Finished product reference

Tafluprost

Solution, Drops · Ophthalmic · 15 µg/1mL · 0.3 mL

List code
22816
Pharmacologic class
Prostaglandin Analog

What it is and how it works

Mechanism of Action Tafluprost acid, a prostaglandin analog is a selective FP prostanoid receptor agonist which is believed to reduce intraocular pressure by increasing uveoscleral outflow. The exact mechanism of action is unknown at this time.

Mechanism class: Prostaglandin Receptor Agonists

Indications

Tafluprost ophthalmic solution, 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Tafluprost ophthalmic solution, 0.0015% is a prostaglandin analog indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Dosage and administration (summary)

The recommended dose is one drop of tafluprost ophthalmic solution in the conjunctival sac of the affected eye(s) once daily in the evening. The dose should not exceed once daily since it has been shown that more frequent administration of prostaglandin analogs may lessen the intraocular pressure lowering effect. Reduction of the intraocular pressure starts approximately 2 to 4 hours after the first administration with the maximum effect reached after 12 hours. Tafluprost ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure.

Contraindications

None. None.

Warnings and precautions

Pigmentation Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation is likely to be permanent. Eyelash Changes Gradual changes to eyelashes including increased length, thickness and number of lashes. Usually reversible. Pigmentation Tafluprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid) and eyelashes. Pigmentation is expected to increase as long as tafluprost is administered.

Pregnancy

Pregnancy Pregnancy Category C. Teratogenic effects: In embryo-fetal development studies in rats and rabbits, tafluprost administered intravenously was teratogenic. Tafluprost caused increases in post-implantation losses in rats and rabbits and reductions in fetal body weights in rats.

Storage and supply

Tafluprost ophthalmic solution, 0.0015% is supplied as a sterile solution in translucent low density polyethylene single-dose containers packaged in foil pouches (5 single-dose containers per pouch). Each single-dose container has 0.3 mL solution corresponding to 0.0045 mg tafluprost. NDC 50742-339-30; Unit-of-Use Carton of 30.

Source: Tafluprost (Tafluprost) — US FDA prescribing information, 2024-12-04, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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