Properties
What is it?
International Nonproprietary Name - tafluprost Clinical-pharmacological group: Ophthalmology → Anti-glaucoma agents → For topical use in ophthalmology → F2 alpha prostaglandin analogs Composition Each 1 ml of eye drops, solution, contains 15 micrograms of tafluprost. Excipients: disodium edetate, glycerol, boric acid, tyloxapol, polyquaternium-1, sodium hydroxide and/or hydrochloric acid (for pH adjustment), purified water. Anti-glaucoma preparations and miotics, prostaglandin analogs. Therapeutic indications Reduction of elevated intraocular pressure in open-angle glaucoma and ocular hypertension. As monotherapy in patients: - who respond inadequately to first-line therapy; - who are intolerant to or have contraindications to first-line therapy. As add-on therapy to beta-blockers. Taflubest 0.015 mg/ml eye drops, solution, is indicated in adults over 18 years of age. Dosage and method of administration Dosage The recommended dose is one drop of Taflubest in the conjunctival sac of the affected eye, once daily, in the evening. The dose should not exceed once daily administration, as more frequent administration may reduce the intraocular pressure-lowering effect. Use in the elderly Dose adjustment is not necessary in elderly patients. Pediatric population The safety and efficacy of tafluprost in children under 18 years of age have not been established. No data are available. Use in patients with renal/hepatic impairment Tafluprost has not been studied in patients with renal/hepatic impairment and therefore should be used with caution in such individuals. Method of administration To prevent potential contamination of the solution, the patient should not touch the dropper tip to the eyelids, surrounding areas, or surfaces. To reduce the risk of eyelid skin darkening, patients should wipe away excess solution. As with all eye drops, nasolacrimal occlusion or gentle eyelid closure is recommended after administration. This may reduce the systemic absorption of the medicinal product instilled into the eye. If more than one topical ophthalmic medicinal product is used, the administration of each should be separated by at least 5 minutes. Contraindications Hypersensitivity to the active substance tafluprost or to any of the excipients. Adverse effects In clinical studies, more than 1200 patients were treated with tafluprost monotherapy or as adjunctive therapy to timolol 0.5%. The most frequently reported treatment-related adverse event was ocular hyperemia. It occurred in approximately 13% of patients, particularly in patients participating in tafluprost clinical trials in Europe and the USA. In most cases, it was mild and caused discomfort, in 13% of patients participating in significant studies conducted in Europe and the USA. It was mild in most cases and led to discontinuation of treatment in an average of 0.4% of patients participating in significant studies. The following treatment-related adverse effects were reported in tafluprost clinical trials in Europe and the USA, after a maximum of 12 months of use: Within each frequency group, adverse reactions are listed in order of decreasing frequency. Nervous system disorders Common (>1/100 - <1/10): Headache Eye disorders Very common (>1/10): Conjunctival/ocular hyperemia. Common (>1/100 - <1/10): Eye pruritus, eye irritation, eye pain, eyelash changes (changes in length, thickness, and number), dry eye, eyelash discoloration, foreign body sensation in eye, eyelid erythema, blurred vision, increased lacrimation, eyelid pigmentation, eye dryness, decreased visual acuity, photophobia, eyelid edema, and increased iris pigmentation.