21 C.F.R. § 520.2280   Sulfamethizole and methenamine mandelate tablets.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 520.2280   Sulfamethizole and methenamine mandelate tablets.

(a) Specifications. Each tablet contains 250 milligrams of sulfamethizole and 250 milligrams of methenamine mandelate.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is indicated for the treatment of urinary tract infections in dogs and cats such as cystitis, nephritis, prostatitis, urethritis, and pyelonephritis. It is also used as an aid in the management of complications resulting from surgical manipulations of the urinary tract such as removal of calculi from the bladder, in ureterostomies, and in instrumentation of the urethra and bladder.

(2) It is administered at a dosage level of one tablet for each 20 pounds of body weight given three times per day. The drug should be given until all signs are alleviated. To reduce the possibility of a relapse, it is suggested that therapy be continued for a further period of a week to 10 days.

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

[40 FR 13838, Mar. 27, 1975, as amended at 50 FR 13561, Apr. 5, 1985]

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