Timoptol-XE

Timoptol-XE

timolol

Manufacturer:

Santen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Timolol maleate
Indications/Uses
Reduction of elevated IOP in patient w/ ocular HTN, chronic open-angle glaucoma, aphakia & glaucoma, secondary glaucoma (some cases), narrow angles & a history of spontaneous or iatrogenically induced narrow-angle closure in the opposite eye in whom reduction of IOP is necessary.
Dosage/Direction for Use
Initially 1 drop of 0.25% Timoptol-XE in the affected eye(s) once daily. If clinical response is not adequate, dosage may be changed to 1 drop of 0.5% Timoptol-XE in the affected eye(s) once a day. Other topically applied medications should be administered no less than 10 min before Timoptol-XE. Transfer from Timoptol to Timoptol-XE Discontinue Timoptol after proper dosing on 1 day & start treatment w/ the same conc of Timoptol-XE the following day. Transfer from another topical ophth β-blocker Discontinue β-blocker after proper dosing on 1 day & start treatment on the following day w/ a max of 1 drop in the affected eye(s) once daily. Transfer from a single antiglaucoma agent other than a topical ophth β-blocker Continue agent & add Timoptol-XE at usual starting dose. On the next day, discontinue the previously used anti-glaucoma agent.
Contraindications
Hypersensitivity. Reactive airway disease, bronchial asthma or a history of bronchial asthma, severe COPD. Sinus bradycardia, sino-atrial block, 2nd & 3rd degree AV block, overt cardiac failure, cardiogenic shock.
Special Precautions
Cardiac failure should be adequately controlled prior to initial therapy. History of CV disease; monitor signs of deterioration & pulse rates. 1st degree heart block. Resp complications, including death due to bronchospasm in patients w/ asthma & cardiac complications. Mild or moderate COPD. Severe peripheral circulatory disturbance or disorders (eg, severe forms of Raynaud's disease or syndrome). Masking of hypoglycemic symptoms in DM patients & clinical signs of hyperthyroidism eg, tachycardia. Avoid abrupt w/drawal in patients suspected of developing thyrotoxicosis. Surgical anesth. Use w/ miotic to reduce elevated IOP in angle-closure glaucoma. Choroidal detachment. Has not been studied in patients wearing contact lenses. History of atopy or a history of severe anaphylactic reaction to a variety of allergens. Pregnancy & lactation. Has not been studied in ped group.
Adverse Reactions
Burning & stinging, conjunctival infection, discharge, foreign body sensation, itching. Ocular irritation including conjunctivitis, blepharitis, keratitis, decreased corneal sensitivity & dry eyes; visual disturbances including refractive changes (due to w/drawal of miotic therapy in some cases), diplopia, ptosis, choroidal detachment following filtration surgery, tinnitus. Bradycardia, arrhythmia, hypotension, syncope, heart block, CVA, cerebral ischaemia, CHF, palpitation, cardiac arrest, oedema, claudication, Raynaud's syndrome, cold hands & feet. Bronchospasm (predominantly in patients with preexisting bronchospastic disease), resp failure, dyspnea, cough; headache, asthenia, fatigue, chest pain. Alopecia, psoriasiform rash or exacerbation of psoriasis. Allergic reactions including anaphylaxis, angioedema, urticaria, localized and generalized rash. Dizziness, depression, insomnia, nightmares, memory loss, paraesthesia. Increase in signs & symptoms of myasthenia gravis; nausea, diarrhoea, dyspepsia, dry mouth, abdominal pain; decreased libido, Peyronie's disease, sexual dysfunction; SLE; myalgia.
Drug Interactions
Potential mydriasis in concomitant use w/ epinephrine. Possible additive effects & production of hypotension &/or marked bradycardia w/ Ca channel blocker, catecholamine-depleting drugs (eg, reserpine), antiarrythmics, parasympathomimetics or another β-adrenergic blocking agent. Potential exists for hypotension w/ dihydropyridine derivatives (eg, nifedipine). Additive effects in prolonging AV conduction time w/ concomitant use w/ β-adrenergic blocking agents & digitalis w/ either diltiazem or verapamil. Oral & IV Ca-channel blocker. Potentiated systemic β-blockade (eg, decreased heart rate) w/ CYP2D6 inhibitors (eg, quinidine & SSRIs) & timolol.
MIMS Class
Antiglaucoma Preparations
ATC Classification
S01ED01 - timolol ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.
Presentation/Packing
Form
Timoptol-XE ophth soln 0.5 %
Packing/Price
2.5 mL x 1's
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