Tetracaine and oxymetazoline (Nasal)

Tetracaine and oxymetazoline combination nasal spray is used to numb the affected tooth (Teeth 4-13 and A-J) before a dental procedure in adults and children who weigh 40 kilograms (kg) or more.

This medicine must be given by or under the direct supervision of your dentist or another health care professional.

It is very important that your doctor checks your or your child's progress closely while you are receiving this medicine. This will help your doctor see if the medicine is working properly and decide if you should keep using it. Blood tests may be needed to check for 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 in patients receiving too much of the medicine, but can also occur with small amounts. Contact your doctor immediately if you or your child experience 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.

Call your dentist or doctor right away if you or your child have a stuffy or runny nose, mild nose bleeds, dizziness, or trouble swallowing after receiving this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Inform your dentist or doctor right away if you or your child have a rash, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while receiving this medicine.

Avoid using other products containing oxymetazoline (e.g., Afrin®) within 24 hours before the scheduled dental procedure. Do not use other inhaled medicines while using Kovanaze™.

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 will need to consider the risks of taking the medicine compared to the benefits it may provide. For this medicine, please think about the following:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional if you have other allergies, such as to foods, dyes, preservatives, or animals. If you are using non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been enough studies to determine how tetracaine and oxymetazoline combination nasal spray affects children younger than 3 years old and those weighing less than 40 kg. Its safety and effectiveness in these groups have not been established.

Geriatric

So far, studies have not found any geriatric-specific issues that would limit the use of tetracaine and oxymetazoline combination nasal spray in older adults. However, older patients are more likely to have higher blood pressure and problems with their kidneys, liver, or heart, which might require extra caution when using this medicine.

Breast Feeding

There are no adequate studies on how this medication affects infants when used by breastfeeding women. Consider the potential benefits and risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together with certain precautions. If you are receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the following medicines. The interactions listed below are based on their potential importance and may not include all possible interactions.

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 frequency for one or both medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Bupivacaine
• Carteolol
• Carvedilol
• Clomipramine
• Desipramine
• Dibenzepin
• Doxepin
• Fentanyl Citrate
• Furazolidone
• Hyaluronidase
• Imipramine
• Iproniazid
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Lofepramine
• Melitracen
• Methylene Blue
• Metipranolol
• Moclobemide
• Nadolol
• Nialamide
• Nortriptyline
• Opipramol
• Oxprenolol
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Protriptyline
• Rasagiline
• Safinamide
• Selegiline
• Sotalol
• St John's Wort
• Tianeptine
• Timolol
• Tranylcypromine
• Trimipramine
• Zavegepant

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around the time of eating food or specific types of food due to possible 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

Other medical issues may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Frequent nosebleeds (epistaxis)
• Uncontrolled high blood pressure (hypertension)
• Poorly controlled thyroid disease—Use is not recommended for patients with these conditions.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
• Heart problems or
• Lung or breathing issues or
• Hereditary or idiopathic (unknown cause) methemoglobinemia (blood disorder)—Use with caution. This may increase the risk of methemoglobinemia.

• High blood pressure (hypertension) or
• Trouble swallowing—Use with caution. This may worsen these conditions.

• Severe liver disease or
• Pseudocholinesterase deficiency (a genetic condition)—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

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

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

Less common

• Bloody nose
• blurred vision
• chest pain or discomfort
• difficulty swallowing
• dizziness
• headache
• lightheadedness, dizziness, or fainting
• nervousness
• pounding in the ears
• slow or fast, irregular heartbeat
• ulcers in the nose
• unusual tiredness

Incidence not known

• Bluish-colored lips, fingernails, or palms
• cough
• dark urine
• difficulty breathing
• fever
• hives or welts, itching, or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• noisy breathing
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid heart rate
• redness of the skin
• sore throat
• tightness in the chest
• unusual bleeding or bruising

Get emergency help right away if any of the following symptoms of overdose occur:

Symptoms of overdose

• Blurred or loss of vision
• chest pain or discomfort
• confusion
• difficulty in speaking
• disturbed color perception
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• double vision
• fainting
• fast, slow, or irregular heartbeat
• halos around lights
• headache
• inability to move the arms, legs, or facial muscles
• inability to speak
• lightheadedness
• loss of consciousness
• nausea
• nervousness
• night blindness
• no blood pressure or pulse
• overbright appearance of lights
• pain or discomfort in the arms, jaw, back, or neck
• pounding in the ears
• slow speech
• stopping of the heart
• stuffy nose
• sweating
• tunnel vision
• unusual tiredness or weakness
• 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. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings in the nose
• change in taste
• loss of taste
• stuffy or runny nose
• watering of the eyes

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.

• Kovanaze

Chemical Class: Tetracaine

A dentist will give you or your child this medicine in a dental clinic. This medicine is given as a spray into your nose on the same side to the maxillary tooth on which the dental procedure will be done.

After 10 minutes of receiving the medicine, the dentist needs to perform a test drill to make sure that the affected tooth is already numb (anesthetized) before starting the dental procedure.