Imizol

Manufacturer: Intervet/Schering-Plough Animal Health

(IMIDOCARB DIPROPIONATE)

NADA 141-071, Approved by FDA.

Each mL contains 120 mg of imidocarb dipropionate.

Sterile solution for intramuscular or subcutaneous injection.

Imizol Caution

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

Description

IMIZOL (imidocarb dipropionate) is a sterile solution containing 120 mg/mL of imidocarb dipropionate suitable for intramuscular or subcutaneous administration. Imidocarb is chemically described as N,N'-bis[3-(4,5-dihydro-1H-imidazol-2-yl)-phenyl]urea dipropionate and has a molecular weight of 496.6. In addition to the active component, imidocarb dipropionate, the formulation also contains propionic acid (22.34 mg/mL), and water for injection.

Imizol Indications

For the treatment of dogs with clinical signs of babesiosis and/or demonstrated Babesia organisms in the blood.

Imizol Dosage And Administration

Use intramuscularly or subcutaneously at a rate of 6.6 mg/kg (3 mg/lb) body weight. Repeat the dose in two (2) weeks, for a total of two (2) treatments.

IMIZOL^® Dosing Guide 6.6 mg/kg Body Weight

Animal Weight	IMIZOL Dosage	Animal Weight	IMIZOL Dosage
10 lb (4.5 kg)	0.25 mL	60 lb (27.3 kg)	1.50 mL
20 lb (9.1 kg)	0.50 mL	80 lb (36.4 kg)	2.00 mL
30 lb (13.6 kg)	0.75 mL	100 lb (45.5 kg)	2.50 mL
40 lb (18.2 kg)	1.00 mL

Warning

NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. IN THE EVENT OF HUMAN EXPOSURE, IMMEDIATELY CONTACT THE MANUFACTURER FOR MEDICAL ADVICE FOR HUMANS.

Oncogenesis: Increased incidence of tumors was observed in rats given imidocarb. Refer to Material Safety Data Sheet (MSDS) for more detailed occupational safety information. For a copy of the MSDS, call 1-800-521-5767.

Precaution

MUST NOT BE ADMINISTERED INTRAVENOUSLY. The safety and effectiveness of imidocarb have not been determined in puppies or in breeding, lactating or pregnant animals. Risk versus benefit should be considered before using this drug in dogs with impaired lung, liver or kidney function.

Do not use this product simultaneously with exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals.

Adverse Reactions

Adverse effects commonly seen are pain during injection and mild cholinergic signs such as salivation, nasal drip or brief episodes of vomiting. Other effects seen less frequently are panting, restlessness, diarrhea , and mild injection site inflammation lasting one to several days. Rarely, injection site ulceration occurs, but the lesion is not resistant to healing.

If severe cholinergic signs occur, they may be reversed with atropine sulfate. To report an adverse reaction, call 1-800-932-0473.

Toxicology

IMIZOL solution was administered subcutaneously to four groups of five dogs at 2.2, 5.5, 7.7, or 9.9 mg/kg. The treatment was repeated 2 weeks later. There were no effects attributed to IMIZOL on body temperature, body weight, hematology, most clinical chemistries or gross pathology. At 9.9 mg/kg there was a slight increase in serum alanine aminotransferase (ALT, SGPT) and arginine aminotransferase (AST, SGOT) indicative of mild liver injury. Other effects noted were pain on injection, injection site swelling, and vomiting. Two of the injection sites ulcerated but healed readily without complication.

In a 90-day toxicity study, imidocarb was given orally to three groups of eight dogs at the rate of 5, 20, or 80 mg/kg/day. The target organs of toxicity were liver and intestines. These results may have been influenced by the oral dosing route. In a pharmacokinetic study by Abdullah et al (1984)¹, imidocarb was administered to dogs intravenously at a dose of 4 mg/kg. One of 13 dogs died. The target organs of toxicity in this dog were lungs and kidneys, and some changes were noted in the liver and spleen.

The toxic syndrome involves lethargy, weakness and anorexia, with possible signs of gastrointestinal, liver, kidney, and lung dysfunction.

Pharmacodynamics

The pharmacodynamics of imidocarb were studied in various species as described by Rao et al (1980)². The study suggests that there is a potential for adverse reactions mediated by the autonomic nervous system and especially through anticholinesterase mechanisms. Clinical experience in dogs at therapeutic dosages of less than 10 mg/kg body weight given intramuscularly or subcutaneously has established a pattern of adverse reactions. These reactions in descending order of frequency are: salivation, vomiting, and occasionally diarrhea.

Storage

Store between 2° and 25°C (36° and 77°F). Protect from light.

How Supplied

IMIZOL^® solution is packaged in 10 mL glass, sterile, multiple-dose vials.

¹A.S. Abdullah et al, Veterinary Research Communications. 1984;(8):55-59.

²K.S. Rao, Indian Veterinary Journal. 1980; 57(4):283-287.

Schering-Plough Animal Health Corp., Union, NJ 07083

Copyright © 1997, Schering-Plough Animal Health Corp.

All rights reserved.

Made in Germany.

Rev. 8/97

us 3055

	NDC
10 mL	0061-5158-01	20663804

Nac No.

10471110