ZIRGAN- ganciclovir gel

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Bausch & Lomb Incorporated

INN (International Name):

GANCICLOVIR

Sammensetning:

GANCICLOVIR 1.5 mg in 1 g

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

ZIRGAN ® (ganciclovir ophthalmic gel) 0.15% is indicated for the treatment of acute herpetic keratitis (dendritic ulcers). None. Teratogenic Effects Ganciclovir has been shown to be embryotoxic in rabbits and mice following intravenous administration and teratogenic in rabbits. Fetal resorptions were present in at least 85% of rabbits and mice administered 60 mg/kg/day and 108 mg/kg/day (approximately 10,000x and 17,000x the human ocular dose of 6.25 mcg/kg/day), respectively, assuming complete absorption. Effects observed in rabbits included: fetal growth retardation, embryolethality, teratogenicity, and/or maternal toxicity. Teratogenic changes included cleft palate, anophthalmia/microphthalmia, aplastic organs (kidney and pancreas), hydrocephaly, and brachygnathia. In mice, effects observed were maternal/fetal toxicity and embryolethality. Daily intravenous doses of 90 mg/kg/day (14,000x the human ocular dose) administered to female mice prior to mating, during gestation, and during lactation caused hypoplasia of the testes and seminal vesicles in the month-old male offspring, as well as pathologic changes in the nonglandular region of the stomach [see Carcinogenesis, Mutagenesis, Impairment of Fertility (13.1)]. There are no adequate and well-controlled studies in pregnant women. ZIRGAN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical ophthalmic ganciclovir administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when ZIRGAN is administered to nursing mothers. Safety and efficacy in pediatric patients below the age of 2 years have not been established. No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Produkt oppsummering:

ZIRGAN ® is supplied as 5 grams of a sterile, preserved, clear, colorless, topical ophthalmic gel containing 0.15% of ganciclovir in a polycoated aluminum tube with a white polyethylene tip and cap and protective band NDC 24208-535-35. Storage Store at 15°C to 25°C (59°F to 77°F). Do not freeze.

Autorisasjon status:

New Drug Application

Preparatomtale

ZIRGAN- GANCICLOVIR GEL
BAUSCH & LOMB INCORPORATED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZIRGAN SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZIRGAN.
ZIRGAN
(GANCICLOVIR OPHTHALMIC GEL) 0.15%
INITIAL U.S. APPROVAL: 1989
INDICATIONS AND USAGE
ZIRGAN 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 ZIRGAN 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
ZIRGAN contains 0.15% of ganciclovir in a sterile preserved topical
ophthalmic gel. ( 3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
ZIRGAN 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 course of therapy with ZIRGAN. ( 5.2)
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, CONTACTBAUSCH & LOMB
INCORPORATED AT 1-800-
553-5340OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 12/2023
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
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIEN