TRYPTYR Ophthalmic solution Ref.[115717] Active ingredients: Acoltremon

Source: FDA, National Drug Code (US) Revision Year: 2025

Product description

TRYPTYR (acoltremon ophthalmic solution) 0.003% contains an agonist of TRPM8 ion channels. Acoltremon's chemical name is (1R,2S,5R)-2-isopropyl-N-(4-methoxyphenyl)-5-methylcyclohexane-1-carboxamide. The molecular formula of acoltremon is C₁₈H₂₇NO₂ and has a molecular weight of 289.42 g/mol.

Acoltremon is a white to pale yellow crystalline solid, that is insoluble in water.

TRYPTYR is a sterile, clear to slightly opalescent, colorless, isotonic aqueous solution for topical ophthalmic use, with a pH of approximately 7 and an osmolality of 280 to 330 mOsm/kg. Each mL of TRYPTYR contains active: acoltremon 0.003%; and inactives: polyoxyl 35 castor oil, sodium dihydrogen phosphate dihydrate, sodium chloride, hypromellose and purified water. Additionally, sodium hydroxide is used to adjust pH. TRYPTYR does not contain an anti-microbial preservative.

Dosage Forms and Strengths
TRYPTYR is a clear to slightly opalescent, colorless ophthalmic solution containing 0.003% acoltremon in a single-dose vial.

How Supplied
TRYPTYR (acoltremon ophthalmic solution) 0.003% is supplied as a sterile, clear to slightly opalescent, and colorless solution in a low-density polyethylene (LDPE), single-dose vial with a 0.4 mL fill. One strip of 5 single-dose vials is packaged in a foil pouch with twelve (12) pouches in a carton. NDC 0065-8595-02; Carton of 60 Single-Dose Vials. Manufactured for Alcon Laboratories, Inc., Fort Worth, TX 76134, USA

How Supplied

TRYPTYR (acoltremon ophthalmic solution) 0.003% is supplied as a sterile, clear to slightly opalescent, and colorless solution in a low-density polyethylene (LDPE), single-dose vial with a 0.4 mL fill. One strip of 5 single-dose vials is packaged in a foil pouch with twelve (12) pouches in a carton.

NDC 0065-8595-02; Carton of 60 Single-Dose Vials.

Manufactured for Alcon Laboratories, Inc., Fort Worth, TX 76134, USA

Drugs

Drug	Countries
TRYPTYR	United States

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