Adequan i.m.

Luitpold Pharmaceuticals, Inc.

Adequan i.m. MULTI-DOSE

FULL PRESCRIBING INFORMATION: CONTENTS*

• ADEQUAN I.M. DESCRIPTION:
• PHARMACOLOGY:
• INDICATIONS:
• ADEQUAN I.M. DOSAGE AND ADMINISTRATION:
• ADEQUAN I.M. CONTRAINDICATIONS:
• WARNINGS:
• PRECAUTIONS:
• SAFETY AND EFFICACY:
• ANIMAL SAFETY:
• STORAGE CONDITIONS:
• HOW SUPPLIED:
• PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 ML LABEL
• PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 ML CARTON

FULL PRESCRIBING INFORMATION

Brand of Polysulfated Glycosaminoglycan (PSGAG)
Solution 100 mg/mL in 20 mL, 30 mL, and 50 mL Preserved Multi-Dose Vials
For Intramuscular Use In Horses Only. Not for Intra-Articular Use.

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

DESCRIPTION:

Each mL contains Polysulfated Glycosaminoglycan 100 mg, Benzyl Alcohol 0.9% v/v as a preservative, and Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid added when necessary to adjust pH.

PHARMACOLOGY:

Polysulfated Glycosaminoglycan is chemically similar to the glycosaminoglycans in articular cartilage matrix. PSGAG is a potent proteolytic enzyme inhibitor and diminishes or reverses the pathologic processes of traumatic or degenerative joint disease which result in a net loss of cartilage matrix components. PSGAG improves joint function by reducing synovial fluid protein levels and increasing synovial fluid hyaluronic acid concentration in traumatized equine carpal and hock joints.

INDICATIONS:

Adequan^® i.m. Multi-Dose is recommended for the intramuscular treatment of non-infectious degenerative and/or traumatic joint dysfunction and associated lameness of the carpal and hock joints in horses.

DOSAGE AND ADMINISTRATION:

The recommended dose of Adequan^® i.m. Multi-Dose in horses is 500 mg every 4 days for 28 days intramuscularly. The injection site must be thoroughly cleansed prior to injection. Do not mix Adequan^® i.m. Multi-Dose with other drugs or solvents.

CONTRAINDICATIONS:

There are no known contraindications to the use of intramuscular Polysulfated Glycosaminoglycan.

WARNINGS:

Do not use in horses intended for human consumption. Not for use in humans. Keep this and all medications out of the reach of children.

PRECAUTIONS:

The safe use of Adequan^® i.m. Multi-Dose in horses used for breeding purposes, during pregnancy, or in lactating mares has not been evaluated.

SAFETY AND EFFICACY:

Safety and efficacy studies utilizing Adequan^® i.m. Multi-Dose were not performed. Adequan^® i.m. Multi-Dose was approved based on the conclusion that the safety and effectiveness of Adequan^® i.m. Multi-Dose will not differ from that demonstrated for the original formulation of Adequan^® i.m.

ANIMAL SAFETY:

Animal Safety studies utilizing Adequan^® i.m. Multi-Dose were not performed. Safety studies were conducted in horses using the single dose formulation. Doses as high as 2,500 mg were administered intramuscularly to 6 horses twice a week for 12 weeks. This dosage is 5 times the recommended dosage and 3 times the recommended therapeutic regimen. Clinical observations revealed no soreness or swelling at the injection site or in the affected joint. No animal had any clinical or laboratory evidence of toxicity.

STORAGE CONDITIONS:

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature). Dispose of spent needles in accordance with all federal, state and local environmental laws.

HOW SUPPLIED:

Adequan^® i.m. Multi-Dose solution, 100 mg/mL is available in 20 mL, 30 mL and 50 mL glass vials, packaged in boxes of 1.

LUITPOLD PHARMACEUTICALS, INC.
Animal Health Division
Shirley, NY 11967
(631) 924-4000
800-458-0163

Made in U.S.A.
IN92901
Rev. 10/08
MG# 28493

NADA #140-901, Approved by FDA

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 ML LABEL

NDC 10797-959-01

Adequan^®i.m. Multi-Dose

(POLYSULFATED GLYCOSAMINOGLYCAN)

100 mg/mL

50 mL Preserved Multiple Dose Vial

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

For Intramuscular Use in Horses Only. Not for Intra-Articular Use.

Each mL contains PSGAG 100 mg, Benzyl Alcohol 0.9% v/v as a preservative, and Water for Injection q.s.

WARNING: Do not use in horses intended for human consumption.

Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature).

See package insert for full directions.

Luitpold Pharmaceuticals, Inc., Animal Health Division

Shirley, NY 11967

NADA 140-901, Approved by FDA

Rev. 2/08