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APO-LATANOPROST 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: APO-LATANOPROST (latanoprost) is indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. APO-LATANOPROST may be used for the reduction of intraocular pressure in patients with chronic angle-closure glaucoma who underwent peripheral iridotomy or laser…
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 APO-LATANOPROST and may be reinserted 15 minutes after administration (see PATIENT MEDICATION INFORMATION). APO-LATANOPROST 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 APO-LATANOPROST 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 APO-LATANOPROST (Latanoprost Ophthalmic Solution) Page 5 of 31 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 APO-LATANOPROST (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 latanoprost ophthalmic solution (see 7 WARNINGS AND PRECAUTIONS) APO-LATANOPROST 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).
APO-LATANOPROST should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 2 Breast-feeding The active substance in APO-LATANOPROST and its metabolites may pass into breast milk and APO-LATANOPROST 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 latanoprost ophthalmic solution 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 latanoprost ophthalmic solution 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.
General Latanoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes, and growth of eyelashes.
Pigmentation is expected to increase as long as latanoprost ophthalmic solution is administered. After discontinuation of latanoprost ophthalmic solution, pigmentation of the iris is likely to be permanent while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients.
Patients who receive treatment should be informed of the possibility of increased pigmentation. The effects of increased pigmentation beyond 5 years are not known. Patients who are expected to receive treatment in only one eye should be informed about the potential for increased pigmentation in the treatment eye and thus, heterochromia between the eyes.
APO-LATANOPROST may gradually increase the pigmentation of the iris. , blue-brown, grey-brown, green-brown or yellow-brown. The eye colour change is due to increased melanin content in the stromal melanocytes rather than to an increase in the number of melanocytes.
This change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish.
Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with APO-LATANOPROST can be continued in patients who develop noticeably increased pigmentation, these patients should be examined regularly. During clinical trials, the increase in brown iris pigment has not been shown to progress further upon discontinuation of treatment, but the resultant colour change may be permanent.
Hepatic/Biliary/Pancreatic Latanoprost ophthalmic solution has not been studied in patients with hepatic impairment and should, therefore, be used with caution in such patients. APO-LATANOPROST (Latanoprost Ophthalmic Solution) Page 7 of 31 Ophthalmologic Macular edema, including cystoid macular edema, has been reported during treatment with latanoprost ophthalmic solution.
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 latanoprost ophthalmic solution 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 latanoprost ophthalmic solution 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%.
3 Less Common Clinical Trial Adverse Reactions The following events were reported in less than 1% of the patients: Eye disorder: conjunctivitis, diplopia, discharge from the eye, retinal artery embolus, retinal detachment, and vitreous hemorrhage from diabetic retinopathy.
5 Post-Market Adverse Reactions APO-LATANOPROST (Latanoprost Ophthalmic Solution) Page 10 of 31 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%). 1 Pediatrics).
These reports have mainly occurred in aphakic patients, in pseudophakic patients with torn posterior lens capsule, or in patients with known risk factors for macular edema. APO-LATANOPROST should be used with caution in patients who do not have an intact posterior capsule or who have known risk factors for macular edema.
There is no experience with latanoprost ophthalmic solution in patients with inflammatory ocular conditions, inflammatory glaucoma, neovascular glaucoma or congenital glaucoma, and only limited experience with pseudophakic patients and in patients with pigmentary glaucoma.
APO-LATANOPROST should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation. APO-LATANOPROST should be used with caution in patients with a history of herpetic keratitis.
APO-LATANOPROST should be avoided in cases of active herpes simplex keratitis and in patients with a history of recurrent herpetic keratitis specifically associated with prostaglandin analogues. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products.
These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of ocular epithelial surface (see PATIENT MEDICATION INFORMATION). This product contains benzalkonium chloride as a preservative, which may be absorbed by soft contact lenses.
Remove contact lenses before administration of APO-LATANOPROST. Contact lenses may be reinstalled 15 minutes after administering APO-LATANOPROST. Renal Latanoprost ophthalmic solution has not been studied in patients with renal impairment and should, therefore, be used with caution in such patients.
Reproductive Health:
Female and Male Potential • Fertility Latanoprost has not been found to have any effect on male or female fertility in animal studies. Respiratory APO-LATANOPROST (Latanoprost Ophthalmic Solution) Page 8 of 31 There is no experience in patients with severe or uncontrolled asthma.
Such patients should therefore be treated with caution until there is sufficient experience (see