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Tapcom-S

Tapcom-S

Manufacturer:

Santen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per mL Tafluprost 15 mcg, timolol 5 mg
Indications/Uses
Reduction of IOP in adult patients 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.
Dosage/Direction for Use
1 eye drop in the conjunctival sac of the affected eye(s) once daily.
Contraindications
Hypersensitivity. Reactive airway disease including bronchial asthma or a history of bronchial asthma, severe COPD. Sinus bradycardia, sick sinus syndrome including SA block, 2nd or 3rd degree AV block not controlled w/ pacemaker. Overt cardiac failure, cardiogenic shock.
Special Precautions
Patients w/ CV disease (eg, CHD, Prinzmetal's angina & cardiac failure) & hypotension; 1st degree heart block; severe peripheral circulatory disturbance/disorders (eg, severe forms of Raynaud's disease or Raynaud's syndrome); mild/ moderate COPD; corneal disease; history of atopy or severe anaphylactic reaction to a variety of allergens; aphakic, pseudophakic w/ torn posterior lens cap or anterior chamber lenses or w/ known risk factors for cystoid macular oedema or iritis/uveitis. May mask signs & symptoms of acute hypoglycaemia & hyperthyroidism. Concomitant use w/ other β-blockers is not recommended. Used w/ miotic for the treatment of close-angle glaucoma. Choroidal detachment. Women of childbearing potential should use effective contraception during treatment. Do not use during pregnancy. Not recommended during lactation. Not recommended for use in childn & adolescent <18 yr.
Adverse Reactions
Conjunctival/ocular hyperaemia, eye pruritus, eye pain, eyelash changes (increased length, thickness & number of lashes), eyelash discolouration, eye irritation, foreign body sensation in eyes, blurred vision, photophobia. Tafluprost: Reduced visual acuity, increased iris pigmentation, blepharal pigmentation, conjunctival oedema, eye discharge, anterior chamber cell, anterior chamber flare, allergic conjunctivitis, conjunctival pigmentation, conjunctival follicles, deepening of eyelid sulcus, iritis/uveitis; hypertrichosis of eyelid; exacerbation of asthma, dyspnea. Timolol: Signs & symptoms of allergic reactions including angioedema, urticaria, localized & generalized rash, anaphylaxis, pruritus; hypoglycaemia; depression, insomnia, nightmares, memory loss, nervousness; dizziness, syncope, paraesthesia, increase in signs & symptoms of myasthenia gravis, CVA, cerebral ischaemia; keratitis, decreased corneal sensitivity, visual disturbances including refractive changes (due to miotic therapy w/drawal in some cases), ptosis, diplopia, choroidal detachment following filtration surgery, tearing, corneal erosion; tinnitus; bradycardia, chest pain, palpitation, oedema, arrhythmia, CHF, cardiac arrest, heartblock, AV block, cardiac failure; hypotension, claudication, Raynaud's phenomenon, cold hands & feet; dyspnoea, bronchospasm (predominantly in patients w/ preexisting bronchospastic disease), resp failure, cough; nausea, dyspepsia, diarrhoea, dry mouth, dysgeusia, abdominal pain, vomiting; alopecia, psoriasiform rash or psoriasis exacerbation, skin rash; SLE, myalgia, arthropathy; Peyronie's disease, decreased libido, sexual dysfunction; asthenia/fatigue, thirst.
Drug Interactions
Potential additive effects resulting in hypotension &/or marked bradycardia w/ oral Ca channel blockers, β-adrenergic blocking agents, antiarrhythmics (including amiodarone), digitalis glycosides, parasympathomimetics, guanethidine. May exacerbate rebound HTN w/ oral β-adrenergic blockers. Potentiated systemic β-blockade w/ CYP2D6 inhibitors eg, quinidine, fluoxetine, paroxetine) & timolol. Mydriasis may occur w/ adrenaline (eg, epinephrine).
MIMS Class
Antiglaucoma Preparations
ATC Classification
S01ED51 - timolol, combinations ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.
Presentation/Packing
Form
Tapcom-S ophth soln
Packing/Price
(single-dose) 0.3 mL x 30 × 1's
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