a liquid, cream, ointment, or spray. Also tell yourhealth care professional if you are allergic to any other substances, suchas foods, preservatives, or dyes.

Pregnancy?Dental anesthetics have not been reported to causebirth defects or other problems in humans.

Breast-feeding?Dental anesthetics have not been reported to causeproblems in nursing babies.

Children?Children may be especially sensitive to the effectsof dental anesthetics. This may increase the chance of unwanted effects, someof which can be serious, during treatment. When using a dental anestheticfor a child, be very careful not to use more of the medicine than directedon the label, unless otherwise directed by your health care professional.Teething medicines that contain benzocaine may be used in babies 4 monthsof 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 beused in children 2 years of age and older. However, these other nonprescriptionproducts should not be used in infants or children younger than 2 years ofage unless prescribed by a health care professional.

Older adults?Elderly people are especially sensitive to the effectsof many local anesthetics. This may increase the chance of side effects duringtreatment, 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 thandirected on the package label, unless otherwise directed by a medical doctoror a dentist.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Before you use a dentalanesthetic, check with your medical doctor, dentist, or pharmacist if youare taking any other prescription or nonprescription (over-the-counter [OTC])medicine.


Proper Use of This Medicine

For safeand effective use of this medicine:

  • Follow your medical doctor's or dentist's instructions if this medicinewas prescribed.
  • Follow the manufacturer's package directions if you are treatingyourself.
  • Do not use more of this medicine, do not useit more often, and do not use it for a longer time than directed. Todo so may increase the chance of absorption into the body and the risk ofside effects. This is particularly important for young children and elderlypatients, especially with lidocaine.
  • Dental anesthetics should be used only for conditions being treatedby your medical doctor or dentist or for problems listed in the package directions. Do not use any of them for other problems without firstchecking with your medical doctor or dentist. These medicines shouldnot 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 isswallowed. Be certain that you understand exactly how you are to use thismedicine, and whether or not you are to swallow it. Follow your medical doctor'sor dentist's directions very carefully. Also, be verycareful to measure the exact amount of medicine that you are to use.Use a special measuring spoon to measure the amount; regular household teaspoonsor 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 youngchildren, who are especially sensitive to its effects.
  • If you are using this medicine for a problem in the mouth, you mayapply it to the sore places with a cotton-tipped applicator. Or, you may swishthe measured amount of medicine around in your mouth until you are certainthat it has reached all of the sore places. Do not swallowthe 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, garglewith 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., OratectGel):

  • 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 includedin the package.
  • Apply the gel to a second swab. Then roll the swab over the driedarea.
  • Keep your mouth open and dry for about 30 to 60 seconds after applyingthe medicine. A film will form where you placed the medicine.
  • Do not remove the film. It will slowly disappear and should be goneabout 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-tippedapplicator, 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 thesore areas in your mouth and wait until the pain is relieved. Then rinse yourmouth with water before replacing the appliance.

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

  • Use a cotton-tipped applicator to dab small amounts of the medicineonto the sore places. Do not rub or try to spread the medicine with your fingerwhile 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 (breathein) the medicine. Also, do not spray the back of your mouth or throat withit unless your medical doctor or dentist directs you to do so.

To use lozenge forms of benzocaine, benzocaine andmenthol, or dyclonine:

  • These lozenges should be dissolved slowly in the mouth. Do not biteor 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 of these medicines will be differentfor different patients. Follow your health care professional'sorders or the directions on the label. The following information includesonly the average doses of these medicines. If your doseis different, do not change it unless your medical doctor or dentisttells you to do so.

    For benzocaine
  • For dental paste dosage form:
    • For sores in and around the mouth, sore gums, or pain caused by dentalappliances:
      • Adults, teenagers, and children 6 years of age and older?Applya small amount of the medicine to the painful areas.
      • Children up to 6 years of age?Use and dose must be determinedby your health care professional.
  • For film-forming gel, liquid, and ointmentdosage forms:
    • For sores in and around the mouth, toothache, sore gums, or paincaused by dental appliances:
      • Adults, teenagers, and children 2 years of age and older?Applya 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 determinedby your health care professional.
  • For gel dosage form:
    • For sores in and around the mouth, toothache, sore gums, or paincaused by dental appliances:
      • Adults, teenagers, and children 2 years of age and older?Applya 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 determinedby your health care professional.
    • For teething pain:
      • Infants up to 4 months of age?Use and dose must be determinedby your health care professional.
      • Infants and children 4 months to 2 years of age?Apply a smallamount of the 7.5% or 10% benzocaine gel to sore gums up to four times a day.
      • Children 2 years of age and older?Apply any strength of benzocainegel to sore gums up to four times a day.
  • For lozenge dosage form:
    • For pain in the mouth or throat:
      • Adults and teenagers?One lozenge, dissolved slowly in the mouthevery two hours as needed.
      • Children up to 2 years of age?Use and dose must be determinedby your health care professional.
      • 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.
  • 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?Onelozenge, dissolved slowly in the mouth every two hours as needed.
      • Children up to 2 years of age?Use and dose must be determinedby 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?Applya 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 determinedby your health care professional.
  • For liquid dosage form:
    • For sores in and around the mouth, toothache, sore gums, or paincaused by dental appliances:
      • Adults, teenagers, and children 2 years of age and older?Applya 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 determinedby 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 up to 2 years of age?Use and dose must be determinedby your health care professional.
      • 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.
    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 hoursfor 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 careprofessional.
  • 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 careprofessional.
  • For viscous (very thick) solution dosageform (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 medicineshould not be used more often than every three hours.
      • Infants and children up to 3 years of age?Apply a total ofone-fourth of a teaspoonful (or less) to the sore places with a cotton-tippedapplicator. This medicine should not be used more often than every three hours.
      • Children 3 years of age and older?Apply a small amount of medicineto the sore places with a cotton-tipped applicator. The largest amount thatcan be used must be determined by your health care professional.
    • For sore throat pain:
      • Adults and teenagers?One tablespoonful, used as a gargle. Swallowafter gargling only if directed to do so by your doctor. Otherwise, spit outthe medicine after gargling with it.
      • Children?Dose must be determined by your doctor.

Missed dose?If your health care professional has directed youto use this medicine on a regular schedule, and you miss a dose, use it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Do not store throat lozenge forms of benzocaine, benzocaine and mentholcombination, or dyclonine in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
  • Keep the medicine from freezing.
  • Do not puncture, break, or burn aerosol containers, even when theyare empty.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Check with your medical doctor:

  • If you are using this medicine for a sore throat and your sore throatis 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 themouth 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 shouldnot 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 treatmentas soon as possible.
  • If you are using this medicine to relieve pain caused by new denturesor other dental appliances. An adjustment to your appliance may be neededto prevent more soreness. Also, if your dentist has ordered you to apply thismedicine to the appliance before inserting it or to keep the appliance inyour mouth while using the medicine, he or she will want to make sure thatthe medicine is not causing any unwanted effects.

False test results may occur if benzocaine or lidocaine is present in yourbody when a certain laboratory test is done. This test uses a medicine calledbentiromide (e.g., Chymex) to show how well your pancreas is working. Youshould not use any products containing benzocaine or lidocaine for about 72hours (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 usingit. When this medicine is applied to these areas, it may interferewith swallowing and cause choking.

Do not chew gum or food while your mouth or throatfeels 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 of This Medicine

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

Stop using this medicineand check with your medical doctor or dentist immediately if any ofthe 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; ringingor buzzing in the ears; shivering or trembling; slow or irregular heartbeat; troubledbreathing; unusual anxiety, excitement, nervousness,or restlessness; unusual paleness; unusual tiredness or weakness

Also, check with your health care professionalas soon as possible if any of the following side effects occur:

    Less common

      Burning, stinging, swelling, or tenderness not present beforetreatment; skin rash, redness, itching, or hivesin or around the mouth

Other side effects not listed above may also occur in some patients. If younotice any other effects, check with your medical doctor or dentist.


Revised: 06/13/2000