Tetracaine + Oxymetazoline intranasal

Indications

Tetracaine + Oxymetazoline intranasal is used for: Dental Anesthesia

Adult Dose

Dental Anesthesia Indicated for regional anesthesia when performing a restorative procedure on Teeth 4-13 and A-J 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

Child Dose

Renal Dose

Administration

Contra Indications

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

Precautions

May increase blood pressure; not studied in adults with BP >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) May cause dysphagia Tetracaine may cause methemoglobinemia (metHB), especially if coadministered with other drugs that also cause metHB; use in patients with 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 a slate grey cyanosis seen in, e.g., 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

Pregnancy-Lactation

Pregnancy 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 from the underlying maternal condition

Interactions

Coadministration with MAOIs, nonselective beta adrenergic antagonists, or TCAs 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 hr 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

Side Effects

Side effects of Tetracaine + Oxymetazoline intranasal : >10% Rhinorrhea (52%) Nasal congestion (32%) Nasal discomfort (26%) Oropharyngeal pain (14%) Lacrimation increased (13%) 1-10% Intranasal hypoesthesia (10%) Pharyngeal hypoesthesia (10%) Headache (10%) Throat irritation (9%) Dysgeusia (8%) Rhinalgia (6%) Systolic BP increased (5%) Sneezing (4%) Diastolic BP increased (3%) Hypertension (3%) Bradycardia (3%) Sinus headache (3%) Dizziness (3%) Sensory disturbance (2%) Epistaxis (2%) Nasal dryness (2%) Oral discomfort (2%)

Mode of Action

Tetracaine: Local anesthetic of the ester type and exerts its activity by blocking sodium ion channels required for the initiation and conduction of neuronal impulses Oxymetazoline: Imidazoline derivative with sympathomimetic activity; believed to be a mixed alpha1/2-adrenoceptor agonist and, by stimulating adrenergic receptors, it elicits vasoconstriction of dilated arterioles and reduces nasal blood flow