Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)
A-S Medication Solutions
OPHTHALMIC
PRESCRIPTION DRUG
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 known or suspected hypersensitivity to any of the ingredients in the formulation. Risk Summary Clinical administration of cyclosporine ophthalmic emulsion 0.05% is not detected systemically following topical ocular administration [see Clinical Pharmacology ( 12.3 ) ], and maternal use is not expected to result in fetal exposure to the drug. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see Data ]. Data Animal Data At maternally toxic doses (30 mg/kg/day in rats and 100 mg/kg/day in rabbits), cyclosporine oral solution (USP) was teratogenic as indicated by i
Product: 50090-4476 NDC: 50090-4476-0 .4 mL in a VIAL, SINGLE-USE / 30 in a TRAY
New Drug Application
RESTASIS- CYCLOSPORINE EMULSION A-S MEDICATION SOLUTIONS ---------- 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 . RESTASIS (CYCLOSPORINE OPHTHALMIC EMULSION) 0.05% FOR TOPICAL OPHTHALMIC USE INITIAL U.S. APPROVAL: 1983 INDICATIONS AND USAGE RESTASIS 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 AND ADMINISTRATION Instill one drop of RESTASIS ophthalmic emulsion twice a day in each eye approximately 12 hours apart. (2) DOSAGE FORMS AND STRENGTHS Cyclosporine ophthalmic emulsion 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 RESTASIS was ocular burning (17%). (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALLERGAN AT 1-800-433-8871 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. SEE 17 FOR PATIENT COUNSELING INFORMATION. REVISED: 4/2021 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 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 ® ® ® ® ® ® 8.2 LACTATION 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 Aqra d-dokument sħiħ