Kovanaze (Tetracaine and Oxymetazoline) nasal spray is the first non-invasive local pulpal anesthetic agent that is used in dental restorative surgeries. Some studies favor the superiority of lidocaine infiltration over Kovanaze (Tetracaine and Oxymetazoline) nasal spray. However, it provides a unique mode of administration that is painless and non-invasive.

Kovanaze (Tetracaine and Oxymetazoline) Uses:

• Dental Anesthesia:

  • It is used in regional anesthesia when performing a restorative procedure on teeth 4-13 and A-J in adults and children who weigh 40 kg or more.

Kovanaze (Tetracaine and Oxymetazoline) Dose in Adults

Kovanaze (Tetracaine and Oxymetazoline) Dose for dental Anesthesia:

• Intranasal:
  • It is used as 2 sprays administered 4 to 5 minutes apart in the nostril ipsilateral to the maxillary tooth on which the dental procedure has to be performed.
  • Initiate the dental procedure 10 minutes after the second spray. It can be administered as 1 additional spray 10 minutes after the second initial spray if there is insufficient anesthesia.

Kovanaze (Tetracaine and Oxymetazoline) Dose in Childrens

Kovanaze (Tetracaine and Oxymetazoline) Dose for dental Anesthesia:

• Children and Adolescents ≥3 years and ≥40 kg:

  • Intranasal:
    • It is administered as 2 sprays administered 4 to 5 minutes apart in the nostril ipsilateral to the maxillary tooth on which the dental procedure has to be performed.
    • Initiate the dental procedure 10 minutes after the second spray.

Kovanaze (Tetracaine and Oxymetazoline) Pregnancy Category: B

• Studies on animal reproduction have revealed negative results.

Use of oxymetazoline and Tetracaine during breastfeeding

• It is not yet known if breast milk contains it.
• Clinical benefits vs. risks of discontinuing breastfeeding are the key factors in deciding whether to continue or stop.

Dose in Kidney Disease:

No dose adjustments have been studied in patients with renal diseases.

Dose in Liver disease:

Caution is advised in severe renal impairment however, in mild to moderate disease, no dose adjustments are required.

Also, see individual agents.

Common Side Effects of Kovanaze (Tetracaine and Oxymetazoline):

• Ophthalmic:

  • Increased Lacrimation

• Respiratory:

  • Rhinorrhea
  • Nasal Congestion
  • Nasal Discomfort
  • Oropharyngeal Pain

Less Common Side Effects of Kovanaze (Tetracaine and Oxymetazoline):

• Cardiovascular:

  • Increased Systolic Blood Pressure
  • Bradycardia
  • Hypertension
  • Increased Diastolic Blood Pressure

• Central Nervous System:

  • Headache
  • Hypoesthesia
  • Nasal Cavity Pain
  • Dizziness
  • Abnormal Sensory Symptoms

• Gastrointestinal:

  • Dysgeusia
  • Oral Discomfort
  • Dysphagia

• Respiratory:

  • Throat Irritation
  • Sneezing
  • Nasal Mucosa Ulcer
  • Sinus Headache
  • Dry Nose
  • Epistaxis

Contraindications to Kovanaze (Tetracaine and Oxymetazoline):

• An absolute contraindication is hypersensitivity or intolerance to tetracaine, benzoyl alcohol, other ester regional anesthetics (PABA), oxymetazoline or any component of the formulation.

Warnings and precautions

• Anaphylactic Reactions

  • Anaphylaxis can include angioedema and urticaria as well as shock.

• Dysphagia

  • Reports have indicated difficulty swallowing.

• Epistaxis

  • It has been reported that there is bleeding from the nose.
  • Patients who have had more than five episodes of nosebleeds per month should not be given this medication. If it is not possible to avoid, you should monitor patients who have frequent nosebleeds.

• Hypertension:

  • After the use of it, a rise in blood pressure was observed. It is important to monitor blood pressure.
  • Patients with uncontrolled hypertension should not use it.

• Methemoglobinemia:

  • It can be treated with local anesthesia. Clinically significant methemoglobinemia must be treated immediately.
  • The onset may occur immediately or later after anesthetic treatment.
  • Patients with glucose-6-phosphate oxidase deficiency or congenital or irreversible methemoglobinemia, cardiac and pulmonary compromise, and exposure to oxidizing agents and their metabolites or infants younger than 6 months old are more vulnerable and should be closely monitored for signs of methemoglobinemia (eg cyanosis and headaches, rapid pulse, shortness or breath, lightheadedness, fatigue, and rapid pulse).

• Hepatic impairment

  • Due to inability to metabolize local painkillers, patients with severe hepatic impairment could be at higher risk for toxic plasma concentrations.
  • For signs of local anesthetic toxicities, monitor patients suffering from liver disease.

• Pseudocholinesterase deficiency:

  • A deficiency in pseudocholinesterase could increase the risk of toxic plasma concentrations. This is because they are unable to metabolize local anesthetics.
  • You should pay attention to signs of toxicology.

• Thyroid disease:

  • If untreated thyroid disease persists, it is contraindicated.

Monitoring parameters:

• Blood pressure.
• Observe for dysphagia.
• Epistaxis.
• Signs of local anesthetic toxicity, especially in patients with hepatic impairment or pseudocholinesterase deficiency.

How to administer Kovanaze (Tetracaine and Oxymetazoline)?

• It is intended for intra-asal use only.
• It is to be administered on the same side as the maxillary teeth on which the dental procedure must be done.
• It is possible to test drill the affected tooth after 10 minutes of administration.
• Avoid use with other intranasal products, including other oxymetazoline-containing nasal sprays. 
• Discontinue oxymetazoline-containing products 24 hours prior to administration of tetracaine/oxymetazoline.

Mechanism of action of Kovanaze (Tetracaine and Oxymetazoline):

Tetracaine

• Local ester anesthetic blocks the conduction and initiation of nerve impulses.
• It decreases the neuronal membranes' permeability to sodiumions.
• This results in inhibition of depolarization, with consequent blockage of conduction.

Oxymetazoline:

• Imidazoline derivative that has a sympathomimetic effect and stimulates the alpha adrenergic receptors of the nasal mucosa to cause vasoconstriction.

Also, see individual agents.

Half-life elimination:

• Pediatric patients 4 to 15 years of age:
  • Oxymetazoline: ~1.6 to 4.3 hours.
  • Tetracaine metabolite p-butylaminobenzoic acid (PBBA): ~1.6 to 2.8 hours.
• Adults:
  • Oxymetazoline: ~5.2 hours.
  • Tetracaine metabolite (PBBA): ~2.6 hours.

Time to peak: Median:

• Pediatric patients 4 to 15 years of age:
  • Oxymetazoline: ~10 to 30 minutes.
  • Tetracaine metabolite (PBBA): ~20 to 30 minutes.
• Adults:
  • Oxymetazoline: 5 minutes;
  • Tetracaine metabolite (PBBA): 20 minutes.

Tetracaine and Oxymetazoline International Brand Names:

• Kovanaze

Tetracaine and Oxymetazoline Brand Names in Pakistan:

No Brands Available in Pakistan.