520.1341—Megestrol acetate tablets.
(a) Specifications.
Each tablet contains 5 or 20 milligrams of megestrol acetate.
(b) Sponsor.
No. 000061 in § 510.600(c) of this chapter.
(c) Conditions of use.
(1)
The drug is used in female dogs for the postponement of estrus and the alleviation of false pregnancy.
(2)
It is administered orally, intact, or crushed and mixed with food as follows:
(i)
For the postponement of estrus by proestrus treatment, 1 milligram per pound of body weight per day for 8 days.
(ii)
For the postponement of estrus by anestrus treatment, 0.25 milligram per pound of body weight per day for 32 days.
(iii)
For alleviation of false pregnancy, 1 milligram per pound of body weight per day for 8 days.
(3)
Full dosage regimen must be completed to produce the desired effect.
(4)
Examination of vaginal smears is recommended to confirm detection of proestrus.
(5)
Do not administer for more than two consecutive treatments.
(6)
Once therapy is started, the animal should be confined for 3 to 8 days or until cessation of bleeding, since dogs in proestrus accept a male.
(7)
Do not use prior to or during first estrus cycle.
(8)
Do not use in pregnant animals.
(9)
Do not use in the presence of a disease of the reproductive system or with mammary tumors.
(10)
Should estrus occur within 30 days after cessation of treatment, mating should be prevented.
(11)
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Code of Federal Regulations
[40 FR 13838, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987]