Ethiciane

 
     
 

DESCRIPTION

Ethicaine (Benoxinate hydrochloride) is a sterile ophthalmic solution containing Benoxinate Hydrochloride 0.4%, and chlorhexidine acetate 0.01% as preservative.

Benoxinate hydrochloride, an anaesthetic agent, is benzoic acid, 4-amino-3-butoxy-, 2-(diethylamino) ethyl ester, monohydrochloride. Its empirical formula is C17H28N2O3 × HCl Benoxinate hydrochloride is a white or slightly off-white, crystalline powder or crystals, very soluble in water, freely soluble in chloroform and in alcohol, insoluble in ether. Its molecular weight is 344.88.
 

ACTIONS/CLINICAL PHARMACOLOGY

Benoxinate hydrochloride is a rapidly acting anaesthetic agent of short duration. It is less irritant than amethocaine hydrochloride when applied to the conjunctiva in similar concentrations.
 

INDICATIONS AND USAGE

Ethicaine is an effective surface anaesthetic when used in short ophthalmological procedures. The sensitivity of the cornea is normal after 1 h. The solution has no effect on the pupil.
 

CONTRAINDICATIONS

Known hypersensitivity to any component of this product.
 

WARNINGS

NOT FOR INJECTION — FOR TOPICAL OPHTHALMIC USE ONLY

Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.
 

PRECAUTIONS

Ethicaine should be used cautiously and sparingly in patients with known allergies.

Protection of the eye from irritating chemicals, foreign bodies and rubbing during the period of anesthesia is very important. Tonometers soaked in sterilizing or detergent solutions should be thoroughly rinsed with sterile distilled water prior to use. Patients should be advised to avoid touching the eye until the anesthesia has worn off.
 

ADVERSE REACTIONS

Occasional temporary stinging, burning and conjunctival redness have been reported after use of ocular anesthetics, as well as a rare severe, immediate-type, apparently hyperallergic corneal reaction with acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing or large areas of necrotic epithelium, corneal filaments and sometimes, iritis with descemetitis.

Allergic contact dermatitis with drying and fissuring of the fingertips has been reported.
 

DOSAGE AND ADMINISTRATION

One drop instilled into the conjunctival sac anaesthetizes the surface sufficiently to allow tonometry after 60 sec and a further drop after 90 sec provides adequate anaesthesia for the fitting of contact lenses.

Three drops at 90-sec intervals produces sufficient anaesthesia after 5 min for a foreign body to be removed from the corneal epithelium, or for incision of a Meibomian cyst through the conjunctiva.
 

HOW SUPPLIED

10 mL in plastic dropper bottle (Sterile).

Store below 15°C. User may store at room temperature for up to three months. Protect from light. Keep tightly closed.