Each mL contains: Latanoprost 50 mcg, Benzalkonium chloride 0.02% w/v (as preservative).
Pharmacology: The active substance Latanoprost, a prostaglandin F2α analogue, is a selective prostanoid FP receptor agonist which reduces the Intra Ocular Pressure (IOP) by increasing the outflow of aqueous humor. Latanoprost has not induced fluorescein leakage in the posterior segment of pseudophakic human eyes during short term treatment. Latanoprost in clinical doses has not been found to have any significant pharmacologic effects on the cardiovascular or respiratory system.
Reduction of elevated intraocular pressure in patients with open angle glaucoma, chronic angle closure glaucoma and ocular hypertension who are intolerant of other intraocular pressure lowering medications or insufficiently responsive (failed to achieve target IOP determined after multiple measurements over time) to another intraocular pressure lowering medication.
Recommended Dosage for Adults (including the elderly): Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if Latanoprost is administered in the evening. If one dose is missed, treatment should continue with the next dose as normal.
Administration: Latanoprost is effective as a single drug therapy. It is effective in combination with beta-adrenergic agonists (dipivalyl epinephrine), oral carbonic anhydrase inhibitors (acetazolamide) and at least partly additive with cholinergic agonist (pilocarpine).
Latanoprost may be used concomitantly with other topical ophthalmic drug product to lower intraocular pressure. In case of combined therapy the eye drops should be administered with an interval of at least five minutes. The dosage of Latanoprost should not exceed once daily since it has been shown that more frequent administration decreases the intraocular pressure lowering effect.
Children: Safety and effectiveness in children has not been established. Therefore, Latanoprost is not recommended for use in children.
Apart from ocular irritation and conjunctival hyperaemia, no other ocular side effects are known if Latanoprost is overdosed.
If Latanoprost is accidentally ingested, the following information may be useful: On bottle contains 125 micrograms latanoprost. More than 90% is metabolized during the first pass through the liver. Intravenous infusion of 3 μg/kg in healthy volunteers induced no symptoms, but a dose of 5.5-10 μg/kg caused nausea, abdominal pain, dizziness, fatigue, hot flushes and sweating. If overdosage with Latanoprost occurs, treatment should be symptomatic.
Known hypersensitivity to any component in Latanoprost. Precipitation occurs when eye drops containing thiomerosal are mixed with Latanoprost. If such drugs are used, the eye drops shall be administered with an interval of at least five minutes.
Benzalkonium chloride, which is commonly used as preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since this drug contains benzalkonium chloride, close monitoring is required with frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised.
Contact Lenses: Patients should be advised not to wear a contact lens if their eye is red. This drug should not be used to treat contact lens related irritation. The preservative in this drug, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should be instructed to wait at least ten minutes after instilling this drug before they insert their contact lenses.
Latanoprost may gradually change the eye color by increasing the amount of brown pigment in the iris. This effect has predominantly been seen in patients with mixed coloured irides, i.e. blue-brown, grey-brown, green-brown or yellow-brown, and is due to increased melanin content in the stromal melanocytes of the iris. A permanent heterochromia can happen. Typically the brown pigmentation around the pupil spreads concentrically towards the periphery in affected eyes, but the entire iris or parts of it may become more brownish. In patients with homogeneously blue, grey, green or brown eyes, the change has only rarely been seen during two years of treatment.
The change in iris colour occurs slowly and may not be noticeable for several months to years. It has not been associated with any symptom or pathological changes. No further increase in brown iris pigment has been observed after discontinuation of treatment, but the resultant colour change may be permanent. Until further long term data is obtained, it is recommended that in patients with mixed coloured irides only those who are intolerant or insufficiently responsive to another intraocular pressure lowering medication be treated.
Neither naevi nor freckles of the iris have been affected by the treatment. Accumulation of pigment in the trabecular meshwork or elsewhere in the anterior chamber has not been observed, but until further long term experience about increased iris pigmentation is available, patients should be examined regularly and depending on the clinical situation, treatment may be stopped if increased iris pigmentation ensues.
Before treatment is instituted patients should be informed of the possibility of a change in eye colour. Unilateral treatment can result in permanent heterochromia.
There is no experience of Latanoprost in inflammatory, neovascular, angle closure or congenital glaucoma and only limited experience in open angle glaucoma of pseudophakic patients and in pigmentary glaucoma. Latanoprost has no or little effect on the pupil, but there is no experience in acute attacks of closed angle glaucoma. Therefore, it is recommended that Latanoprost should be used with caution in these conditions until more experience is obtained.
Macular oedema, including cystoid macular oedema, has been reported during treatment with Latanoprot. 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 oedema. Latanoprost should be used with caution in these patients.
Latanoprost contains benzalkonium chloride which may be absorbed by contact lenses. The contact lenses should be removed before instillation of the eye drops and maybe reinserted after 15 minutes. Latanoprost should not be administered while wearing contact lenses. Latanoprost has not been studied in patients with renal or hepatic impairment and should therefore be used with caution in such patients.
Latanoprost should be used with caution in patients with history of herpetic keratitis and should be avoided in cases of active herpes simplex keratitis and in patients with a history of recurrent herpetic keratitis specially associated with prostaglandin analogues.
Effect on ability to drive and use machine: In common with other preparations, instillation of eye drops may cause transient blurring of vision. Until this has resolved, patients should not drive or use machines.
Pregnancy: This medicinal product does not increase the spontaneous incidence of birth defects, but it has potential hazardous pharmacological effects with respect to the course of pregnancy, to the unborn or the neonate. Latanoprost should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Lactation: The active substance in Latanoprost and its metabolites may pass into breast milk and Latanoprost should therefore be used with caution in nursing women.
The following events were considered drug related:
Eye Disorders: Eye irritation (burning, grittiness, itching, stinging and foreign body sensation), blepharitis, conjunctival hyperemia, eye pain, increased pigmentation of the iris (see PRECAUTIONS), transient punctate epithelial erosions, and eyelid edema.
Skin and Subcutaneous Tissue Disorders: Skin rash.
The following events have been reported:
Nervous System Disorders: Dizziness, headache.
Eye Disorders: Corneal oedema and erosions, conjunctivitis, eyelash and vellus hair changes (increased length, thickness, pigmentation, and number), iritis/uveitis, keratitis, macular oedema (including cystoid macular oedema), misdirected eyelashes sometimes resulting in eye irritation, vision blurred (see PRECAUTIONS).
Respiratory, Thoracic and Mediastinal Disorders: Asthma, asthma aggravation, acute asthma attacks, and dyspnea.
Skin and Subcutaneous Tissue Disorders: Darkening of the palpebral skin of the eyelids and localized skin reaction on the eyelids.
Musculoskeletal and Connective Tissue Disorders: Muscle/joint pain.
General Disorders and Administration Site Conditions: Non-specific chest pain.
Infections and Infestations: Not known: herpetic keratitis.
Case 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.
The intraocular pressure reducing effect of latanoprost has been shown to be additive to that of beta-adrenergic antagonists (timolol), adrenergic agonists (dipivalyl epinephrine), carbonic anhydrase inhibitors (acetazolamide), and at least partly to cholinergic agonists (pilocarpine). There have been reports of paradoxical elevations in IOP following the concomitant ophthalmic administration of two prostaglandin analogues. Therefore, the use of two or more prostaglandins, prostaglandin analogues, or prostaglandin derivatives is not recommended.
Store in a refrigerator (2°C - 8°C). Protect from light.
Should be used within 30 days if stored in air conditioned room below 25°C after first opening.
S01EE01 - latanoprost ; Belongs to the class of prostaglandin analogues. Used in the treatment of glaucoma.
Latanoprost Fahrenheit eye drops 50 mcg/mL
2.5 mL x 1's
Sign Out
