Complete Up To Date Information about Mylepsin Tablets.
NADA Number: 010-091 | |
| Proprietary Name |
Mylepsin Tablets |
|---|---|
| Sponsor |
Fort Dodge Animal Health, Division of Wyeth |
| Sponsor Address |
800 Fifth Street NW Fort Dodge, IA 50501 USA |
| Ingredients |
Primidone |
| Species |
Dog, no use class stated or implied |
| Routes of Administration |
Per Os |
| Dose Form |
Tablet |
| Drug Form |
Tablet |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
520.1900 Primidone tablets. Specifications: Each tablet contains 50 or 250 milligrams of primidone. Conditions of use: Dogs Amount: Twenty-five milligrams of primidone per pound of body weight (55 milligrams per kilogram of body weight) daily. Indications: For the control of convulsions associated with idiopathic epilepsy, epileptiform convulsions, viral encephalitis, distemper, and hardpad disease that occurs as a clinically recognizable lesion in certain entities in dogs. Limitations: The tablets may be administered whole or crushed and mixed with the food. When convulsions are frequent, the dosage should be divided and administered at intervals. Reduction in dosage should be made gradually and never be abruptly discontinued. Do not use in feline species, as primidone appears to have a specific neurotoxicity in cats. Federal law restricts this drug to use by or on the order of a licensed veterinarian. NAS/NRC status: These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include data as specified by 514.111 of this chapter, but may require bioequivalency and safety information. |