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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1130]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1130 Hetacillin.

(a) Specifications. (1) Each capsule or tablet contains hetacillin potassium equivalent to 50, 100, or 200 milligrams (mg) of ampicillin.

(2) Each milliliter of suspension contains hetacillin potassium equivalent to 50 mg of ampicillin.

(b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats - (1) Amount - (i) Dogs. Administer 5 mg per pound (/lb) of body weight orally, twice daily. In severe infections, administer 5 mg/lb three times daily, or up to 10 mg/lb twice daily. For stubborn urinary tract infections, administer up to 20 mg/lb twice daily.

(ii) Cats. Administer 50 mg twice daily.

(2) Indications for use. For the treatment of respiratory tract infections, urinary tract infections, gastrointestinal infections, skin infections, soft tissue infections, and postsurgical infections associated with strains of organisms susceptible to hetacillin potassium.

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

[75 FR 10166, Mar. 5, 2010]

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