Pronunciation:

TE-tra-kane hye-droe-KLOR-ide, ox-i-me-TAZ-oh-leen hye-droe-KLOR-ide

Brand Names:

• Kovanaze

Classifications:

Chemical—

Tetracaine

Uses of This Medicine:

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 weighing 40 kilograms (kg) or more.

This medicine is to be given by or under the direct supervision of your dentist or other health care professional.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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 tell your health care 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of tetracaine and oxymetazoline combination nasal spray in children younger than 3 years of age and in children weighing less than 40 kg. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tetracaine and oxymetazoline combination nasal spray in the elderly. However, elderly patients are more likely to have increased blood pressure and kidney, liver, or heart problems, which may require caution in patients receiving this medicine.

Breast-feeding—

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

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, 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 know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 of the 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

Other interactions—

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

• Epistaxis (nosebleeds), frequent or
• Hypertension (high blood pressure), uncontrolled or
• Thyroid disease, poorly controlled—Use is not recommended in patients with these conditions.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
• Heart problems or
• Lung or breathing problems or
• Methemoglobinemia (blood disorder), hereditary or idiopathic (unknown cause)—Use with caution. May increase risk of having methemoglobinemia.

• Hypertension (high blood pressure) or
• Trouble swallowing—Use with caution. May make these conditions worse.

• Liver disease, severe or
• Pseudocholinesterase deficiency (a genetic disease)—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive 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 increased in children younger than 6 months of age, elderly patients, or patients with certain inborn defects. It is more likely to occur in patients receiving too much of the medicine, but can also occur with small amounts. Check with your doctor right away if you or your child has 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 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. Tell 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 you are receiving this medicine.

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

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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately 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 immediately 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. 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:

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.