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warnings and cautions
5 WARNINGS AND PRECAUTIONS Poor Illumination : Exercise caution in night driving and other hazardous occupations in poor illumination. ( 5.1 ) Preexisting Retinal Disease : Rare cases of retinal detachment have been reported; a thorough examination of the retina, including funduscopy is advised in all patients prior to the initiation of therapy. ( 5.2 ) Iritis : Caution is advised in patients with iritis. ( 5.3 ) Congenital Glaucoma : Caution is advised in pediatric patients with primary congenital glaucoma for control of IOP as cases of a paradoxical increase in IOP have been reported. ( 5.4 ) 5.1 Poor Illumination Patients should be advised to exercise caution in night driving and other hazardous occupations in poor illumination. In addition, miotics may cause accommodative spasm. Patients should be advised not to drive or use machinery if vision is not clear. 5.2 Preexisting Retinal Disease As with all miotics, rare cases of retinal detachment have been reported when used in certain susceptible individuals and those with preexisting retinal disease; therefore, a thorough examination of the retina including funduscopy is advised in all patients prior to the initiation of therapy. 5.3 Iritis Isopto ® Carpine is not recommended to be used when iritis is present. 5.4 Primary Congenital Glaucoma Caution is advised when using Isopto ® Carpine in pediatric patients with primary congenital glaucoma for control of IOP as cases of a paradoxical increase in IOP have been reported. In addition, the use of Isopto ® Carpine is not recommended in pediatric patients diagnosed with glaucoma secondary to anterior segment dysgenesis or uveitis (especially if uveitis is active). 5.5 Contact Lens Wear Contact lens wearers should be advised to remove their lenses prior to the instillation of Isopto ® Carpine ophthalmic solution and to wait 10 minutes after dosing before reinserting their contact lenses.
6 ADVERSE REACTIONS Most common adverse reactions are headache/browache, accommodative change, eye irritation, eye pain, blurred vision, and/or visual impairment. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect exposure in four controlled clinical trials of 90 days to 2 years duration in 317 patients diagnosed with open-angle glaucoma or ocular hypertension. In the four clinical trials, patients were treated with Isopto ® Carpine 2%, two to four times daily or with pilocarpine 1%, 1.75%, or 2% in fixed combination with betaxolol 0.25%, two or three times daily. The most frequently reported adverse reactions occurring in ≥ 5% of patients in the pilocarpine 2% populations were: headache/brow ache, accommodative change, blurred vision, eye irritation, visual impairment (dim, dark, or “jumping” vision), and eye pain. The adverse reaction profile reported for the use of Isopto ® Carpine in pediatric patients is comparable to that seen in adult patients.