RESTASIS .5 mg/mL
cyclosporine · EMULSION · Allergan, Inc.
RESTASIS is a emulsion containing cyclosporine at .5 mg/mL, taken ophthalmic. Manufactured by Allergan, Inc..
Key Facts
- Brand Name
- RESTASIS
- Generic Name
- cyclosporine
- NDC Code (Product)
0023-9163- Manufacturer
- Allergan, Inc.
- Strength
- .5 mg/mL
- Dosage Form
- EMULSION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA050790
- Drug Class
- Calcineurin Inhibitor Immunosuppressant [EPC]
- Marketing Start
- 04/01/2003
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE RESTASIS MULTIDOSE ® 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. RESTASIS MULTIDOSE 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
2 DOSAGE AND ADMINISTRATION Instill one drop of RESTASIS MULTIDOSE ophthalmic emulsion twice a day in each eye approximately 12 hours apart. RESTASIS MULTIDOSE can be used concomitantly with lubricant eye drops, allowing a 15-minute interval between products. Prime by squeezing two drops onto a tissue before initial use. ( 2.1 ) Instill one drop of RESTASIS MULTIDOSE ophthalmic emulsion twice a day in each eye approximately 12 hours apart. ( 2.2 ) Pull off the clear shipping cover by pulling straight up. Throw the shipping cover away. Do not use RESTASIS MULTIDOSETM if shipping cover or pull tab are damaged or missing. Remove the pull tab on the olive green colored protective cap by pulling the end of the pull tab away from the bottle then winding it counterclockwise. Throw away the pull tab. Remove the olive green colored protective cap by pulling it straight up. Keep the colored protective cap. Prime the bottle for first-time use by squeezing two drops onto a tissue. Do not let the bottle tip touch the tissue. The bottle is now ready for use. After use, recap the bottle with the olive green colored protective cap by pushing it straight down onto the bottle. Turn the bottle upside…
Contraindications
4 CONTRAINDICATIONS RESTASIS MULTIDOSE is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation [ see Adverse Reactions (6.2) ] . Hypersensitivity ( 4 )
Adverse Reactions
6 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 0.05% was ocular burning (17%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-633-9110 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 ophthalmic emulsion, 0.05% 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 ophtha…
Frequently Asked Questions
What is RESTASIS used for?
RESTASIS contains cyclosporine. It is a emulsion taken ophthalmic. Consult your doctor for specific uses.
Is RESTASIS a controlled substance?
RESTASIS is not classified as a controlled substance by the DEA.
What is the generic name for RESTASIS?
The generic name for RESTASIS is cyclosporine. There are 12 other brand versions of cyclosporine.
What is the NDC code for RESTASIS .5 mg/mL?
The NDC (National Drug Code) for RESTASIS .5 mg/mL is 0023-9163, listed by Allergan, Inc..