Prilocaine and epinephrine (Injection)

Prilocaine and epinephrine (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 that your doctor 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 cause a rare but serious blood problem called methemoglobinemia. The risk may be higher in children younger than 6 months of age, elderly patients, or patients with certain inborn defects. It is more likely to happen if you receive too much of the medicine, but it can also occur with small amounts. Check with your doctor right away 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.

Tell your doctor or nurse right away if you have any of 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 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.

This medicine may also 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.

Before you have any medical tests, tell the medical doctor in charge that you are receiving this medicine. The results of some tests may be affected by 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 and your doctor must consider the risks of taking the medicine against the benefits it may provide. 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 health care professional know if you have any other kinds of allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Due to the potential toxicity of this medicine, 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 available about how this medicine affects older adults. However, because of its 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 medicine during breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together, even if an interaction might happen. In these cases, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when you are receiving this medicine. The following interactions are based on 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 medicine 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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the 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 medicines may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or how often you use one or both of the medicines.

• Labetalol
• Nitric Oxide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around meal times or with specific foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how this medicine works. 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
• 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, they may need medical attention.

Check with your doctor or nurse immediately 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 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:

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.