Kovanaze (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 for your doctor to monitor your or your child's progress closely while using this medicine. This helps the doctor see if the medicine is working correctly and decide if you should keep receiving 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 genetic conditions. It is more likely to happen in patients taking too much of the medicine, but it can also occur with small amounts. Contact your doctor immediately if you or your child experience any of the following symptoms after taking 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 using this medicine.

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

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

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 should consider the risks against the benefits of the medicine. The following points should be taken into account for this medicine:

Allergies

Inform your doctor if you have ever experienced any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

Research has not been done to determine how tetracaine and oxymetazoline combination nasal spray affects children younger than 3 years old or those weighing less than 40 kg. Safety and effectiveness have not been established for these groups.

Geriatric

Studies so far have not shown any specific issues in elderly patients that would limit the use of tetracaine and oxymetazoline combination nasal spray. However, older adults are more likely to have higher blood pressure and kidney, liver, or heart problems, which may require caution when using this medicine.

Breast Feeding

There are no sufficient studies on the risks to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before using this medication 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 very important that your healthcare professional knows if you are taking any of the medicines listed below while receiving this medicine. The following interactions are important to consider and may not include all possible interactions.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some circumstances. If both medicines are prescribed, your doctor may adjust the dose or frequency of one or both.

• 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 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. Talk to your healthcare professional about the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to inform your doctor about any other medical issues, especially:

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

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Heart problems
• Lung or breathing problems
• Hereditary or idiopathic methemoglobinemia (blood disorder)—Use with caution, as this may raise the risk of methemoglobinemia.

• High blood pressure (hypertension)
• Trouble swallowing—Use with caution, as it may worsen these conditions.

• Severe liver disease
• Pseudocholinesterase deficiency (a genetic disorder)—Use with caution, as the effects may be stronger due to slower elimination of the medicine from the body.

Along with its necessary effects, Kovanaze (Nasal) may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to Kovanaze (Nasal). Also, your health care professional may 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 or 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 happen 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.