Xalacom

Xalacom

latanoprost + timolol

Manufacturer:

Upjohn

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per mL Latanoprost 50 mcg, timolol 5 mg
Indications/Uses
Reduction of elevated IOP in patients w/ open-angle glaucoma or ocular HTN who are insufficiently responsive to topical IOP lowering agents.
Dosage/Direction for Use
Adult (including the elderly) 1 drop in the affected eye(s) once daily. Should not exceed once daily.
Contraindications
Hypersensitivity. Reactive airway disease eg, 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, or cardiogenic shock.
Special Precautions
Do not drive or use machines until transient blurring of vision is resolved. Remove contact lenses before instillation due to benzalkonium Cl content. Pregnancy & lactation. Childn. Latanoprost: May gradually increase iris pigmentation, change eyelashes & vellus hair in the treated eye; eyelid skin darkening. Aphakic & pseudophakic patients w/ torn posterior lens cap, or known risk factor for macular edema. Inflammatory, neovascular, chronic angle closure glaucoma, in open angle glaucoma of pseudophakic patients & in pigmentary glaucoma. History of herpetic keratitis; avoid in patients w/ active herpes simplex keratitis & history of recurrent herpetic keratitis specifically associated w/ prostaglandin analogues. Timolol maleate: Patients w/ a history of atopy or severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge w/ such allergens when treated w/ β-adrenergic blocking agents. Monitor patients w/ history of severe cardiac disease. Patients w/ 1st degree heart block, severe peripheral circulatory disturbance/disorders (ie, severe forms of Raynaud's disease or syndrome), mild/moderate chronic COPD; corneal diseases. Consider gradual w/drawal of β-adrenergic blocking agents pre-op. May increase hypoglycaemia w/ anti-diabetic agents. May mask signs & symptoms of hypoglycaemia & hyperthyroidism. Myasthenia gravis. Choroidal detachment & corneal disease. Childn.
Adverse Reactions
Cataract. Headache; corneal disorder, keratitis, conjunctivitis, blepharitis, eye pain/irritation/hyperaemia, iris hyperpigmentation, visual field defect; HTN; upper resp tract infection. Latanoprost: Eyelash & eyelid vellus hair changes (increased length, thickness, pigmentation & number of eyelashes). Timolol: Systemic allergic reactions eg, anaphylaxis, angioedema, urticaria, pruritus, localised & generalised rash; masked symptoms of hypoglycaemia in diabetic patients, anorexia; behavioral changes & psychic disturbances; CVA, cerebral ischemia, dizziness, increase in signs & symptoms of myasthenia gravis, paraesthesia, somnolence, syncope; cystoid macular edema, choroidal detachment following filtration surgery, diplopia, decreased corneal sensitivity, signs & symptoms of ocular irritation, dry eyes, ptosis, visual disturbances eg, refractive changes, blurred vision; tinnitus; cardiac arrest, cardiac failure, heart block, AV block, CHF, worsening of angina pectoris, arrhythmia, bradycardia, palpitation; claudication, cold hands & feet, hypotension, Raynaud's phenomenon; resp failure, pulmonary oedema, bronchospasm, cough, dyspnoea, nasal congestion; retroperitoneal fibrosis, abdominal pain, vomiting, diarrhoea, dry mouth, dysgeusia, dyspepsia, nausea; psoriasiform rash, pseudopemphigoid, exacerbation of psoriasis, alopecia; myalgia, SLE; sexual dysfunction, decreased libido, impotence, Peyronie's disease; chest pain, oedema, asthenia, fatigue.
Drug Interactions
May potentiate effect on IOP & known effects of systemic β-blockade w/ oral & ≥2 topical β-adrenergic blocking agents. Paradoxical elevations in IOP w/ other prostaglandins, prostaglandin analogs or prostaglandin derivatives. Timolol maleate: Mydriasis w/ epinephrine. Systemic hypotension &/or marked bradycardia w/ Ca channel blockers, catecholamine-depleting drugs or β-adrenergic blocking agents, antiarrhythmics (including amiodarone), digitalis glycosides, guanethidine. Potentiated systemic β blockade eg, decreased heart rate, depression w/ CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine). May increase the hypoglycaemic effect of diabetic agents w/ β-adrenergic blocking agents.
ATC Classification
S01ED51 - timolol, combinations ; Belongs to the class of beta blocking agents. Used in the treatment of glaucoma.
Presentation/Packing
Form
Xalacom ophth soln
Packing/Price
2.5 mL x 1's
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