Travoprost

Travoprost ophthalmic (for the eye) reduces pressure in the eye by increasing the amount of fluid that drains from the eye.

Travoprost ophthalmic is used to treat certain types of glaucoma and other causes of high pressure inside the eye.

Travoprost ophthalmic may also be used for other purposes not listed in this medication guide.

Do not use this medication if you are allergic to travoprost.

Before using travoprost, tell your doctor if you are allergic to any drugs, or if you have swelling or infection of your eye.

Travoprost ophthalmic may cause a gradual change in the color of your eyes or eyelids and lashes, as well as increased growth or thickness of your eyelashes. These color changes, usually an increase in brown pigment, occur slowly and you may not notice them for months or years. Color changes may be permanent even after your treatment ends, and may occur only in the eye being treated. This could result in a cosmetic difference in eye or eyelash color from one eye to the other.

FDA pregnancy category C. It is not known whether travoprost is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether travoprost passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

None currently known.7

• Tell all of your health care providers that you take travoprost. This includes your doctors, nurses, pharmacists, and dentists.
• Use care when driving or doing other tasks that call for clear eyesight.
• Have your eye pressure checked. Talk with your doctor.
• Tell your doctor if you have an eye infection, eye injury, or will be having eye surgery.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Eye irritation.
• Feeling that something is in the eye.
• Itching.
• This medicine may cause eyelash changes like dark eyelashes, thickness, or more eyelashes. Most of the time, these changes go back to normal after travoprost is stopped.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Ophthalmic Agent, Antiglaucoma
• Prostaglandin, Ophthalmic

There are no dosage adjustments provided in the manufacturer's labeling; dosage adjustments are unlikely due to low systemic absorption.

Concerns related to adverse effects:

• Bacterial keratitis: Inadvertent contamination of multiple-dose ophthalmic solutions has caused bacterial keratitis.

• Ocular effects: May permanently change/increase brown pigmentation of the iris, the eyelid skin, and eyelashes. In addition, may increase the length, thickness, and/or number of eyelashes (may vary between eyes); changes occur slowly and may not be noticeable for months or years. Long-term consequences and potential injury to eye are not known.

Disease-related concerns:

• Ocular disease: Use with caution in patients with intraocular inflammation (eg, uveitis), aphakic patients, pseudophakic patients with a torn posterior lens capsule, or patients with risk factors for macular edema. Safety and efficacy have not been determined for use in patients with angle-closure-, inflammatory-, or neovascular glaucoma.

Special populations:

• Contact lens wearers: Remove contact lens prior to instillation; may reinsert 15 minutes following administration.

• Pediatric: Use in pediatric patients (<16 years of age) is not recommended due to possible safety issues of increased pigmentation following long-term chronic use.

Applies to travoprost ophthalmic: ophthalmic solution

Ocular

Very common (10% or more): Ocular hyperemia (up to 50%)
Common (1% to 10%): Decreased visual acuity, eye discomfort, foreign body sensation, eye pain, eyelid pruritus, abnormal vision, blepharitis, blurred vision, cataract, conjunctivitis, corneal staining, dry eye, iris discoloration, keratitis, lid margin crusting, ocular inflammation, photophobia, subconjunctival hemorrhage, tearing
Uncommon (0.1% to 1%): Corneal erosion, uveitis, iritis, anterior chamber inflammation, punctate keratitis, eye discharge, erythema of eyelid, periorbital edema, ectropion cataract, eyelid margin crusting, growth of eyelashes, eyelash discoloration, asthenopia
Rare (less than 0.1%): Iridocyclitis, eye inflammation, photopsia, eyelid eczema, conjunctival edema, halo vision, conjunctival follicles, eye hypoesthesia, meibomianitis, anterior chamber pigmentation, mydriasis, eyelash thickening, macular edema, sunken eyes
Postmarketing reports: Periorbital/lid changes (including deepening of the eyelid sulcus)[Ref]

Dermatologic

Uncommon (0.1% to 1%): Skin hyperpigmentation (periocular), skin discoloration, abnormal hair texture, hypertrichosis
Rare (less than 0.1%): Allergic dermatitis, contact dermatitis, erythema, rash, hair color changes, madarosis
Frequency not reported: Pruritus, abnormal hair growth[Ref]

Cardiovascular

Common (1% to 10%): Angina pectoris, bradycardia, chest pain, hypertension, hypotension
Uncommon (0.1% to 1%): Palpitations
Rare (less than 0.1%): Irregular heart rate, decreased heart rate, decreased diastolic blood pressure, increased systolic blood pressure
Frequency not reported: Tachycardia[Ref]

Gastrointestinal

Common (1% to 10%): Dyspepsia, gastrointestinal disorder
Rare (less than 0.1%): Reactivated peptic ulcer, constipation, dry mouth
Frequency not reported: Diarrhea, abdominal pain, nausea[Ref]

Genitourinary

Common (1% to 10%): Prostate disorder, urinary incontinence, urinary tract infections
Frequency not reported: Dysuria, increased prostatic specific antigen[Ref]

Musculoskeletal

Common (1% to 10%): Arthritis, back pain
Uncommon (0.1% to 1%): Shoulder pain
Rare (less than 0.1%): Musculoskeletal pain
Frequency not reported: Arthralgia[Ref]

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness
Rare (less than 0.1%): Dysgeusia
Frequency not reported: Vertigo, tinnitus[Ref]

Respiratory

Common (1% to 10%): Bronchitis, cold/flu syndrome, sinusitis
Uncommon (0.1% to 1%): Dyspnea, asthma, nasal congestion, throat irritation
Rare (less than 0.1%): Respiratory disorder, oropharyngeal pain, cough, dysphonia
Frequency not reported: Aggravated asthma[Ref]

Metabolic

Common (1% to 10%): Hypercholesterolemia[Ref]

Other

Common (1% to 10%): Pain
Uncommon (0.1% to 1%): Asthenia, malaise[Ref]

Psychiatric

Common (1% to 10%): Anxiety, depression[Ref]

Immunologic

Rare (less than 0.1%): Herpes simplex, herpetic keratitis[Ref]

General

The most commonly reported side effect was ocular hyperemia.[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity, seasonal allergy[Ref]

Some side effects of travoprost ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

No adjustment recommended

Safety and efficacy have not been established in patients younger than 16 years.

Consult WARNINGS section for additional precautions.

Storage requirements:
-Store between 2 C to 25 C

Patient Advice:
-You should wipe off any excess solution from the skin to reduce the risk of darkening of the eyelid skin.
-As with any other eye drops, nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of drugs administered via the ocular route.