Tetracaine-Oxymetazoline Intranasal

Tetracaine-Oxymetazoline Intranasal is a combination medication indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J.

• Tetracaine-Oxymetazoline Intranasal is available under the following different brand names: Kovanaze.

Common side effects of Tetracaine-Oxymetazoline Intranasal include:

• runny nose
• nasal congestion
• watery eyes
• nasal discomfort
• sore or numb throat
• a temporary rise in blood pressure
• nasal pain
• sneezing
• nosebleed
• nasal dryness
• headache
• changes in taste
• dizziness
• sensory disturbance
• oral discomfort
• slow heart rate
• high blood pressure

Serious side effects of Tetracaine-Oxymetazoline Intranasal include:

• Not available

Rare side effects of Tetracaine-Oxymetazoline Intranasal include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Intranasal solution

• (5.27mg/0.088 mg)/0.2 mL (equivalent to 6 mg tetracaine HCl and 0.1 mg oxymetazoline HCl)

Dental Anesthesia

Adult and pediatric dosage

• 2 sprays (0.2 mL/spray) intranasally administered 4-5 minutes apart
• Administer in the nostril ipsilateral to the maxillary tooth on which the dental procedure will be performed
• Initiate the dental procedure 10 minutes after the second spray
• May administer 1 additional spray (0.2 mL) if adequate anesthesia to initiate the dental procedure has not been achieved 10 minutes after the second spray

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Tetracaine-Oxymetazoline Intranasal has severe interactions with no other drugs
• Tetracaine-Oxymetazoline Intranasal has serious interactions with the following drugs:
  • bupivacaine implant
  • isocarboxazid
• Tetracaine-Oxymetazoline Intranasal has moderate interactions with at least 41 other drugs
• Tetracaine-Oxymetazoline Intranasal has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, p-aminobenzoic acid (PABA), oxymetazoline, or any other component of the product

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Tetracaine-Oxymetazoline Intranasal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Tetracaine-Oxymetazoline Intranasal?”

Cautions

• May increase blood pressure; not studied in adults with BP more than 150/100 mmHg or those with inadequately controlled active thyroid disease
• Epistaxis reported; do not use in patients with a history of frequent nose bleeds (ie, 5/month and more)
• May cause dysphagia
• Tetracaine may cause methemoglobinemia (metHB), especially if coadministered with other drugs that also cause metHB; use in patients with a history of congenital or idiopathic metHB is not advised; initial signs and symptoms of metHB (which may be delayed for up to several hours following exposure) are characterized by slate grey cyanosis seen in, eg, buccal mucous membranes, lips and nail beds; in severe cases, symptoms may include central cyanosis, headache, lethargy, dizziness, fatigue, syncope, dyspnea, CNS depression, seizures, dysrhythmia and shock
• Allergic or anaphylactic reactions reported, characterized by urticaria, angioedema, bronchospasm, and shock; if an allergic reaction occurs, seek emergency help immediately
• MetHB
  • Use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly; patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition
  • Advise patients or caregivers to seek immediate medical attention if the patient experiences the following signs or symptoms: pale, gray, or blue-colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue; discontinue Bicillin C-R and any other oxidizing agents; depending on the severity of signs and symptoms, patients may respond to supportive care, including oxygen therapy and hydration; a more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen
• Drug interaction overview
  • Coadministration with monoamine oxidase inhibitors, nonselective beta-adrenergic antagonists, or tricyclic antidepressants may cause hypertension and is not recommended; select an alternant anesthetic if these drugs cannot be discontinued
  • Do not use with other oxymetazoline-containing products (eg, Afrin); discontinue other intranasal oxymetazoline products 24 hours before use of Tetracaine-Oxymetazoline Intranasal
  • Oxymetazoline is known to slow the rate, but not the extent of absorption of other intranasal drugs; do not coadminister with other intranasal products
  • Tetracaine may cause metHB, particularly if coadministered with other drugs that cause metHB (eg, sulfonamides, acetaminophen, acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, naphthalene, nitrates and nitrites, nitrofurantoin, nitroglycerin, nitroprusside, pamaquine, p- aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine); monitor carefully for signs of metHB

Pregnancy and Lactation

• Limited published data on tetracaine use in pregnant women are not sufficient to inform any risks
• Published epidemiologic studies of nasal oxymetazoline used as a decongestant during pregnancy do not identify a consistent association with any specific malformation or pattern of malformations
• Lactation
  • There are no data on the presence of tetracaine, oxymetazoline, or their metabolites in human milk, the effects on the breastfed infant, or the effects on milk production
  • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition