Citanest Plain Dental (Injection)

Prilocaine 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 monitor your or your child's progress closely while using this medicine to ensure it is working correctly. 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 happen if a patient receives too much of the medicine, but it can also occur with small amounts. Contact your doctor immediately 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.

Notify your doctor or nurse right away if you experience any of the following symptoms while taking 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 also cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you experience a rash, itching, hoarseness, difficulty breathing, difficulty 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 problems, such as a heart attack, changes in heart rhythm, or low blood pressure. Contact your doctor if you have chest pain or discomfort, pain or discomfort in the arms, jaw, back, or neck, dizziness, fainting, a pounding or slow heartbeat, difficulty breathing, or unusual tiredness or weakness.

Before having any medical tests, inform 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 your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. 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, inform your healthcare 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.

Pediatric

Because this medicine can be toxic, it should be used very carefully in children. Recommended doses should not be exceeded, and the patient should be closely monitored during treatment.

Geriatric

There is no information available on how age affects the effects of prilocaine injection in older patients. However, because this medicine can be toxic, it should be used with caution. Recommended doses should not be exceeded, 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 during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, 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 knows if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

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 medicines.

• Bupivacaine
• Bupivacaine Liposome
• Disopyramide
• Encainide
• Flecainide
• Hyaluronidase
• Mexiletine
• Moricizine
• Procainamide
• Propafenone
• Propranolol
• Quinidine
• St John's Wort
• Tocainide

Using this medicine with any of the following medicines may increase the 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 medicines.

• Nitric Oxide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or specific types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to happen. 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 to tell your doctor if you have any other medical problems, especially:

• 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 due to slower removal of the medicine from the body.

• Methemoglobinemia (blood disorder), hereditary or idiopathic (unknown cause)—Should not be used in patients with this condition.

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

Contact your doctor or nurse right away if any of these 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
• ringing or buzzing or other unexplained noises in the ears that continue
• cough
• trouble swallowing
• feeling discouraged
• dizziness, faintness, or lightheadedness when standing up quickly from a lying or sitting position
• drowsiness
• excitement
• unusual or false 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 might happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your healthcare professional might also be able to suggest ways to prevent or lessen some of these side effects. Contact your healthcare professional if any of these side effects persist 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 happen in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Citanest Plain Dental

Available Dosage Forms:

• Solution

Therapeutic Class: Anesthetic, Local

Chemical Class: Amino Amide

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.