Zioptan (tafluprost/PF)

The recommended adult dosage of tafluprost for the treatment of open-angle glaucoma or ocular hypertension is 1 drop of a 0.0015% ophthalmic solution in the conjunctival sac of the affected eye(s) once daily in the evening. Tafluprost should not be administered more frequently than once daily since more frequent dosing may diminish the intraocular pressure (IOP)-lowering effect of the drug.

If the target IOP is not achieved, alternative or additional ocular hypotensive agents may be required. (See Uses: Ocular Hypertension and Glaucoma.)

Tafluprost is applied topically to the eye(s) as an ophthalmic solution.

If the patient is receiving more than one topical ophthalmic drug, the drugs should be administered at least 5 minutes apart.

Tafluprost is available as a preservative-free 0.015-mg/mL (0.0015%) solution packaged in single-use containers; each single-use container has 0.3 mL of solution, corresponding to 0.0045 mg of tafluprost. Because tafluprost ophthalmic solution contains no preservatives, the drug should be used immediately after opening the single-use container; any unused portion should be discarded immediately after administration since sterility cannot be maintained after the container is opened.

No formal drug interaction studies have been performed. However, no interactions are expected because of limited systemic exposure.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

Moderate Interaction: Assess the risk to the patient and take action as needed.

Iop-Lowering Prostaglandin Analogs/Bimatoprost Topical

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: When used ophthalmically to lower intraocular pressure, prostaglandin analogs may be at the top of the dose-response curve. Use of an additional prostaglandin may result in decreased effectiveness.(1)

CLINICAL EFFECTS: Concurrent use of topical bimatoprost may result in decreased effectiveness of ophthalmic prostaglandin analogs and an increase in intraocular pressure.(1)

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: Patients using ophthalmic prostaglandin analogs to lower intraocular pressure should be monitored for changes in their intraocular pressure.(1) Use of topical bimatoprost may need to be discontinued in patients who stop responding to their ophthalmic prostaglandin analogue.

DISCUSSION: Studies have shown that the ophthalmic administration of bimatoprost twice daily is less effective at lowering intraocular pressure than ophthalmic bimatoprost administered once daily. Concurrent use of topical bimatoprost may decrease the effectiveness of ophthalmic prostaglandin analogs.(1)

The manufacturer states there are no known contraindications to the use of tafluprost.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• Aphakia
• Cystoid macular edema
• Iritis
• Macular retinal edema
• Pseudophakia
• Uveitis

Adverse ocular effects reported in 2% or more of patients receiving tafluprost ophthalmic solution include conjunctival hyperemia, ocular stinging/irritation, ocular pruritus (including allergic conjunctivitis), cataract, dry eye, ocular pain, eyelash darkening, growth of eyelashes, and blurred vision.

Adverse nonocular effects reported in 2% or more of patients receiving tafluprost ophthalmic solution include headache, common cold, cough, and urinary tract infection.

Less Frequent

• Cataracts
• Infection

Rare or Very Rare

• Asthma exacerbation
• Cystoid macular edema
• Dyspnea
• Iris hyperpigmentation
• Iritis
• Macular retinal edema
• Ocular inflammation
• Uveitis

More Frequent

• Conjunctival hyperemia
• Headache disorder
• Hyperpigmentation of eyelid
• Hypertrichosis of eyelid eyelashes
• Ocular irritation

Less Frequent

• Allergic conjunctivitis
• Blurred vision
• Cold symptoms
• Cough
• Dry eye
• Hypertrichosis of eyelid vellus hair
• Ocular itching
• Ocular pain
• Urinary tract infection

Rare or Very Rare

• Deepening of upper eyelid sulcus

No enhanced messaging available.

Use of tafluprost ophthalmic solution in pediatric patients is not recommended because of potential safety concerns related to increased pigmentation following long-term use. (See Pigmentation under Cautions: Warnings/Precautions.)

Category C. (See Users Guide.)

Teratogenicity, embryolethality, and decreased fetal weight have been demonstrated in animals receiving IV tafluprost. There are no adequate and well-controlled studies using tafluprost in pregnant women. Tafluprost should not be used during pregnancy unless the potential benefits justify the potential risk to the fetus. Women of childbearing potential should use effective contraceptive methods during tafluprost therapy.

Tafluprost and/or its metabolites are distributed into milk in rats; it is not known whether tafluprost and/or its metabolites are distributed into human milk. Because many drugs are distributed into human milk, caution should be exercised when tafluprost ophthalmic solution is administered to a nursing woman.

No overall differences in safety or efficacy have been observed between geriatric patients and younger adults.