Citanest Forte Dental (Injection)

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

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

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

This medicine may cause a rare but serious blood issue called methemoglobinemia. The risk may be higher in children younger than 6 months, elderly patients, or those with certain genetic conditions. It is more likely to occur in patients who receive too much of the medicine, but it can also happen with small amounts. Contact your doctor immediately if you or your child has 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.

Inform your doctor or nurse right away if you experience any of these symptoms while taking this medicine: anxiety; blurred vision; depression; drowsiness; lightheadedness; nausea or vomiting; numbness and tingling in the mouth or lips; restlessness; ringing in the ears; speech issues; or tremors.

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

This medicine may increase your risk of serious heart and blood vessel issues, 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, pounding or slow heartbeat, difficulty breathing, or unusual tiredness or weakness.

Before undergoing any medical tests, inform the doctor in charge that you are using this medicine. The results of some tests may be influenced by this medicine.

Do not take any other medicines unless you have discussed them with your doctor. This includes prescription and nonprescription (over-the-counter [OTC]) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your healthcare professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Due to this medicine's toxicity, it should be used very carefully in children. Do not exceed the recommended doses, and the patient should be closely monitored during treatment.

Geriatric

There is no information on how this medicine affects older adults. However, because of this medicine's toxicity, it should be used with caution. Do not exceed the recommended doses, and the patient should be closely monitored during treatment.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there is a chance of interaction. In these situations, your doctor may want to adjust the dose or take other precautions. When receiving this medicine, it is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions are based on their potential significance and may not include all possibilities.

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 your other medicines.

• 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 together, your doctor may adjust the dose or frequency of one or both medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Benperidol
• Bromperidol
• Bucindolol
• Bupivacaine
• Bupivacaine Liposome
• Carteolol
• Carvedilol
• Clomipramine
• Desipramine
• Dibenzepin
• Digoxin
• Dilevalol
• Disopyramide
• Dixyrazine
• Doxepin
• Droperidol
• Encainide
• Entacapone
• Ergonovine
• Fexofenadine
• Flecainide
• Fluphenazine
• Furazolidone
• Haloperidol
• Halothane
• Hyaluronidase
• Imipramine
• Iobenguane I 123
• Iproniazid
• Levalbuterol
• Levobunolol
• Lofepramine
• Loxapine
• Melitracen
• Melperone
• Methdilazine
• Methotrimeprazine
• Methylene Blue
• Methylergonovine
• Metipranolol
• Metopimazine
• Mexiletine
• Milnacipran
• Moperone
• Moricizine
• Nadolol
• Nialamide
• Nortriptyline
• Opicapone
• Opipramol
• Oxprenolol
• Penbutolol
• Perazine
• Periciazine
• Perphenazine
• Pindolol
• Pipamperone
• Piperazine
• Pipotiazine
• Practolol
• Procainamide
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propafenone
• Propiomazine
• Propranolol
• Protriptyline
• Quinidine
• Rasagiline
• Safinamide
• Selegiline
• Sotalol
• St John's Wort
• Terfenadine
• Tertatolol
• Thiethylperazine
• Thioproperazine
• Thioridazine
• Tianeptine
• Timolol
• Tocainide
• 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 drugs might be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Labetalol
• Nitric Oxide

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or 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. Be sure to tell your doctor if you have any other medical problems, especially:

• Asthma or
• Blood vessel disease or
• 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 increased 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, Citanest Forte Dental (Injection) may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

Incidence not known

• Blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings in the lips or mouth
• chest pain or discomfort
• cold, clammy, pale skin
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• cough
• difficulty swallowing
• discouragement
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• excitement
• false or unusual sense of well-being
• fast or irregular heartbeat
• feeling sad or empty
• general feeling of illness
• hearing loss
• hives, itching, skin rash
• irritability
• lack of appetite
• loss of consciousness
• loss of interest or pleasure
• nausea
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• restlessness
• seizures
• severe headache
• shivering
• slow heart rate
• slowing of labor
• stiff neck or back
• sweating
• tightness in the chest
• trouble concentrating
• trouble sleeping
• unusual tiredness or weakness
• vomiting
• weakness of the muscles in your face

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 Citanest Forte Dental (Injection). Your healthcare professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Feeling of heat
• numbness

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.

• Citanest Forte Dental

Available Dosage Forms:

• Solution

Therapeutic Class: Anesthetic, Amino Amide Combination

Pharmacologic Class: Epinephrine

Chemical Class: Prilocaine

Your dentist or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into the head and neck area or injected directly into your gums.

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 chew solid foods until normal feeling has returned to the area. Do not test the feeling in your mouth by biting or poking the treated area.