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Catiolanze is a brand name for Latanoprost. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Catiolanze is indicated for the reduction of elevated intraocular pressure (IOP) in adult patients with open angle glaucoma or ocular hypertension. Catiolanze is indicated for the reduction of elevated IOP in children from 4 years of age and adolescents with elevated IOP and paediatric glaucoma.
Verbatim from this product's EMA label. Tap a section to expand.
Posology Catiolanze may be used in paediatric patients from 4 years old onwards at the same posology as in adults. Recommended therapy is one eye drop in the affected eye(s) once daily. Optimal effect is obtained if Catiolanze is administered in the evening.
The dose of Catiolanze should not exceed once daily since it has been shown that more frequent administration decreases the IOP lowering effect. Missed dose If one dose is missed, treatment should continue with the next dose as normal.
3 Paediatric population The safety of Catiolanze in children aged less than 4 years old has not been established as no data for this formulation (emulsion) are available. 1. Method of administration Ocular use. For single use only. A single-dose container contains enough eye drops liquid to treat both eyes.
As with any eye drops, it is recommended that the lachrymal sac be compressed at the medial canthus (punctal occlusion) for one minute, in order to reduce possible systemic absorption. 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 must be administered at least 5 minutes apart.
5). This medicinal product is a sterile white liquid that does not contain a preservative. The liquid from one individual single-dose container is to be used immediately after opening for administration to the affected eye(s). Since sterility cannot be maintained after the individual single-dose container is opened, any remaining contents must be discarded immediately after administration.
Patients should be instructed: - to avoid contact between the dropper tip and the eye or eyelids - to use the eye drops emulsion immediately after first opening the single-dose container and to discard the single-dose after use.
Summary of the safety profile The majority of adverse reactions relate to the ocular system. 4). Other ocular adverse reactions are generally transient and occur on dose administration. Safety data specific for Catiolanze are available from 330 patients.
0%). There were no serious adverse reactions during the studies specific for Catiolanze. Long term safety data are available from a Phase 3 study in which 118 patients received Catiolanze at least for 360 days. The long term safety profile did not differ from that observed during the first 3 months of treatment.
2%). Tabulated list of adverse reactions The table below describes adverse reactions for preserved latanoprost eye drops, solution from clinical trials and postmarketing data. Adverse reactions occurring with a different frequency observed in clinical trials with Catiolanze eye drops emulsion product are labelled in the table with ¥.
The adverse reactions are categorised by frequency as follows: 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) and very rare (<1/10 000), not known (frequency cannot be estimated from the available data).
System organ class 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 Infections and infestations Herpetic keratitis*§ Nervous system disorders Headache*; dizziness* 7 Eye disorders Iris hyperpigmentati on Mild to moderate conjunctival hyperaemia¥ Eye irritation (burning grittiness, itching, stinging, foreign body sensation and abnormal sensation)¥; Punctate keratitis, mostly without symptoms; eye pain; Photophobia; Conjunctivitis* Eyelid oedema¥; eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation and number of eyelashes)¥; blepharitis¥; dry eye; keratitis*; vision blurred¥; macular oedema including cystoid macular oedema*; uveitis* Iritis*; corneal oedema*; corneal erosion; periorbital oedema; trichiasis*; distichiasis; iris cyst*§; localised skin reaction on the eyelids; darkening of the palpebral skin of the eyelids; pseudopemphigoid of ocular conjunctiva*§ Periorbital and lid changes resulting in deepening of the eyelid sulcus Cardiac disorders Angina; palpitations* Angina unstable Respiratory, thoracic and mediastinal disorders Asthma*; dyspnoea* Asthma exacerbation Gastrointestin al disorders Nausea*; vomiting* Skin and subcutaneous tissue disorder Rash Pruritis Musculoskele tal and connective tissue disorders Myalgia*; arthralgia* General disorders and administration site conditions Chest pain* *ADR identified post-marketing §ADR frequency estimated using “The Rule of 3” ¥ADR frequency estimated from studies specific to Catiolanze eye drops emulsion 8 Description of selected adverse reactions No information is provided.
Change in eye colour Catiolanze 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 4 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.
The colour change with latanoprost treatment 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 latanoprost 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 latanoprost treatment.
Accumulation of pigment in the trabecular meshwork or elsewhere in the anterior chamber has not been observed with latanoprost in clinical trials. Based on 5 years clinical experience with latanoprost, increased iris pigmentation has not been shown to have any negative clinical sequelae and Catiolanze can be continued if iris pigmentation ensues.
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Paediatric population In two short term clinical trials (≤12 weeks), involving 93 (25 and 68) paediatric patients treated with preserved latanoprost eye drops, solution, the safety profile was similar to that in adults and no new adverse events were identified.
1). Adverse events seen more frequently with preserved latanoprost in the paediatric population as compared to adults were nasopharyngitis and pyrexia. Catiolanze was not specifically studied in the paediatric population. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
However, patients should be monitored regularly and if the clinical situation warrants, Catiolanze treatment may be discontinued. Chronic angle closure glaucoma 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 Catiolanze should be used with caution in these conditions until more experience is obtained. Cataract surgery There are limited study data on the use of latanoprost during the peri-operative period of cataract surgery.
Catiolanze should be used with caution in these patients. History of herpetic keratitis, aphakic, and pseudophakic patients Catiolanze 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).
Catiolanze 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. Iritis/ uveitis Catiolanze should be used with caution in patients with known predisposing risk factors for iritis/uveitis.
5 Patients with asthma There is limited experience with latanoprost in patients with asthma, but some cases of exacerbation of asthma and/or dyspnoea were reported with latanoprost in post marketing experience. 8). Periorbital skin discolouration Periorbital skin discolouration has been observed with latanoprost, 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. Eyelash changes 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 latanoprost treatment. 5). Excipient with known effect Catiolanze contains cetalkonium chloride which may cause eye irritation.