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Each 1 mL contains Latanoprost 50 μg.
Clear and colorless solution.

Pharmacology: Pharmacodynamics: Latanoprost, synthetic isopropyl ester analog of prostaglandin F2α (PGF2α), is a selective FP prostanoid receptor agonist. Latanoprost reduce intraocular pressure (IOP) by increasing the outflow of aqueous humor through the uveoscleral routes. Latanoprost is also decrease IOP by increasing aqueous outflow through the trabecular meshwork. Reduction of IOP starts about 3 to 4 hours after instillation and is maximal after 8 to 12 hours. Pressure reduction lasts for at least 24 hours.
Pharmacokinetics: Absorption: Latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biologically active. Peak concentration is reached within 2 hours after topical administration.
Distribution: The volume of distribution (Vd) of latanoprost in humans is 0.16 L/kg. The acid of Latanoprost could be measured in aqueous humor during the first 4 hours, and in plasma only during the first hour after local administration.
Metabolism: Latanoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea to the biologically active acid. The active acid of Latanoprost reaching the systemic circulation is primarily metabolized in the liver to the 1,2-dinor and 1,2,3,4-tetranor metabolites via fatty acid beta oxidation.
Excretion: The elimination of the acid of Latanoprost from human plasma is rapid, the t_½ is 17 minutes after topical administration. Systemic clearance is approximately 7 ml/min/kg. Following hepatic beta oxidation, the metabolites are mainly eliminated via the kidneys. Approximately 88% of the administered dose is recovered in the urine after topical dosing.

Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma, chronic angle closure glaucoma, and ocular hypertension.
Reduction of elevated intraocular pressure in pediatric patients with elevated intraocular pressure and pediatric glaucoma.

Use in adults (including the elderly): One drop in the affected eye(s) once daily. Optimal effect is obtained if Latanoprost is administered in the evening.
The dosage of Latanoprost should not exceed once daily since it has been shown that more frequent administration decreases the IOP lowering effect.
If one dose is missed, treatment should continue with the next dose as normal.
Latanoprost may be used concomitantly with other classes of topical ophthalmic drug products to lower IOP.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.
Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes.
Pediatric population: Latanoprost eye drops may be used in pediatric patients at the same posology as in adults. No data are available for preterm infants (less than 36 weeks gestational age). Data in the age group <1 year are limited.

If overdosage with Latanoprost occurs, treatment should be symptomatic.
Apart from ocular irritation and conjunctival hyperemia, no other ocular adverse effects are known if Latanoprost is overdosed.
If Latanoprost is accidentally ingested the following information may be useful: One 2.5 ml bottle contains 125 micrograms Latanoprost. More than 90% is metabolized during the first pass through the liver. Intravenous infusion of 3 mcg/kg in healthy volunteers induced no symptoms, but a dose of 5.5-10 mcg/kg caused nausea, abdominal pain, dizziness, fatigue, hot flushes and sweating. In patients with moderate bronchial asthma, bronchoconstriction was not induced by Latanoprost when applied topically on the eyes in a dose of seven times the clinical dose of Latanoprost.

Known hypersensitivity to Latanoprost or any other component of the product.

Iris pigment changes: Latanoprost has been associated with an increase in brown pigmentation of the iris in some patients, especially those with mixed colored irides that contain the color brown at baseline, due to increased melanin content in the stromal melanocytes of the iris, rather than to an increase in the number of melanocytes. Typically, brown pigmentation around the pupil gradually spreads concentrically toward the periphery and the entire iris or parts of the iris also may become brownish in color. The change in iris color is mild in most cases and may not be detected clinically. The increase in iris pigmentation in one or both eyes has been documented. Iris freckles or nevi do not appear to be affected by Latanoprost therapy. No accumulation of pigment in the trabecular meshwork or elsewhere in the anterior chamber has been observed.
There was no evidence of adverse consequences due to increased pigmentation even when administration of Latanoprost continued. IOP reduction was similar in patients regardless of the development of increased iris pigmentation. Latanoprost therapy can be continued in patients who develop increased iris pigmentation. These patients should be examined regularly and, depending on the clinical situation, treatment may be discontinued.
Onset of increased iris pigmentation generally occurred within the first year of treatment, rarely during the second or third year, and has not been after the fourth year of treatment. The rate of progression of iris pigmentation decreases with time and is stable by five years. The increase in brown pigment generally does not progress further if Latanoprost is discontinued, but the change in iris color is likely to be permanent. Unilateral treatment can result in permanent heterochromia.
Eyelid and eyelash changes: Pigmentation of the eyelid and eyelash changes associated Latanoprost treatment may be reversible. Latanoprost may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, number of lashes or hairs and misdirected growth of eyelashes. Eyelash changes are reversible upon discontinuation of treatment.
Macular oedema: Macular edema, including cystoid macular edema, has been reported during treatment with Latanoprost in aphakic patients, in pseudophakic patients with torn posterior lens capsule, or in patients with known risk factors for macular edema. Latanoprost should be used with caution in these patients.
Glaucoma: There is limited experience in inflammatory neovascular glaucoma with Latanoprost treatment. Latanoprost should be used with caution in these conditions.
Herpetic keratitis: Latanoprost should be used with caution in patients with a 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 specifically associated with prostaglandin analogues.
Contact lenses: This product contains benzalkonium chloride, which may be absorbed by contact lenses.
Effects on ability to drive and use machines: Instillation of eye drops may cause transient blurring of vision. Until this has resolved, patients should not drive or use machines.
Use in children: Efficacy and safety data in the age group <1 year are very limited. No data are available for preterm infants (less than 36 weeks gestational age).
In children from 0 to <3 years old that mainly suffer from primary congenital glaucoma (PCG), surgery (e.g., trabeculotomy/goniotomy) remains the first line treatment.
Long-term safety in children has not yet been established.

Latanoprost has not been found to have any effect on male or female fertility in animal studies.
Pregnancy: There are no adequate and well-controlled studies in pregnant women. Latanoprost should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Latanoprost and its metabolites may pass into breast milk. Latanoprost should therefore be used with caution in nursing women.

Infections and infestations: Herpetic keratitis.
Nervous system disorders: Dizziness, headache.
Eye disorders: Eye irritation (burning, grittiness, itching, stinging and foreign body sensation), eye pain, eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation, and number of eyelashes), ocular hyperaemia, iris hyperpigmentation, blepharitis, conjunctivitis, macular oedema including cystoid macular oedema, photophobia, eyelid oedema, keratitis, uveitis, corneal oedema, iritis, punctate keratitis, corneal erosion, trichiasis, vision blurred, periorbital and lid changes resulting in deepening of the eyelid sulcus, darkening of the palpebral skin of the eyelids, localized skin reaction on the eyelids, iris cyst, pseudopemphigoid of the ocular conjunctiva.
Cardiac disorders: Angina, palpitations, angina unstable.
Respiratory thoracic and mediastinal disorders: Asthma, dyspnoea, asthma aggravation, acute asthma attacks.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia.
General disorders and administration site conditions: Chest pain.

There have been reports of paradoxical elevations in IOP following the concomitant ophthalmic administration of two prostaglandin analogs. Therefore, concomitant use of 2 or more prostaglandins, prostaglandin analogs or prostaglandin derivatives is not recommended.

Keep in refrigerator or at temperature 2-8°C (No freezing).
Once opened the container may be stored at room temperature below 25°C.
To be used within 6 weeks after opening.
Protect from light.

Antiglaucoma Preparations

S01EE01 - latanoprost ; Belongs to the class of prostaglandin analogues. Used in the treatment of glaucoma.

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