Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING CEQUA ophthalmic solution is packaged in sterile, preservative-free, single-use vials. Each vial contains 0.25 mL fill in a 0.9 mL LDPE vial; 10 vials (2 cards of 5 vials) are packaged in a polyfoil aluminum pouch; 6 pouches are packaged in a box. The entire contents of each box of 60 vials must be dispensed intact. 60 Single-Use Vials 0.25 mL each - NDC 47335-506-96 Storage: Store at 20°C to 25°C (68°F to 77°F). Store single-use vials in the original foil pouch.; PRINCIPAL DISPLAY PANEL NDC 47355-506-96 For topical use in the eye sterile, Preservative-Free Cequa ® (cyclosporine ophthalmic solution) 0.09% 60 SINGLE-USE VIALS 6 pouches x 10 single-use vials (0.25 mL each) Rx only Keep out of reach of children. Not child resistant. SUN PHARMA Image; PRINCIPAL DISPLAY PANEL NDC 47355-507-97 For topical use in the eye sterile, Preservative-Free Cequa ® (cyclosporine ophthalmic solution) 0.09% 10 SINGLE-USE SAMPLE VIALS 1 pouches x 10 single-use vials (0.25 mL each) Rx only Keep out of reach of children. Not child resistant. SUN PHARMA image1
- 16 HOW SUPPLIED/STORAGE AND HANDLING CEQUA ophthalmic solution is packaged in sterile, preservative-free, single-use vials. Each vial contains 0.25 mL fill in a 0.9 mL LDPE vial; 10 vials (2 cards of 5 vials) are packaged in a polyfoil aluminum pouch; 6 pouches are packaged in a box. The entire contents of each box of 60 vials must be dispensed intact. 60 Single-Use Vials 0.25 mL each - NDC 47335-506-96 Storage: Store at 20°C to 25°C (68°F to 77°F). Store single-use vials in the original foil pouch.
- PRINCIPAL DISPLAY PANEL NDC 47355-506-96 For topical use in the eye sterile, Preservative-Free Cequa ® (cyclosporine ophthalmic solution) 0.09% 60 SINGLE-USE VIALS 6 pouches x 10 single-use vials (0.25 mL each) Rx only Keep out of reach of children. Not child resistant. SUN PHARMA Image
- PRINCIPAL DISPLAY PANEL NDC 47355-507-97 For topical use in the eye sterile, Preservative-Free Cequa ® (cyclosporine ophthalmic solution) 0.09% 10 SINGLE-USE SAMPLE VIALS 1 pouches x 10 single-use vials (0.25 mL each) Rx only Keep out of reach of children. Not child resistant. SUN PHARMA image1
Overview
CEQUA (cyclosporine ophthalmic solution) 0.09% contains a topical calcineurin inhibitor immunosuppressant. Cyclosporine’s chemical name is Cyclo[[(E)-(2S,3R,4R)-3-hydroxy-4-methyl-2-(methylamino)-6-octenoyl]-L-2-aminobutyryl-N-methylglycyl-N-methyl-L-leucyl-L-valyl-N-methyl-L-leucyl-L-alanyl-D-alanyl-N-methyl-L-leucyl-N-methyl-L-leucyl-N-methyl-L-valyl] and it has the following structure: Structural Formula Formula: C 62 H 111 N 11 O 12 Mol. Wt.: 1202.6 Cyclosporine is a white powder that is insoluble in water. CEQUA is supplied as a sterile, clear, colorless ophthalmic solution for topical ophthalmic use. It has an osmolality of 160 to 190 mOsmol/kg and a pH of 6.5-7.2. Each mL of CEQUA contains: Active: cyclosporine 0.09% Inactives: Polyoxyl 40 Hydrogenated Castor Oil, Octoxynol-40, polyvinylpyrrolidone, sodium phosphate monobasic dihydrate, sodium phosphate dibasic anhydrous, sodium chloride, water for injection, and sodium hydroxide or hydrochloric acid to adjust pH. structure
Indications & Usage
CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). ( 1 ) CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye) ( 1 ).
Dosage & Administration
Instill one drop of CEQUA twice daily (approximately 12 hours apart) into each eye. CEQUA can be used concomitantly with artificial tears, allowing a 15 minute interval between products. Discard the vial immediately after using in both eyes. ( 2 ) Instill one drop of CEQUA twice daily (approximately 12 hours apart) into each eye. Discard the vial immediately after using in both eyes ( 2 ).
Warnings & Precautions
To avoid the potential for eye injury and contamination, advise patients not to 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, advise patients not to touch the vial tip to the eye or other surfaces. 5.2 Use with Contact Lenses CEQUA 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 CEQUA ophthalmic solution.
Contraindications
None. ( 4 ) None ( 4 ).
Adverse Reactions
The most common adverse reactions following the use of CEQUA (cyclosporine ophthalmic solution) 0.09% was instillation site pain (22%) and conjunctival hyperemia (6%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 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 clinical trials, 769 subjects received at least 1 dose of cyclosporine ophthalmic solution. The majority of the treated subjects were female (83%). The most common adverse reactions reported in greater than 5% of subjects were pain on instillation of drops (22%) and conjunctival hyperemia (6%). Other adverse reactions reported in 1% to 5% of the patients were blepharitis, eye irritation, headache, and urinary tract infection.
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