Antizol Vet

Name: Antizol Vet

Active ingredient

One single use vial (1.5 mL) of Antizol-Vet® (fomepizole) for injection contains 1.5 grams of fomepizole without excipients. When one vial is diluted with 28.5 mL of sterile 0.9% sodium chloride, the final diluted concentration is 50 mg/mL fomepizole.

Indications

Antizol-Vet® is indicated as an antidote for ethylene glycol (antifreeze) poisoning in dogs that have ingested or are suspected of having ingested ethylene glycol.

Prognosis

Antizol-Vet® is only effective if administered prior to complete metabolism of ethylene glycol. To evaluate whether ethylene glycol has been completely metabolized, it is advisable to measure serum BUN and creatinine, and to monitor urine output. Correction of dehydration is essential to obtain accurate serum BUN and creatinine values. Serum concentrations of blood urea nitrogen >40 mg/dl and creatinine >1.8 mg/dl that do not resolve after dehydration is corrected indicate that ethylene glycol has been fully metabolized and significant renal damage may exist. However, if urine flow is maintained, benefit-to-risk considerations suggest that treatment with Antizol-Vet® is warranted.

Human warnings

Not for use in humans. Keep out of reach of children. Irritant. Avoid ocular, dermal or inhalation exposures. In case of eye or skin exposure, flush immediately with copious amounts of water. Seek medical attention if irritation persists. Use product only in a well-ventilated area. If accidental inhalation occurs, move to fresh air. The material safety data sheet (MSDS) contains additional information regarding the safe use of this product.

For emergency medical assistance, to report adverse effects in users and/or to obtain a copy of the MSDS, call 1-888-867-7426.

Safety

A subacute toxicity study was conducted in dogs for 14 days with doses of 10, 20, and 30 mg/kg of Antizol-Vet® administered intravenously twice daily in 0.9% sodium chloride injection, USP. Dogs dosed at 30 mg/kg showed increased hypoactivity, decreased food consumption, decreased serum potassium, increased sodium and bicarbonate levels, increased urinary output, increased alkaline phosphatase and alanine amino transferase (ALT) values, decreased triglycerides and increased liver weights. These effects in liver were not life-threatening and most (all except alkaline phosphatase and ALT values) were reversible following a 28-day recovery period. A two phase toxicity study was conducted in dogs for 14 days. Dose levels of 75 and 150 (phase I) and 25 and 50 (phase II) mg/kg of Antizol-Vet® were administered intravenously twice per day in 0.9% sodium chloride injection. Antizol-Vet® administered at 25 mg/kg resulted in decreased food consumption, body weight loss, and breaths with sweet odors. At 50 mg/kg or greater, Antizol-Vet® resulted in ataxia, hypoactivity, hypothermia, tremors and/or prostration, injected sclera, ptosis, decreased defecation, and protruding tongues. Chronic daily oral administration of fomepizole (110 mg/kg) to rats for 40-42 days resulted in decreased testicular mass (approximately 8%).

Mutagenesis studies of fomepizole revealed a positive Ames test involving Escherichia coli tester strain WP2uvrA and the Salmonella typhimurium tester strain TA102 in the absence of S9 mix. However, the use of in vivo mouse micronucleus assay did not indicate bone marrow cytotoxicity and is considered negative for mutagenicity. No long-term studies have been conducted in laboratory animals to evaluate the carcinogenicity of this drug.

Adverse Reactions

In a clinical field study, one of 105 dogs experienced an anaphylactic type reaction following the second dose of Antizol-Vet®. Clinical signs included tachypnea, gagging, excessive salivation and trembling. Dosing with Antizol-Vet® was discontinued and the animal survived.

How is Antizol Vet Supplied

Antizol-Vet® (fomepizole) for injection is supplied as a sterile single-use vial containing 1.5 mL (1.5 g) of Antizol-Vet® without excipients. Store at room temperature 15° to 30°C (59° to 86°F).

NDC: 46129-300-01

Distributed in the U.S. by:

Paladin Labs (USA) Inc.

Dover, Kent County,

Delaware, 19904

Antizol-Vet® can be ordered by calling Paladin Labs (USA) Inc. Customer Service at

1-888-678-7840 or by contacting your local wholesaler.

ANV PI-FOLD1 04/09

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-1.5 mL Box

NDC 46129-300-01

 

Rx only

Antizol-Vet®

(fomepizole)

for injection


ANTIZOL-VET 
fomepizole injection
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:46129-300
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOMEPIZOLE (FOMEPIZOLE) FOMEPIZOLE 50 mg  in 1 mL
Packaging
# Item Code Package Description
1 NDC:46129-300-01 1.5 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141075 07/31/2009
Labeler - PALADIN LABORATORIES (USA) INC (831011775)
Registrant - Ben Venue Laboratories (004327953)
Establishment
Name Address ID/FEI Operations
Ben Venue Laboratories 004327953 manufacture
Revised: 07/2009   PALADIN LABORATORIES (USA) INC
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