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  • CLASSES

    Prostaglandins, Ophthalmic

    DEA CLASS

    Rx

    DESCRIPTION

    Topical ophthalmic agent; prodrug used to lower IOP in patients with open-angle glaucoma or ocular hypertension; synthetic analog of prostaglandin F2alpha; this drug is associated with iridal brown pigmentation similar to latanoprost.

    COMMON BRAND NAMES

    Travatan

    HOW SUPPLIED

    Travatan Ophthalmic Sol: 0.004%

    DOSAGE & INDICATIONS

    For the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.
    Ophthalmic dosage (Travatan 0.004% and Travatan Z 0.004%)
    Adults and Adolescents >= 16 years

    Apply 1 drop to each affected eye once daily in the evening. More frequent administration may decrease the IOP-lowering effect.

    MAXIMUM DOSAGE

    Adults

    1 drop/day per affected eye.

    Geriatric

    1 drop/day per affected eye.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    It appears that no dosage adjustment is needed. Use with caution; data are lacking in these patients.

    Renal Impairment

    It appears that no dosage adjustment is needed. Use with caution; data are lacking in these patients.
     
    Intermittent hemodialysis:
    No dosage adjustment is needed.

    ADMINISTRATION

    Ophthalmic Administration

    Travoprost Ophthalmic solution is for ophthalmic use only.
    Instruct patient on proper instillation of the eye solution (see Patient Information).
    Wash hands before and after use.
    Contact lenses should be removed prior to ocular application and may be reinserted 15 minutes following drug administration. Travatan contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses.
    Tilt the head back slightly and pull the lower eyelid down with the index finger to form a pouch. Squeeze the prescribed number of drops into the pouch and gently close the eyes for 1—2 minutes. Do not blink.
    To avoid contamination, do not touch the tip of the dropper to the eye, fingertips, or other surface.
    The solution may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.
    Since prostaglandins are biologically active and may be absorbed through the skin, women who are pregnant or attempting to become pregnant should not use travoprost and should use caution to avoid direct exposure to travoprost. In case of accidental contact, cleanse the exposed area thoroughly with soap and water.

    STORAGE

    Travatan:
    - Refrigeration is not needed
    - Store between 36 to 77 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    Closed-angle glaucoma

    Travoprost should not be used in patients with closed-angle glaucoma, inflammatory or neovascular glaucoma.

    Iritis, sunlight (UV) exposure, uveitis

    Travoprost should be used with caution in patients with active intraocular inflammation (e.g., iritis, uveitis). Some patients may also develop photophobia and may be more sensitive to sunlight (UV) exposure.

    Aphakia

    Macular edema, including cystoid macular edema, has been reported during treatment with other prostaglandin F2alpha analogs. For this reason, travoprost should be used with caution in patients with aphakia, pseudophakic patients with a torn posterior lens capsule, and patients with known risk factors for macular edema.

    Contact lenses

    Contact lenses should be removed prior to administration of travoprost and may be reinserted after 15 minutes. Travatan ophthalmic solution contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses. Travatan Z does not contain this preservative.

    Corneal abrasion, keratitis, ocular infection, ocular surgery, ocular trauma

    There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. Inadvertent contamination of the containers may increase the risk of infection if the patient has an ocular infection, or develops ocular trauma including corneal abrasion, or undergoes ocular surgery while using travoprost.

    Children, infants, neonates

    The use of travoprost in neonates, infants, children, and adolescents < 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.

    Pregnancy

    Travoprost is classified by the FDA as a pregnancy risk category C. Although there are no adequate and well-controlled studies of travoprost in pregnant women, limited experience with a similar drug, latanoprost, in human pregnancy has not resulted in clinically significant risk to the fetus. After ophthalmic administration of travoprost, the drug does not significantly accumulate in the plasma suggesting exposure to the fetus would be low. High doses of intravenous travoprost were found to be teratogenic in rat modules. According to the manufacturer, travoprost should be used during pregnancy only if the potential benefit justifies the potential fetal risk.

    Breast-feeding

    It is not known if travoprost or its metabolites are excreted in breast milk. Because the half-life is short after ophthalmic administration, clinically significant amounts of the drug would not be expected to be excreted into breast milk. According to the manufacturer, caution should be exercised when it is administered to a breast-feeding woman. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Severe

    visual impairment / Early / 5.0-10.0
    bradycardia / Rapid / 1.0-5.0
    keratitis / Delayed / 1.0-4.0
    ocular hemorrhage / Delayed / 1.0-4.0
    arrhythmia exacerbation / Early / Incidence not known

    Moderate

    conjunctival hyperemia / Early / 30.0-50.0
    depression / Delayed / 1.0-5.0
    hypercholesterolemia / Delayed / 1.0-5.0
    hypertension / Early / 1.0-5.0
    angina / Early / 1.0-5.0
    chest pain (unspecified) / Early / 1.0-5.0
    hypotension / Rapid / 1.0-5.0
    urinary incontinence / Early / 1.0-5.0
    blurred vision / Early / 1.0-4.0
    photophobia / Early / 1.0-4.0
    blepharitis / Early / 1.0-4.0
    conjunctivitis / Delayed / 1.0-4.0
    cataracts / Delayed / 1.0-4.0
    iritis / Delayed / 1.0-4.0
    sinus tachycardia / Rapid / Incidence not known

    Mild

    ocular pain / Early / 5.0-10.0
    ocular pruritus / Rapid / 5.0-10.0
    ocular irritation / Rapid / 5.0-10.0
    foreign body sensation / Rapid / 5.0-10.0
    headache / Early / 1.0-5.0
    anxiety / Delayed / 1.0-5.0
    back pain / Delayed / 1.0-5.0
    dyspepsia / Early / 1.0-5.0
    sinusitis / Delayed / 1.0-5.0
    infection / Delayed / 1.0-5.0
    iridal discoloration / Delayed / 1.0-4.0
    xerophthalmia / Early / 1.0-4.0
    lacrimation / Early / 1.0-4.0
    hypertrichosis / Delayed / Incidence not known
    insomnia / Early / Incidence not known
    epistaxis / Delayed / Incidence not known
    vomiting / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Travoprost products.

    PREGNANCY AND LACTATION

    Pregnancy

    Travoprost is classified by the FDA as a pregnancy risk category C. Although there are no adequate and well-controlled studies of travoprost in pregnant women, limited experience with a similar drug, latanoprost, in human pregnancy has not resulted in clinically significant risk to the fetus. After ophthalmic administration of travoprost, the drug does not significantly accumulate in the plasma suggesting exposure to the fetus would be low. High doses of intravenous travoprost were found to be teratogenic in rat modules. According to the manufacturer, travoprost should be used during pregnancy only if the potential benefit justifies the potential fetal risk.

    It is not known if travoprost or its metabolites are excreted in breast milk. Because the half-life is short after ophthalmic administration, clinically significant amounts of the drug would not be expected to be excreted into breast milk. According to the manufacturer, caution should be exercised when it is administered to a breast-feeding woman. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Mechanism of Action: Travoprost, is an analog of prostaglandin F2alpha, and a prodrug hydrolyzed to the active drug, travoprost free acid. Travoprost free acid selectively stimulates a subtype of prostaglandin receptors, known as the FP receptor. According to the manufacturer, increased uveoscleral outflow is thought to be the primary mechanism; although the exact mechanism of action is unknown.

    PHARMACOKINETICS

    Travoprost is administered topically to the eye. Following ophthalmic administration, travoprost is absorbed primarily through the cornea, where it is hydrolyzed by esterases to the biologically active travoprost free acid. Peak blood concentrations of travoprost free acid (<= 25 pg/ml) are achieved within 30 minutes and are undetectable (< 1 pg/ml) within 1 hour. Reduction of IOP begins approximately 2 hours after the first dose with maximum effect occurring after 12 hours. Travoprost free acid is systemically metabolized to inactive metabolites.

    Other Route(s)

    Ophthalmic Route
    Travoprost is absorbed primarily through the cornea.