Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most frequently reported adverse reactions have been burning and stinging upon instillation in 38% of patients treated with timolol maleate ophthalmic solution.
Additional reactions reported with timolol maleate ophthalmic solution at a frequency of 4 to 10% include: blurred vision, cataract, conjunctival injection, headache, hypertension, infection, itching and decreased visual acuity .
(6) To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1-800-417-9175 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 most frequently reported adverse reactions have been burning and stinging upon instillation in 38% of patients treated with timolol maleate ophthalmic solution.
Additional reactions reported with timolol maleate ophthalmic solution at a frequency of 4 to 10% include: blurred vision, cataract, conjunctival injection, headache, hypertension, infection, itching and decreased visual acuity.
The following additional adverse reactions have been reported less frequently with ocular administration of this or other timolol maleate formulations.
Timolol (Ocular Administration) Body as a Whole: Asthenia/fatigue and chest pain;
Cardiovascular: Bradycardia, arrhythmia, hypotension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud's phenomenon and cold hands and feet;
Digestive: Nausea, diarrhea, dyspepsia, anorexia, and dry mouth;
Immunologic: Systemic lupus erythematosus;
5 WARNINGS AND PRECAUTIONS Potentiation of Respiratory Reactions Including Asthma (5.1) Cardiac Failure (5.2) Obstructive Pulmonary Disease (5.3) Increased Reactivity to Allergens (5.4) Potentiation of Muscle Weakness (5.5) Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus (5.6) Masking of Thyrotoxicosis (5.7) 5.1 Potentiation of Respiratory Reactions Including Asthma Timolol maleate ophthalmic solution contains timolol maleate;
and although administered topically, it can be absorbed systemically.
Therefore, the same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration.
For example, severe respiratory reactions and cardiac reactions including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported following systemic or ophthalmic administration of timolol maleate [see Contraindications, (4.1)] .
5.2 Cardiac Failure Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition of beta-adrenergic receptor blockade may precipitate more severe failure.
Like all medications, Timolol Hemihydrate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: