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Tafluprost

Pronunciation

(TA floo prost)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Ophthalmic [preservative free]:

Zioptan: 0.0015% (30 ea, 90 ea [DSC]) [contains disodium edta, polysorbate 80]

Brand Names: U.S.

  • Zioptan

Pharmacologic Category

  • Ophthalmic Agent, Antiglaucoma
  • Prostaglandin, Ophthalmic

Pharmacology

Tafluprost acid is a fluorinated prostaglandin F2-alpha analog believed to reduce intraocular pressure by increasing outflow of aqueous humor via the uveoscleral pathway; exact mechanism by which it reduces IOP is unknown.

Absorption

Through the cornea

Metabolism

Ester prodrug (tafluprost) is hydrolyzed to the biologically active acid metabolite (tafluprost acid); tafluprost acid metabolized further via fatty acid beta oxidation and phase II conjugation

Onset of Action

Reduction of intraocular pressure (IOP): 2 to 4 hours; Peak effect: Maximum reduction of IOP: ~12 hours

Time to Peak

Plasma: ~10 minutes

Use: Labeled Indications

Elevated intraocular pressure: Reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Contraindications

There are no contraindications listed in the manufacturer’s prescribing information.

Dosing: Adult

Elevated intraocular pressure: Ophthalmic: One drop in the affected eye(s) once daily in the evening; do not exceed the once daily dosage because it has been shown that more frequent administration may decrease the IOP-lowering effect

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Administration

For ophthalmic use only. Wash hands before use. Avoid touching the tip of the single-use container to eye or other surfaces. Each single-use container has adequate solution to treat both eyes (if applicable); discard immediately after use. If more than one topical ophthalmic drug is being used, administer the drugs at least 5 minutes apart.

Storage

Store unopened foil pouches refrigerated at 2°C to 8°C (36°F to 46°F). During shipping, may be stored at temperatures up to 40°C (104°F) for no more than 2 days; do not use if mail-order prescriptions arrive after 2 days of the dispensing date. Upon opening the foil pouch, store the single-dose containers at 20°C to 25°C (68°F to 77°F) in the foil pouch; discard unused containers after 30 days. Discard opened single-dose containers immediately after use. Protect from moisture.

Drug Interactions

Nonsteroidal Anti-Inflammatory Agents: May diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents may also enhance the therapeutic effects of Prostaglandins (Ophthalmic). Monitor therapy

Adverse Reactions

>10%: Ocular: Conjunctival hyperemia (4% to 20%)

1% to 10%:

Central nervous system: Headache (6%)

Genitourinary: Urinary tract infection (2%)

Ocular: Stinging/irritation (7%), conjunctivitis (5%), cataract (3%), dry eye (3%), ocular pain (3%), eyelash darkening (2%), eyelash growth (2%), vision blurred (2%)

Respiratory: Common cold (4%), cough (3%)

Postmarketing and/or case reports (Limited to important or life-threatening): Dyspnea, exacerbation of asthma; macular edema (reported with prostaglandin analog use)

Warnings/Precautions

Concerns related to adverse effects:

• Ocular effects: May change/increase brown pigmentation of the iris, eyelid, and eyelashes; length, color, thickness, shape, and/or number of eyelashes may also be increased. Pigmentation of the iris is likely to be permanent although iris color change may not be noticeable for months to years; pigmentation of the eyelid and eyelash changes may be reversible following discontinuation of therapy. Long-term consequences and potential injury to eye are not known.

Disease-related concerns:

• Ocular disease: Use with caution in patients with intraocular inflammation, aphakic patients, pseudophakic patients with a torn posterior lens capsule, or patients with risk factors for macular edema.

Special populations:

• Pediatric: Use in pediatric patients is not recommended due to possible safety issues of increased pigmentation following long-term use.

Monitoring Parameters

Intraocular pressure; regularly examine patients who develop increased iris pigmentation

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Effective contraception during treatment is recommended for women of childbearing potential.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience stinging, itching, blurred vision, eyelash changes, cough, rhinitis, rhinorrhea, sneezing, dry eyes, or headache. Have patient report immediately to prescriber shortness of breath, vision changes, painful urination, difficult urination, severe eye irritation, eye pain, eye discharge, eyelid changes, or eye discoloration (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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