Tapros Tafluprost Eye Drops

Brand Name: 泰普罗斯 ®(Tapros®)
Generic Name: Tafluprost
Strength: 0.0015% (37.5 μg per 2.5 mL), 2.5 mL per bottle
Manufacturer: Santen Pharmaceutical Co., Ltd. (Japan)
Marketing Authorization Holder: Santen Pharmaceutical Co., Ltd.
Domestic Sub-packager: Santen Pharmaceutical (China) Co., Ltd.
Approval Date in China: April 23, 2015
Registration Number:国药准字 H20150423
Storage: Store at 2–8°C before opening; after opening, store below 25°C and use within 4 weeks, protect from light. Refer to the package insert for full storage requirements.

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1. Indications and Usage
Glaucoma and Ocular Hypertension:
Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
2. Dosage and Administration
Route of Administration:
For Ophthalmic Use ONLY.
Recommended Dosage:
Standard Dose: One drop in the affected eye(s) once daily (preferably in the evening).
Frequency Limit: Do not administer more than once daily, as efficacy may be reduced with more frequent dosing.
Critical Administration Instructions:
Preservative-Free Packaging: Typically supplied in single-dose unit containers. Discard any unused portion after instillation.
Contact Lenses: Remove contact lenses prior to administration (though preservative-free, it is good practice to avoid contamination).
Storage: Refrigerate unopened foil pouches at 2–8°C. Once opened, may be stored at room temperature (1–25°C) for up to 1 month.
3. Mechanism of Action
Prostaglandin FP Receptor Agonist:
Tafluprost is a selective FP prostaglandin receptor agonist.
Increased Uveoscleral Outflow:
It is believed to lower IOP by increasing the outflow of aqueous humor through the uveoscleral pathway.
Therapeutic Result: Enhanced fluid drainage leads to a significant reduction in intraocular pressure.
4. Safety and Warnings
Pigmentation Changes:
Iris: May cause increased pigmentation of the iris (brown melanin), which is likely to be permanent.
Periocular Tissue: May cause darkening of the eyelid skin and increased hair growth, which may be reversible upon discontinuation.
Contraindications:
Hypersensitivity to the drug or its components.
Concomitant use with Omidenepag Isopropyl (another IOP-lowering agent).
Asthma Precautions:
Use with caution in patients with a history of bronchial asthma, as prostaglandins may exacerbate or induce asthma attacks.
Macular Edema:
Use with caution in aphakic patients or pseudophakic patients with a torn posterior lens capsule, as it may cause cystoid macular edema.
5.Adverse Reactions
Most Common:
Conjunctival hyperemia (redness), eyelash changes (increased length, thickness, number), ocular itching, ocular irritation/stinging, and iris hyperpigmentation.
6.Drug Interactions
Omidenepag Isopropyl:
Concomitant use is contraindicated.
Other Topical Drugs:
If administering other ophthalmic drugs, allow at least 5–10 minutes between applications.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Tafluprost (0.0015%).
Appearance: Clear, colorless to pale yellow solution.
Key Feature: Preservative-free (contains no benzalkonium chloride), making it suitable for patients with ocular surface sensitivity.
Molecular Formula: C25H34F2O5.

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