Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Cyclosporine ophthalmic emulsion, 0.05% is packaged in sterile, preservative-free single-use vials. Each vial contains 0.4 mL fill in a 0.5 mL natural colored low density polyethylene vial; five vials are packaged in an aluminum pouch and six pouches are packaged in a carton. The entire contents of each carton (30 vials) must be dispensed intact. Cyclosporine ophthalmic emulsion is also provided in a 60 count carton that must be dispensed intact. NDC 0378-8760-58 carton of 30 vials NDC 0378-8760-91 carton of 60 vials Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]; PRINCIPAL DISPLAY PANEL – 0.05% NDC 0378-8760-58 CycloSPORINE Ophthalmic Emulsion 0.05% FOR USE IN THE EYES Sterile, Preservative-Free Rx only 30 Single-Use Vials (0.4 mL Each) Each mL contains: Active: Cyclosporine, USP 0.05% Inactives: anhydrous glycerin, carbomer copolymer type A, castor oil, polysorbate 80, water for injection, and sodium hydroxide to adjust pH. Usual Dosage: Twice daily approximately 12 hours apart. Invert the vial before using. Use immediately after opening and then discard. See accompanying prescribing information. Keep this and all medication out of the reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store vials in the carton until use. The entire contents of the carton (30 vials) must be dispensed intact. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in U.S.A. Carton 1; PRINCIPAL DISPLAY PANEL – 0.05% NDC 0378-8760-91 CycloSPORINE Ophthalmic Emulsion 0.05% FOR USE IN THE EYES Sterile, Preservative-Free Rx only 60 Single-Use Vials (0.4 mL Each) Each mL contains: Active: Cyclosporine, USP 0.05% Inactives: anhydrous glycerin, carbomer copolymer type A, castor oil, polysorbate 80, water for injection, and sodium hydroxide to adjust pH. Usual Dosage: Twice daily approximately 12 hours apart. Invert the vial before using. Use immediately after opening and then discard. See accompanying prescribing information. Keep this and all medication out of the reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store vials in the carton until use. The entire contents of the carton (60 vials) must be dispensed intact. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in U.S.A. Carton 2
- 16 HOW SUPPLIED/STORAGE AND HANDLING Cyclosporine ophthalmic emulsion, 0.05% is packaged in sterile, preservative-free single-use vials. Each vial contains 0.4 mL fill in a 0.5 mL natural colored low density polyethylene vial; five vials are packaged in an aluminum pouch and six pouches are packaged in a carton. The entire contents of each carton (30 vials) must be dispensed intact. Cyclosporine ophthalmic emulsion is also provided in a 60 count carton that must be dispensed intact. NDC 0378-8760-58 carton of 30 vials NDC 0378-8760-91 carton of 60 vials Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]
- PRINCIPAL DISPLAY PANEL – 0.05% NDC 0378-8760-58 CycloSPORINE Ophthalmic Emulsion 0.05% FOR USE IN THE EYES Sterile, Preservative-Free Rx only 30 Single-Use Vials (0.4 mL Each) Each mL contains: Active: Cyclosporine, USP 0.05% Inactives: anhydrous glycerin, carbomer copolymer type A, castor oil, polysorbate 80, water for injection, and sodium hydroxide to adjust pH. Usual Dosage: Twice daily approximately 12 hours apart. Invert the vial before using. Use immediately after opening and then discard. See accompanying prescribing information. Keep this and all medication out of the reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store vials in the carton until use. The entire contents of the carton (30 vials) must be dispensed intact. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in U.S.A. Carton 1
- PRINCIPAL DISPLAY PANEL – 0.05% NDC 0378-8760-91 CycloSPORINE Ophthalmic Emulsion 0.05% FOR USE IN THE EYES Sterile, Preservative-Free Rx only 60 Single-Use Vials (0.4 mL Each) Each mL contains: Active: Cyclosporine, USP 0.05% Inactives: anhydrous glycerin, carbomer copolymer type A, castor oil, polysorbate 80, water for injection, and sodium hydroxide to adjust pH. Usual Dosage: Twice daily approximately 12 hours apart. Invert the vial before using. Use immediately after opening and then discard. See accompanying prescribing information. Keep this and all medication out of the reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store vials in the carton until use. The entire contents of the carton (60 vials) must be dispensed intact. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in U.S.A. Carton 2
Overview
Cyclosporine ophthalmic emulsion 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporine’s chemical name is Cyclo[[( E )-(2 S ,3 R ,4 R )-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, USP is a white or almost white powder. Cyclosporine ophthalmic emulsion appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5 to 8.0. Each mL of cyclosporine ophthalmic emulsion contains: Active: cyclosporine USP, 0.05%. Inactives: anhydrous glycerin, carbomer copolymer type A, castor oil, polysorbate 80, water for injection, and sodium hydroxide to adjust pH. Chemical Structure
Indications & Usage
Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. Cyclosporine ophthalmic emulsion is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs. ( 1 )
Dosage & Administration
Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of cyclosporine ophthalmic emulsion twice a day in each eye approximately 12 hours apart. Cyclosporine ophthalmic emulsion can be used concomitantly with lubricant eye drops, allowing a 15-minute interval between products. Discard vial immediately after use. Instill one drop of cyclosporine ophthalmic emulsion twice a day in each eye approximately 12 hours apart. ( 2 )
Warnings & Precautions
• To avoid the potential for eye injury and contamination, be careful not to touch the vial tip to your eye or other surfaces. ( 5.1 ) 5.1 Potential for Eye Injury and Contamination Be careful not to touch the vial tip to your eye or other surfaces to avoid potential for eye injury and contamination. 5.2 Use with Contact Lenses Cyclosporine ophthalmic emulsion should not be administered while wearing contact lenses. Patients with decreased tear production typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of cyclosporine ophthalmic emulsion.
Contraindications
Cyclosporine ophthalmic emulsion is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. • Hypersensitivity ( 4 )
Adverse Reactions
The following serious adverse reactions are described elsewhere in the labeling: • Potential for Eye Injury and Contamination [ see Warnings and Precautions (5.1) ] The most common adverse reaction following the use of cyclosporine ophthalmic emulsion was ocular burning (17%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877-446-3679 (1-877-4-INFO-RX) 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, the most common adverse reaction following the use of cyclosporine opthalmic emulsion was ocular burning (17%). Other reactions reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring). 6.2 Post-marketing Experience The following adverse reactions have been identified during post approval use of cyclosporine ophthalmic emulsion. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Reported reactions have included: hypersensitivity (including eye swelling, urticaria, rare cases of severe angioedema, face swelling, tongue swelling, pharyngeal edema, and dyspnea); and superficial injury of the eye (from the vial tip touching the eye during administration).
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