CYCLOSPORINE emulsion

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Mylan Pharmaceuticals Inc.

Начин на приложение:

OPHTHALMIC

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Cyclosporine 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. Cyclosporine ophthalmic emulsion is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. 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 ]. 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-

Каталог на резюме:

Cyclosporine ophthalmic emulsion, 0.05% is packaged in sterile, preservative-free single-use vials. Each vial contains 0.4 mL fill in a 0.5 mL natural colored low density polyethylene vial; five vials are packaged in an aluminum pouch and six pouches are packaged in a carton. The entire contents of each carton (30 vials) must be dispensed intact. Cyclosporine ophthalmic emulsion is also provided in a 60 count carton that must be dispensed intact. NDC 0378-8760-58 carton of 30 vials NDC 0378-8760-91 carton of 60 vials Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

CYCLOSPORINE- CYCLOSPORINE EMULSION
MYLAN PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CYCLOSPORINE
OPHTHALMIC EMULSION 0.05% SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
CYCLOSPORINE OPHTHALMIC EMULSION.
CYCLOSPORINE OPHTHALMIC EMULSION 0.05%
FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1983
INDICATIONS AND USAGE
Cyclosporine ophthalmic emulsion 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 cyclosporine 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
•
WARNINGS AND PRECAUTIONS
•
ADVERSE REACTIONS
The most common adverse reaction following the use of cyclosporine
ophthalmic emulsion was ocular
burning (17%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS
INC. AT 1-877-
446-3679 (1-877-4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2022
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
Hypersensitivity (4)
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)
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanis