Alcon, the global leader in eye care and a division of Novartis, expands its surgical offerings with the addition of a group of products fundamental to many ophthalmic procedures done in the clinic and operating room. These products, which include mydriatic, cycloplegic, diagnostic and anesthetic products, were transferred from Alcon’s parent company, Novartis, beginning earlier this year with ISOPTO® Atropine (atropine sulfate ophthalmic solution) 1%. 

“At Alcon, we strive to provide surgeons the most complete line of ophthalmic products available – not only through innovations in technology, but now through a portfolio of mydriatic, cycloplegic, diagnostic and anesthetic products,” said Brian O’Neal, Head of Marketing, US Surgical, Alcon. “With the transition of this portfolio from Novartis, we’re excited to provide our customers with a comprehensive line of products to support surgical and clinical ophthalmic procedures.” 

The products offered in the portfolio include:

• ISOPTO® Atropine (atropine sulfate ophthalmic solution) 1%, indicated for mydriasis (dilation of the pupil), cycloplegia (paralysis of the ciliary muscle of the eye), and penalization of the healthy eye in the treatment of amblyopia, a condition where vision in one or both eyes does not develop properly during childhood 
• CYCLOGYL® (cyclopentolate hydrochloride ophthalmic solution, USP), an anticholinergic used to produce mydriasis and cycloplegia
• MYDRIACYL® (tropicamide ophthalmic solution, USP), an anticholinergic indicated for mydriasis and cycloplegia for diagnostic procedures
• CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution), indicated for the production of mydriasis
• FLUORESCITE® (fluorescein injection, USP) 10%, indicated in diagnostic fluorescein angiography (examination by X-ray of blood or lymph vessels) or angioscopy of the retina and iris vasculature 
• Tetracaine Hydrochloride Ophthalmic Solution 0.5% STERI-UNIT®, an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic

The portfolio of products is available now and can be purchased through authorized wholesalers and distributors. ISOPTO® Atropine 1% Solution is also available for purchase through Alcon Customer Service. To learn more, visit www.Alcon.com/Products. 

Important Safety Information About the Alcon Products Featured in this Alert

ISOPTO® Atropine (atropine sulfate ophthalmic solution) 1%
ISOPTO® Atropine 1% Solution is a muscarinic antagonist indicated for mydriasis, cycloplegia, and penalization of the healthy eye in the treatment of amblyopia. ISOPTO® Atropine 1% Solution should not be used in anyone who has demonstrated a previous hypersensitivity or known allergic reaction to any ingredient of the formulation because it may recur. The most common adverse reactions that have been reported are eye pain and stinging on administration, blurred vision, photophobia, superficial keratitis, decreased lacrimation, drowsiness, increased heart rate and blood pressure.

Please click here to see the full Prescribing Information for ISOPTO® Atropine 1% Solution.

CYCLOGYL® (cyclopentolate hydrochloride ophthalmic solution, USP) 0.5%, 1% or 2%
CYCLOGYL® Solution 0.5%, 1% or 2% is an anticholinergic used to produce mydriasis and cycloplegia. CYCLOGYL® Solution 0.5%, 1% or 2% should not be used when untreated narrow-angle glaucoma or untreated anatomically narrow angles are present, or if the patient is hypersensitive to any component of the preparation. The most common ocular adverse reactions include increased intraocular pressure, burning, photophobia, blurred vision, irritation, hyperemia, conjunctivitis, blepharoconjunctivitis, punctate keratitis, synechiae have been reported. Use of cyclopentolate has been associated with psychotic reactions and behavioral disturbances, usually in children, especially with 2% concentration. This drug produces reactions similar to those of other anticholinergic drugs.

Please click here to see the full Prescribing Information for CYCLOGYL® Solution 0.5%, 1% or 2%.

MYDRIACYL® (tropicamide ophthalmic solution, USP) 1%
MYDRIACYL® Solution 1% is an anticholinergic indicated for mydriasis and cycloplegia for diagnostic procedures. MYDRIACYL® Solution 1% should not be used in persons showing hypersensitivity to any component of the preparation. The most common ocular adverse reactions include transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydriatics. The most common non-ocular adverse reactions include dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.

Please click here to see the full Prescribing Information for MYDRIACYL® Solution 1%. 

CYCLOMYDRIL® (cyclopentolate hydrochloride and phenylephrine hydrochloride ophthalmic solution)
CYCLOMYDRIL® Solution is indicated for the production of mydriasis. CYCLOMYDRIL® Solution should not be used in patients with untreated narrow-angle glaucoma or with untreated anatomically narrow angles, or where there is hypersensitivity to any component of the preparation. The following ocular adverse experiences have been associated with the use of CYCLOMYDRIL® Solution: increased intraocular pressure, burning/irritation upon instillation, photophobia, blurred vision and superficial punctate keratitis. Use of cyclopentolate hydrochloride has been associated with psychotic reactions and behavioral disturbances in children. This drug produces reactions similar to those of other adrenergic and anticholinergic drugs. 

Please click here to see the full Prescribing Information for CYCLOMYDRIL® Solution. 

FLUORESCITE® (fluorescein injection, USP) 10%
FLUORESCITE® Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. FLUORESCITE® Injection 10% should not be used by patients with a known hypersensitivity to fluorescein sodium or any other ingredients in this product. FLUORESCITE® Injection 10% is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product. Rare cases of death due to anaphylaxis have been reported. Fluorescein sodium can induce serious intolerance reactions. These reactions of intolerance are always unpredictable but they are more frequent in patients who have previously experienced an adverse reaction after fluorescein injection (symptoms other than nausea and vomiting) or in patients with history of allergy such as food or drug induced urticaria, asthma, eczema, allergic rhinitis. Detailed questioning of each patient is recommended before the angiography to evaluate any prior history of allergy. The most common adverse reactions include skin discoloration, urine discoloration, nausea, vomiting, and gastrointestinal distress.

Please click here to see the full Prescribing Information for FLUORESCITE® Injection 10%. 

Tetracaine Hydrochloride Ophthalmic Solution 0.5% STERI-UNIT®
Tetracaine Hydrochloride Ophthalmic Solution 0.5% is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic. The most common adverse reactions include transient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort. 

Please click here to see the full Prescribing Information for Tetracaine Hydrochloride Ophthalmic Solution 0.5% STERI-UNIT®.