ve-free timoptic in ocudose should be discontinued. obstructive pulmonary disease patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease (other than bronchial asthma or a history of bronchial asthma, in which timoptic in ocudose is contraindicated [see contraindications ]) should, in general, not receive beta-blockers, including preservative-free timoptic in ocudose. major surgery the necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial. beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. this may augment the risk of general anesthesia in surgical procedures. some patients receiving beta-adrenergic receptor blocking agents have experienced protracted severe hypotension during anesthesia. difficulty in restarting and maintaining the heartbeat has also been reported. for these reasons, in patients undergoing elective surgery, some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents. if necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of adrenergic agonists. diabetes mellitus beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia. thyrotoxicosis beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid storm.

ld include a determination of intraocular pressure after approximately 4 weeks of treatment with preservative-free timoptic in ocudose. if the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eye(s). because of diurnal variations in intraocular pressure, satisfactory response to the once-a-day dose is best determined by measuring the intraocular pressure at different times during the day. dosages above one drop of 0.5% timoptic (timolol maleate ophthalmic solution) twice a day generally have not been shown to produce further reduction in intraocular pressure. if the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy with other agent(s) for lowering intraocular pressure can be instituted taking into consideration that the preparation(s) used concomitantly may contain one or more preservatives. the concomitant use of two topical beta-adrenergic blocking agents is not recommended (see precautions , drug interactions , beta-adrenergic blocking agents ).

s, anxiety, disorientation, nervousness, and memory loss. skin alopecia and psoriasiform rash or exacerbation of psoriasis. hypersensitivity signs and symptoms of systemic allergic reactions including anaphylaxis, angioedema, urticaria, and localized and generalized rash. respiratory bronchospasm (predominantly in patients with pre-existing bronchospastic disease), respiratory failure, dyspnea, nasal congestion, cough and upper respiratory infections. endocrine masked symptoms of hypoglycemia in diabetic patients ( see warnings ). special senses signs and symptoms of ocular irritation including conjunctivitis, blepharitis, keratitis, ocular pain, discharge (e.g., crusting), foreign body sensation, itching and tearing, and dry eyes; ptosis; decreased corneal sensitivity; cystoid macular edema; visual disturbances including refractive changes and diplopia; pseudopemphigoid; choroidal detachment following filtration surgery (see precautions , general ); and tinnitus. urogenital retroperitoneal fibrosis, decreased libido, impotence, and peyronie’s disease. the following additional adverse effects have been reported in clinical experience with oral timolol maleate or other oral beta-blocking agents, and may be considered potential effects of ophthalmic timolol maleate: allergic : erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; body as a whole : extremity pain, decreased exercise tolerance, weight loss; cardiovascular : worsening of arterial insufficiency, vasodilatation; digestive : gastrointestinal pain, hepatomegaly, vomiting, mesenteric arterial thrombosis, ischemic colitis; hematologic: nonthrombocytopenic purpura, thrombocytopenic purpura, agranulocytosis; endocrine : hyperglycemia, hypoglycemia; skin : pruritus, skin irritation, increased pigmentation, sweating; musculoskeletal : arthralgia; nervous system/psychiatric : vertigo, local weakness, diminished concentration, reversible mental depression progressing to catatonia, an acute reversible syndrome characterized by disorientation for time and place, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics; respiratory : rales, bronchial obstruction; urogenital : urination difficulties. to report suspected adverse reactions, contact bausch & lomb incorporated at 1-800-553-5340 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

e, whether or not accompanied by glaucoma. elevated intraocular pressure is a major risk factor in the pathogenesis of glaucomatous visual field loss. the higher the level of intraocular pressure, the greater the likelihood of glaucomatous visual field loss and optic nerve damage. the onset of reduction in intraocular pressure following administration of timoptic (timolol maleate ophthalmic solution) can usually be detected within one-half hour after a single dose. the maximum effect usually occurs in one to two hours, and significant lowering of intraocular pressure can be maintained for periods as long as 24 hours with a single dose. repeated observations over a period of one year indicate that the intraocular pressure-lowering effect of timoptic (timolol maleate ophthalmic solution) is well maintained. the precise mechanism of the ocular hypotensive action of timoptic (timolol maleate ophthalmic solution) is not clearly established at this time. tonography and fluorophotometry studies in man suggest that its predominant action may be related to reduced aqueous formation. however, in some studies a slight increase in outflow facility was also observed. pharmacokinetics in a study of plasma drug concentration in six subjects, the systemic exposure to timolol was determined following twice daily administration of timoptic 0.5%. the mean peak plasma concentration following morning dosing was 0.46 ng/ml and following afternoon dosing was 0.35 ng/ml. clinical studies in controlled multiclinic studies in patients with untreated intraocular pressures of 22 mmhg or greater, timoptic (timolol maleate ophthalmic solution) 0.25 or 0.5% administered twice a day produced a greater reduction in intraocular pressure than 1, 2, 3, or 4% pilocarpine solution administered four times a day or 0.5, 1, or 2% epinephrine hydrochloride solution administered twice a day. in these studies, timoptic (timolol maleate ophthalmic solution) was generally well tolerated and produced fewer and less severe side effects than either pilocarpine or epinephrine. a slight reduction of resting heart rate in some patients receiving timoptic (timolol maleate ophthalmic solution) (mean reduction 2.9 beats/minute standard deviation 10.2) was observed.

se container should be kept in the protective foil overwrap and used within one month after the foil package has been opened. distributed by: bausch & lomb americas inc. bridgewater, nj 08807 usa manufactured by: laboratoire unither 1 rue de l’arquerie 50200 coutances france timoptic and ocudose are trademarks of bausch & lomb incorporated or its affiliates. © 2022 bausch & lomb incorporated or its affiliates revised: 01/2022 65not8556/d 9390305