Tapcom-S

Per mL Tafluprost 15 mcg, timolol (as maleate) 5 mg

Reduction of IOP in adults w/ open angle glaucoma or ocular HTN who are insufficiently responsive to topical monotherapy w/ β-blockers or prostaglandin analogues & require a combination therapy, & who would benefit from preservative-free eye drops.

Instill 1 drop in the conjunctival sac of the affected eye(s) once daily. Max: 1 drop in the affected eye(s) daily.

Hypersensitivity. Reactive airway disease (eg, bronchial asthma or history thereof, severe COPD). Sinus bradycardia, sick sinus syndrome (eg, SA block, 2nd or 3rd degree AV block not controlled w/ pacemaker). Overt cardiac failure, cardiogenic shock.

Wipe off any excess soln to reduce risk of darkening of eyelid skin. Use nasolacrimal occlusion or close eyelids for 2 min to reduce systemic absorption. Administer at least 5 min apart if >1 topical ophth medicinal product is being used. Remove contact lenses before instillation; may reinsert after 15 min. May impair ability to drive or operate machinery. Caution in patients w/ severe peripheral circulatory disturbance/disorders (ie, severe forms of Raynaud's disease or syndrome); mild/moderate COPD; renal/hepatic impairment. Women of childbearing potential have to use effective contraception during treatment. Do not use during pregnancy unless clearly necessary. Lactation is not recommended if treatment is required. Not recommended in childn & adolescents <18 yr. Tafluprost: Possibility of eyelash growth, darkening of eyelid skin & increased iris pigmentation. Potential for hair growth on skin surface w/ repeated exposure. No experience in neovascular, angle-closure, narrow-angle or congenital glaucoma. Limited experience in aphakic patients & in pigmentary or pseudoexfoliative glaucoma. Caution in aphakic patients, pseudophakic patients w/ torn posterior lens cap or anterior chamber lenses, or in patients w/ known risk factors for cystoid macular oedema or iritis/uveitis. Timolol (as maleate): Risk of CV, pulmonary & other adverse reactions as seen w/ systemic β-adrenergic blockers. Monitor for CV disease deterioration & for adverse reactions in patients w/ CV diseases. May mask signs & symptoms of acute hypoglycaemia; mask signs of hyperthyroidism; induce dryness of eyes; block systemic β-agonist effects eg, of adrenaline. Caution in patients w/ history of atopy or severe anaphylaxis to a variety of allergens; 1st degree heart block; corneal diseases; patients subject to spontaneous hypoglycaemia or those w/ labile diabetes. Not recommended to use 2 topical β-adrenergic blockers. Use w/ miotic when treating angle-closure glaucoma. Reports of choroidal detachment w/ aq suppressant therapy.

Conjunctival/ocular hyperaemia, eye pruritus/pain/irritation, eyelash changes (increased length, thickness, number) or discolouration, foreign body sensation in eyes, blurred vision, photophobia.

Potential for additive effects resulting in hypotension &/or marked bradycardia when ophth β-blocker soln is administered concomitantly w/ oral Ca channel blockers, β-adrenergic blockers, antiarrhythmics (including amiodarone), digitalis glycosides, parasympathomimetics, guanethidine. Oral β-adrenergic blockers may exacerbate rebound HTN which can follow clonidine w/drawal. Potentiated systemic β-blockade during combined treatment w/ CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine) & timolol. Reports of mydriasis resulting from concomitant use of ophth β-blockers & adrenaline (epinephrine).

Antiglaucoma Preparations

S01ED51 - timolol, combinations ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.

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