522.1362—Melarsomine dihydrochloride for injection.
(a) Specifications.
The drug consists of a vial of lyophilized powder containing 50 milligrams of melarsomine dihydrochloride which is reconstituted with the provided 2 milliliters of sterile water for injection.
(c) Conditions of use—
(1) Amount.
For asymptomatic to moderate (class 1 to class 2) heartworm disease: 2.5 milligrams per kilogram of body weight (1.1 milligram per pound) twice, 24 hours apart. The series can be repeated in 4 months depending on the response to the first treatment and the condition, age, and use of the dog. For severe (class 3) heartworm disease: Single injection of 2.5 milligrams per kilogram followed, approximately 1 month later, by 2.5 milligrams per kilogram administered twice, 24 hours apart.
(2) Indications.
Treatment of stabilized, class 1, 2, and 3 heartworm disease (asymptomatic to mild, moderate, and severe, respectively) caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis in dogs.
(3) Limitations.
Administer only by deep intramuscular injection in the lumbar muscles (L3 -L5 ). Use a 23 gauge 1 inch needle for dogs less than or equal to 10 kilograms (22 pounds) and a 22 gauge 1 1/2 inch needle for dogs greater than 10 kilograms (22 pounds). Use alternate sides with each administration. The drug is contraindicated in dogs with class 4 (very severe) heartworm disease (Caval Sydrome). Not for use in breeding animals and lactating or pregnant bitches. Federal law restricts this drug to use by or on the order of a licensed veterinarian.