CEQUA .0009 mg/mL
cyclosporine · SOLUTION/ DROPS · Sun Pharmaceutical Industries, Inc.
Cequa is a prescription eye drop containing cyclosporine that works by suppressing immune activity in the eye to treat dry eye disease. It is used when the dry eye condition is caused or worsened by inflammation.
Key Facts
- Brand Name
- CEQUA
- Generic Name
- cyclosporine
- NDC Code (Product)
47335-507- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Strength
- .0009 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC, TOPICAL
- Marketing Status
- Application #
- NDA210913
- Drug Class
- Calcineurin Inhibitor Immunosuppressant [EPC]
- Marketing Start
- 08/15/2018
Recall History
SUN PHARMACEUTICAL INDUSTRIES INC
Subpotent
SUN PHARMACEUTICAL INDUSTRIES INC
Subpotent and Presence of Particulates .
SUN PHARMACEUTICAL INDUSTRIES INC
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
SUN PHARMACEUTICAL INDUSTRIES INC
Subpotent: Out of Specification result observed for low assay
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND 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
2 DOSAGE AND 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 ).
Contraindications
4 CONTRAINDICATIONS None. ( 4 ) None ( 4 ).
Adverse Reactions
6 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.
Frequently Asked Questions
What is CEQUA used for?
Cequa is a prescription eye drop containing cyclosporine that works by suppressing immune activity in the eye to treat dry eye disease. It is used when the dry eye condition is caused or worsened by inflammation.
Is CEQUA a controlled substance?
CEQUA is not classified as a controlled substance by the DEA.
What is the generic name for CEQUA?
The generic name for CEQUA is cyclosporine. There are 10 other brand versions of cyclosporine.
What is the NDC code for CEQUA .0009 mg/mL?
The NDC (National Drug Code) for CEQUA .0009 mg/mL is 47335-507, listed by Sun Pharmaceutical Industries, Inc..