Complete Up To Date Information about Orbax™ Tablets.
NADA Number: 141-081 | |
| Proprietary Name |
Orbax™ Tablets |
|---|---|
| Sponsor |
Schering-Plough Animal Health Corp. |
| Sponsor Address |
P.O. Box 21 Sandown Village, NJ 3171 VIC Australia |
| Ingredients |
Orbifloxacin |
| Species |
Cat, no use class stated or implied Dog, no use class stated or implied |
| Routes of Administration |
Per Os |
| Dose Form |
Tablet |
| Drug Form |
Tablet |
| Dispensing Status |
RX |
| Patent Number |
4795751 |
| Exclusivity |
No active ingredient of the drug has been previously approved. Granted for expanded indications for the use in cats. |
|
Dosage Amount, Indications & Limitations |
520.1616 Orbifloxacin tablets. Specifications: Each tablet contains 5.7, 22.7, or 68 milligrams of orbifloxacin. Conditions of use: Dogs Amount: 2.5 to 7.5 milligrams per kilogram body weight. Indications: For management of diseases associated with bacteria susceptible to orbifloxacin. Limitations: Administer orally 2.5 milligrams per kilogram of body weight once daily for 2 to 3 days beyond cessation of clinical signs for up to a maximum of 30 days. May be increased to 7.5 milligrams per kilogram if needed. For treatment of skin and associated soft tissue infections, administer for 2 to 3 days beyond cessation of clinical signs to a maximum of 30 days. For treatment of urinary tract infections, use for at least 10 consecutive days. If no improvement is seen within 5 days, diagnosis should be reevaluated and a different course of therapy considered. Orbifloxacin is contraindicated in immature dogs during the rapid growth phase. Orbifloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food producing animals. Cats Amount: 2.5 to 7.5 milligrams per kilogram body weight. Indications: For management of diseases associated with bacteria susceptible to orbifloxacin. Limitations: Administer orally 2.5 milligrams per kilogram of body weight once daily for 2 to 3 days beyond cessation of clinical signs for up to a maximum of 30 days. May be increased to 7.5 milligrams per kilogram if needed. For treatment of skin and associated soft tissue infections, administer for 2 to 3 days beyond cessation of clinical signs to a maximum of 30 days. For treatment of urinary tract infections, use for at least 10 consecutive days. If no improvement is seen within 5 days, diagnosis should be reevaluated and a different course of therapy considered. Orbifloxacin is contraindicated in immature dogs during the rapid growth phase. Orbifloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food producing animals. |