GANCICLOVIR gel

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

GANCICLOVIR (UNII: P9G3CKZ4P5) (GANCICLOVIR - UNII:P9G3CKZ4P5)

Tilgjengelig fra:

Amici Pharmaceuticals LLC

INN (International Name):

GANCICLOVIR

Sammensetning:

GANCICLOVIR 1.5 mg in 1 g

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

New Drug Application Authorized Generic

Preparatomtale

GANCICLOVIR- GANCICLOVIR GEL
AMICI PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GANCICLOVIR OPHTHALMIC GEL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GANCICLOVIR
OPHTHALMIC GEL.
GANCICLOVIR OPHTHALMIC GEL 0.15%
INITIAL U.S. APPROVAL: 1989
INDICATIONS AND USAGE
Ganciclovir Ophthalmic Gel is a topical ophthalmic antiviral that is
indicated for the treatment of acute herpetic keratitis
(dendritic ulcers). (1)
DOSAGE AND ADMINISTRATION
The recommended dosing regimen for Ganciclovir Ophthalmic Gel is 1
drop in the affected eye 5 times per day
(approximately every 3 hours while awake) until the corneal ulcer
heals, and then 1 drop 3 times per day for 7 days. (2)
DOSAGE FORMS AND STRENGTHS
Ganciclovir Ophthalmic Gel contains 0.15% of ganciclovir in a sterile
preserved topical ophthalmic gel. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
Most common adverse reactions reported in patients were blurred vision
(60%), eye irritation (20%), punctate keratitis
(5%), and conjunctival hyperemia (5%). (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAUSCH + LOMB, A
DIVISION OF VALEANT PHARMACEUTICALS
NORTH AMERICA LLC, AT 1-800-321-4576 OR FDA AT 1-800-FDA-1088 OR
WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 11/2016
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 Topical Ophthalmic Use Only
5.2 Avoidance of Contact Lenses
6 ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
Ganciclovir Ophthalmic Gel is indicated for topical ophthalmic use
only. (5.1)
Patients should not wear contact lenses if they have signs or symptoms
of herpetic keratitis or during the c