Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 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. Storage Store refrigerated at 2°C to 8°C (36°F to 46°F). After opening the carton, TRYPTYR may be stored refrigerated or at room temperature at 2°C to 25°C (36°F to 77°F). If stored at room temperature, TRYPTYR should be used within 30 days, not to exceed the expiration date printed on the carton and foil pouch. After opening each foil pouch, the single-dose vials should be used within 7 days, not to exceed the expiration date printed on the vial. Store unopened single-dose vials in the original foil pouch until ready to use.; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL TRYPTYR ® (acoltremon ophthalmic solution) 0.003% 3390 Alcon Lot: Exp.: NDC 0065-8595-02 441121 Rx only TRYPTYR ® (acoltremon ophthalmic solution) 0.003% For topical use in eye Recommended Dosage: Place one drop in each eye twice daily (approximately 12 hours apart). Discard single-dose vial immediately after use. Do not reuse. Store in foil pouch until ready for use. After opening the foil pouch, TRYPTYR can be stored refrigerated or at room temperature, 2°C to 25°C (36°F to 77°F), and used within 7 days. Date of first opening _____/_____/_____ Contains 5 single-use vials (0.4 mL each) Sterile; Does not contain anti-microbial preservatives Alcon LOT: ####A EXP.: YYYY-MM Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134 USA NDC 0065-8595-02 Rx only TRYPTYR ® (acoltremon ophthalmic solution) 0.003% For topical application in the eye 60 SINGLE-DOSE VIALS ● 30-Day SUPPLY Does not contain anti-microbial preservatives Sterile Alcon CONTAINS 12 pouches x 5 single-dose vials (0.4 mL each) Each mL contains: Active: acoltremon 0.003% Inactives: polyoxyl 35 castor oil, sodium dihydrogen phosphate dihydrate, sodium chloride, hypromellose, sodium hydroxide to adjust pH, and purified water. STORAGE Store unopened carton in the refrigerator, 2°C to 8°C (36°F to 46°F). After opening, TRYPTYR can be stored refrigerated or at room temperature up to 30 days in the unopened foil pouch, 2°C to 25°C (36°F to 77°F). Date carton first opened ___/___/___ See additional discard instructions on the pouch. DOSING Recommended Dosage: Place one drop in each eye twice daily (approximately 12 hours apart). To avoid contamination, do not touch tip of container to any surface. Use one single-dose vial immediately after opening and then discard. Do not reuse. Please see full Prescribing Information and Instructions for Use, inside carton, for additional dosage, storage and safety information. Manufactured in France for Alcon Laboratories, Inc. Fort Worth, TX 76134 USA Product of India U.S. Pat.: www.alconpatents.com NDC 0065-8595-02 GTIN: 00300658595027 LOT: ####A EXP.: YYYY-MM SN: 01234567891234 TRYPTYR ® (acoltremon ophthalmic solution) 0.003% 439701
- 16 HOW SUPPLIED/STORAGE AND HANDLING 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. Storage Store refrigerated at 2°C to 8°C (36°F to 46°F). After opening the carton, TRYPTYR may be stored refrigerated or at room temperature at 2°C to 25°C (36°F to 77°F). If stored at room temperature, TRYPTYR should be used within 30 days, not to exceed the expiration date printed on the carton and foil pouch. After opening each foil pouch, the single-dose vials should be used within 7 days, not to exceed the expiration date printed on the vial. Store unopened single-dose vials in the original foil pouch until ready to use.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL TRYPTYR ® (acoltremon ophthalmic solution) 0.003% 3390 Alcon Lot: Exp.: NDC 0065-8595-02 441121 Rx only TRYPTYR ® (acoltremon ophthalmic solution) 0.003% For topical use in eye Recommended Dosage: Place one drop in each eye twice daily (approximately 12 hours apart). Discard single-dose vial immediately after use. Do not reuse. Store in foil pouch until ready for use. After opening the foil pouch, TRYPTYR can be stored refrigerated or at room temperature, 2°C to 25°C (36°F to 77°F), and used within 7 days. Date of first opening _____/_____/_____ Contains 5 single-use vials (0.4 mL each) Sterile; Does not contain anti-microbial preservatives Alcon LOT: ####A EXP.: YYYY-MM Manufactured for: Alcon Laboratories, Inc. Fort Worth, TX 76134 USA NDC 0065-8595-02 Rx only TRYPTYR ® (acoltremon ophthalmic solution) 0.003% For topical application in the eye 60 SINGLE-DOSE VIALS ● 30-Day SUPPLY Does not contain anti-microbial preservatives Sterile Alcon CONTAINS 12 pouches x 5 single-dose vials (0.4 mL each) Each mL contains: Active: acoltremon 0.003% Inactives: polyoxyl 35 castor oil, sodium dihydrogen phosphate dihydrate, sodium chloride, hypromellose, sodium hydroxide to adjust pH, and purified water. STORAGE Store unopened carton in the refrigerator, 2°C to 8°C (36°F to 46°F). After opening, TRYPTYR can be stored refrigerated or at room temperature up to 30 days in the unopened foil pouch, 2°C to 25°C (36°F to 77°F). Date carton first opened ___/___/___ See additional discard instructions on the pouch. DOSING Recommended Dosage: Place one drop in each eye twice daily (approximately 12 hours apart). To avoid contamination, do not touch tip of container to any surface. Use one single-dose vial immediately after opening and then discard. Do not reuse. Please see full Prescribing Information and Instructions for Use, inside carton, for additional dosage, storage and safety information. Manufactured in France for Alcon Laboratories, Inc. Fort Worth, TX 76134 USA Product of India U.S. Pat.: www.alconpatents.com NDC 0065-8595-02 GTIN: 00300658595027 LOT: ####A EXP.: YYYY-MM SN: 01234567891234 TRYPTYR ® (acoltremon ophthalmic solution) 0.003% 439701
Overview
TRYPTYR (acoltremon ophthalmic solution) 0.003% contains an agonist of TRPM8 ion channels. Acoltremon’s chemical name is (1 R ,2 S ,5 R )-2-isopropyl- N -(4-methoxyphenyl)-5-methylcyclohexane-1-carboxamide. The molecular formula of acoltremon is C 18 H 27 NO 2 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.
Indications & Usage
TRYPTYR is indicated for the treatment of the signs and symptoms of dry eye disease. TRYPTYR is a TRPM8 thermoreceptor agonist indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 )
Dosage & Administration
Instill one drop in each eye twice daily (approximately 12 hours apart). ( 2 ) 2.1 Recommended Dosage Instill one drop in each eye twice daily (approximately 12 hours apart). 2.2 Administration Instructions Wash hands before use. The single-dose vials are to be used immediately after opening and can be used to dose both eyes. Discard the single-dose vial, including any remaining contents, immediately after use. TRYPTYR can be used concomitantly with other topical ophthalmic eye drops. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart . Contact lenses should be removed prior to the administration of TRYPTYR and may be reinserted 15 minutes following administration. If one dose is missed, treatment should continue with the next dose.
Warnings & Precautions
To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other surfaces. ( 5.1 ) 5.1 Potential for Eye Injury and Contamination To avoid the potential for eye injury and contamination, do not touch the vial tip to the eye or other surfaces. 5.2 Use with Contact Lenses TRYPTYR should not be administered while wearing contact lenses. If contact lenses are worn, they should be removed prior to administration of the solution. Lenses may be reinserted 15 minutes following administration of TRYPTYR.
Contraindications
None. None. ( 4 )
Adverse Reactions
The most common adverse reaction was instillation site pain (50%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9780, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In patients with dry eye disease, 766 patients received at least one dose of TRYPTYR in four randomized controlled clinical trials across 71 sites in the United States. The most common ocular adverse reaction observed in controlled clinical studies with TRYPTYR was instillation site pain (50%). Less than 1% of patients discontinued therapy due to burning or stinging sensation in the eyes.
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