RESTASIS- cyclosporine emulsion

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)

Prieinama:

Physicians Total Care, Inc.

INN (Tarptautinis Pavadinimas):

CYCLOSPORINE

Sudėtis:

CYCLOSPORINE 0.5 mg in 1 mL

Vartojimo būdas:

OPHTHALMIC

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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. 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.

Produkto santrauka:

RESTASIS ® ophthalmic emulsion is packaged in single use vials. Each vial contains 0.4 mL fill in a 0.9 mL LDPE vial; 30 vials are packaged in a polypropylene tray with an aluminum peelable lid. The entire contents of each tray (30 vials) must be dispensed intact. RESTASIS ® is also provided in a 60 count (2 x 30) package (one month supply) that must be dispensed intact. 30 Vials 0.4 mL each - NDC 54868-4793-1 Storage: Store RESTASIS ® ophthalmic emulsion at 15 - 25° C (59 - 77° F). KEEP OUT OF THE REACH OF CHILDREN. Rx Only Revised: 02/2010 © 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 Relabeling of "Additional" bar code label by: Physicians Total Care, Inc. Tulsa, OK      74146

Autorizacija statusas:

New Drug Application

Prekės savybės

RESTASIS - CYCLOSPORINE EMULSION
PHYSICIANS TOTAL CARE, INC.
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RESTASIS
(CYCLOSPORINE OPHTHALMIC EMULSION) 0.05%
Sterile, Preservative-Free
DESCRIPTION
RESTASIS (cyclosporine ophthalmic emulsion) 0.05% contains a topical
immunomodulator 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
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 copolymer type A; purified water; and
sodium hydroxide to adjust pH.
CLINICAL PHARMACOLOGY
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.
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.
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CLINICAL EVALUATIONS
Four multicenter, randomized, adequate and well-controlled clinical
studies were performed in
approximately 1200 patients with moderate to severe
keratoconjunctivitis sicca. RESTASIS
demonst