Tapcom/Tapcom-S

Tapcom/Tapcom-S

Manufacturer:

Santen

Distributor:

DKLL
Concise Prescribing Info
Contents
Tafluprost 0.0015%, timolol maleate 0.5%
Indications/Uses
Tapcom: Open angle glaucoma & ocular HTN. Tapcom-S: Reduction of IOP in adult patients w/ open angle glaucoma or ocular HTN.
Dosage/Direction for Use
1 drop in the affected eye(s) once daily. Not to be used more than once daily.
Contraindications
Patients treated in combination w/ products containing omidenepag isopropyl. Hypersensitivity. Pre-existing or history of bronchial asthma, severe chronic COPD. Sinus bradycardia, 2nd & 3rd degree AV block (Tapcom-S: not controlled w/ pacemaker), cardiogenic shock. Tapcom: Bronchospasm; poor-controlled cardiac failure. Tapcom-S: Sick sinus syndrome including SA block; overt cardiac failure.
Special Precautions
Pregnancy & lactation. Tapcom: Patients w/ right ventricular failure caused by pulmonary HTN; CHF, diabetic ketoacidosis or metabolic acidosis, poor-controlled diabetes, aphakia or pseudophakia, intraocular inflammation (iritis, uveitis). Pigmentation in iris & eyelid or hypetrichosis around the eyes may occur. Corneal epithelium disorder may occur during treatment. Closed angle glaucoma. Refrain from activities including driving or operating machinery. Remove contact lenses prior to administration & re-insert after at least 15 min. Parturient women. Elderly. Childn. Tapcom-S: CV diseases (eg, CHD, Prinzmetal's angina & cardiac failure) & hypotension. Patients w/ 1st degree heart block, severe peripheral circulatory disturbance/disorders (ie, severe forms of Raynaud's disease or syndrome), mild/moderate COPD, subject to spontaneous hypoglycaemia or w/ labile diabetes, corneal diseases, angle-closure glaucoma, history of atopy or severe anaphylactic reaction. May mask signs of hyperthyroidism. Avoid abrupt w/drawal of β-blocker therapy. Choroidal detachment. Aphakic & pseudophakic patients w/ torn posterior lens cap or anterior chamber lenses, or w/ known risk factors for cystoid macular oedema or iritis/uveitis. Possible eyelash growth, eyelid skin darkening & increase in iris pigmentation may occur & be permanent. Concomitant use w/ another topical β-adrenergic blocking agent & surgical anesth.
Adverse Reactions
Tapcom: lris pigmentation, ocular pemphigoid; bronchospasm, dyspnea, resp failure; heart block, CHF, cerebral ischemia, cardiac arrest, cerebrovascular disorder; SLE. Tapcom-S: Conjunctival/ocular hyperemia, eye pruritus, pain & irritation, change of eyelashes (increased length, thickness & number), eyelash discolouration, foreign body sensation in eyes, blurred vision, photophobia.
Drug Interactions
Tapcom: Enhancement of mydriatic action w/ adrenaline & dipivefrin HCl. Excessive suppression of sympathetic nervous system w/ catecholamine-depleting drugs eg, reserpine. Enhanced IOP lowering effect or systemic effect w/ atenolol, propranolol HCl & metoprolol tartrate. AV conduction disorder, left ventricular failure or hypotension may be induced w/ Ca antagonists eg, verapamil HCl, diltiazem HCl. Bradycardia & AV block w/ digitalis prep eg, digoxin & digitoxin. β-blocking action including decreased heart rate & bradycardia may be enhanced w/ CYP2D6 inhibitors eg, quinidine sulfate hydrate, SSRIs. Tapcom-S: Potential additive effects resulting in hypotension &/or marked bradycardia w/ oral Ca channel & β-adrenergic blockers, antiarrhythmics (including amiodarone), digitalis glycoside, parasympathomimetics, guanethidine. May exacerbate rebound HTN which can follow w/drawal of clonidine. Potentiated systemic blockade w/ CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine) & timolol. Mydriasis may occur w/ adrenaline.
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 ophth soln
Packing/Price
2.5 mL x 1's
Form
Tapcom-S ophth soln
Packing/Price
0.3 mL x 30 × 1's
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