Kovanaze

Kovanaze is a prescription medication used as a local anesthetic to numb the nerves in upper teeth prior to certain dental procedures.

It is a single product containing 2 medications: tetracaine and oxymetazoline. Tetracaine belongs to a group of drugs called local anesthetics. These work by temporarily blocking nerve signals. Oxymetazoline belongs to a group of medications called nasal decongestants. These work by narrowing the blood vessels in the nasal passages. 

This medication comes in nasal spray solution form and is sprayed twice (4 to 5 minutes apart) into the nostril on the same side as the tooth the procedure is being performed on.

Common side effects of Kovanaze include a runny nose, stuffy nose, nasal discomfort, throat pain, and increased tear production.

Kovanaze is a prescription medication used to numb the nerves in upper teeth for certain dental (restorative) procedures.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Receive this medication exactly as prescribed by your dentist.  

The recommended dose of Kovanaze for adults and children weighing 40 kilograms or more is 2 sprays (0.2 mL per spray), 4 to 5 minutes apart

In those who are 18 years or older, 1 additional spray (0.2 mL) can be given (in addition to the 2 sprays) if adequate anesthesia has not been achieved 10 minutes after the second spray.

Serious side effects have been reported with Kovanaze including the following:

• Increased Blood Pressure. This medication is not recommended in those whose blood pressure is not well controlled.  
• Thyroid disease. This medication is not recommended in those with active thyroid disease. 
• Nosebleeds. Tell your healthcare provider right away if you have nosebleeds.
• Difficulty Swallowing. Tell your healthcare provider right away if you have difficulty swallowing.
• Methemoglobinemia (a type of blood disorder). Tell your healthcare provider right away if you have some or all of the following symptoms of methemoglobinemia:
  • discoloration of the skin (pale blue or gray)
  • headache
  • tiredness
  • dizziness
  • trouble breathing
• Serious Allergic Reactions. Tell your healthcare provider right away if you have some or all of the following symptoms of a serious allergic reaction:
  • Skin rash
  • Hives
  • Chest discomfort or tightness
  • Difficulty breathing, coughing, wheezing, or high-pitched breathing sounds
  • Difficulty swallowing
  • Swelling of the face, eyes, or tongue

Do not receive Kovanaze if you are allergic to tetracaine, benzyl alcohol, other ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, or to any of its ingredients. 

Serious side effects have been reported with Kovanaze. See the “Kovanaze Precautions” section.

Common side effects of Kovanaze include the following:

• runny nose
• stuffy nose
• increased tear production
• nasal discomfort
• throat pain
• temporary increase in blood pressure

This is not a complete list of Kovanaze side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• monoamine oxidase inhibitors such as tranylcypromine (Parnate), phenelzine (Nardil), selegiline (Eldepryl, Zelapar), isocarboxazid (Marplan), and rasagiline (Azilect)
• oxymetazoline-containing products
• intranasal products
• drugs that can cause methemoglobinemia such as sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, p- aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, and quinine.

This is not a complete list of Kovanaze drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

In animal studies, pregnant animals were given the active medications in Kovanaze, and some babies had problems. The data is limited regarding the use of this medication in pregnant women. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Kovanaze crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Kovanaze.