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:

Elanco Animal Health Co

INN (International Name):

FLUOXETINE HYDROCHLORIDE

Composition:

FLUOXETINE HYDROCHLORIDE 8 mg

Prescription type:

PRESCRIPTION

Authorization status:

New Animal Drug Application

Summary of Product characteristics

RECONCILE - FLUOXETINE HYDROCHLORIDE TABLET, CHEWABLE
ELANCO ANIMAL HEALTH CO
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RECONCILE
(fluoxetine hydrochloride)
Chewable Tablets
CAUTION:
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
DES CRIPTION:
RECONCILE is a chewable, flavored tablet that contains fluoxetine
hydrochloride. RECONCILE
chewable tablets are available in 8, 16, 32, and 64 mg tablet
strengths for oral administration to dogs.
The active ingredient in RECONCILE chewable tablets is fluoxetine
hydrochloride, a selective
serotonin reuptake inhibitor (SSRI). The molecular weight of
fluoxetine is 345.79. The structural
formula is depicted below.
INDICATIONS :
RECONCILE chewable tablets are indicated for the treatment of canine
separation anxiety in
conjunction with a behavior modification plan.
DOSAGE AND ADMINISTRATION:
The recommended dose of RECONCILE chewable tablets is 1-2 mg/kg
(0.5-0.9 mg/lb) administered
once daily, in conjunction with a behavior modification plan. A
typical behavior modification plan
consists of the pet owner implementing standard training techniques
based on principles such as
rewarding appropriate behavior; coming and going in a manner that does
not elicit inappropriate
responses from the dog; and teaching the dog to be content while
alone.
TABLE 1: RECOMMENDED DOSE OF RECONCILE CHEWABLE TABLETS
DOG WEIGHT
NO. OF
TABLETS /DAY
TABLET STRENGTH
(MG)
(LB)
(KG)
8.8 -17.6
4.0 – 8.0
1
8
17.7 - 35.2
8.1 –16.0
1
16
35.3 - 70.4
16.1 – 32.0
1
32
70.5 - 140.8
32.1 – 64.0
1
64
The effectiveness and safety of RECONCILE chewable tablets was
demonstrated in a field study in
client-owned dogs (see EFFECTIVENESS and ADVERSE REACTIONS). At the
end of the 8-week
study, 73% of dogs treated with RECONCILE chewable tablets showed
significant improvement
(p=0.010), as compared to behavior modification alone (51%). During
the course of therapy, 42% of
®
dogs showed improvement within the first week, which was significantly
greater (p=0.005) than with
behavior modification alone (18%)