RESTASIS Emulsion (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

A-S Medication Solutions

Λέξεις κλειδιά

50090-1242

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Indications and Usage

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. ...

2. Dosage and Administration

Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using. Instill one drop of RESTASIS ophthalmic emulsion twice a day in each eye approximately 12 hours apart. RESTASIS ...

3. Dosage Forms and Strengths

Ophthalmic emulsion containing cyclosporine 0.5 mg/mL.

4. Contraindications

RESTASIS is contraindicated in patients with known or suspected hypersensitivity to any of the ingredients in the formulation.

5. Warnings and Precautions

5.1 Potential for Eye Injury and Contamination Be careful not to touch the vial tip to your eye or other surfaces to avoid potential for eye injury and contamination. 5.2 Use with Contact Lenses RESTASIS ...

6. Adverse Reactions

The following serious adverse reactions are described elsewhere in the labeling: Potential for Eye Injury and Contamination [see Warnings and Precautions (5.1)]

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post approval use of RESTASIS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

8.1. Pregnancy

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 ...

8.2. Lactation

Risk Summary Cyclosporine is known to appear in human milk following systemic administration, but its presence in human milk following topical treatment has not been investigated. Although blood concentrations ...

8.4. Pediatric Use

Safety and efficacy have not been established in pediatric patients below the age of 16.

8.5. Geriatric Use

No overall difference in safety or effectiveness has been observed between elderly and younger patients.

11. Description

RESTASIS (cyclosporine ophthalmic emulsion) 0.05% contains a topical calcineurin inhibitor immunosuppressant with anti-inflammatory effects. Cyclosporines chemical name is Cyclo[[(E)-(2S ...

12.1. Mechanism of Action

Cyclosporine is an immunosuppressive agent when administered systemically. In patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis ...

12.3. Pharmacokinetics

Blood cyclosporine A concentrations were measured using a specific high pressure liquid chromatography-mass spectrometry assay. Blood concentrations of cyclosporine, in all the samples collected, after ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Systemic carcinogenicity studies were conducted in male and female mice and rats. In the 78-week oral (diet) mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically ...

14. Clinical Studies

Four multicenter, randomized, adequate and well-controlled clinical studies were performed in approximately 1,200 patients with moderate to severe keratoconjunctivitis sicca. RESTASIS demonstrated statistically ...

16.1. How Supplied

Product: 50090-1242 NDC: 50090-1242-0 .4 mL in a VIAL, SINGLE-USE / 30 in a TRAY Irvine, CA 92612, Made in the U.S.A.

17. Patient Counseling Information

Handling the Container Advise patients to not allow the tip of the vial to touch the eye or any surface, as this may contaminate the emulsion. Advise patients to not touch the vial tip to their eye to ...