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MEDIZOL 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 in patients with open angle glaucoma and ocular hypertension. Reduction of elevated intraocular pressure in paediatric patients with elevated intraocular pressure and paediatric glaucoma.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology 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 Medizol/ Latanoprost is administered in the evening. The dosage of Medizol/ Latanoprost should not exceed once daily since it has been shown that more frequent administration decreases the intraocular pressure lowering effect.
If one dose is missed, treatment should continue with the next dose as normal. Paediatric population Medizol/ Latanoprost 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 drug is being used, the drugs should be administered at least five minutes apart.
a. Summary of the safety profile The majority of adverse events relate to the ocular system. 4). Other ocular adverse events are generally transient and occur on dose administration. b. Tabulated list of adverse reactions Adverse events are categorized by frequency as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000) and very rare (<1/10,000).
Not known (frequency cannot be estimated from the available data).
Infections and Rare:
Herpetic keratitis*§ Nervous System Uncommon: Headache*, dizziness* Very common: iris hyperpigmentation; mild to moderate conjunctival hyperaemia, eye irritation (burning, grittiness, itching, stinging and foreign body sensation); eyelash and vellus hair changes of the eyelid (increased length, thickness, pigmentation and number of eyelashes) Common: Punctate keratitis, mostly without symptoms; blepharitis; eye pain, photophobia; conjunctivitis* Uncommon: Eyelid oedema; dry eye; keratitis*; vision blurred; macular oedema including cystoid macular oedema*; uveitis* Rare: 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*§ Eye Disorders Very rare: Periorbital and lid changes resulting in deepening of the eyelid sulcus Uncommon: Angina; palpitations*Cardiac Disorders : Very Rare: Unstable angina Uncommon: Asthma*, dyspnoea*Respiratory, Thoracic and Mediastinal Disorders: Rare: Asthma exacerbation Uncommon: RashSkin and Subcutaneou s Tissue Disorders: Rare: Pruritus Musculoskeleta l and Connective Tissue Uncommon: Myalgia*; arthralgia* General Disorders and Administration Site Uncommon: Chest pain* Gastrointestina l Disorders Uncommon: Nausea Vomiting *ADR identified post-marketing §ADR frequency estimated using “The Rule of 3” Cases 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.
Medizol/ 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.
e. blue-brown, grey-brown, yellow-brown and green-brown. In clinical 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.
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 Medizol/ Latanoprost can be continued if iris pigmentation ensues.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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a. Description of selected adverse reactions No information is provided. b. Paediatric Population In two short term clinical trials (≤ 12 weeks), involving 93 (25 and 68) paediatric patients the safety profile was similar to that in adults and no new adverse events were identified.
1). Adverse events seen more frequently in the paediatric population as compared to adults are: nasopharyngitis and pyrexia. 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
However, patients should be monitored regularly and if the clinical situation warrants, Medizol/ Latanoprost 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. Medizol/ 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 Medizol/ 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.
Medizol/ Latanoprost should be used with caution in these patients. Medizol/ 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.
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).
Medizol/ 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, Medizol/ 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. 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. Medizol/ Latanoprost contains benzalkonium chloride, which is commonly used as a preservative in ophthalmic products. Benzalkonium chloride has been reported to cause punctuate keratopathy and/or toxic ulcerative keratopathy, may cause eye irritation and is known to discolour soft contact lenses.
Close monitoring is required with frequent or prolonged use of Medizol/ Latanoprost in dry eye patients, or in conditions where the cornea is compromised. 2). 1). No data are available for preterm infants (less than 36 weeks gestational age).
g. trabeculotomy/goniotomy) remains the first line treatment. Long-term safety in children has not yet been established.