LAT PF | Latanoprost Eye Drops IP 0.005% w/v

Pharmacokinetic:

Absorption:

Latanoprost is absorbed through the cornea where the isopropyl ester prodrug is hydrolyzed to the acid form to become biogically active. Studies in man indicate that the peak concentration in the aqueous humor is reached about two hours after topical administration.

Distribution:

The distribution volume in humans is 0.6±0.02 L/kg. The acid of latanoprost can be measured in aqueous humor during the first 4 hours and in plasma only during the first hours after local administration.

Metabolism

Latanoprost, an isopropyl ester prodrug, is hydrolysed by esterases in the cornea to the biologically active acid. The active acid of latanoprost reaching the systemic circulation is primarily metabolized by the liver to the 1, 2-dinor and 1, 2, 3, 4-tetranor metabolites via fatty acid β-oxidation.

Excretion

The elimination of the acid of latanoprost from human plasma is rapid (t1/2 = 17 min) after both intravenous and topical administration. Systemic clearance is approximately 7ml/min/kg. Following hepatic β-oxidation, the metabolites are mainly eliminated via the kidneys. Approximately 88% and 98% of the administered dose is recovered in the urine after topical and intravenous dosing, respectively.

Indication:

Reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension.

Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma.

Dosage & Administration:

The recommended dosage is one drop (1.5 µg) in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose as normal.

The dosage of Latanoprost Ophthalmic Solution should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including Latanoprost Ophthalmic Solution is not recommended. It has been shown that administration of these prostaglandins drug products more than once daily may decrease the intraocular pressure lowering effect or cause paradoxical elevations in IOP. Reduction of the intraocular pressure starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

Contraindications:

Known hypersensitivity to latanoprost or any other ingredients in this product.

Warning & Precautions:

Latanoprost may gradually change eye colour by increasing the amount of brown pigment in the iris. Before treatment is instituted, patients should be informed of the possibility of a permanent change in eye colour. Unilateral treatment can result in permanent heterochromia.

There is limited experience of latanoprost in chronic angle closure glaucoma, open angle glaucoma of pseudophakic patients and in pigmentary glaucoma. There is no experience of latanoprost in inflammatory and neovascular glaucoma or inflammatory ocular conditions.

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.

There are limited study data on the use of latanoprost during the peri-operative period of cataract surgery. Latanoprost should be used wit caution in these patients.

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 specially associated with prostaglandin analogues.

Reports of macular oedema have occurred mainly in aphakic patients, in pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema (such as diabetic retinopathy and retinal vein occlusion). Latanoprost should be used with caution in aphakic patients, in pseudophakic patients with torn posterior lens capsule or anterior chamber lenses, or in patients with known risk factors for cystoid macular oedema.

In patients with known predisposing risk factors for iritis/uveitis, latanoprost can be used with caution.

There is limited experience from patients with asthma, but some cases of exacerbation of asthma and/or dyspnoea were reported in post marketing experience. Asthmatic patients should therefore be treated with caution until there is sufficient experience.

Periorbital skin discolouration has been observed, the majority of reports being in Japanese patients. Experience to date shows that periorbital skin discolouration is not permanent and in some cases has reversed while continuing treatment with latanoprost.

Latanoprost may gradually change eyelashes and vellus hair in the treated eye and surrounding areas; 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.

Pregnancy & Lactation:

Pregnancy

The safety of this medicinal product for use in human pregnancy has not been established. It has potential hazardous pharmacological effects with respect to the course of pregnancy, to the unborn or the neonate. Therefore, latanoprost should not be used during pregnancy.

Lactation

Latanoprost and its metabolites may pass into breast milk and latanoprost should therefore not be used in nursing women or breast feeding should be stopped.

Fertility:

Latanoprost has not been found to have any effect on male or female fertility in animal studies

Effects on ability to drive and use machines:

In common with other eye preparations, instillation of eye drops may cause transient blurring of vision. Until this has resolved, patients should not drive or use machines.

Drug Interactions & Incompatibilities:

Definitive drug interaction data are not available.

There have been reported of paradoxical elevations in intraocular pressure following the concomitant ophthalmic administration of two prostaglandin analogues. Therefore, the use of two or more prostaglandins analogues or prostaglandin derivatives is not recommended.

Side Effects:

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following are known side effects of using Latanoprost eye drops.

Very Common:

Change in eye color: Latanoprost can slowly and permanently change eye colour, particularly in eyes of mixed colour (blue-brown, grey-brown, yellow-brown or green-brown). Any changes in your eye colour may take years to develop although it is normally seen within 8 months of treatment. The colour change may be permanent and may be more noticeable if you use Latanoprost eye drops in only one eye. There appears to be no problems associated with the change in eye colour. The colour change does not continue after Latanoprost eye drops treatment is stopped.

Redness of the eye.

Eye irritation (a feeling of burning, grittiness, itching, stinging or the sensation of a foreign body in the eye).

A gradual change to eyelashes of the treated eye and the fine hairs around the treated eye, seen mostly in people of Japanese origin. These changes involve an increase of the colour (darkening), length, thickness and number of your eyelashes.

Common:

Irritation or disruption to the surface of the eye, eyelid inflammation (blepharitis(, eye pain, light sensitivity (photophobia), conjunctivitis.

Uncommon:

Eyelid swelling, dryness of the eye, inflammation or irritation of the surface of the eye (keratitis), blurred vision, inflammation of the coloured part of the eye (uveitis), swelling of the retina (macular oedema).

Skin rash.

Chest pain (angina), awareness of heart rhythm (palpitations).

Asthma, shortness of breath (dsypnoea).

Chest pain.

Headache, dizziness.

Muscle pain, joint pain.

Rare:

Inflammation of the iris (iritis), symptoms of swelling or scratching/ damage to the surface of the eye, swelling around the eye (periorbital oedema), misdirected eyelashes or an extra row of eyelashes, scarring of the surface of the eye, fluid filled area within the coloured part of the eye (iris cyst).

Skin reactions on the eyelids, darkening of the skin of the eyelids. Worsening of asthma.

Severe itching of the skin.

Developing a viral infection of the eye caused by the herpes simplex virus (HSV).

Very rare:

Worsening of angina in patients who also have heart disease, sunken eye appearance (eye sulcus deepening). Side effects seen more often in children compared to adults are runny itchy nose and fever.

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

Overdosage and its treatment:

Apart from ocular irritation and conjunctival or episcleral hyperemia, the ocular effects of latanoprost administered at high doses are not known. Intravenous administration of large doses of latanoprost in monkeys has been associated with transient bronchoconstriction; however, in 11 patients with bronchial asthma treated with latanoprost, bronchoconstriction was not induced.

Intravenous infusion of up to 3 µg/kg in healthy volunteers produced mean plasma concentrations 200 times higher than during clinical treatment and no adverse reactions were observed. Intravenous dosages of 5.5 to 10 g/kg caused abdominal pain, dizziness, fatigue, hot flushes, nausea and sweating.

If overdosage with Latanoprost Ophthalmic Solution occurs, treatment should be symptomatic.

Storage: Store at a temperature not exceeding 30°C. Do not freeze. Protect from light & moisture.

Presentation: 2.5ml filled in 5ml LDPE bottle packed in a carton along with pack insert.

KEEP MEDICINE OUT OF REACH OF CHILDREN.

PRESCRIPTION ONLY MEDICINE