Travofix Plus Ophthalmic Solution 0.004%+0.5%
Travofix Plus Ophthalmic Solution 0.004%+0.5% Uses, Dosage, Side Effects, Food Interaction and all others data.
Travoprost, an isopropyl ester prodrug, is a synthetic prostaglandin F2 alpha analogue that is rapidly hydrolyzed by esterases in the cornea to its biologically active free acid. The travoporst free acid is potent and highly selective for the FP prostanoid receptor.
Travoprost free acid is a selective FP prostanoid receptor agonist and is believed to reduce intraocular pressure by increasing the drainage of aqueous humor, which is done primarily through increased uveoscleral outflow and to a lesser extent, trabecular outflow facility.
Travoprost, 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 .
| Trade Name | Travofix Plus Ophthalmic Solution 0.004%+0.5% |
| Generic | Travoprost + Timolol Maleate |
| Weight | 0.004%+0.5% |
| Type | Ophthalmic Solution |
| Therapeutic Class | Drugs for miotics and glaucoma |
| Manufacturer | OSL Pharma Limited |
| Available Country | Bangladesh |
| Last Updated: | October 19, 2023 at 6:27 am |
Uses
This Sterile Ophthalmic Solution is indicated for the treatment of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension who are insufficiently responsive to single therapy with prostaglandin analogue or topical beta blocker.Travofix Plus Ophthalmic Solution 0.004%+0.5% is also used to associated treatment for these conditions: Increased Intra Ocular Pressure (IOP)
How Travofix Plus Ophthalmic Solution 0.004%+0.5% works
Travoprost, 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 .
Dosage
Travofix Plus Ophthalmic Solution 0.004%+0.5% dosage
Instill one drop in the conjunctival sac of the affected eye(s) once daily at about the same time each day, preferably in the evening.Side Effects
No serious adverse reactions are reported. Most frequently reported side effects are ocular hyperemia.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 .
Travoprost has harmful pharmacological effects on pregnancy and/or the fetus/new-born child. Travoprost 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 .
Travoprost 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 .
Precaution
For ophthalmic use only. Patients should remove their contact lenses prior to instilling this preparation and should not insert their lenses until 15 minutes after instillation of the preparation.Interaction
Although Timolol used alone has little or no effect on pupil size, mydriasis resulting from concomitant therapy with Timolol Maleate and epinephrine has been reported occasionally. Drug interactions of Timolol Maleate have been noticed with concomitant administration of beta-adrenergic blocking agents (both oral and topical), calcium antagonists, catecholamine-depleting drugs, digitalis, quinidin, clonidine, injectable epinephrine.Reduced therapeutic effect with NSAIDs.
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 .
Elimination Route
Travoprost 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 .
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.
Elimination Route
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 .
Pregnancy & Breastfeeding use
Use in pregnancy: There are no adequate and well-controlled studies in pregnant women. It should not be used during pregnancy.Use in lactation: Caution should be exercised when Travofix Plus Ophthalmic Solution 0.004%+0.5% is administered to a nursing mother.Contraindication
Contraindicated in patients who are hypersensitive to Travoprost, Timolol or any of the components of this preparation.Special Warning
Use in children: Safety and effectiveness in pediatric patients have not been established.Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.Acute Overdose
There have been reports of inadvertent overdosage with Timolol Ophthalmic Solution resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest.Storage Condition
Store in a cool, dry place, away from heat and direct light. Keep out of the reach of children. Do not use more than 4 weeks after opening the bottleInnovators Monograph
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