CEQUA- cyclosporine solution/ drops

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Sun Pharmaceutical Industries, Inc.

Ievadīšanas:

OPHTHALMIC

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). (1) None. (4) Risk Summary There are no adequate and well-controlled studies of CEQUA administration in pregnant women to inform a drug-associated risk. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses [see Data]. Data Animal Data Oral administration of cyclosporine oral solution (USP) to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. These doses (normalized to body weight) were approximately 3200 and 21000 times higher than the maximum recommended human ophthalmic dose (MRHOD) of 1.5 mcg/kg/day, respectively. No adverse embryofetal effects were observed in rats or rabbits receiving cyclosporine duri

Produktu pārskats:

CEQUA ophthalmic solution is packaged in sterile, preservative-free, single-use vials. Each vial contains 0.25 mL fill in a 0.9 mL LDPE vial; 10 vials (2 cards of 5 vials) are packaged in a polyfoil aluminum pouch; 6 pouches are packaged in a box. The entire contents of each box of 60 vials must be dispensed intact. 60 Single-Use Vials 0.25 mL each - NDC 47335-506-96 Storage: Store at 20°C to 25°C (68°F to 77°F). Store single-use vials in the original foil pouch.

Autorizācija statuss:

New Drug Application

Produkta apraksts

CEQUA- CYCLOSPORINE SOLUTION/ DROPS
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEQUA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEQUA.
CEQUA (CYCLOSPORINE OPHTHALMIC SOLUTION) 0.09%, FOR TOPICAL OPHTHALMIC
USE
INITIAL U.S. APPROVAL: 1983
INDICATIONS AND USAGE
CEQUA ophthalmic solution is a calcineurin inhibitor immunosuppressant
indicated to increase tear
production in patients with keratoconjunctivitis sicca (dry eye) (1).
DOSAGE AND ADMINISTRATION
Instill one drop of CEQUA twice daily (approximately 12 hours apart)
into each eye. Discard the vial
immediately after using in both eyes (2).
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing cyclosporine 0.9 mg/mL (3).
CONTRAINDICATIONS
None (4).
WARNINGS AND PRECAUTIONS
To avoid the potential for eye injury and contamination, advise
patients not to touch the vial tip to the eye
or other surfaces (5.1).
ADVERSE REACTIONS
The most common adverse reactions following the use of CEQUA
(cyclosporine ophthalmic solution) 0.09%
was instillation site pain (22%) and conjunctival hyperemia (6%)
(6.1).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SUN PHARMACEUTICAL
INDUSTRIES, INC. AT
1-800-406-7984 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 7/2022
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
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 STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMAT