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. 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%). The patient's response to therapy should be
monitored. If no improvement is noted within 8 weeks, case management
should be reevaluated.
The effectiveness and
clinical safety of RECONCILE chewable tablets for long-term use (i.e.
for more than 8 weeks) has not been evaluated. RECONCILE chewable
tablets were evaluated at the recommended label dose for one year in a
laboratory safety study in dogs.
Professional judgment
should be used in monitoring the patient's response to therapy to
determine the need to continue treatment with RECONCILE chewable tablets
beyond 8 weeks. To discontinue therapy, it is not necessary to taper or
reduce doses because of the long half-life of this product. Continued
behavioral modification is recommended to prevent recurrence of the
clinical signs.
RECONCILE chewable tablets
are readily consumed by dogs or can be administered like other tablet
medications, and can be given with or without food.
Professional discretion
should be used in determining the need for dose reduction in the event
of a possible adverse reaction. Approximately half of patients tolerate
a return to the previous dose after 1-2 weeks on a reduced schedule.
If a dose is missed, the
next scheduled dose should be administered as prescribed. Do not
increase or double the dose.
Contraindications:
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 combination 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 chewable tablets prior to the administration of any drug that
may adversely interact with fluoxetine or norfluoxetine.
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