RECONCILE- fluoxetine hydrochloride tablet, chewable

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)

Available from:

Pegasus Laboratories, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

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

Product summary:

RECONCILE is supplied in 8mg, 16mg, 32mg and 64mg strengths; as 30 or 90 tablets per bottle, with a child-resistant cap.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

RECONCILE - FLUOXETINE HYDROCHLORIDE TABLET, CHEWABLE
PEGASUS LABORATORIES, INC.
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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?