Timoptol-XE Special Precautions

As with other topically applied ophthalmic drugs, TIMOPTOL-XE may be absorbed systemically.
The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration.
CARDIO-RESPIRATORY REACTIONS: Cardiac failure should be adequately controlled before beginning therapy with TIMOPTOL-XE. Patients with a history of cardiovascular disease, including cardiac failure, should be watched for signs of deterioration of these diseases, and pulse rates should be monitored.
Due to its negative effect on conduction time, beta-blockers should be given with caution to patients with first degree heart block.
Respiratory complications, including death due to bronchospasm in patients with asthma, and cardiac complications, including rarely death in association with cardiac failure, have been reported following administration of beta-adrenergic blocking agents. These are potential complications of therapy with TIMOPTOL-XE.
In patients with mild/moderate chronic obstructive pulmonary disease (COPD), TIMOPTOL-XE should be used with caution and only if the potential benefit outweighs the potential risk.
VASCULAR DISORDERS: Patients with severe peripheral circulatory disturbance/disorders (eg, severe forms of Raynaud's disease or Raynaud's syndrome) should be treated with caution.
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 blocking agents may mask the signs and symptoms of acute hypoglycemia.
MASKING OF THYROTOXICOSIS: Beta-adrenergic blocking agents may mask certain clinical signs of hyperthyroidism (e.g., tachycardia). Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents which might precipitate a thyroid storm.
SURGICAL ANESTHESIA: The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial. If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of adrenergic agonists.
OTHER: Patients who are already receiving a beta-adrenergic blocking agent systemically and who are given TIMOPTOL-XE should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta-blockade (see circular for systemic timolol maleate products). The use of two topical beta-adrenergic blocking agents is not recommended.
In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This requires constricting the pupil with a miotic. Timolol maleate has little or no effect on the pupil. Should TIMOPTOL-XE be used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be used with a miotic and not alone.
Choroidal detachment has been reported with administration of aqueous suppressant therapy (eg, timolol, acetazolamide) after filtration procedures.
TIMOPTOL-XE has not been studied in patients wearing contact lenses. In a clinical study, the time required to eliminate 50% of the gellan solution from the eye was up to 30 minutes.
RISK FROM ANAPHYLACTIC REACTION: While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.
DRUG INTERACTIONS: Although timolol maleate used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with epinephrine has been reported occasionally. The potential for mydriasis exists from concomitant therapy with TIMOPTOL-XE and epinephrine.
The potential exists for additive effects and production of hypotension and/or marked bradycardia when TIMOPTOL-XE is administered together with a calcium-channel blocker, a catecholamine-depleting drug, antiarrhythmics, parasympathomimetics or another β-adrenergic blocking agent (see Interactions).
Oral β-adrenergic blocking agents may exacerbate the rebound hypertension which can follow the withdrawal of clonidine.
Use in Pregnancy: TIMOPTOL-XE has not been studied in human pregnancy. The use of TIMOPTOL-XE requires that the anticipated benefit be weighed against possible hazards.
Use in Lactation: Timolol is detectable in human milk. Because of the potential for serious adverse reactions from TIMOPTOL-XE in infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in Children: Timolol maleate ophthalmic solution has been shown to be efficacious and well tolerated in children; however, the formulation of timolol maleate found in TIMOPTOL-XE has not been studied in the pediatric age group.