DESCRIPTION
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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.
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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. |
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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. |
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CONTRAINDICATIONS |
| Known hypersensitivity to any component of this product. |
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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. |
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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. |
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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. |
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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.
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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. |
