RESTASIS (cyclosporine ophthalmic emulsion) 0.05%
RESTASIS Information
Product Code 54868-4793 Company Name Physicians Total Care, Inc. Dosage From EMULSION Strength 0.5 mg Active Ingredient CYCLOSPORINE
Restasis (Cyclosporine) Description
Structural Formula
Cyclosporine is a fine white powder. appears as a white opaque to slightly translucent homogeneous emulsion. It has an osmolality of 230 to 320 mOsmol/kg and a pH of 6.5-8.0. Each mL of ophthalmic emulsion contains: cyclosporine 0.05%. glycerin; castor oil; polysorbate 80; carbomer copolymer type A; purified water; and sodium hydroxide to adjust pH.
Restasis (Cyclosporine) Clinical Pharmacology
Cyclosporine is an immunosuppressive agent when administered systemically.
In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca, cyclosporine emulsion is thought to act as a partial immunomodulator. The exact mechanism of action is not known.
Four multicenter, randomized, adequate and well-controlled clinical studies were performed in approximately 1200 patients with moderate to severe keratoconjunctivitis sicca. demonstrated statistically significant increases in Schirmer wetting of 10 mm versus vehicle at six months in patients whose tear production was presumed to be suppressed due to ocular inflammation. This effect was seen in approximately 15% of ophthalmic emulsion treated patients versus approximately 5% of vehicle treated patients. Increased tear production was not seen in patients currently taking topical anti-inflammatory drugs or using punctal plugs.
No increase in bacterial or fungal ocular infections was reported following administration of .
Restasis (Cyclosporine) Indications And Usage
Restasis (Cyclosporine) Contraindications
Restasis (Cyclosporine) Warning
Restasis (Cyclosporine) Precautions
General:
The emulsion from one individual single-use vial is to be used immediately after opening for administration to one or both eyes, and the remaining contents should be discarded immediately after administration.
Do not allow the tip of the vial to touch the eye or any surface, as this may contaminate the emulsion.
Systemic carcinogenicity studies were carried out in male and female mice and rats. In the 78-week oral (diet) mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males significantly exceeded the control value.
In the 24-month oral (diet) rat study, conducted at 0.5, 2, and 8 mg/kg/day, pancreatic islet cell adenomas significantly exceeded the control rate in the low dose level. The hepatocellular carcinomas and pancreatic islet cell adenomas were not dose related. The low doses in mice and rats are approximately 1000 and 500 times greater, respectively, than the daily human dose of one drop (28 μL) of 0.05% BID into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed.
Cyclosporine has not been found mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the micronucleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA-repair test in sperm from treated mice. A study analyzing sister chromatid exchange (SCE) induction by cyclosporine using human lymphocytes gave indication of a positive effect (i.e., induction of SCE).
No impairment in fertility was demonstrated in studies in male and female rats receiving oral doses of cyclosporine up to 15 mg/kg/day (approximately 15,000 times the human daily dose of 0.001 mg/kg/day) for 9 weeks (male) and 2 weeks (female) prior to mating.
Restasis (Cyclosporine) Adverse Reactions
The most common adverse event following the use of was ocular burning (17%).
Other events 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).
Restasis (Cyclosporine) Dosage And Administration
Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of ophthalmic emulsion twice a day in each eye approximately 12 hours apart. can be used concomitantly with artificial tears, allowing a 15 minute interval between products. Discard vial immediately after use.
Restasis (Cyclosporine) How Supplied
30 Vials 0.4 mL each - NDC 54868-4793-1
© 2010 Allergan, Inc. Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc. U.S. Patent 5,474,979 Made in the U.S.A.
71876US14B
Restasis (Cyclosporine) Label –
NDC 54868-4793-1
Restasis
