CYCLOSPORINE emulsion

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Lupin Pharmaceuticals, Inc.

Spôsob podávania:

OPHTHALMIC

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Cyclosporine ophthalmic emulsion, 0.05% 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, 0.05% 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

Prehľad produktov:

Cyclosporine ophthalmic emulsion, 0.05% 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 68180-214-30 60 Vials 0.4 mL each - NDC 68180-214-60 Storage: Store at 15°-25 °C (59°-77 °F).

Stav Autorizácia:

New Drug Application Authorized Generic

Súhrn charakteristických

CYCLOSPORINE- CYCLOSPORINE EMULSION
LUPIN 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, 0.05%.
CYCLOSPORINE OPHTHALMIC EMULSION, 0.05%
FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1983
INDICATIONS AND USAGE
Cyclosporine ophthalmic emulsion, 0.05% 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, 0.05% 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 cyclosporine
ophthalmic emulsion, 0.05% was
ocular burning (17%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT LUPIN PHARMACEUTICALS
INC., AT 1-800-
399-2561 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 1/2019
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 USE IN SPECIFIC POPULATIONS
8.1 PREGNANCY
8.2 LACTATION
8.4 PEDIATRIC USE
8.5 GERIATRIC USE
11 DESCRIPTION
12