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Brand Name :
Tryptyr
Synonyms :
Acoltremon
Class :
TRPM8 Agonists
Brand Name :
Tryptyr
Synonyms :
Acoltremon
Class :
TRPM8 Agonists
Dosage forms & Strengths:
Adult
Solution
0.003%
In single dose vial form:
Put one drop in each eye for two times daily with minimum 12 hours of interval in two doses
Pediatric
Safety and efficacy not determined.
Geriatrics
Refer as per adult dose
Actions and Spectrum
Acoltremon is a novel neuromodulator that stimulates ocular sensory nerves and significantly increases the production of natural tears.
Dry eye disease is a complicated and multifaceted disorder that is caused by either increased tear evaporation or decreased tear production, which results in a lack of natural tears.
Frequency defined
Instillation site pain
Black Box Warning
None
Contraindication / Caution:
Contraindication:
None
Caution:
Keep the vial tip away from the eye and other surfaces to prevent contamination and possible eye damage.
Use only when contact lenses were removed.
Pregnancy / Lactation:
Pregnancy Warnings:
Pregnancy category: N/A
Lactation: Excretion in human breastmilk is not known
Pregnancy categories:
Category A: Satisfactory and well-controlled studies show no evidence of risk to the fetus in the first trimester or in the later trimester.
Category B: No evidence of risk to fetus found in animal reproduction studies and there are not enough studies on pregnant women.
Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for an effect in humans, care must be taken for potential risks in pregnant women.
Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms, but despite potential risks may be used only in emergency cases for potential benefits.
Category X: Drugs listed in this category clearly outweigh risks over benefits. These category drugs should be prohibited for pregnant women.
Category N: There is no data available for the drug under this category.
| Pharmacology | It was proven that stimulation of the TRPM8 thermoreceptor activates trigeminal nerve transmission, which increases the generation of basal tears. |
Pharmacology
It was proven that stimulation of the TRPM8 thermoreceptor activates trigeminal nerve transmission, which increases the generation of basal tears.
Pharmacodynamics
Acoltremon has more selectivity and potency than menthol, which also targets TRPM8, but the process is similar, resulting in increased efficacy and a lower chance of off-target effects.
Pharmacokinetics
On Days 1, 14, and 90, PK was measured in 25 dry eye patients who were receiving TRYPTYR (1 drop twice day). The highest plasma concentration was 213 pg/mL, and three of them had values over the lower limit of quantification of 20 pg/mL.
Administration
It is available in solution form with single- dose vial for ophthalmic use only.
Both eyes can be dosed with the single-dose vials, which must be used right away after opening.
the single-dose vial should be discarded immediately after use including any remaining contents.
It is possible to use Acoltremon in combination with other topical ophthalmic eye drops. When using multiple topical ophthalmic medications, they should be given minimum at 5 minutes interval.
Before TRYPTYR is administered, contact lenses should be taken out, and they may be inserted again 15 minutes later.
Patient information leaflet
Generic Name: acoltremon
Why do we use acoltremon?
Tryptyr (acoltremon) is newly approved by the FDA for the treatment of signs and symptoms related with dry eye disease.
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