Rozatrav
Rozatrav Uses, Dosage, Side Effects, Food Interaction and all others data.
Rozatrav, 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.
Rozatrav 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.
Rozatrav, 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 | Rozatrav |
Generic | Travoprost |
Travoprost Other Names | Travoprost, Travoprostum |
Type | |
Formula | C26H35F3O6 |
Weight | Average: 500.5477 Monoisotopic: 500.238573467 |
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) . |
Groups | Approved |
Therapeutic Class | Drugs for miotics and glaucoma |
Manufacturer | |
Available Country | Netherlands |
Last Updated: | September 19, 2023 at 7:00 am |
Uses
Rozatrav Eye Drops is used for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of or insufficiently responsive to another intraocular pressure lowering medication, as monotherapy or as adjunctive therapy.
Rozatrav is also used to associated treatment for these conditions: Increased Intra Ocular Pressure (IOP)
How Rozatrav works
Rozatrav, 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
Rozatrav dosage
Use in adults: The recommended dose is one drops of Rozatrav in the conjunctival sac of the affected eye (s) once daily in the evening, If more than one topical ophthalmic product is being used, the medicines must be administered at least 5 minutes apart. When substituting another ophthalmic antiglaucoma agent with Rozatrav, discontinue the other agent and start the following day with Rozatrav.
Pediatric patients: The efficacy and safety of travoprost eye drops in patients below the age of 18 years have not been established.
Side Effects
The most frequently reported treatment-related side-effect is ocular hyperaemia.
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 .
Rozatrav has harmful pharmacological effects on pregnancy and/or the fetus/new-born child. Rozatrav 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 .
Rozatrav 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
Rozatrav should be used with caution in patients with active intraocular inflammation (iritis/uveitis). Rozatrav should not be administered while wearing contact lenses. Contact lenses should be removed prior to the administration of the solution. Lenses may be reinserted 15 minutes following administration of Rozatrav.
Interaction
Reduced therapeutic effect with NSAIDs.
Food Interaction
No interactions found.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
Rozatrav 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
There are no adequate and well-controlled clinical study En pregnant women. Rozatrav should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether the drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when travoprost is administered to a lactating woman.
Contraindication
Rozatrav eye drops is contraindicated in patients with hypersensitive to travoprost or any excipients of Rozatrav.
Storage Condition
Store in a cool, dry place and protected from light. Keep out of reach of children. Discard the container 4 weeks after opening.
Innovators Monograph
You find simplified version here Rozatrav
Rozatrav contains Travoprost see full prescribing information from innovator Rozatrav Monograph, Rozatrav MSDS, Rozatrav FDA label
FAQ
What is Rozatrav used for?
Rozatrav is used to treat glaucoma a condition in which increased pressure in the eye can lead to gradual loss of vision and ocular hypertension (a condition which causes increased pressure in the eye).
How safe is Rozatrav?
Rozatrav is well-tolerated, and no treatment-related systemic adverse events were reported.
What are the common side effects of Rozatrav?
Common side effects of Rozatrav are include:
- eye discomfort.
- a decrease in sharpness of vision called reduced visual acuity.
- an increased amount of blood in the lining of the eye called conjunctival hyperemia.
- eye pain.
- eye irritation.
- eye itching.
- a feeling that something is in the eye.
Is Rozatrav safe during pregnancy?
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Rozatrav is contraindicated.
Is Rozatrav safe during breastfeeding?
This drug is not recommended unless there are no safer alternatives.
Can I drink alcohol with Rozatrav?
No information is available on interactions of Rozatrav when taken with alcohol, consult your doctor or pharmacist for further details.
Can I drive after taking Rozatrav?
Rozatrav eye drops can cause blurred vision immediately after instilling them in the eyes. This may affect your ability to drive or operate machinery.If you experience blurring, avoid driving or using machinery until your vision has cleared.
How long does it take Rozatrav to work?
Rozatrav takes about 2 hours to kick in and 12 hours to reach maximum effect. Your eye pressure is best controlled if you use this medication once a day in the evening consistently.
When should I take Rozatrav?
Comes as a solution to instill in the eye. It is usually instilled in the affected eye once a day in the evening. To help you remember to use Rozatrav use it around the same time every day.
Does Rozatrav make my eyelashes grow?
Rozatrav may gradually change eyelashes and vellus hair in the treated eye. These changes include increased length, thickness, and number of lashes. Eyelash changes are usually reversible upon discontinuation of treatment.
Can I use Rozatrav in the morning?
Take once-daily travoprost drops in the morning.
How long does Rozatrav stay in my system?
Plasma half-life of bram acid is approximately 45 minutes and less than 2% of topical ocular dose is excreted in the urine within 4 hours from administration.
What happens if you don't use Rozatrav?
If you don't use them as prescribed, you could lose your vision.
What happens if you stop taking Rozatrav?
Rozatrav cause the iris, eyelid, or eyelashes of your treated eye to turn ne brown. Your eyelashes may also become longer, thicker, and darker. Some of these changes may be permanent even if you stop using Rozatrav.
How should I used the Rozatrav?
Do not use this medicine in larger or smaller amounts or for longer than recommended.
The usual dose of this medicine is 1 drop into the affected eye every evening. Follow your doctor's dosing instructions very carefully.
What happens if I miss a dose?
Skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.
What happens if I overdose?
An overdose of Rozatrav ophthalmic is not expected to be dangerous. Seek emergency medical attention.
Who should not take Rozatrav?
You may not use Rozatrav if you have allergies of Rozatrav.