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Tafluprost

Pronunciation: TA-floo-prost
Class: Prostaglandin agonist

Trade Names

Zioptan
- Solution, ophthalmic 0.0015%

Pharmacology

May reduce IOP by increasing uveoscleral outflow.

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Pharmacokinetics

Absorption

C max range is 26 to 27 pg/mL, AUC range is 394 to 432 pg•min/mL, and T max is 10 min.

Metabolism

Hydrolyzed to its biologically active acid metabolite, tafluprost acid, in the eye. The acid metabolite is further metabolized via fatty acid beta-oxidation and phase 2 conjugation.

Special Populations

Renal Function Impairment

No data are available.

Hepatic Function Impairment

No data are available.

Indications and Usage

For reducing elevated IOP in patients with open-angle glaucoma or ocular hypertension.

Contraindications

None well documented.

Dosage and Administration

Adults

Ophthalmic Instill 1 drop in the conjunctival sac of the affected eye(s) once daily in the evening.

General Advice

  • For ophthalmic use only.
  • The solution from 1 individual unit is to be used immediately after opening for administration to 1 or both eyes.
  • May be used with other ophthalmic drug products to lower IOP.

Storage/Stability

Store refrigerated, between 36° and 46°F, in the original pouch. After the pouch is opened, the single-use containers may be stored in the opened foil pouch for up to 28 days at room temperature, between 68° and 77°F. Protect from moisture. Discard any unused containers 28 days after first opening the pouch. Because sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration.

Drug Interactions

None well documented.

Adverse Reactions

EENT

Conjunctival hyperemia (4% to 20%); ocular stinging/irritation (7%); ocular pruritus, including allergic conjunctivitis (5%); cataract, dry eye, ocular pain (3%); eyelash darkening, growth of eyelashes, vision blurred (2%); periorbital and lid changes, including deepening of the eyelid sulcus, have been observed (postmarketing).

Miscellaneous

Headache (6%); common cold (4%); cough (3%); UTI (2%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Not recommended for use.

Eyelash changes

May gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, color, thickness, shape, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.

Intraocular inflammation

Use with caution in patients with active intraocular inflammation (eg, iritis/uveitis) because the inflammation may be exacerbated.

Macular edema

Macular edema, including cystoid macular edema, has been reported during treatment. Use with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.

Pigmentation changes

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. After discontinuation, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Iris color change may not be noticeable for several months to years.

Patient Information

  • Advise patients not to exceed once-daily dosing.
  • Advise patients that tafluprost is a sterile solution that does not contain a preservative. Because sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration.
  • Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Patients should also be informed about the possibility of eyelid skin darkening, which may be reversible after discontinuation.
  • Inform patients of the possibility of eyelash and vellus hair changes in the treated eye during treatment. These changes may result in a disparity between eyes in length, thickness, pigmentation, and/or number of eyelashes or vellus hairs and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment.
  • Advise patients that if they develop a new ocular condition (eg, trauma, infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their health care provider's advice concerning the continued use of tafluprost.
  • Inform patients that if more than 1 topical ophthalmic drug is being used, the drugs should be administered with at least 5 min between applications.
  • Advise women of childbearing age to use adequate contraception.

Copyright © 2009 Wolters Kluwer Health.

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