Country: United States
Language: English
Source: NLM (National Library of Medicine)
CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)
Allergan, Inc.
CYCLOSPORINE
CYCLOSPORINE 0.5 mg in 1 mL
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 increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. These doses (normalized to body surface area) are 5,000 and 32,000 times greater, respectively, than the daily recommended human dose of one drop (approximately 28 mcL) of cyclosporine ophthalmic emulsion 0.05% twice daily into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. No evidence of embryofetal toxicity was observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively. These doses in rats and rabbits are approximately 3,000 and 10,000 times greater, respectively, than the daily recommended human dose. An oral dose of 45 mg/kg/day cyclosporine administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. This dose is 7,000 times greater than the daily recommended human dose. No adverse effects in dams or offspring were observed at oral doses up to 15 mg/kg/day (2,000 times greater than the daily recommended human dose). Risk Summary Cyclosporine is known to appear in human milk following systemic administration, but its presence in human milk following topical treatment has not been investigated. Although blood concentrations are undetectable following topical administration of RESTASIS ® ophthalmic emulsion [see Clinical Pharmacology ( 12.3 )] , caution should be exercised when RESTASIS ® is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for RESTASIS ® and any potential adverse effects on the breast-fed child from cyclosporine. Safety and efficacy have not been established in pediatric patients below the age of 16. No overall difference in safety or effectiveness has been observed between elderly and younger patients.
RESTASIS ® ophthalmic emulsion is packaged in sterile, preservative-free single-use vials. Each vial contains 0.4 mL fill in a 0.9 mL LDPE vial; 30 or 60 vials are packaged in a polypropylene tray with an aluminum peelable lid. The entire contents of each tray (30 vials or 60 vials) must be dispensed intact. 30 Vials 0.4 mL each - NDC 0023-9163-30 60 Vials 0.4 mL each - NDC 0023-9163-60 Storage: Store at 15°-25°C (59°-77°F).
New Drug Application
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 . 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: 7/2017 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 CLINICAL S Read the complete document