§ 520.1010a - Furosemide tablets or boluses.

(a) Specifications. Each tablet contains 12.5 or 50 milligrams of furosemide. Each bolus contains 2 grams of furosemide.

(b) Sponsor. See No. 012799 in § 510.600(c) of this chapter for conditions of use provided for in paragraphs (c) (1) and (2) of this section; see No. 000010 in § 510.600(c) of this chapter for use in dogs as provided for in paragraph (c)(1) of this section; see No. 000093 in § 510.600(c) of this chapter for use of a 12.5- and 50-milligram tablet for conditions of use provided for in paragraph (c)(3) of this section.

(c) Conditions of use. It is used as follows:

(1) Dogs and cats—(i) Amount. 1 to 2 milligrams per pound of body weight, once or twice daily, with a 6- to 8-hour interval between successive daily doses.

(ii) Indications for use. It is used for the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency and acute noninflammatory tissue edema.

(iii) Limitations. The dosage should be adjusted to the animal's response. In severe edematous or refractory cases, the dosage may be doubled or increased by increments of 1 milligram per pound of body weight to establish the effective dose. This dose should be administered once or twice daily on an intermittent schedule. Diuretic therapy should be discontinued after reduction of edema, or when necessary, maintained after determining a programmed dosage schedule to prevent recurrence. The drug, if given in excessive amounts or over extended periods of time may result in dehydration and/or electrolyte imbalance. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) Cattle—(i) Amount. 1 to 2 milligrams per pound of body weight, or one 2-gram bolus per animal, per day.

(ii) Indications for use. The drug is used for the treatment of physiological parturient edema of the mammary gland and associated structures.

(iii) Limitations. Treatment not to exceed 48 hours post-parturition. For oral use only. When treatment is initiated with an injectable, it is followed by a 12-hour interval, and maintained by oral administration. Milk taken during treatment and for 48 hours (four milkings) after the last treatment must not be used for food. Cattle must not be slaughtered for food within 48 hours following last treatment. The drug, if given in excessive amounts or over extended periods of time, may result in dehydration and/or electrolyte imbalance. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(3) Dogs—(i) Amount. 1 to 2 milligrams per pound of body weight, once or twice daily, with a 6- to 8-hour interval between successive daily doses.

(ii) Indications for use. It is used for the treatment of edema (pulmonary congestion, ascites) associated with cardiac insufficiency.

(iii) Limitations. The dosage should be adjusted to the animal's response. In severe cases, the dosage may be doubled or increased by increments of 1 milligram per pound of body weight to establish the effective dose. This dose should be administered once or twice daily on an intermittent schedule. Diuretic therapy should be discontinued after reduction of edema, or when necessary, maintained after determining a programmed dosage schedule to prevent recurrence. The drug, if given in excessive amounts or over extended periods of time, may result in dehydration and/or electrolyte imbalance. Federal law restricts this drug to use by or on the order of a licensed veterinarian.