Tapcom-S

Tapcom-S

Manufacturer:

Santen Pharma

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per mL Tafluprost 15 mcg, timolol maleate 5 mg
Indications/Uses
Reduction of IOP in adult patients w/ open-angle glaucoma or ocular HTN who are insufficiently responsive to topical β-blockers or prostaglandin analogues & who would benefit from preservative-free eye drops.
Dosage/Direction for Use
Instill 1 drop into conjunctival sac of affected eye(s) once daily.
Contraindications
Hypersensitivity. Reactive airway disease, bronchial asthma or history of bronchial asthma or severe COPD, sinus bradycardia, sick sinus syndrome, SA block, 2nd- or 3rd-degree AV block, overt cardiac failure, cardiogenic shock. Combination w/ omidenepag isopropyl.
Special Precautions
History of atopy or severe anaphylactic reaction. Monitor signs of CV diseases; 1st-degree heart block; severe peripheral circulatory disturbances/disorders eg, severe forms of Raynaud's disease or Raynaud's syndrome; mild or moderate COPD; spontaneous hypoglycaemia or w/ labile diabetes; corneal diseases; angle-closure glaucoma; choroidal detachment; neovascular, narrow-angle or congenital glaucoma; aphakic patients, pigmentary or pseudoexfoliative glaucoma, pseudophakic patients w/ torn posterior lens cap or anterior chamber lenses; known risk factors for cystoid macular oedema or iritis/uveitis. Possibility of eyelash growth, darkening eyelid skin & increased iris pigmentation. Potential hair growth in skin surface areas where soln comes in contact repeatedly. May mask signs & symptoms of acute hypoglycemia, hyperthyroidism. Avoid abrupt w/drawal. Remove contact lens prior to administration & reinsert after 15 min. Not recommended w/ another topical β-blocker. Allow 5-min interval if >1 ophth drug is used. Concomitant use w/ anaesth. May affect ability to drive & use machines. Renal & hepatic impairment. Women of childbearing potential should use effective contraception. Not to be used during pregnancy. Not recommended during lactation. Not recommended in childn & adolescents <18 yr.
Adverse Reactions
Conjunctival/ocular hyperaemia, eye pruritus, pain & irritation, change & discolouration of eyelashes, foreign body sensation in eyes, blurred vision, photophobia.
Drug Interactions
Eye inflammation w/ omidenepag isopropyl. Additive effects w/ oral Ca-channel blockers, β-adrenergic blocking agents, antiarrhythmics, digitalis glycosides, parasympathomimetics, guanethidine. Exacerbated rebound HTN w/ oral β-adrenergic blockers. Potentiated systemic β-blockade w/ CYP2D6 inhibitors eg, quinidine, fluoxetine, paroxetine. Mydriasis w/ 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 3 × 10 × 1's
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