Ultacan (Injection)

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.

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

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

Inform your dentist immediately if you experience any of the following symptoms while using 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 higher in children younger than 6 months old, elderly patients, or patients with certain genetic conditions. It is more likely to occur in patients receiving too much of the medicine, but can also happen with small amounts. Contact your doctor right away if you or your child experiences any of 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 requires immediate medical attention. Call your doctor right away if you notice a rash, itching, hoarseness, trouble breathing, difficulty 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.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it will provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you have, 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 done on how articaine and epinephrine combination injection affects children younger than 4 years of age. Safety and effectiveness have not been established.

Geriatric

Studies so far have not shown specific problems in the elderly that would limit the usefulness of articaine and epinephrine combination injection. However, older patients may be more sensitive to the effects of this medicine than younger adults.

Breast Feeding

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

Interactions with Medicines

While some medicines should never be used together, others may be used together with caution. In such cases, your doctor may want to adjust the dose or take other precautions. When you receive this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are highlighted due to their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or alter 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both of the medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Benperidol
• Bromperidol
• Bucindolol
• Bupivacaine
• 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
• Milnacipran
• Moperone
• Nadolol
• Nialamide
• Nortriptyline
• Opicapone
• Opipramol
• Oxprenolol
• Penbutolol
• Perazine
• Periciazine
• Perphenazine
• Pindolol
• Pipamperone
• Piperazine
• Pipotiazine
• Practolol
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propiomazine
• Propranolol
• Protriptyline
• Rasagiline
• Safinamide
• Selegiline
• Sotalol
• Terfenadine
• Tertatolol
• Thiethylperazine
• Thioproperazine
• Thioridazine
• Tianeptine
• Timolol
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimipramine
• Zavegepant

Using this medicine with any of the following medicines may increase the risk of certain side effects, but taking both medicines could 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 them.

• Labetalol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Asthma or
• Blood vessel disease or
• Heart disease or
• Heart rhythm problems (e.g., 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
• Severe liver disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

• Methemoglobinemia (blood disorder), hereditary or idiopathic (unknown cause) or
• Sulfite allergy—Should not be used in patients with these conditions.

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

• Bleeding, redness, or swelling of the gums
• chills
• cough
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• hoarseness
• lower back or side pain
• mouth ulcers
• painful or difficult urination
• swelling of the face
• swelling or irritation of the mouth

Rare

• Blurred vision
• body aches or pain
• bruising
• congestion
• coughing up blood
• difficulty in breathing or swallowing
• difficulty opening the mouth
• dizziness
• dryness or soreness of the throat
• earache
• facial paralysis
• fainting
• headache, severe and throbbing
• increase in bone pain
• increased menstrual flow or vaginal bleeding
• increased sensitivity to pain or touch
• large, flat, blue or purplish patches in the skin
• lockjaw
• muscle spasm, especially of the neck and back
• nervousness
• nosebleeds
• paralysis
• pounding in the ears
• prolonged bleeding from cuts
• red or black, tarry stools
• red or dark brown urine
• redness or swelling in the ear
• runny or stuffy nose
• slow or fast heartbeat
• swelling of the tongue
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tingling in the hands and feet
• trouble in swallowing
• voice changes

Incidence not known

• Bigger, dilated, or enlarged pupils (black part of the eye)
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings of the mouth
• chest pain or discomfort
• double vision
• drooping upper eyelids
• increased sensitivity of the eyes to light
• nausea
• pain in the shoulders, arms, jaw, or neck
• seeing double
• 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

• Sleepiness

Rare

• Belching
• change in taste
• bad unusual or unpleasant (after) taste
• difficulty in moving
• dry mouth
• heartburn
• increased salivation
• indigestion
• itching skin
• joint pain or swelling
• lack or loss of strength
• muscle pain or stiffness
• nervousness
• pain or burning at the injection site
• runny nose
• sleepiness or unusual drowsiness
• sneezing
• 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.

In the U.S.

• Articadent Dental with Ephinephrine
• Ultacan
• Ultacan Forte

Available Dosage Forms:

• Solution

Therapeutic Class: Anesthetic, Amino Amide Combination

Pharmacologic Class: Sympathomimetic

Chemical Class: Articaine

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.