- (a) Specifications. A non-pressurized metered dose inhaler and drug cartridge combination containing a solution of 30 milligrams/milliliter of the prodrug ciclesonide. Each actuation releases 343 micrograms (mcg) of ciclesonide.
- (b) Sponsor. See No. 000010 in § 510.600(c) of this chapter.
- (c) Conditions of use—(1) Amount. Administer an initial dose of 8 actuations (2,744 mcg ciclesonide) twice daily for 5 days, followed by 12 actuations (4,116 mcg ciclesonide) once daily for 5 days.
- (2) Indications for use. For the management of clinical signs associated with severe equine asthma.
- (3) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[86 FR 13188, Mar. 8, 2021]