FLUNAZINE-S- flunixin meglumine injection, suspension

Flunazine-S by

Drug Labeling and Warnings

Flunazine-S by is a Animal medication manufactured, distributed, or labeled by Bimeda, Inc., Bimeda-MTC Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Flunazine®-S

(flunixin meglumine)

INJECTABLE SOLUTION

50 mg/mL         Sterile Solution

Veterinary         Multi-Dose Vial

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

For intramuscular use in swine.

Not for use in breeding swine.

PRECAUTIONS

CAUTION

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

DESCRIPTION

DESCRIPTION

Each mL of Flunazine®-S 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.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY

Flunixin meglumine is a potent non-narcotic, non-steroidal, analgesic agent with anti-inflammatory and antipyretic activity. It is significantly more potent that 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%.

INDICATIONS & USAGE

INDICATION

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

DOSAGE & ADMINISTRATION

DOSAGE 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

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 WARNING

RESIDUE WARNINGS

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

PRECAUTIONS

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 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.

ADVERSE REACTIONS

ADVERSE REACTIONS

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.

OTHER SAFETY INFORMATION

ANIMAL SAFETY

Minimal toxicity manifested itself as statistically significant increased spleen weight at elevated doses (5X or higher daily for 9 days) with no change in microscopic architecture.

HOW SUPPLIED

HOW SUPPLIED

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

STORAGE AND HANDLING

STORE BETWEEN 2°C - 30°C (36°F - 86°F).

PROTECT FROM FREEZING

REFERENCES

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 F2α metabolite concentrations after oral and intravenous administration in heifers. J Vet Pharmacol Ther. 1995; 18:254-259

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLUNAZINE-S 
flunixin meglumine injection, suspension

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 61133-6015
Route of Administration	INTRAMUSCULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Flunixin Meglumine (UNII: 8Y3JK0JW3U) (Flunixin - UNII:356IB1O400)	Flunixin Meglumine	50 mg  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61133-6015-2	100 mL in 1 VIAL, MULTI-DOSE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200489	03/01/2010

Labeler - Bimeda, Inc. (060492923)

Registrant - Bimeda, Inc. (060492923)

Establishment
Name	Address	ID/FEI	Business Operations
Bimeda-MTC Animal Health		256232216	manufacture