Amforol Suspension

Veterinary Oral Suspension and Tablets

NADA 042-548, Approved by FDA

NADA 042-841, Approved by FDA

Each 5 mL of suspension and each tablet contains:

Therapeutic Action Of Ingredients

Kanamycin Sulfate (Kantrim^®): Kanamycin is active against Salmonella, Shigella, Alcaligenes faecalis, E. coli, Proteus and Staphylococcus aureus, all species associated with bacterial enteric infections. Most of the dose is not absorbed from the gastrointestinal tract, providing bactericidal action at the site of infection.

Bismuth subcarbonate and activated attapulgite (aluminum magnesium silicate) are antidiarrheals.

Amforol Suspension Indications

AMFOROL is indicated for the treatment of bacterial enteritis in dogs (caused by organisms susceptible to kanamycin) and the symptomatic relief of the associated diarrhea.

Contraindication

AMFOROL is contraindicated in treatment of Salmonella septicemias.

Warning

Treatment of Salmonella infections confined to the gastrointestinal tract with kanamycin may result in prolonged shedding of this microorganism. Follow-up cultures after treatment are strongly advised.

Precautions

Because of the bactericidal activity of kanamycin, prolonged treatment may permit overgrowth of nonsusceptible organisms (e.g., fungi). If remission of symptoms is not evident after 2 to 3 days treatment, the diagnosis should be re-established. Do not treat for longer than 5 days.

Dogs, especially those weighing less than 5 lbs, when treated with oral kanamycin should be under close clinical observation for potential nephrotoxic and ototoxic side effects, as the recommended dosage may produce systemic levels of this aminoglycoside. Kanamycin should be used cautiously if the dog is also receiving other nephrotoxic or ototoxic drugs.

Side Effects

The bismuth subcarbonate in AMFOROL may produce darkening of the tongue and stools which can be confused with melena. Prolonged exposure to orally administered bismuth salts has been associated with encephalopathies in other species. Signs may include lack of energy, muscle twitching, confusion, convulsions and comas.

Dosage

Dogs - The following dosage schedule is recommended, based upon a simple estimation of animal size:

Oral Suspension: Five mL (5 mL) per 20 lbs body weight every 8 hours. Maximum dose, 15 mL every 8 hours. For animals under 10 lbs, 2.5 mL every 8 hours.

Oral Tablets: One tablet per 20 lbs body weight every 8 hours. Maximum dose, three tablets every 8 hours. For animals under 10 lbs, one-half tablet every 8 hours.

It is recommended that an initial loading dose preceded the above schedule, consisting of twice the amount of a single dose.

Amforol Suspension Cautions

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

Supply

AMFOROL Veterinary Oral Suspension is available in bottles of 474 mL (16 fl oz).

NDC 0856-2005-60 - bottles of 474 mL (16 fl oz)

AMFOROL Veterinary Oral Tablets are available in bottles of 100.

NDC 0856-2006-60 - 100 tablets - bottle

AMFOROL Veterinary Oral Suspension

Store below 25°C (77°F).

AMFOROL Veterinary Oral Tablets

Store at controlled room temperature 15° to 30°C (59° to 86°F).

Fort Dodge Animal Health, Fort Dodge, Iowa 50501 USA

91067

Rev. April 1997

6020H

NAC No.: 10030041