RESTASIS MULTIDOSE- cyclosporine emulsion

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Allergan, Inc.

প্রশাসন রুট:

OPHTHALMIC

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

RESTASIS  MULTIDOSE TM   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  MULTIDOSE TM is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation [see Adverse Reactions (6.2) ]. 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),

পণ্য সারাংশ:

RESTASIS   MULTIDOSE TM ophthalmic emulsion is packaged in a sterile, multi-dose preservative-free bottle. Each bottle consists of a white opaque LDPE bottle, a white opaque polypropylene top with unidirectional valve and air filter, a protective olive green polypropylene cap, and a clear disposable shipping cover over the colored cap. 5.5 mL in 10-mL bottle - NDC 0023-5301-05 Storage:   Store at 15-25 °C (59-77 °F).

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

RESTASIS MULTIDOSE- CYCLOSPORINE EMULSION
ALLERGAN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RESTASIS MULTIDOSE™ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RESTASIS
MULTIDOSE™.
RESTASIS MULTIDOSE™ (CYCLOSPORINE OPHTHALMIC EMULSION) 0.05%
FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1983
INDICATIONS AND USAGE
RESTASIS MULTIDOSE™ 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
Prime by squeezing two drops onto a tissue before initial use. (2.1)
Instill one drop of RESTASIS MULTIDOSE™ ophthalmic emulsion twice a
day in each eye approximately 12 hours
apart. (2.2)
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 bottle tip to your eye or other
surfaces. (5.1)
ADVERSE REACTIONS
The most common adverse reaction following the use of cyclosporine
ophthalmic emulsion 0.05% 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 AND FDA-APPROVED PATIENT
LABELING.
REVISED: 10/2016
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Preparation for First-Time Use
2.2 Preparation for Use
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 POPULA