Ultacan Forte (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 taking this medicine to ensure it is working properly. Blood tests may be necessary to check for any unwanted effects.

This medicine may increase your risk of serious heart and blood vessel problems, such as a heart attack, changes in heart rhythm, or low blood pressure. Contact your doctor if you experience chest pain or discomfort, pain or discomfort in the arms, jaw, back, or neck, dizziness, fainting, a pounding or 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 condition known as methemoglobinemia. The risk is higher in children younger than 6 months, elderly patients, or those with certain genetic conditions. It is more likely to happen if too much of the medicine is used, but it can also occur with small amounts. Contact your doctor right away if you or your child shows any of these symptoms after receiving this medicine: pale, gray, or blue 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 needs 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 you have discussed them 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 and your doctor need to consider both the risks and the benefits. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know 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

Studies have not been done on how articaine and epinephrine combination injection affects children younger than 4 years old. Its safety and effectiveness have not been established for this age group.

Geriatric

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

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be taken together, while others may be used together with caution. If you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

Do not use this medicine with any of the following medicines. 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 it may be necessary in some cases. If both medicines are prescribed, your doctor may change the dose or how often you take 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 using both may be necessary for your treatment. If both medicines are prescribed, your doctor may adjust the dose or how often you take one or both of the medicines.

• Labetalol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtimes or with certain foods due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to inform your doctor about any other medical problems you have, 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
• Liver disease, severe—Use with caution. The effects may be stronger due to 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.

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.