CEQUA

CEQUA is an FDA-registered drug product whose active ingredient is CYCLOSPORINE. It is labelled by Sun Pharmaceutical Industries, Inc. taken by ophthalmic and marketed as a human prescription drug product. Identifiers on file: NDC 47335-506, application NDA210913, label effective 20260615. It is one of 9 FDA drug label records sharing the active ingredient CYCLOSPORINE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing CYCLOSPORINE are most often described in connection with: cequa ophthalmic, solution calcineurin, inhibitor immunosuppressant, indicated increase, tear production, keratoconjunctivitis sicca, dry eye. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 ).

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 ).

4 CONTRAINDICATIONS None. ( 4 ) None ( 4 ).

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.

FDA lists 9 drug label records with CYCLOSPORINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is CEQUA used for?
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 ).

Who makes CEQUA?
Sun Pharmaceutical Industries, Inc. is the labeler of record for CEQUA. 9 FDA label records share the active ingredient CYCLOSPORINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does CEQUA come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is CEQUA prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing CYCLOSPORINE?
Yes. 9 FDA drug label records list CYCLOSPORINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has CEQUA been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.