Pronunciation:

AR-ti-kane hye-droe-KLOR-ide, ep-i-NEF-rin

Brand Names:

• Articadent Dental with Ephinephrine
• Ultacan
• Ultacan Forte

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Anesthetic, Amino Amide Combination

Pharmacologic—

Sympathomimetic

Chemical—

Articaine

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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
• 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 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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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.