Reconcile Chewable Tablets

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 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.

Recommended Dose of RECONCILE Chewable Tablets

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

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.

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.

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, ketoconazole). 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.

Clinical Pharmacology:

Fluoxetine exerts its effect by inhibiting the reuptake of serotonin at the pre-synaptic neuron. Fluoxetine does not act as a sedative. Fluoxetine is well absorbed after oral administration (~72%). It is largely metabolized in the liver by cytochrome P-450 enzyme system to norfluoxetine, an equipotent SSRI that contributes to the efficacy of Reconcile chewable tablets.

Eli Lilly and Company