Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Articadent Dental with Ephinephrine
  2. Ultacan
  3. Ultacan Forte

Descriptions


Articaine and epinephrine combination injection is used to numb the mouth before a dental procedure.

This medicine is to be given by or under the direct supervision of your dentist.

This product is available in the following dosage forms:

  • Solution

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

Appropriate studies have not been performed on the relationship of age to the effects of articaine and epinephrine combination injection in children younger than 4 years of age. 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 articaine and epinephrine combination injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Pregnancy

Information about this articaine-and-epinephrine-injection-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 receiving 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.

  • Dihydroergotamine
  • Isocarboxazid
  • Linezolid
  • Phenelzine
  • Tranylcypromine

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.

  • Amineptine
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Benperidol
  • Bromperidol
  • Bucindolol
  • Carteolol
  • Carvedilol
  • Clomipramine
  • Desipramine
  • Dibenzepin
  • Digoxin
  • Dilevalol
  • Dixyrazine
  • Doxepin
  • Droperidol
  • Entacapone
  • Ergonovine
  • Fexofenadine
  • Fluphenazine
  • Furazolidone
  • Haloperidol
  • Halothane
  • Imipramine
  • Iobenguane I 123
  • Iproniazid
  • Levalbuterol
  • Levobunolol
  • Lofepramine
  • Loxapine
  • Melitracen
  • Melperone
  • Methdilazine
  • Methotrimeprazine
  • Methylene Blue
  • Methylergonovine
  • Metipranolol
  • Metopimazine
  • Nadolol
  • Nialamide
  • Nortriptyline
  • Opicapone
  • Opipramol
  • Oxprenolol
  • Penbutolol
  • Perazine
  • Periciazine
  • Perphenazine
  • Pindolol
  • Pipamperone
  • Pipotiazine
  • Practolol
  • Procarbazine
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propiomazine
  • Propranolol
  • Protriptyline
  • Rasagiline
  • Selegiline
  • Sotalol
  • Terfenadine
  • Tertatolol
  • Thiethylperazine
  • Thioproperazine
  • Thioridazine
  • Tianeptine
  • Timolol
  • Trifluoperazine
  • Triflupromazine
  • Trimipramine

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.

  • Labetalol

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:

  • Asthma or
  • Blood vessel disease or
  • Heart disease or
  • Heart rhythm problems (eg, heart block)—Use with caution. May increase risk for more side effects.
  • Glucose-6-phosphate dehydrogenase deficiency (G6PD) or
  • Heart problems or
  • Lung or breathing problems—Use with caution. May increase risk of having methemoglobinemia.
  • Kidney disease or
  • Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • Methemoglobinemia (blood disorder), hereditary or idiopathic (unknown cause) or
  • Sulfite allergy—Should not be used in patients with these conditions.

Proper Use

Your dentist or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into your gum, usually near the underside of your tongue. Before you receive the injection, a numbing gel may be rubbed onto the gum to make the injection more comfortable.

This medicine should cause numbness only to the area where it is injected. You may experience temporary loss of sensation or movement in the injected area. This type of numbing procedure is called local anesthesia. It is not meant to cause you to fall asleep or become unconscious.

Your mouth may be numb for several hours. To avoid injury after dental work, do not eat or drink until normal feeling has returned to the area. Do not test the feeling in your mouth by biting or poking the treated area.

Precautions

It is very important that your dentist check your or your child's progress closely while receiving this medicine to see if it is working properly. Blood tests may be needed to check for any unwanted effects.

This medicine may increase your risk of having serious heart and blood vessel problems such as a heart attack, heart rhythm changes, or low blood pressure. Check with your doctor if you have chest pain or discomfort, pain or discomfort in the arms, jaw, back, or neck, dizziness, fainting, pounding, slow heartbeat, troubled breathing, or unusual tiredness or weakness.

Tell your dentist right away if you have the following symptoms with this medicine: anxiety, blurred vision, depression, drowsiness, lightheadedness, nausea or vomiting, numbness and tingling of the mouth or lips, restlessness, ringing in the ears, speech problems, or tremors.

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. Check with your doctor right away if you or your child has the following symptoms after receiving this medicine: pale, gray, or blue-colored skin, lips, or nails, confusion, headache, lightheadedness, fast heartbeat, or unusual tiredness or weakness.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat after receiving this medicine.

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 or nurse immediately if any of the following side effects occur:

Less common

  1. Bleeding, redness, or swelling of the gums
  2. chills
  3. cough
  4. fast, irregular, pounding, or racing heartbeat or pulse
  5. fever
  6. hoarseness
  7. lower back or side pain
  8. mouth ulcers
  9. painful or difficult urination
  10. swelling of the face
  11. swelling or irritation of the mouth

Rare

  1. Blurred vision
  2. body aches or pain
  3. bruising
  4. congestion
  5. coughing up blood
  6. difficulty in breathing or swallowing
  7. difficulty opening the mouth
  8. dizziness
  9. dryness or soreness of the throat
  10. earache
  11. facial paralysis
  12. fainting
  13. headache, severe and throbbing
  14. increase in bone pain
  15. increased menstrual flow or vaginal bleeding
  16. increased sensitivity to pain or touch
  17. large, flat, blue or purplish patches in the skin
  18. lockjaw
  19. muscle spasm, especially of the neck and back
  20. nervousness
  21. nosebleeds
  22. paralysis
  23. pounding in the ears
  24. prolonged bleeding from cuts
  25. red or black, tarry stools
  26. red or dark brown urine
  27. redness or swelling in the ear
  28. runny or stuffy nose
  29. slow or fast heartbeat
  30. swelling of the tongue
  31. swollen, painful, or tender lymph glands in the neck, armpit, or groin
  32. tingling in the hands and feet
  33. trouble in swallowing
  34. voice changes

Incidence not known

  1. Bigger, dilated, or enlarged pupils (black part of the eye)
  2. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings of the mouth
  3. chest pain or discomfort
  4. double vision
  5. drooping upper eyelids
  6. increased sensitivity of the eyes to light
  7. nausea
  8. pain in the shoulders, arms, jaw, or neck
  9. seeing double
  10. vomiting

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:

Less common

  1. Sleepiness

Rare

  1. Belching
  2. change in taste
  3. bad unusual or unpleasant (after) taste
  4. difficulty in moving
  5. dry mouth
  6. heartburn
  7. increased salivation
  8. indigestion
  9. itching skin
  10. joint pain or swelling
  11. lack or loss of strength
  12. muscle pain or stiffness
  13. nervousness
  14. pain or burning at the injection site
  15. runny nose
  16. sleepiness or unusual drowsiness
  17. sneezing
  18. stomach discomfort, upset, or pain

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.