Prescription Required
In stock
Manufacturer
VALEANT
SKU
24208092064

tetracaine 0.5% eye drops

Generic
$10.80 / drop btl
+ -
1,000 drop btls Available
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Uses

Tetracaine hydrochloride is applied topically to the eye to produce local anesthesia for tonometry, gonioscopy, removal of foreign bodies or sutures from the cornea, conjunctival and corneal scraping for diagnostic purposes, paracentesis of the anterior chamber, thorough examination and irrigation of painful injuries, or short procedures involving the cornea and conjunctiva.

Tetracaine hydrochloride is also applied topically to produce anesthesia of the nose and throat, and when laryngeal and esophageal reflexes are to be abolished prior to diagnostic procedures such as bronchoscopy, bronchography, or esophagoscopy.

For other uses of tetracaine hydrochloride as a local anesthetic, see 72:00.

Dosage and Administration

Tetracaine hydrochloride is applied topically to the eye in the form of a 0.5% solution. For surface anesthesia of the nose and throat, or to abolish laryngeal and esophageal reflexes prior to diagnostic procedures such as bronchoscopy, tetracaine hydrochloride is administered by direct application of a 0.25 or 0.5% solution or by oral inhalation of a nebulized 0.5% solution.

To produce local anesthesia on the eye, the usual adult dose is 1 or 2 drops of a 0.5% tetracaine hydrochloride solution.

When anesthetizing the larynx, trachea, or esophagus, the total dose of tetracaine hydrochloride should usually not exceed 20 mg (8 mL of a 0.25% solution or 4 mL of a 0.5% solution). The manufacturer recommends that 0.06 mL of a 0.1% epinephrine solution be added to each mL of anesthetic solution to retard absorption of the anesthetic.

Cautions

Adverse Effects

Instillation of tetracaine onto the eye in concentrations higher than 0.5% occasionally causes stinging. Rarely, local idiosyncratic reactions, including lacrimation, photophobia, and chemosis, have occurred. When applied to the conjunctiva, tetracaine usually does not cause pupillary dilation, disturbance of accommodation, or increased intraocular pressure. Prolonged use of tetracaine ophthalmic preparations has been associated with corneal epithelial erosions and retardation or prevention of healing of corneal erosions.

Excessive doses of topically applied tetracaine hydrochloride or rapid absorption producing high blood concentrations can result in adverse systemic effects that can lead to cardiac arrest and death if not promptly and appropriately treated. Systemic reactions to tetracaine are characteristic of those associatd with other local anesthetics and may involve the CNS and cardiovascular systems.

Serious adverse effects (e.g., seizures, coma, irregular heart beat, respiratory depression) have been reported following topical application of local anesthetics to the skin. These events have occurred following application of extemporaneously prepared topical preparations containing high concentrations of anesthetics for cosmetic procedures and following use of commercially available products for indications approved by the US Food and Drug Administration (FDA).

Life-threatening adverse effects (e.g., irregular heart beat, seizures, breathing difficulties, coma, death) may occur when topical anesthetics are applied to a large area of skin, when the area of application is covered with an occlusive dressing, if a large amount of topical anesthetic is applied, if the anesthetic is applied to irritated or broken skin, or if the skin temperature increases (from exercise or use of a heating pad). When applied in such a manner, the amount of anesthetic that is absorbed systemically is unpredictable and the plasma concentrations achieved may be high enough to cause life-threatening adverse effects. Use of lidocaine gel has been investigated to reduce discomfort during mammography. During the study, the topical anesthetic was spread over a wide area of the chest and covered with an occlusive dressing. Whether such use could result in serious reactions has not been determined.

Precautions and Contraindications

Prolonged use of tetracaine ophthalmic preparations for topical anesthesia of the eye is not recommended, especially if the preparations are self-administered by the patient. (See Cautions: Adverse Effects.) Prolonged use of topical ophthalmic local anesthetics has been associated with severe keratitis and permanent corneal opacification and scarring with accompanying reduction of visual acuity or visual loss. Although extremely rare following ophthalmic administration of local anesthetics, it should be kept in mind that systemic toxicity, manifested by CNS stimulation followed by depression, may occur. Patients should be warned not to touch or rub the eye(s) until the anesthesia has worn off.

When tetracaine hydrochloride is applied topically to produce anesthesia of the nose and throat, or to abolish laryngeal and esophageal reflexes, the usual precautions associated with the systemic use of local anesthetics should be observed.

If signs or symptoms of allergy or sensitivity occur during treatment with ophthalmic tetracaine preparations, the drug should be discontinued. Tetracaine preparations are contraindicated in patients with known hypersensitivity to tetracaine hydrochloride or other local anesthetics of the ester type, or to p-aminobenzoic acid or its derivatives, or to any ingredient in the formulation.

Serious adverse effects have occurred following topical application of local anesthetic preparations to the skin. When a topical anesthetic is needed for a procedure, use of a preparation approved by the FDA has been recommended. A preparation containing the lowest concentration of anesthetic likely to be effective should be used; a small amount of topical anesthetic should be applied to the affected area for the shortest period necessary for the desired effect. The patient should apply the topical preparation as directed by a clinician, and should not apply the topical preparation to broken or irritated skin.

Patients should speak with their clinician if they are considering using a topical anesthetic before obtaining a mammogram.

Pediatric Precautions

Safety and efficacy of tetracaine hydrochloride ophthalmic preparations and tetracaine hydrochloride topical solution in children have not been established.

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