Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Ophthalmic [preservative free]:
Zioptan: 0.0015% (10 ea, 30 ea) [contains disodium edta, polysorbate 80]
Pharmacology
Mechanism of Action
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.
Pharmacokinetics/Pharmacodynamics
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.
Dosage and Administration
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.
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
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May diminish the therapeutic effect of Prostaglandins (Ophthalmic). Nonsteroidal Anti-Inflammatory Agents (Ophthalmic) may enhance the therapeutic effect of Prostaglandins (Ophthalmic). Monitor therapy
Adverse Reactions
>10%: Ophthalmic: Conjunctival hyperemia (4% to 20%)
1% to 10%:
Central nervous system: Headache (6%)
Genitourinary: Urinary tract infection (2%)
Infection: Common cold (4%)
Ophthalmic: Eye irritation (≤7%), stinging of eyes (≤7%), conjunctivitis (5%), cataract (3%), eye pain (3%), xerophthalmia (3%), blurred vision (2%), hyperpigmentation of eyelashes (2%), increased eyelash length (2%)
Respiratory: Cough (3%)
<1%, postmarketing, and/or case reports: Dyspnea, exacerbation of asthma, iris hyperpigmentation, iritis, uveitis
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
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, eye redness, eyelash changes, cough, common cold symptoms, dry eyes, or headache. Have patient report immediately to prescriber signs of a urinary tract infection (blood in the urine, burning or painful urination, passing a lot of urine, fever, lower abdominal pain, or pelvic pain), shortness of breath, vision changes, 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.
