ISTALOL- timolol maleate solution/ drops
Bausch & Lomb Incorporated
1 INDICATIONS AND USAGE
ISTALOL ® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
2 DOSAGE AND ADMINISTRATION
One drop of ISTALOL should be administered in the affected eye(s) once a day in the morning (AM).
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
3 DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing 0.5% (5 mg/mL) of timolol (6.8 mg/mL of timolol maleate).
4 CONTRAINDICATIONS
4.1 Asthma, COPD
ISTALOL is contraindicated in patients with bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [see Warnings and Precautions( 5.1, 5.3)] .
4.2 Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock
ISTALOL is contraindicated in patients with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure; cardiogenic shock [see Warnings and Precautions (5.2)] .
4.3 Hypersensitivity Reactions
ISTALOL is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this product in the past.
5 WARNINGS AND PRECAUTIONS
5.1 Potentiation of Respiratory Reactions Including Asthma
ISTALOL 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.
In patients without a history of cardiac failure, continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, ISTALOL should be discontinued [see Contraindications (4.2)].
5.3 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 ISTALOL is contraindicated] should, in general, not receive beta-blocking agents, including ISTALOL [see Contraindications (4.1)].
5.4 Increased Reactivity to Allergens
While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.
5.5 Potentiation of Muscle Weakness
Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, and generalized weakness). Timolol has been reported rarely to increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms.
5.6 Masking of Hypoglycemic Symptoms in Patients with 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.
5.7 Masking of 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.
5.8 Contamination of Topical Ophthalmic Products After Use
There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface [see Patient Counseling Information (17)].
5.9 Impairment of Beta-adrenergically Mediated Reflexes During 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.
5.10 Angle-Closure Glaucoma
In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This may require constricting the pupil. Timolol maleate has little or no effect on the pupil. ISTALOL should not be used alone in the treatment of angle-closure glaucoma.
5.11 Cerebrovascular Insufficiency
Because of potential effects of beta-adrenergic blocking agents on blood pressure and pulse, these agents should be used with caution in patients with cerebrovascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with ISTALOL, alternative therapy should be considered.
5.12 Choroidal Detachment
Choroidal detachment after filtration procedures has been reported with the administration of aqueous suppressant therapy (e.g., timolol).
5.13 Contact Lens Use
ISTALOL contains benzalkonium chloride, an anti-microbial preservative which may be absorbed by soft contact lenses. Contact lenses should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following ISTALOL administration.
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