Travatan

Ophthalmic Prostaglandins including Analogs and Receptor Agonists

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.

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

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

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

Travatan, Travatan Z

Rx

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.

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

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

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

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

There are no drug interactions associated with Travoprost products.

Travatan/Travatan Z/Travoprost Ophthalmic Sol: 0.004%

1 drop/day per affected eye.

1 drop/day per affected eye.

16 to 17 years: 1 drop/day per affected eye.
13 to 15 years: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

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.

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.

Ophthalmic Route
Travoprost is absorbed primarily through the cornea.

There are no adequate and well-controlled studies regarding the use of travoprost during human pregnancy. In animal studies, clinically relevant subcutaneous doses administered to pregnant rats and mice during organogenesis resulted in embryo-fetal lethality, spontaneous abortions, and premature deliveries. Administer travoprost during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

It is unknown whether travoprost or its metabolites are excreted into human milk following ophthalmic administration. Further, there are no data regarding the effects of travoprost on a breast-fed infant or on milk production. 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 administered drug, health care providers are encouraged to report the adverse effect to the FDA.[41683]