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XALATAN is a brand name for Latanoprost, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: XALATAN (latanoprost) is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. XALATAN may be used for the reduction of intraocular pressure in patients with chronic angle-closure glaucoma who underwent peripheral iridotomy or laser iridoplasty. 1.3 Pediatrics…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Contact lenses should be removed prior to the administration of XALATAN, and may be reinserted 15 minutes after administration (see PATIENT MEDICATION INFORMATION). XALATAN may be used concomitantly with other topical ophthalmic products to further lower intraocular pressure.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart. 2 Recommended Dose and Dosage Adjustment The recommended dose for adults, including the elderly (over 60 years of age), is one drop in the affected eye(s) once daily.
The dose of XALATAN should not exceed once daily as it has been shown that more frequent administration decreases the IOP lowering effect. Reduction of IOP in humans starts about 3 to 4 hours after treatment and maximum effect is reached after 8 to 12 hours.
Pressure reduction is maintained for at least 24 hours. 3 Pediatrics). 4 Administration Optimal effect is obtained if XALATAN (latanoprost) is administered in the evening. 5 Missed Dose If one dose is missed, treatment should continue with the next dose the following day.
). Skin Eyelid skin darkening, which may be reversible, has been reported in association with the use of XALATAN (see 7 WARNINGS AND PRECAUTIONS). XALATAN may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes.
Eyelash changes are usually reversible upon discontinuation of treatment. 1 Pregnant Women Reproduction studies have been performed in rats and rabbits. In rabbits an incidence of 4 of 16 dams had no viable fetuses at a dose that was approximately 80 times the maximum human dose, and the highest nonembryocidal dose in rabbits was approximately 15 times the maximum human dose (see 16 NON-CLINICAL TOXICOLOGY).
XALATAN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 2 Breast-feeding The active substance in XALATAN and its metabolites may pass into breast milk and XALATAN should therefore be used with caution in nursing women (see 16 NON-CLINICAL TOXICOLOGY).
3 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of the use of XALATAN in children has not been established; therefore, Health Canada has not authorized an indication for pediatric use. 2 Clinical Trial Adverse Reactions).
2 Clinical Trial Adverse Reactions). 2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The ocular adverse events and ocular signs and symptoms reported in 5 to 15% of the patients on XALATAN (latanoprost) in the three 6 month, multi-centre, double-masked, active- controlled trials were blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased iris pigmentation and punctate epithelial keratopathy.
, Ophthalmologic 09/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................................
2 TABLE OF CONTENTS .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ......................................................................
4 1 INDICATIONS ............................................................................................................... 4 2 CONTRAINDICATIONS .................................................................................................
4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 5 OVERDOSAGE..............................................................................................................
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 5 7 WARNINGS AND PRECAUTIONS .................................................................................. 8 8 ADVERSE REACTIONS ..................................................................................................
9 XALATAN (latanoprost) Page 3 of 28 9 DRUG INTERACTIONS ................................................................................................ 10 10 CLINICAL PHARMACOLOGY .......................................................................................
11 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 12 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 12 PART II: SCIENTIFIC INFORMATION .......................................................................................
Latanoprost is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Local conjunctival hyperemia was observed: however, less than 1% of the XALATAN treated patients required discontinuation of therapy because of intolerance to conjunctival hyperemia. In addition to the above listed ocular events/signs and symptoms, the following were reported in 1 to 4% of the patients: dry eye, excessive tearing, eye pain, lid crusting, lid edema, lid erythema, lid discomfort/pain and photophobia.
The most common systemic adverse events seen with XALATAN were upper respiratory tract infection/cold/flu which occurred at a rate of approximately 4%. Pain in muscle/joint/back, chest pain/angina pectoris and rash/allergic skin reaction each occurred at a rate of 1 to 2%.
5 Post-Market Adverse Reactions System Organ Class Adverse Drug Reactions Eye disorders Macular oedema including cystoid macular oedema, corneal erosion, punctate keratitis, corneal oedema, uveitis, iritis, pseudopemphigoid of ocular conjunctiva, trichiasis, eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation, and number of eyelashes), localised skin reaction on the eyelids, iris cyst, periorbital and lid changes resulting in deepening of the eyelid sulcus, darkening of the palpebral skin of the eyelids Infections and infestations Herpetic keratitis Nervous system disorders Dizziness, headache Gastrointestinal disorders Vomiting, nausea Respiratory, thoracic and mediastinal disorders Acute asthma attacks, asthma aggravation, asthma, dyspnoea Skin and subcutaneous tissue disorders Pruritus Cases of corneal calcification have been reported very rarely in association with the use of phosphate-containing eye drops in some patients with significantly damaged corneas.
In a long-term observational cohort safety study evaluating hyperpigmentation changes in the eye, 100 paediatric glaucoma patients were followed for up to 10 years: 67 were treated with latanoprost, and 33 were not exposed to prostaglandin analogs (control group).
The proportion of patients with hyperpigmentation was larger in the latanoprost group compared to the control group: iris colour darkening (13% vs 6%), localised iris pigmentation (6% vs 3%), and increase of nevi/freckles of iris, conjunctiva or choroid (12% vs 3%).
5% to 12%) compared to the control group (0%). 3 Pediatrics). XALATAN (latanoprost) Page 10 of 28
13 13 PHARMACEUTICAL INFORMATION ............................................................................ 13 14 CLINICAL TRIALS ........................................................................................................
13 15 MICROBIOLOGY ........................................................................................................ 17 16 NON-CLINICAL TOXICOLOGY .....................................................................................
17 PATIENT MEDICATION INFORMATION .................................................................................. 24 XALATAN (latanoprost) Page 4 of 28 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS XALATAN (latanoprost) is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
XALATAN may be used for the reduction of intraocular pressure in patients with chronic angle-closure glaucoma who underwent peripheral iridotomy or laser iridoplasty. 3 Pediatrics). 4 Geriatrics Geriatrics: Based on the data submitted and reviewed by Health Canada, there is no overall difference in the safety and efficacy of XALATAN use in the geriatric patient population.
2 CONTRAINDICATIONS Latanoprost is contraindicated in patients who are hypersensitive to this drug or to any […]