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:

  • When performing a restorative procedure on teeth 4–13 and A–J in adults and children who weigh 40 kg or more, it is employed in regional anaesthesia.

Kovanaze (Tetracaine and Oxymetazoline) Dose in Adults

Kovanaze (Tetracaine and Oxymetazoline) Dose for dental Anesthesia:

• Intranasal:
  • It is applied as two sprays placed four to five minutes apart in the nose directly across from the maxillary tooth that needs to have the dental work done.
  • 10 minutes after the second spray, begin the dental procedure. If there is insufficient anaesthetic, it can be given as 1 extra spray 10 minutes after the second initial spray.

Kovanaze (Tetracaine and Oxymetazoline) Dose in Children

Kovanaze (Tetracaine and Oxymetazoline) Dose for dental Anesthesia:

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

  • Intranasal:
    • It is applied as two sprays four to five minutes apart in the nose directly across from the maxillary tooth that needs to undergo the dental operation.
    • 10 minutes after the second spray, begin the dental procedure.

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):

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

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 cardiac and pulmonary compromise, exposure to oxidising agents and their metabolites, congenital or irreversible methemoglobinemia, glucose-6-phosphate oxidase deficiency, or infants younger than 6 months of age 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

  • Patients with significant hepatic impairment may be at higher risk for hazardous plasma concentrations because they are unable to metabolise local anaesthetics.
  • 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.
•  local anesthetic toxicity

How to administer Kovanaze (Tetracaine and Oxymetazoline)?

• It is intended for intra-asal use only.
• It must be administered on the side where the maxillary teeth will be treated during the dental surgery.
• After 10 minutes of administration, the afflicted tooth can be test-drilled.
• Use with other intranasal products, such as other nasal sprays that include oxymetazoline, should be avoided.
• 24 hours before administering tetracaine/oxymetazoline, stop using items containing oxymetazoline.

Mechanism of action of Kovanaze (Tetracaine and Oxymetazoline):

Tetracaine

• Nerve impulse initiation and conduction are both blocked by local ester anaesthetic.
• It lessens the sodium ion permeability of the neuronal membranes.
• Depolarization is inhibited as a consequence, and conduction is subsequently blocked.

Oxymetazoline:

• Imidazoline derivative that causes vasoconstriction by stimulating the nasal mucosa's alpha adrenergic receptors and having a sympathomimetic action.

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.