Timoptic Ocudose Side Effects

Generic name: timolol ophthalmic

Note: This document contains side effect information about timolol ophthalmic. Some of the dosage forms listed on this page may not apply to the brand name Timoptic Ocudose.

Some side effects of Timoptic Ocudose may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to timolol ophthalmic: ophthalmic gel forming solution, ophthalmic solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking timolol ophthalmic (the active ingredient contained in Timoptic Ocudose) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• swelling or redness of your eyelids;

• eye redness, discomfort, or sensitivity to light;

• drainage, crusting, or oozing of your eyes or eyelids;

• depressed mood, confusion, hallucinations, unusual thoughts or behavior;

• wheezing, gasping, or other breathing problems;

• swelling, rapid weight gain;

• chest pain, slow or uneven heart rate; or

• feeling short of breath, even with mild exertion.

Less serious side effects of timolol ophthalmic may include:

• blurred vision, double vision, drooping eyelid;

• burning or stinging in your eye;

• headache, weakness, drowsiness;

• numbness, tingling, or cold feeling in your hands or feet;

• ringing in your ears;

• dry mouth;

• nausea, diarrhea, loss of appetite, upset stomach;

• skin rash or worsening psoriasis;

• sleep problems (insomnia); or

• cough, stuffy nose.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to timolol ophthalmic: ophthalmic gel forming solution, ophthalmic solution

General

Topically applied timolol ophthalmic (the active ingredient contained in Timoptic Ocudose) drops may be absorbed systemically and side effects similar to systemically administered timolol or other beta-blockers such as severe respiratory or cardiac reactions may be experienced.

In clinical trials, timolol ophthalmic solution and gel forming solution had a similar incidence of side effects.

Ocular

The results of a comparative trial suggest that timolol maleate may be more irritating than timolol hemihydrate.

Blurred vision upon instillation lasting from 30 seconds to 5 minutes has been reported in 33% of patients receiving the sustained release gel forming solution.

Ocular side effects have included burning and stinging upon instillation, which has been reported in approximately 12% of patients receiving timolol ophthalmic drops. Signs of ocular irritation including but not limited to conjunctivitis, blepharitis, keratitis, ocular pain, discharge/crusting, foreign body sensation, itching, tearing, and dry eyes. Ptosis, decreased corneal sensitivity, cystoid macular edema, visual disturbances (including refractive changes and diplopia), pseudopemphigoid, impairment of tear production and turnover, and choroidal detachment following filtration surgery have also been reported. In addition, cases of bacterial keratitis have been reported as a result of inadvertent contamination by patients.

Cardiovascular

Cardiovascular side effects have included bradycardia, arrhythmia, hypotension, hypertension, syncope, heart block, cerebral vascular accident, cerebral ischemia, exacerbation of angina, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud's phenomenon, and cold hands and feet. It should be noted that death due to cardiac failure has been reported following use of ophthalmic timolol.

Cardiovascular side effects associated with oral timolol or other oral beta-blockers have included worsening of arterial insufficiency and vasodilatation.

Respiratory

Respiratory side effects have included respiratory failure, dyspnea, nasal congestion, cough, and upper respiratory infections. It should be noted that death due to bronchospasm, in patients with asthma, has been reported following use of ophthalmic timolol.

Respiratory side effects associated with timolol, as with other beta-antagonists, have included bronchial constriction in susceptible patients. Alternative therapy should be considered in patients with reactive airways disease.

Respiratory side effects associated with oral timolol or other oral beta-blockers have included rales and bronchial obstruction.

A case of refractory rhinitis is reported. The rhinitis may have been due to timolol-induced vasomotor changes.

The results of one study show that in otherwise healthy patients with glaucoma, long-term (3 yrs) treatment with ophthalmic timolol 0.5% can result in a significant reduction from baseline in FEV1 and a subclinical increase in bronchial reactivity which may not be completely reversible upon discontinuation of therapy.

Endocrine

Alternative therapy should be considered in patients with diabetes mellitus who are prone to hypoglycemia.

Endocrinologic side effects have included masking the signs and symptoms and blunting the normal physiologic response to hypoglycemia.

Endocrinologic side effects associated with timolol have included an increase in serum triglycerides, LDL cholesterol, and VLDL cholesterol, a decrease in HDL cholesterol, hyperglycemia, and hypoglycemia.

Nervous system

A case of amaurosis fugax is associated with timolol. However, the patient involved had underlying cerebrovascular disease, autonomic dysfunction, and an arrhythmia.

Nervous system side effects have included dizziness, headache, paresthesia, anxiety, somnolence, insomnia, nightmares, nervousness, memory loss, and disorientation. Timolol may worsen myasthenia gravis.

Nervous system side effects associated with oral timolol or other oral beta-blockers have included vertigo, local weakness, diminished concentration, an acute reversible syndrome characterized by disorientation for time and place, and slightly clouded sensorium.

Psychiatric

Sexual dysfunction is reported from questionnaires, although the questions may have biased the data since the responses were not spontaneous.

Psychiatric side effects such as depression, confusion, hallucinations, and psychosis have been reported in rare cases. These effects may occur suddenly and are typically reversible upon discontinuation.

Psychiatric side effects associated with oral timolol or other oral beta-blockers have included reversible mental depression progressing to catatonia, emotional lability, and decreased performance on neuropsychometrics.

Dermatologic

Dermatologic side effects have included contact dermatitis, urticaria and alopecia. Rare cases of psoriasis, prurigo and hyperpigmented nail beds have been reported.

Dermatologic side effects associated with oral timolol or other oral beta-blockers have included pruritus, skin irritation, and increased pigmentation.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, diarrhea, dyspepsia, anorexia, and dry mouth.

Gastrointestinal side effects associated with oral timolol or other oral beta-blockers have included gastrointestinal pain, hepatomegaly, vomiting, mesenteric arterial thrombosis, and ischemic colitis.

Immunologic

An 86-year-old male with a 10 year history of chronic open angle glaucoma developed fever, malaise, pleurisy and recurrent sterile pleural effusions while taking only topical ophthalmic timolol. Antinuclear antibodies were present and the patient was felt to have timolol induced systemic lupus erythematosus. The patient improved upon the discontinuation of timolol and was not rechallenged.

Immunologic side effects have rarely included systemic lupus erythematosus and arthropathies.

Hypersensitivity

Hypersensitivity reactions have included allergic conjunctivitis, anaphylaxis, angioedema, urticaria, and localized/generalized rash.

Hypersensitivity side effects associated with oral timolol and other oral beta-blockers have included erythematous rash, fever combined with aching and sore throat, and laryngospasm with respiratory distress.

Genitourinary

Genitourinary side effects have rarely included complaints of impotence, retroperitoneal fibrosis, decreased libido, and Peyronie's disease.

Genitourinary side effects associated with oral timolol or other oral beta-blockers have included urination difficulties.

Other

Other side effects have included asthenia/fatigue, chest pain, and tinnitus.

Other side effects associated with oral timolol or other oral beta-blockers have included extremity pain, decreased exercise tolerance, sweating, and weight loss.

Hematologic

Hematologic side effects associated with oral timolol or other oral beta-blockers have included nonthrombocytopenic purpura, thrombocytopenic purpura, and agranulocytosis.

Musculoskeletal

Musculoskeletal side effects associated with oral timolol or other oral beta blockers have included arthralgia.

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