Description
NDC: 73043-005-02
Cyclosporine 0.05% Ophthalmic Emulsion, 60 x 0.4 mL Single-Use Vials — Devatis
| Active ingredients | Cyclosporine 0.05% (0.5 mg/mL) |
| Dosage form | Ophthalmic emulsion |
| Route | Topical ophthalmic |
| Size | 60 single-use vials of 0.4 mL each |
| Manufacturer | Devatis |
| NDC | 73043-005-02 |
Indications and Usage
Indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca (dry eye disease).
Dosage and Administration
Instill one drop in each eye twice daily, approximately 12 hours apart. Invert the unit-dose vial a few times to obtain a uniform emulsion before use. May be used with artificial tears, allowing at least 15 minutes between products.
Warnings and Precautions
- To avoid eye injury and contamination, do not touch the vial tip to the eye or any surface
- Contains no preservative; use immediately after opening and discard the vial after use
- Remove contact lenses before instillation and reinsert 15 minutes after administration
- Not for use during active ocular infection
Contraindications
Contraindicated in patients with known or suspected hypersensitivity to any of the ingredients.
Adverse Reactions
The most common adverse reaction was ocular burning (about 17%). Other reactions in 1 to 5% of patients included conjunctival hyperemia, discharge, eye pain, and blurred vision.
Storage and Handling
Store at 15°C to 25°C (59°F to 77°F).
How Supplied
Supplied as a sterile, preservative-free ophthalmic emulsion in single-use vials of 0.4 mL, packaged in cartons of 60 vials.
Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.
