CFR

522.650—Dihydrostreptomycin sulfate injection.

(a) Specifications. Each milliliter contains dihydrostreptomycin sulfate equivalent to 500 milligrams of dihydrostreptomycin.

(b) Sponsor. See Nos. 000069 and 055529 in § 510.600(c) of this chapter.

(c) National Academy of Sciences/National Research Council (NAS/NRC) status. The conditions of use were NAS/NRC reviewed and found effective. Applications for these uses need not include effectiveness data as specified by § 514.111 of this chapter but may require bioequivalency and safety information.

(d) Conditions of use— (1) Amount. 5 milligrams per pound of body weight every 12 hours.

(2) Indications for use. Treatment of leptospirosis in dogs and horses due to Leptospira canicola, L. icterohemorrhagiae, and L. pomona; in cattle due to L. pomona; and in swine due to L. pomona; and L. grippotyphosa.

(3) Limitations. Administer by deep intramuscular injection only. Treatment should be continued for 3 to 5 days or until the urine is free of leptospira for at least 72 hours as measured by darkfield microscopic examination. Treatment with subtherapeutic dosages, excessive duration of therapy, or inappropriate use of this antibiotic may lead to the emergence of streptomycin or dihydrostreptomycin resistant organisms. Discontinue use 30 days before slaughter for food. Not for use in animals producing milk because use of the drug will contaminate the milk. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[57 FR 37331, Aug. 18, 1992; 57 FR 42623, Sept. 15, 1992]

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