Recall of All Lots of Sandoz Timolol Ophthalmic Solution (Timolol Maleate Ophthalmic Solution USP) 0.25% and 0.5% - For Health Professionals

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Contact: Drug Compliance Verification & Investigation Unit

Health Canada Endorsed Important Safety Information on SANDOZ TIMOLOL OPHTHALMIC SOLUTION 0.25% and 0.5%

July 17, 2008

Subject: URGENT - Recall of All Lots of Sandoz^® Timolol Ophthalmic Solution (Timolol Maleate Ophthalmic Solution USP) 0.25% and 0.5%

Dear Health Care Professional,

Sandoz Canada, in consultation with Health Canada, is recalling Sandoz^® Timolol Ophthalmic Solution 0.25% (DIN 02166712) and 0.5% (DIN 02166720), bottles of 5 mL, 10 mL and 15 mL (products codes 8550, 8560, 8570, 8580, 8590 and 8600) because certain bottles from different lots of these products were found to contain a higher concentration of timolol than the approved labelled specifications. By using the solution at a higher concentration, the maximum recommended dosage of 1 drop twice daily of 0.5% may be exceeded. The possible adverse effects that could be expected are the same as those with therapeutic dosage, however there is a theoretical risk for an increase in severity or frequency. Adverse reactions reported with systemic beta-adrenergic blocking agents may occur with topical administration.

Sandoz^® Timolol Ophthalmic Solution is a general beta-adrenergic receptor blocking agent that does not have significant intrinsic sympathomimetic, direct myocardial depressant, or local anesthetic (membrane stabilizing) activity. Timolol ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with chronic open-angle glaucoma and in patients with ocular hypertension.

The dosage for adults usually consists of 1 drop of the 0.25% solution in the affected eye twice a day. If clinical response is not adequate, dosage may be increased to 1 drop of 0.5% solution in the affected eye twice a day. If the intraocular pressure is maintained at satisfactory values, many patients can be placed on once-a-day therapy. Since in some patients the pressure lowering response to timolol may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment.

Adverse reactions may occasionally include signs and symptoms of ocular irritation, including conjunctivitis, blepharitis, keratitis, blepharoptosis, and decreased corneal sensitivity. Visual disturbances including refractive changes (due to withdrawal of myotic therapy in some cases), diplopia, and ptosis have been reported infrequently. Hypersensitivity reactions including localized and generalized rash and urticaria, have been reported rarely. As with other topically applied ophthalmic drugs, this drug may be absorbed systemically. There have been reports of inadvertent overdosage with timolol maleate ophthalmic resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospam and cardiac arrest. It is important to note that these side effects were also reported at therapeutic dosage.

Patients are being advised to discontinue use and consult their health care practitioner immediately to ensure that treatment of the original condition is not interrupted. Sandoz recommends that all pharmacists contact their patients to whom they have dispensed these products within the last sixty (60) days.

Patients should be advised to consult their health care professional if they have used these products and are concerned about their health.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients receiving Sandoz^® Timolol Ophthalmic Solution 0.25% and 0.5% should be reported to Sandoz Canada or Health Canada at the following addresses:

Sincerely yours

original signed by

France Montgrain, M.Sc. Chem P.
Vice-President, Quality Unit