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1、英文版 Restasis Cyclosporine 药品使用说明书 环孢素0 05 眼用乳剂 用于干眼症 HAOEYOU 好医友 RESTASIS cyclosporine emulsion Allergan Inc HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RESTASIS 0 05 safely and effectively See full prescribing information for RESTASIS REST
2、ASIS cyclosporine ophthalmic emulsion 0 05 Initial U S Approval 1983 INDICATIONS AND USAGE RESTASIS is a topical immunomodulator indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca
3、Increased tear production was not seen in patients currently taking topical anti inflammatory drugs or using punctal plugs 1 DOSAGE AND ADMINISTRATION Instill one drop of RESTASIS ophthalmic emulsion twice a day in each eye approximately 12 hours apart 2 DOSAGE FORMS AND STRENGTHS Ophthalmic emulsio
4、n containing cyclosporine 0 5 mg mL 3 CONTRAINDICATIONS Hypersensitivity 4 WARNINGS AND 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 ADVERSE REACTIONS The most common adverse reaction following the use of R
5、ESTASIS was ocular burning 17 6 1 To report SUSPECTED ADVERSE REACTIONS contact Allergan Inc at 1 800 433 8871 or FDA at 1 800 FDA 1088 or www fda gov medwatch See 17 for PATIENT COUNSELING INFORMATION Revised 6 2013 FULL PRESCRIBING INFORMATION CONTENTS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINIST
6、RATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5 1 Potential for Eye Injury and Contamination 5 2 Use with Contact Lenses 6 ADVERSE REACTIONS 6 1 Clinical Trials Experience 6 2 Post marketing Experience 8 USE IN SPECIFIC POPULATIONS 8 1 Pregnancy 8 3 Nursing Mothe
7、rs 8 4 Pediatric Use 8 5 Geriatric Use 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12 1 Mechanism of Action 12 3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13 1 Carcinogenesis Mutagenesis Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 1
8、7 1 Handling the Container 17 2 Use with Contact Lenses 17 3 Administration FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE RESTASIS ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated
9、with keratoconjunctivitis sicca Increased tear production was not seen in patients currently taking topical anti inflammatory drugs or using punctal plugs 2 DOSAGE AND ADMINISTRATION Invert the unit dose vial a few times to obtain a uniform white opaque emulsion before using Instill one drop of REST
10、ASIS 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 3 DOSAGE FORMS AND STRENGTHS Ophthalmic emulsion containing cyclosporine 0 5 mg mL
11、4 CONTRAINDICATIONS RESTASIS is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation 5 WARNINGS AND PRECAUTIONS 5 1 Potential for Eye Injury and Contamination To avoid the potential for eye injury and contamination be careful not to touch
12、the vial tip to your eye or other surfaces 5 2 Use with Contact Lenses 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 th
13、e emulsion Lenses may be reinserted 15 minutes following administration of RESTASIS ophthalmic emulsion Sections or subsections omitted from the full prescribing information are not listed 6 ADVERSE REACTIONS 6 1 Clinical Trials Experience Because clinical trials are conducted under widely varying c
14、onditions 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 RESTASIS was ocular burni
15、ng 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
16、 use of RESTASIS 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 8 USE IN SPECIFIC
