Reconcile Flavored Chew Tab

How to Order Prescriptions

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Description

Reconcile® is a flavored chewable tablet that contains fluoxetine hydrochloride, and was developed specifically for dogs with separation anxiety. 

Key Benefits

• FDA approved for dogs in conjunction with a behavior modification plan
• Once-a-day, flavored, chewable tablet: highly appealing and easy to administer
• Clinically proven safe and effective when used as prescribed under the guidance of a veterinarian
• Affordably priced
• Reduces stress for both the pet and the owner to strengthen the human, animal bond

How does Reconcile® work? 

Neurotransmitters like serotonin are released from the presynaptic neuron and attach to receptors on the postsynaptic site. Then they are reabsorbed into the presynaptic site. Research shows that control of anxiety is one function of serotonin. Reconcile® helps correct the imbalance by blocking the reuptake of serotonin and temporarily increasing the level in the synapse. 

Directions

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.

Dog Weight		No. of Tablets/Day	Tablet Strength
(lb)	(kg)		(mg)
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	21.1-64.0	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%). 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 (see ANIMAL SAFETY).

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 (see Adverse Reactions).

If a dose is missed, the next scheduled dose should be administered as prescribed. Do not in crease or double the dose.

Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Contraindications

Reconcile chewable tablets are contraindicated for use in dogs with epilepsy or 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.

Warnings

Not for use in humans. Keep out of reach of children. In case of accidental ingestion seek medical attention immediately. In humans, the most common symptoms associated with over dosage include seizures, somnolence, nausea, tachycardia, and vomiting. In case of ingestion by a human, contact a physician immediately. For a copy of the Material Safety Data Sheet (MSDS) or to report adverse reactions call 1-800-874-9764.

Precautions

Reconcile chewable tablets are not recommended for the treatment of aggression. Reconcile chewable tablets have not been clinically tested for the treatment of other behavioral disorders. Studies to determine the effects of Reconcile chewable tablets in breeding, pregnant, or lactating dogs and in patients less than 6 months of age have not been conducted.

Seizures may occur in dogs treated with Reconcile chewable tablets, even in dogs without a history of epilepsy or seizures (see Adverse Reactions).

Before prescribing Reconcile chewable tablets, a comprehensive physical examination should be conducted to rule out causes of inappropriate behavior unrelated to separation anxiety. The examination should include a thorough history and assessment of the patient's household environment and standard practice laboratory tests as appropriate for the patient's age and health status. Veterinarians should be familiar with the risks and benefits of the treatment of behavioral disorders in dogs before initiating therapy. Inappropriate use of Reconcile chewable tablets, i.e., in the absence of a diagnosis or without concurrent behavior modification, may expose the animal to unnecessary adverse reactions and may not provide any lasting benefit of therapy.

Reconcile chewable tablets have not been evaluated with drugs that affect the cytochrome P450 enzyme system. Reconcile chewable tablets should be used with caution when co-administered with any drug that affects the cytochrome P450 enzyme system (for example, ketaconazole). Studies to assess the interaction of Reconcile chewable tablets with tricyclic antidepressants (TCAs) (for example, amitriptyline and clomipramine) have not been conducted. The minimum washout period to transition dogs from TCAs to Reconcile chewable tablets has not been evaluated. Published pharmacokinetic data demonstrates that TCAs are cleared 4 days following discontinuation.

Storage

Store at 20-25°C (68-77°F). Excursions permitted between 15-30°C (59-86°F). Do not remove desiccant from the bottle. Completely close bottle between uses.