Zioptan label

Zioptan

Zioptan Recall

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Side Effects & Adverse Reactions

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

ZIOPTAN® (tafluprost ophthalmic solution) 0.0015% is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

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History

There is currently no drug history available for this drug.

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Other Information

Tafluprost is a fluorinated analog of prostaglandin F2α. The chemical name for tafluprost is 1-methylethyl (5Z)-7-{(1R, 2R, 3R, 5S)-2-[(1E)-3,3-difluoro-4-phenoxy-1-butenyl}-3,5-dihydroxycyclopentyl]-5-heptenoate. The molecular formula of tafluprost is C25H34F2O5 and its molecular weight is 452.53.

Its structural formula is:

Structural Formula

Tafluprost is a colorless to light yellow viscous liquid that is practically insoluble in water.

ZIOPTAN (tafluprost ophthalmic solution) 0.0015% is supplied as a sterile solution of tafluprost with a pH range of 5.5 — 6.7 and an Osmolality range of 260 — 300 mOsmol/kg.

ZIOPTAN contains Active: tafluprost 0.015 mg/mL; Inactives: glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, hydrochloric acid and/or sodium hydroxide (to adjust pH) and Water for Injection.

ZIOPTAN does not contain a preservative.

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Zioptan Manufacturers

  • Akorn, Inc.
    Zioptan | Akorn, Inc.
    No Recall

    Zioptan | Akorn, Inc.

    Zioptan | Akorn, Inc.

    The recommended dose is one drop of ZIOPTAN® 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.

    ZIOPTAN® may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is being used, each one should be administered at least 5 minutes apart.

    The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration.

  • Merck Sharp & Dohme Corp.
    Zioptan | Merck Sharp & Dohme Corp.
    No Recall

    Zioptan | Merck Sharp & Dohme Corp.

    Zioptan | Merck Sharp & Dohme Corp.

    The recommended dose is one drop of ZIOPTAN 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.

    ZIOPTAN may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is being used, each one should be administered at least 5 minutes apart.

    The solution from one individual unit is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the individual unit is opened, the remaining contents should be discarded immediately after administration.

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