The increased occurrence of mammary adenocarcinomas was associated with elevations in serum prolactin which occurred in female mice administered oral timolol at 500 mg/kg/day, but not at doses of 5 or 50 mg/kg/day. For example, severe respiratory reactions and cardiac reactions including death due to bronchospasm in …

Find information about common, infrequent and rare side effects of Timolol Maleate Ophthalmic. Four patients reported that timolol was highly effective in comparison to place­bo; another patient noted the opposite. Most Viewed content is not available. In a lifetime oral study in mice, there were statistically significant increases in the incidence of benign and malignant pulmonary tumors, benign uterine polyps and mammary adenocarcinomas in female mice at 500 mg/kg/day, (approximately 71,000 times the systemic exposure following the maximum recommended human ophthalmic dose), but not at 5 or 50 mg/kg/day (approximately 700 or 7,000, respectively, times the systemic exposure following the maximum recommended human ophthalmic dose). The oral beta-blockers approved for migraine prophylaxis may not be effective for acute attacks because of slow absorption and modification by first-pass metabolism, which delays effective plasma levels for hours or even days. 68682-045-50 Although the risk of serious side effects is low when timolol is used in the eyes, side effects can occur if the medicine is absorbed into your bloodstream. Product of United Kingdom. Therefore, the same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. This may augment the risk of general anesthesia in surgical procedures. Manufactured by Santen UK Limited . Most people with Tell your doctor right away if any of these unlikely but serious side effects occur: Tell your doctor right away if any of these rare but very serious side effects occur: Seek immediate medical attention if any of these rare but very serious side effects occur: This is not a complete list of possible side effects. Difficulty in restarting and maintaining the heartbeat has also been reported. advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The concomitant use of two topical beta-adrenergic blocking agents is not recommended.

Contact lenses should be removed prior to administration of the solution. If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with Timolol Maleate Ophthalmic Solution 0.5%, alternative therapy should be considered.Choroidal detachment after filtration procedures has been reported with the administration of aqueous suppressant therapy (e.g., timolol).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 most frequently reported adverse reactions have been burning and stinging upon instillation in 38% of patients treated with Timolol Maleate Ophthalmic Solution 0.5%. Patients were assigned ran­domly to receive timolol maleate 0.5% or artificial tears (placebo) and were instructed to insert 1 drop in each eye at migraine onset and 30 minutes later.

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Some patients receiving beta-adrenergic receptor blocking agents have experienced protracted severe hypotension during anesthesia. If you think there has been an overdose, call your poison control center or get medical care right away. We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. You may also report side effects at https://www.fda.gov/medwatch. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, … Properly discard this product when it is expired or no longer needed.