Tyglacom

Tyglacom

latanoprost + timolol

Manufacturer:

Alvogen

Distributor:

International Med
Concise Prescribing Info
Contents
Per mL Latanoprost 50 mcg, timolol 5 mg
Indications/Uses
Reduction of IOP in patients w/ open angle glaucoma & ocular HTN who are insufficiently responsive to topical β-blockers or prostaglandin analogues.
Dosage/Direction for Use
Adult (including the elderly) 1 drop in the affected eye(s) once daily.
Contraindications
Hypersensitivity. Patients w/ reactive airway disease including bronchial asthma or history of bronchial asthma, severe COPD; sinus bradycardia, sick sinus syndrome, SA block, 2nd or 3rd degree AV block not controlled w/ pace-maker, overt cardiac failure, cardiogenic shock.
Special Precautions
May be absorbed systemically. Remove contact lenses before instillation of eye drops; reinsert after 15 min. If >1 topical ophth medicinal product is being used, administer at least 5 min apart. Contains benzalkonium Cl, Na dihydrogen phosphate monohydrate, disodium phosphate anhydrous. Minor influence on the ability to drive & use machines. Do not use during pregnancy & in breastfeeding women. Safety & effectiveness in childn & adolescents have not been established. Timolol: Caution in patients w/ CV diseases; 1st degree heart block; severe peripheral circulatory disturbance/disorders (ie, severe forms of Raynaud's disease or Raynaud's syndrome); asthma, mild/moderate COPD; patients subject to spontaneous hypoglycaemia or w/ labile diabetes; history of atopy or of severe anaphylactic reaction. May mask signs & symptoms of acute hypoglycaemia & signs of hyperthyroidism. May induce eye dryness. Reports of choroidal detachment w/ administration of aq suppressant therapy (eg, timolol, acetazolamide) after filtration procedures. Closely observe response of patients concomitantly receiving other systemic β-blocking agent. Use of 2 topical β-blockers is not recommended. β-blocking ophth prep may block systemic β-agonist effects eg, of adrenaline. Latanoprost: Risk of gradual change in eye colour, predominantly seen in patients w/ mixed coloured irides. Unilateral treatment can result in permanent heterochromia. Reports of eyelid skin darkening. May gradually change eyelashes & vellus hair in the treated eye. Caution in inflammatory, neovascular or chronic angle closure glaucoma, in open angle glaucoma of pseudophakic patients & in pigmentary glaucoma; in acute attacks of closed angle glaucoma; patients w/ history of herpetic keratitis. Avoid in cases of active herpes simplex keratitis & in patients w/ history of recurrent herpetic keratitis specifically associated w/ prostaglandin analogues. Reports of macular oedema mainly in aphakic patients, in pseudophakic patients w/ torn posterior lens cap, or in patients w/ known risk factors for macular oedema. Not recommended w/ ≥2 prostaglandins, prostaglandin analogues or prostaglandin derivatives.
Adverse Reactions
Iris hyperpigmentation. Eye pain, eye irritation (including stinging, burning, itching, foreign body sensation).
Drug Interactions
Latanoprost: Reports of paradoxical elevations in IOP w/ concomitant ophth administration of 2 prostaglandin analogues. Timolol: Potential additive effects w/ oral Ca channel blockers, β-blocking agents, antiarrhythmics, digitalis glycosides, parasympathomimetics, guanethidine. Potentiated systemic β-blockade w/ CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). Potentiated effects w/ oral β-adrenergic blocking agent or ≥2 topical β-adrenergic blocking agent. Mydriasis w/ ophth β-blockers & adrenaline (epinephrine). Potentiated hypertensive reaction to sudden w/drawal of clonidine. Increased hypoglycaemic effect of antidiabetic agents.
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
Tyglacom eye drops soln
Packing/Price
2.5 mL x 1's
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