Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)
Pegasus Laboratories, Inc.
ORAL
PRESCRIPTION
RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan. RECONCILE chewable tablets are contraindicated for use in dogs with epilepsy or a history of seizures. RECONCILE chewable tablets should not be given concomitantly with drugs that lower the seizure threshold (e.g., phenothiazines such as acepromazine or chlorpromazine). RECONCILE chewable tablets should not be given in combina-tion with a monoamine oxidase inhibitor (MAOI) [e.g., selegiline hydrochloride (L-deprenyl) or amitraz], or within a minimum of 14 days of discontinuing therapy with an MAOI. RECONCILE chewable tablets are contraindicated in dogs with a known hypersensitivity to fluoxetine HCl or other SSRIs. Because fluoxetine and its major metabolite, norfluoxetine, have long half-lives, a 6-week washout interval should be observed following discontinuation of therapy with RECONCILE chew-able tablets prior to the administration of any drug that may adversely interac
RECONCILE is supplied in 8mg, 16mg, 32mg and 64mg strengths; as 30 or 90 tablets per bottle, with a child-resistant cap.
New Animal Drug Application
RECONCILE - FLUOXETINE HYDROCHLORIDE TABLET, CHEWABLE PEGASUS LABORATORIES, INC. ---------- PRINCIPAL DISPLAY PANEL NDC: #49427-343-57; 49427-343-44 Reconcile® (fluoxetine hydrochloride) Chewable Tablets 64 mg 70.5 - 140.8 lbs Approved by FDA under NADA #141-272 PRN Pharmacal Net Contents: 30 or 90 Tablets INDICATION: For the treatment of canine SEPARATION ANXIETY in conjunction with a behavior modification plan DOSAGE AND ADMINISTRATION: For use in dogs only. The recommended dose of Reconcile chewable tablets is 1-2 mg/kg administered once daily, in conjunction with a behavior modification plan. STORAGE: Store at 20-25° C (68-77° F), excursions permitted between 15-30° C (59-86° F). Do not remove desiccant from bottle. Completely close bottle between uses. WARNINGS: NOT FOR USE IN HUMANS. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. ADDITIONAL INFORMATION: For complete product information, see attached package insert. For technical assistance or to report an adverse drug experience, call 1-800-874-9764. Additional information available at reconcile.com. Manufactured by Pegasus Laboratories, Inc., Employee-Owned, Pensacola, FL 32514. 07-2021 ® PRN® and Reconcile are registered trademarks of Pegasus Laboratories, Inc. CLIENT INFORMATION Your veterinarian has chosen to prescribe RECONCILE chewable tablets along with a simple training plan (a behavioral modification plan) to treat the separation anxiety that affects your dog. Please read this leaflet, which describes the use of RECONCILE chewable tablets. If you have any questions about this information, please consult your veterinarian. Additional information can be found at www.reconcile.com. WHAT ARE RECONCILE CHEWABLE TABLETS? RECONCILE is a chewable, flavored tablet that you give to your dog once a day to treat separation anxiety. It is administered in conjunction with a simple training plan. RECONCILE chewable tablets are for use in dogs and puppies 6 months of age or older, and 8.8 pounds (4.0 kilograms) or greater. WHAT IS SEPARATION ANXIETY? Citiți documentul complet