VIROPTIC (Page 2 of 2)

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

ADVERSE REACTIONS

The most frequent adverse reactions reported during controlled clinical trials were mild, transient burning or stinging upon instillation (4.6%) and palpebral edema (2.8%). Other adverse reactions in decreasing order of reported frequency were superficial punctate keratopathy, epithelial keratopathy, hypersensitivity reaction, stromal edema, irritation, keratitis sicca, hyperemia, and increased intraocular pressure.

OVERDOSAGE

Overdosage by ocular instillation is unlikely because any excess solution should be quickly expelled from the conjunctival sac.

Acute overdosage by accidental oral ingestion of VIROPTIC has not occurred. However, should such ingestion occur, the 75 mg dosage of trifluridine in a 7.5 mL bottle of VIROPTIC is not likely to produce adverse effects. Single intravenous doses of 1.5 to 30 mg/kg/day in children and adults with neoplastic disease produce reversible bone marrow depression as the only potentially serious toxic effect and only after three to five courses of therapy. The acute oral LD50 in the mouse and rat was 4379 mg/kg or higher.

DOSAGE AND ADMINISTRATION

Instill one drop of VIROPTIC Ophthalmic Solution, 1% onto the cornea of the affected eye every 2 hours while awake for a maximum daily dosage of nine drops until the corneal ulcer has completely re-epithelialized. Following re-epithelialization, treatment for an additional 7 days of one drop every 4 hours while awake for a minimum daily dosage of five drops is recommended.

If there are no signs of improvement after 7 days of therapy or complete re-epithelialization has not occurred after 14 days of therapy, other forms of therapy should be considered. Continuous administration of VIROPTIC for periods exceeding 21 days should be avoided because of potential ocular toxicity.

HOW SUPPLIED

VIROPTIC Ophthalmic Solution, 1% is supplied as a sterile ophthalmic solution in a plastic Drop Dose® dispenser bottle of 7.5 mL (NDC 61570-037-75).

Store under refrigeration 2° to 8°C (36° to 46°F).

ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY

Corneal wound healing studies in rabbits showed that VIROPTIC did not significantly retard closure of epithelial wounds. However, mild toxic changes such as intracellular edema of the basal cell layer, mild thinning of the overlying epithelium and reduced strength of stromal wounds were observed.

Whereas instillation of VIROPTIC into rabbit eyes during a subchronic toxicity study produced some degree of corneal epithelial thinning, a 12-month chronic toxicity study in rabbits in which VIROPTIC was instilled into eyes in intermittent, multiple, full-therapy courses showed no drug-related changes in the cornea.

Rx Only.

Prescribing Information as of April 2007.

Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620

Manufactured by: DSM Pharmaceuticals, Inc., Greenville, NC 27834

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VIROPTIC
trifluridine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61570-037
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIFLURIDINE (TRIFLURIDINE) TRIFLURIDINE 1 g in 100 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61570-037-75 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
1 7.5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (61570-037-75)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018299 04/10/1980
Labeler — Monarch Pharmaceuticals, Inc (809587413)

Revised: 07/2011 Monarch Pharmaceuticals, Inc

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