Flunazine-S Injectable Solution

This page contains information on Flunazine-S Injectable Solution for veterinary use.
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  • Flunazine-S Injectable Solution Indications
  • Warnings and cautions for Flunazine-S Injectable Solution
  • Direction and dosage information for Flunazine-S Injectable Solution

Flunazine-S Injectable Solution

This treatment applies to the following species:
Manufacturer: Bimeda

(flunixin meglumine)

Injectable Solution

50 mg/mL

Veterinary

For intramuscular use in swine.

Not for use in breeding swine.

ANADA# 200-489, Approved by FDA.

Flunazine-S Injectable Solution Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description

Each mL of FLUNAZINE®-S Injectable Solution contains flunixin meglumine equivalent to 50 mg flunixin, 0.1 mg edetate disodium, 2.2 mg sodium formaldehyde sulfoxylate, 4.0 mg diethanolamine, 207.2 mg propylene glycol, 5.0 mg phenol as preservative, hydrochloric acid, water for injection q.s.

Pharmacology

Flunixin meglumine is a potent, non-narcotic, non-steroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is significantly more potent than pentazocine, meperidine, and codeine as an analgesic in the rat yeast paw test.

Flunixin is known to persist in inflammatory tissues1 and is associated with anti-inflammatory properties which extend well beyond the period associated with detectable plasma drug concentrations2. Therefore, prediction of drug concentrations based upon estimated plasma terminal elimination half-life will likely underestimate both the duration of drug action and the concentration of drug remaining at the site of activity.

The pharmacokinetic profiles were found to follow a 2-compartmental model, although a deep (third) compartment was observed in some animals. The mean terminal elimination half-life (β half-life) of flunixin after a single intramuscular injection of flunixin (2.2 mg/kg) to pigs was between 3 and 4 hours. The mean observed maximum plasma concentration was 2944 ng/mL, achieved at a mean time of approximately 0.4 hours. The mean AUC(0-LOQ) was 6431 ng*hr/mL. Following IM administration of flunixin, quantifiable drug concentration could be measured up to 18 hours post dose. The mean volume of distribution was 2003 mL/kg and the mean total clearance was 390 mL/hr/kg. The mean absolute bioavailability of flunixin following an intramuscular injection in the neck was 87%.

Flunazine-S Injectable Solution Indication

FLUNAZINE®-S Injectable Solution is indicated for the control of pyrexia associated with swine respiratory disease.

Dose And Administration

The recommended dose for swine is 2.2 mg/kg (1 mg/lb; 2 mL per 100 lbs) body weight given by a single intramuscular administration. The injection should be given only in the neck musculature with a maximum of 10 mL per site.

Note: Intramuscular injection may cause local tissue irritation and damage. In an injection-site irritation study, the tissue damage did not resolve in all animals by Day 28 post-injection. This may result in trim loss of edible tissue at slaughter.

Contraindications

There are no known contraindications to this drug in swine when used as directed. Do not use in animals showing hypersensitivity to flunixin meglumine. Use judiciously when renal impairment or gastric ulceration is suspected.

Residue Warnings

Swine must not be slaughtered for human consumption within 12 days of the last treatment.

Precautions

As a class, cyclo-oxygenase inhibitory NSAIDs may be associated with gastrointestinal, renal and hepatic toxicity. Sensitivity to drug-associated adverse events varies with the individual patient. Patients at greatest risk for adverse events are those that are dehydrated, on concomitant diuretic therapy, or those with existing renal, cardiovascular, and/or hepatic dysfunction. Concurrent administration of potentially nephrotoxic drugs should be carefully approached. NSAIDs may inhibit the prostaglandins that maintain normal homeostatic function. Such prostaglandin effects may result in clinically significant disease in patients with underlying or pre-existing disease that has not been previously diagnosed.

Since many NSAIDs possess the potential to produce gastrointestinal ulceration, concomitant use of flunixin meglumine with other anti-inflammatory drugs, such as other NSAIDs and corticosteroids, should be avoided.

Not for use in breeding swine. The reproductive effects of FLUNAZINE®-S Injectable Solution have not been investigated in this class of swine. Intramuscular injection may cause local tissue irritation and damage. In an injection-site irritation study, the tissue damage did not resolve in all animals by Day 28 post-injection. This may result in trim loss of edible tissue at slaughter.

Safety

Flunixin was mildly irritating at the injection sites. No other flunixin-related changes (adverse reactions) were noted in swine administered a 1X (2.2 mg/kg; 1.0 mg/lb) dose for 9 days. Minimal toxicity manifested itself as statistically significant increased spleen weight at elevated doses (5X or higher daily for 9 days) with no change in normal microscopic architecture.

How Supplied

FLUNAZINE®-S Injectable Solution, 50 mg/mL, is available in 100 mL multi-dose vial.

Store between 2° and 30°C (36° and 86°F).

REFERENCES

1. Lees P, Higgins AJ. Flunixin inhibits prostaglandin E2 production in equine inflammation. Res Vet Sci. 1984; 37:347-349.

2. Odensvik K. Pharmacokinetics of flunixin and its effect on prostaglandin F metabolite concentrations after oral and intravenous administration in heifers. J Vet Pharmacol Ther. 1995; 18:254-259.

For Animal Use Only

Keep this and all drugs out of reach of children.

Restricted Drug (California)-Use Only as Directed

Manufactured by: Bimeda-MTC Animal Health Inc., Cambridge, ON Canada

Manufactured for: Bimeda, Inc., Le Sueur, MN 56058

Flunazine is a Registered Trademark of Bimeda, Inc.

Bimeda, Inc. and Bimeda-MTC Animal Health Inc. are Divisions of Cross Vetpharm Group Ltd.

Net Contents:

Product No.

 

100 mL Multi-Dose Vial

1FLU009

8FLU015A REV.10.11

NAC No.: 13990931

BIMEDA, INC.
Div. Cross Vetpharm Group, Ltd.

ONE TOWER LANE-SUITE 2250, OAKBROOK TERRACE, IL, 60181
Telephone:   630-928-0361
Fax:   630-928-0362
Website:   www.bimedaus.com
Email:   sales@bimedaus.com
Every effort has been made to ensure the accuracy of the Flunazine-S Injectable Solution information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-05-28

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