Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/235
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Restasis (Emulsion)
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Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of RESTASIS ophthalmic emulsion twice a day in each eye approximately 12 hours apart. RESTASIS can be used concomitantly with artificial tears, allowing a 15 minute interval between products. Discard vial immediately after use.
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RESTASIS (cyclosporine ophthalmic emulsion) 0.05% contains a topical immunomodulator with anti-inflammatory effects. Cyclosporine's chemical name is Cyclo[[(E)-(2S,3R,4R)-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: Cyclosporine is a fine white powder. RESTASIS 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 RESTASIS ophthalmic emulsion contains: Active: cyclosporine 0.05%. Inactives: glycerin; castor oil; polysorbate 80; carbomer 1342; purified water and sodium hydroxide to adjust the pH.
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Mechanism of action: 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.<br/>Pharmacokinetics: Blood cyclosporin A concentrations were measured using a specific high pressure liquid chromatography-mass spectrometry assay. Blood concentrations of cyclosporine, in all the samples collected, after topical administration of RESTASIS 0.05%, BID, in humans for up to 12 months, were below the quantitation limit of 0.1 ng/mL. There was no detectable drug accumulation in blood during 12 months of treatment with RESTASIS ophthalmic emulsion.<br/>Clinical Evaluations: Four multicenter, randomized, adequate and well-controlled clinical studies were performed in approximately 1200 patients with moderate to severe keratoconjunctivitis sicca. RESTASIS 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 RESTASIS 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.
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RESTASIS is contraindicated in patients with active ocular infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.
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RESTASIS ophthalmic emulsion is packaged in single use vials. Each vial contains 0.4 mL fill in a 0.9 mL LDPE vial; 32 vials are packaged in a polypropylene tray with an aluminum peelable lid. The entire contents of this tray (32 vials) must be dispensed as one unit. RESTASIS 32 Vials 0.4 mL each - NDC 0023-9163-32 Storage: Store RESTASIS ophthalmic emulsion at 15��to 25��C (59��-77��F). KEEP OUT OF THE REACH OF CHILDREN.Rx Only Rev February 2004 ��2004 Allergan, Inc.Irvine, CA 92612, U.S.A.' Marks owned by Allergan, Inc.U.S. Pat. 4,649,047; 4,839,342; 5,474,979.Inspire and the Inspire logo are registered trademarksof Inspire Pharmaceuticals Inc. 9054X71271US15P
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General: For ophthalmic use only.<br/>Information for Patients: 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. RESTASIS 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 RESTASIS ophthalmic emulsion.<br/>Carcinogenesis, Mutagenesis, and Impairment of Fertility: 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 exceededthe 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��L) of 0.05% RESTASIS 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 in vitro 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.<br/>Pregnancy-Teratogenic effects: Pregnancy category C.<br/>Nursing Mothers: Cyclosporine is known to be excreted in human milk following systemic administration but excretion in human milk after topical treatment has not been investigated. Although blood concentrations are undetectable after topical administration of RESTASIS ophthalmic emulsion, caution should be exercised when RESTASIS is administered to a nursing woman.<br/>Pediatric Use: The safety and efficacy of RESTASIS ophthalmic emulsion have not been established in pediatric patients below the age of 16.<br/>Geriatric Use: No overall difference in safety or effectiveness has been observed between elderly and younger patients.
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cyclosporine
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Restasis (Emulsion)
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The most common adverse event following the use of RESTASIS 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).
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| dailymed-instance:indicatio... |
RESTASIS 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.
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Restasis
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