Introduction
Travofix Ophthalmic Solution 0.004% ophthalmic solution is a topical medication used for controlling the progression of glaucoma or ocular hypertension, by reducing intraocular pressure . It is a synthetic prostaglandin F2alpha analog . Having been a well-received therapeutic agent with demonstrated efficacy and safety. It used as a first-line treatment for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypotension .
Uses
Travofix Ophthalmic Solution 0.004% is a prostaglandin analog used in the treatment of elevated intraocular pressure due to open angle glaucoma or ocular hypertension.
Travofix Ophthalmic Solution 0.004% ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension .
Travofix Ophthalmic Solution 0.004% is also currently indicated for the decrease of elevated intraocular pressure in paediatric patients aged 2 months to < 18 years with ocular hypertension or paediatric glaucoma .
Associated Conditions
Pharmacodynamics
Travofix Ophthalmic Solution 0.004%, an isopropyl ester prodrug, is a synthetic prostaglandin F2 alpha analog that is rapidly hydrolyzed by esterases in the cornea to its biologically active free acid . The travoprost free acid is potent and highly selective for the FP prostanoid receptor .
Mechanism of Action
Travofix Ophthalmic Solution 0.004%, a prostaglandin F2α analogue, is a highly selective full agonist which has a high affinity for the prostaglandin FP receptor, and facilitates reductions in intraocular pressure by increasing the outflow of aqueous humour via trabecular meshwork and uveoscleral pathways . Reduction of the intraocular pressure in man starts about 2 hours after administration and maximum effect is reached after 12 hours. Significant lowering of intraocular pressure can be maintained for periods exceeding 24 hours with a single dose .
Absorption
Travofix Ophthalmic Solution 0.004% is systemically absorbed through the cornea . In humans, peak plasma concentrations of travoprost free acid were low (25 pg/mL or less) and occurred within 30 minutes following topical ocular administration of one drop of 0.004% travoprost ophthalmic solution .
Volume of Distribution
Given the data currently available, it has been recorded that travoprost free acid is moderately distributed into body tissues with a volume of distribution of 2.6 L/kg in rats .
Protein Binding
The binding of travoprost free acid to plasma proteins is moderate at 80% and linear over a 10,000-fold concentration range (0.10 - 100 ng/mL) .
Route of Elimination
Less than 2% of the topical ocular dose of travoprost was excreted in the urine within 4 hours as the travoprost free acid . Moreover, elimination from plasma is rapid, resulting in concentrations below the limit of quantitation (< 10 pg/mL) by one hour .
Furthermore, in rats, 95% of a subcutaneous radiolabeled dose was eliminated within 24 hours . The major route of elimination was via the bile (61%) with the remainder excreted by the kidneys .
Half Life
The terminal elimination half-life of travoprost free acid is determined to be approximately 45 minutes, although studies demonstrated half-life values that ranged from 17 to 86 minutes .
Clearance
Data regarding the clearance of travoprost is not readily available or accessible.
Toxicity
No cases of overdose have been reported for travoprost . A topical overdose is not likely to occur or to be associated with toxicity . A topical overdose of travoprost may be flushed from the eye(s) with lukewarm water . Treatment of a suspected oral ingestion is symptomatic and supportive .
Travofix Ophthalmic Solution 0.004% has harmful pharmacological effects on pregnancy and/or the fetus/new-born child. Travofix Ophthalmic Solution 0.004% should not be used during pregnancy unless clearly necessary . The medication subsequently must not be used in women of childbearing age/potential unless adequate contraceptive measures are in place .
It is unknown whether travoprost from the eye drops is excreted in human breast milk. Animal studies have shown excretion of travoprost and metabolites in breast milk . The use of travoprost by breast-feeding mothers is not recommended .
There are no data on the effects of TRAVATAN on human fertility . Animal studies showed no effect of travoprost on fertility at doses more than 250 times the maximum recommended human ocular dose .
Use in patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use .
No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients .
Travofix Ophthalmic Solution 0.004% has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as 14 ml/min) [L514. No dosage adjustment is necessary for these patients .
Food Interactions
No interactions found.
Dosage
Pediatric patients: The efficacy and safety of travoprost eye drops in patients below the age of 18 years have not been established.