Elevated intraocular pressure: Ophthalmic: Instill 1 drop into affected eye(s) once daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use caution.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied); use caution.
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Also see individual agents.
>10%: Ophthalmic: Abnormal eyelash growth (including darkening, lengthening, thickening; 37%), eye irritation (12%; including burning sensation of eyes, eye pruritus, foreign body sensation of eye, stinging of eyes), iris hyperpigmentation (2% to 20%)
1% to 10%:
Cardiovascular: Chest pain (1%), hypertension (4%; exacerbation of hypertension [<1%])
Dermatologic: Dermatologic disorder (2%), hypertrichosis (2%), skin rash (1%)
Endocrine & metabolic: Diabetes mellitus (1%), hypercholesterolemia (2%)
Infection: Infection (1%)
Nervous system: Depression (2%), headache (2%)
Neuromuscular & skeletal: Arthritis (2%), back pain (1%)
Ophthalmic: Blepharitis (3%), cataract (3%), conjunctival abnormalities (1%), conjunctivitis (3%), corneal disorder (3%), error of refraction (2%), eye pain (2%), keratitis (1%), ocular hyperemia (7%), photophobia (2%), visual disturbance (7%), visual field defect (5%)
Respiratory: Flu-like symptoms (3%), sinusitis (2%), upper respiratory tract infection (6%)
<1%:
Dermatologic: Seborrhea, skin discoloration, skin pigmentation
Endocrine & metabolic: Hyperglycemia
Gastrointestinal: Dyspepsia
Genitourinary: Cystitis, glycosuria, urinary tract infection
Nervous system: Dizziness, insomnia, sleep disorder
Ophthalmic: Corneal ulcer, cystoid macular edema, epiphora, eyelid edema, increased intraocular pressure, optic atrophy, retinopathy, uveitis
Respiratory: Bronchitis, cough, dyspnea, pneumonia
Postmarketing:
Cardiovascular: Atrial fibrillation (Alm 2011), bradycardia (Alm 2011), heart failure (Alm 2011), syncope (Alm 2011)
Dermatologic: Hyperpigmentation (periorbital) (Alm 2011)
Ophthalmic: Iridocyclitis (Alm 2011), iritis (Alm 2011), macular edema (Alm 2011), ocular allergy (Alm 2011), punctate keratitis (Alm 2011), retinal vein occlusion (Alm 2011)
Respiratory: Pulmonary edema (Alm 2011)
Hypersensitivity to latanoprost, timolol, benzalkonium chloride, or any component of the formulation; reactive airway disease including severe chronic obstructive pulmonary disease (COPD) and presence or history of bronchial asthma; sinus bradycardia, sick sinus syndrome, sinoatrial block, second- or third-degree atrioventricular block not controlled with pacemaker, overt cardiac failure, cardiogenic shock
Concerns related to adverse effects:
• Anaphylactic reactions: Use caution with history of atopy or severe anaphylaxis to allergens; patients taking beta-blockers may become more sensitive to repeated challenges. Treatment of anaphylaxis (eg, epinephrine) in patients taking beta-blockers may be ineffective or promote undesirable effects.
• Bacterial keratitis: Inadvertent contamination of multiple-dose ophthalmic solutions has caused bacterial keratitis.
• Ocular effects: Use of agents that reduce/suppress aqueous humor production has been associated with choroidal detachment after filtration procedures. Discontinue use in patients with chronic or recurrent choroidal detachment. Macular edema (including cystoid macular edema), mainly in aphakic or pseudophakic patients with a torn posterior lens capsule, has been associated with use of prostaglandin analogues such as latanoprost. May permanently change/increase brown pigmentation of the iris, the eyelid skin, and eyelashes. Patients should be examined regularly and, depending on the clinical situation, treatment may be stopped if increased iris pigmentation ensues. In addition, may increase the length, darken and thicken eyelashes (may vary between eyes); changes occur slowly and may not be noticeable for months or years. Long-term consequences and potential injury to eye are not known. Ophthalmic beta-blockers may cause eye dryness; use caution in corneal diseases.
Disease-related concerns:
• Cardiovascular disease: Consider pre-existing conduction abnormalities prior to initiation; use is contraindicated in several conditions (refer to contraindications). Use with caution in first-degree heart block. Use with caution in heart failure (HF); fatalities have been reported. Prior to initiating therapy HF should be controlled. Monitor for signs/symptoms of HF and discontinue use immediately if suspected. Use with caution in patients with orthostatic hypotension; signs and symptoms of hypotension may be enhanced.
• Closed-angle glaucoma: Should not be used alone in the treatment of acute closed angle glaucoma (immediate objective is to reopen the angle by constricting the pupil). Latanoprost and timolol maleate have little or no effect on the pupil.
• Diabetes: Use with caution in patients with diabetes mellitus (especially labile diabetes); may potentiate hypoglycemia and/or mask signs and symptoms.
• Hepatic impairment: Use with caution in hepatic impairment (has not been studied).
• Herpetic keratitis: Use with caution in patients with a history of herpes simplex keratitis; reactivation may occur. Avoid use in patients with active herpes simplex keratitis or patients with a history of recurrent herpetic keratitis specifically associated with prostaglandin analogs.
• Iritis/uveitis: Use caution in patients with active intraocular inflammation.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis; may worsen disease or other myasthenic symptoms (diplopia, ptosis, generalized weakness).
• Peripheral vascular disease (PVD) and Raynaud disease: Can precipitate or aggravate symptoms of arterial insufficiency in patients with PVD and Raynaud disease. Use with caution and monitor for progression of arterial obstruction.
• Pulmonary disease: Use with caution in patients with mild or moderate COPD and closely monitor; beta blockers should generally be avoided in patients with bronchospastic disease.
• Renal impairment: Use with caution in renal impairment (has not been studied).
• Thyroid disease: May mask signs of hyperthyroidism (eg, tachycardia). If thyrotoxicosis is suspected, carefully manage and monitor; abrupt withdrawal may exacerbate symptoms of hyperthyroidism or precipitate thyroid storm.
Concurrent drug therapy issues:
• Thimerosal: Precipitation may occur if mixed with benzalkonium chloride-containing products; allow at least 5 minutes between the application of latanoprost/timolol and ophthalmic preparations containing thimerosal.
Special populations:
• Contact lens wearers: Product contains benzalkonium chloride which may be absorbed by soft contact lenses; remove lens prior to administration and wait 15 minutes before reinserting.
Other warnings/precautions:
• Absorption: Systemic absorption of timolol and adverse effects may occur with ophthalmic use, including bradycardia and/or hypotension. Beta-blocker therapy should not be withdrawn abruptly in order to avoid acute tachycardia, hypertension, and/or ischemia. In patients undergoing major surgery, anesthesia provider should be informed that patient is receiving timolol; gradually taper off therapy prior to procedure if possible.
• Appropriate use: Limited or no experience in the treatment of chronic angle-closure, congenital, inflammatory, neovascular, or pigmentary glaucoma or in pseudophakic patients with open angle glaucoma.
• Initial therapy: Combination product should not be used for initial therapy.
Not available in the US
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic:
Xalacom: Latanoprost 0.005% and timolol maleate 0.5% (2.5 mL) [contains benzalkonium chloride]
Generic: Latanoprost 0.005% and timolol maleate 0.5% (2.5 mL)
Ophthalmic: Wash hands prior to use. Remove contact lenses prior to administration; wait 15 minutes before reinserting if using products containing benzalkonium chloride. Separate administration of other ophthalmic agents by 5 minutes. Nasolacrimal occlusion or closing the eye for 2 minutes after administration may limit systemic absorption.
Note: Not approved in the US
Elevated intraocular pressure: Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blockers, prostaglandin analogues, or other IOP-reducing agents and in whom combination therapy is appropriate
Xalacom may be confused with Xalatan
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetylcholinesterase Inhibitors: May enhance the bradycardic effect of Beta-Blockers. Risk C: Monitor therapy
Ajmaline: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
Alpha2-Agonists: May enhance the AV-blocking effect of Beta-Blockers. Sinus node dysfunction may also be enhanced. Beta-Blockers may enhance the rebound hypertensive effect of Alpha2-Agonists. This effect can occur when the Alpha2-Agonist is abruptly withdrawn. Management: Closely monitor heart rate during treatment with a beta blocker and clonidine. Withdraw beta blockers several days before clonidine withdrawal when possible, and monitor blood pressure closely. Recommendations for other alpha2-agonists are unavailable. Risk D: Consider therapy modification
Amiodarone: May enhance the bradycardic effect of Beta-Blockers. Possibly to the point of cardiac arrest. Amiodarone may increase the serum concentration of Beta-Blockers. Risk C: Monitor therapy
Antidiabetic Agents: Beta-Blockers (Nonselective) may enhance the hypoglycemic effect of Antidiabetic Agents. Beta-Blockers (Nonselective) may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy
Antipsychotic Agents (Phenothiazines): May enhance the hypotensive effect of Beta-Blockers. Beta-Blockers may decrease the metabolism of Antipsychotic Agents (Phenothiazines). Antipsychotic Agents (Phenothiazines) may decrease the metabolism of Beta-Blockers. Risk C: Monitor therapy
Artemether and Lumefantrine: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
Beta2-Agonists: Beta-Blockers (Nonselective) may diminish the bronchodilatory effect of Beta2-Agonists. Risk X: Avoid combination
Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: Monitor therapy
Cannabis: Beta-Blockers may enhance the adverse/toxic effect of Cannabis. Specifically, the risk of hypoglycemia may be increased. Risk C: Monitor therapy
Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Risk D: Consider therapy modification
Cholinergic Agonists: Beta-Blockers may enhance the adverse/toxic effect of Cholinergic Agonists. Of particular concern are the potential for cardiac conduction abnormalities and bronchoconstriction. Risk C: Monitor therapy
CYP2D6 Inhibitors (Strong): May increase the serum concentration of Timolol (Ophthalmic). Risk C: Monitor therapy
Dipyridamole: May enhance the bradycardic effect of Beta-Blockers. Risk C: Monitor therapy
Disopyramide: May enhance the bradycardic effect of Beta-Blockers. Beta-Blockers may enhance the negative inotropic effect of Disopyramide. Risk C: Monitor therapy
DOBUTamine: Beta-Blockers may diminish the therapeutic effect of DOBUTamine. Risk C: Monitor therapy
Dronedarone: May enhance the bradycardic effect of Beta-Blockers. Dronedarone may increase the serum concentration of Beta-Blockers. This likely applies only to those agents that are metabolized by CYP2D6. Management: Use lower initial beta-blocker doses; adequate tolerance of the combination, based on ECG findings, should be confirmed prior to any increase in beta-blocker dose. Increase monitoring for clinical response and adverse effects. Risk D: Consider therapy modification
EPHEDrine (Systemic): Beta-Blockers may diminish the therapeutic effect of EPHEDrine (Systemic). Risk C: Monitor therapy
EPINEPHrine (Nasal): Beta-Blockers (Nonselective) may enhance the hypertensive effect of EPINEPHrine (Nasal). Risk C: Monitor therapy
EPINEPHrine (Oral Inhalation): Beta-Blockers (Nonselective) may enhance the hypertensive effect of EPINEPHrine (Oral Inhalation). Risk C: Monitor therapy
EPINEPHrine (Systemic): Beta-Blockers (Nonselective) may enhance the hypertensive effect of EPINEPHrine (Systemic). Risk C: Monitor therapy
Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): Beta-Blockers may enhance the vasoconstricting effect of Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates). Risk C: Monitor therapy
Etilefrine: May enhance the bradycardic effect of Beta-Blockers. Beta-Blockers may diminish the therapeutic effect of Etilefrine. Risk C: Monitor therapy
Etofylline: Beta-Blockers may diminish the therapeutic effect of Etofylline. Risk X: Avoid combination
Etrasimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Fexinidazole: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole. Risk X: Avoid combination
Fingolimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider therapy modification
Grass Pollen Allergen Extract (5 Grass Extract): Beta-Blockers may enhance the adverse/toxic effect of Grass Pollen Allergen Extract (5 Grass Extract). More specifically, Beta-Blockers may inhibit the ability to effectively treat severe allergic reactions to Grass Pollen Allergen Extract (5 Grass Extract) with epinephrine. Some other effects of epinephrine may be unaffected or even enhanced (e.g., vasoconstriction) during treatment with Beta-Blockers. Management: Consider alternatives to either grass pollen allergen extract (5 grass extract) or beta-blockers in patients with indications for both agents. Canadian product labeling specifically lists this combination as contraindicated. Risk D: Consider therapy modification
Insulins: Beta-Blockers (Nonselective) may enhance the hypoglycemic effect of Insulins. Beta-Blockers (Nonselective) may diminish the therapeutic effect of Insulins. Risk C: Monitor therapy
Isoproterenol: Beta-Blockers may diminish the therapeutic effect of Isoproterenol. Risk C: Monitor therapy
Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy
Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy
Mavacamten: Beta-Blockers may enhance the adverse/toxic effect of Mavacamten. Specifically, negative inotropic effects may be increased. Risk C: Monitor therapy
Mavorixafor: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Methacholine: Beta-Blockers may enhance the adverse/toxic effect of Methacholine. Risk C: Monitor therapy
Methoxyflurane: May enhance the hypotensive effect of Beta-Blockers. Risk C: Monitor therapy
Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Mivacurium: Beta-Blockers may enhance the therapeutic effect of Mivacurium. Risk C: Monitor therapy
NIFEdipine: May enhance the hypotensive effect of Beta-Blockers. NIFEdipine may enhance the negative inotropic effect of Beta-Blockers. Risk C: Monitor therapy
Nitrendipine: May enhance the therapeutic effect of Beta-Blockers. Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May diminish the antihypertensive effect of Beta-Blockers. Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents may also enhance the therapeutic effects of Prostaglandins (Ophthalmic). Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents (Topical): May diminish the therapeutic effect of Beta-Blockers. Risk C: Monitor therapy
Ozanimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
Ponesimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider therapy modification
Prostaglandins (Ophthalmic): The concomitant use of Prostaglandins (Ophthalmic) and Latanoprost may result in increased intraocular pressure. Risk X: Avoid combination
Reserpine: May enhance the bradycardic effect of Beta-Blockers. Reserpine may enhance the hypotensive effect of Beta-Blockers. Risk C: Monitor therapy
Rivastigmine: May enhance the bradycardic effect of Beta-Blockers. Risk X: Avoid combination
Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider therapy modification
Succinylcholine: Beta-Blockers may enhance the neuromuscular-blocking effect of Succinylcholine. Risk C: Monitor therapy
Sulfonylureas: Beta-Blockers (Nonselective) may enhance the hypoglycemic effect of Sulfonylureas. Beta-Blockers (Nonselective) may diminish the therapeutic effect of Sulfonylureas. Risk C: Monitor therapy
Tasimelteon: Beta-Blockers may diminish the therapeutic effect of Tasimelteon. Management: Consider avoiding nighttime administration of beta-blockers during tasimelteon therapy due to the potential for reduced tasimelteon efficacy. Risk D: Consider therapy modification
Theophylline Derivatives: Beta-Blockers (Nonselective) may diminish the bronchodilatory effect of Theophylline Derivatives. Risk C: Monitor therapy
Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy
White Birch Allergen Extract: Beta-Blockers may enhance the adverse/toxic effect of White Birch Allergen Extract. Specifically, beta-blockers may reduce the effectiveness of beta-agonists that may be required to treat systemic reactions to white birch allergen extract. Risk X: Avoid combination
Reproductive studies have not been conducted with this combination. See individual agents.
Timolol has been detected in human breast milk following ophthalmic administration. Latanoprost may enter human breast milk. See individual agents.
IOP, iris color changes, eyelash changes; systemic effects of beta blockade
Latanoprost: A prostaglandin F2-alpha analog believed to reduce intraocular pressure by increasing the outflow of the aqueous humor
Timolol: Blocks both beta1- and beta2-adrenergic receptors, reduces intraocular pressure by reducing aqueous humor production or possibly increases the outflow of aqueous humor
See individual agents.
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