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Tapcom/Tapcom-S

Tapcom/Tapcom-S

Manufacturer:

Santen

Distributor:

Metro Drug
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 monotherapy w/ β-blockers or prostaglandin analogues & require a combination therapy, & who would benefit from preservative-free eye drops (Tapcom-S).
Dosage/Direction for Use
Instill 1 drop in the conjunctival sac of the affected eye(s) once daily.
Contraindications
Hypersensitivity. Patients w/ reactive airway disease including bronchial asthma, or a history of bronchial asthma, bronchospasm, or severe COPD; poor-controlled cardiac failure, sinus bradycardia, sick sinus syndrome, including sino-atrial block, 2nd- or 3rd-degree AV block not controlled w/ pace-maker. Overt cardiac failure, cardiogenic shock.
Special Precautions
May be absorbed systemically & cause adverse drug reactions similar to those caused by systemic administration of a β-blocker. Take at least 5 min of interval when >1 ophth drug is used. Remove contact lenses prior to administration & wait at least 15 min prior to wearing them again. 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); closed-angle glaucoma. The following conditions may occur: Pigmentation in iris & eyelid, or hypertrichosis around eyes; corneal epithelium disorder (superficial punctate keratitis, filamentary keratitis or corneal erosion). Switch from amiotic may require refraction adjustment. Pregnancy & lactation, parturient women. Low-birth-wt infants, neonates, infants or childn. Elderly. Tapcom-S: History of atopy or severe anaphylactic reaction. May mask signs of hyperthyroidism. Choroidal detachment. May block systemic β-agonist effect eg, adrenaline. Possibility of eyelash growth, darkening of eyelid skin & increased iris pigmentation. Patients w/ CV diseases (eg, CHD, Prinzmetal's angina & cardiac failure) & hypotension; 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. Aphakic or pseudophakic patients, & those w/ torn posterior lens cap or anterior chamber lenses, or in patients w/ known risk factors for cystoid macular oedema or iritis/uveitis. Use of 2 topical β-adrenergic blockers is not recommended. Renal & hepatic impairment. Not recommended in childn & adolescent <18 yr. Not to be used during pregnancy. Not recommended during lactation.
Adverse Reactions
Tapcom: Eyelash abnormality, conjunctival inj, corneal epithelium disorder including punctate keratitis, blepharal pigmentation, irritation, itching, blepharitis, keratoconjunctivitis sicca. Iris pigmentation, ocular pemphigoid, bronchospasm, dyspnea, resp failure, heart block, CHF, cerebral ischemia, cardiac arrest, cerebrovascular disorder, SLE. Tapcom-S: Conjunctival/ocular hyperaemia, eye pruritus, pain & irritation, change of eyelashes (increased length, thickness & number), eyelash discolouration, foreign body sensation in eyes, blurred vision, photophobia.
Drug Interactions
Tapcom-S: Potential additive effects resulting in hypotension &/or marked bradycardia w/ oral Ca channel blockers, β-adrenergic blockers, antiarrhythmics (including amiodarone), digitalis glycosides, parasympathomimetics, guanethidine. May exacerbate rebound HTN following clonidine w/drawal. Potentiated systemic β-blockade w/ CYP2D6 inhibitors eg, quinidine, fluoxetine, paroxetine. Mydriasis w/ adrenaline (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 ophth soln
Packing/Price
2.5 mL x 1's
Form
Tapcom-S ophth soln
Packing/Price
(single dose) 0.3 mL x 30 × 1's
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