RESTASIS- cyclosporine emulsion

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

A-S Medication Solutions

Antoreitti:

OPHTHALMIC

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

Product: 50090-4476 NDC: 50090-4476-0 .4 mL in a VIAL, SINGLE-USE / 30 in a TRAY

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

RESTASIS- CYCLOSPORINE EMULSION
A-S MEDICATION SOLUTIONS
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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
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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