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LATANOPROST is a brand name for Latanoprost. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma and ocular hypertension in adults (including the elderly). Reduction of elevated IOP in paediatric patients with elevated IOP and paediatric glaucoma.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults (including the elderly) Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if Ablatan is administered in the evening. The dosage of Ablatan 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. Paediatric population Ablatan eye drops, solution may be used in paediatric patients at the same posology as in adults. No data are available for preterm infants (less than 36 weeks gestational age).
1). Method of administration As with any eye drops, to reduce possible systemic absorption, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute. This should be performed immediately following the instillation of each drop.
Contact lenses should be removed before instillation of the eye drops and may be reinserted after 15 minutes. If more than one topical ophthalmic medicinal product is being used, the medicinal products should be administered at least five minutes apart.
8. 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.
Preservative Ablatan contains benzalkonium chloride, which is commonly used as a preservative in ophthalmic products. From the limited data available, there is no difference in the adverse event profile in children compared to adults.
Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye. Irritation may have an effect on treatment adherence in children. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface.
Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use. 2). 1). No data are available for preterm infants (less than 36 weeks gestational age).
g. trabeculotomy/goniotomy) remains the first line treatment. 5 Interaction with other medicinal products and other forms of interaction Definitive medicinal product interaction data are not available. 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. Paediatric population Interaction studies have only been performed in adults. 3). Pregnancy The safety of this medicinal product for use in human pregnancy has not been established.
Iris pigmentation changes Ablatan 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. e. blue-brown, grey-brown, yellow-brown and green-brown. In studies with latanoprost, the onset of the change is usually within the first 8 months of treatment, rarely during the second or third year, and has not been seen after the fourth year of treatment.
The rate of progression of iris pigmentation decreases with time and is stable for five years. The effect of increased pigmentation beyond five years has not been evaluated. 8). The iris colour change is slight in the majority of cases and often not observed clinically.
The incidence in patients with mixed colour irides ranged from 7 to 85%, with yellow-brown irides having the highest incidence. In patients with homogeneously blue eyes, no change has been observed and in patients with homogeneously grey, green or brown eyes, the change has only rarely been seen.
1). The colour change is due to increased melanin content in the stromal melanocytes of the iris and not to an increase in number of melanocytes. 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.
No further increase in brown iris pigment has been observed after discontinuation of treatment. It has not been associated with any symptom or pathological changes in clinical trials to date. Neither naevi nor freckles of the iris have been affected by treatment.
Accumulation of pigment in the trabecular meshwork or elsewhere in the anterior chamber has not been observed in clinical trials. Based on 5 years clinical experience, increased iris pigmentation has not been shown to have any negative clinical sequelae and Ablatan can be continued if iris pigmentation ensues.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Latanoprost in United Kingdom.
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It has potential hazardous pharmacological effects with respect to the course of pregnancy, to the unborn or the neonate. Therefore, this medicine should not be used during pregnancy. Breast-feeding Latanoprost and its metabolites may pass into breast milk and Ablatan should therefore not be used in breast-feeding women or breast feeding should be stopped.
7 Effects on ability to drive and use machines Ablatan has minor influence on the 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.
8 Undesirable effects Bimatoprost/Timolol medicinal product Summary of the safety profile The adverse reactions reported in clinical studies using bimatoprost/timolol were limited to those earlier reported for either of the single active substances bimatoprost and timolol.
No new adverse reactions specific for bimatoprost/timolol have been observed in clinical studies. The majority of adverse reactions reported in clinical studies using bimatoprost/timolol were ocular, mild in severity and none were serious.
5 % of patients. Tabulated list of adverse reactions Table 1 presents the adverse reactions that have been reported during clinical trials with bimatoprost/timolol formulations (multi-dose and single-dose) (within each frequency grouping, adverse reactions are presented in order of decreasing seriousness) or in the post- marketing period.
The frequency of possible adverse reactions listed below is defined using the following convention: Very common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Very rare <1/10,000 Not known Frequency cannot be estimated from available data Table 1 System Organ Class Frequency Adverse reaction Immune system disorders Not known Hypersensitivity reactions including signs or symptoms of allergic dermatitis, angioedema, eye allergy Psychiatric disorders Not known Insomnia2, nightmare2 Common HeadacheNervous system disorders Not known Dysgeusia2, dizziness Very common Prostaglandin analogue periorbitopathy, conjunctival hyperaemia Common Punctuate keratitis, corneal erosion2, burning sensation2, conjunctival irritation1, eye pruritus, stinging sensation in the eye2, foreign body sensation, dry eye, erythema of eyelid, eye pain, photophobia, eye discharge, visual disturbance2, eyelid pruritus, visual acuity worsened2, blepharitis2, eyelid oedema, eye irritation, lacrimation increased, growth of eyelashes Uncommon Iritis2, conjunctival oedema2, eyelid pain2, abnormal sensation in the eye1, asthenopia, trichiasis2, iris hyperpigmentation2, eyelid retraction2, eyelash discolouration (darkening)1 Eye disorders Not known Cystoid macular oedema2, eye swelling, vision blurred2, ocular discomfort Cardiac disorders Not known Bradycardia Vascular disorders Not known Hypertension Common Rhinitis2 Uncommon Dyspnoea Respiratory, thoracic and mediastinal disorders Not known Bronchospasm (predominantly in patients with pre- System Organ Class Frequency Adverse reaction existing bronchospastic disease)2, asthma Common Blepharal pigmentation2, hirsutism2, skin hyperpigmentation […]
However, patients should be monitored regularly and if the clinical situation warrants, Ablatan treatment may be discontinued. 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 Ablatan 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.
Ablatan should be used with caution in these patients. Ablatan 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.
8) 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).
Ablatan 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, Ablatan 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. 8. 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. Preservative Ablatan contains benzalkonium chloride, which is commonly used as a preservative in ophthalmic products. From the limited data available, there is no difference in the adverse event profile in children compared to adults.
Generally, however, eyes in children show a stronger reaction for a given stimulus than the adult eye. Irritation may have an effect on treatment adherence in children. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface.
Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use. 2). Paediatric population Efficacy and safety data in the age group < 1 year are […]