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Reconcile 16 mg Chewable Tablets - 30 Count Bottle - Vet Rx
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Product ID: *V**RECONCILE16
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Product Summary
  • VETERINARY PRESCRIPTION REQUIRED
  • This drug is not approved for use in humans.

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


DESCRIPTION


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).


INDICATIONS:<


RECONCILE chewable tablets are indicated for the treatment of canine separation anxiety in conjunction with a behavior modification plan.


DOSAGE


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.


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, 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 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.


HUMAN 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 1-888-545-5973.


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.


Adverse Reactions:


In two North American multi-site field studies, which included a total of 427 dogs, the following adverse reactions were observed:


Seizures: In one study, one of 112 dogs in the control group and three of 117 dogs that received RECONCILE chewable tablets experienced the serious adverse reaction of seizures. One of the three dogs treated with RECONCILE chewable tablets experienced two seizures 10 days after the end of therapy.

Despite escalating phenobarbital doses, the seizures continued and this dog died in status epilepticus approximately six months after the first seizure. Another of the three dogs treated with RECONCILE chewable tablets had experienced one seizure approximately 1 1/2 years prior to study enrollment immediately after receiving head trauma.

No additional seizures were reported to have occurred until 45 days after concluding treatment with RECONCILE chewable tablets. During the 1 1/2-year period since the second seizure, this dog’s seizure activity increased from single seizures to cluster seizures despite increasing doses of phenobarbital and the addition of oral potassium bromide and rectal diazepam. The third dog treated with RECONCILE chewable tablets and the control dog experienced one seizure 24 days and 35 days, respectively, after the start of therapy; no anticonvulsant therapy was initiated and no further seizures were reported in either dog.

In the second study, one of 99 dogs treated with RECONCILE chewable tablets and one of 99 dogs treated with the control tablet experienced the serious adverse reaction of seizures 9 and 27 days, respectively, after initiation of therapy. The dog treated with RECONCILE chewable tablets was subsequently diagnosed with vestibular disease and the control dog had a history of recurrent hind leg weakness.

In a European multi-site study, 234 dogs were treated with daily doses of fluoxetine chewable tablets ranging from 0.25 mg/kg to 4 mg/kg. One dog treated with a daily dose of 0.4 mg/kg for one month experienced one seizure one week after discontinuing therapy. No anticonvulsant therapy was initiated and no further seizures were reported.


Weight loss: Of the dogs in the two North American field studies with body weight measurements throughout the study (n=196 and n=185 in the RECONCILE chewable tablets and control group, respectively), a 5% or greater weight loss (when compared to initial, pre-study body weight) was observed in 58 (29.6%) of dogs treated with RECONCILE chewable tablets and 24 (13.0%) of dogs in the control group. No dogs were withdrawn from clinical studies due to weight loss alone.


Other adverse reactions: Additional adverse reactions observed in dogs treated with RECONCILE chewable tablets at a rate of 1% or greater were: Calm/Lethargy/Depression (32.9%), Decreased Appetite (26.9%), Vomiting (17.1%), Shaking/Shivering/Tremor (11.1%), Diarrhea (9.7%), Restlessness (7.4%), Excessive Vocalization Including Whining (6.0%), Aggression (4.2%), Otitis Externa (2.8%), Disorientation (2.3%), Incoordination (2.3%), Constipation (1.4%), Excessive Salivation (1.4%)


Dose Reduction:


Twenty dogs in the RECONCILE chewable tablet group and five dogs in the control group required a reduction in dose due to unacceptable adverse reactions, generally anorexia, vomiting, shaking and depression. Lowering the dose eliminated or reduced the severity of these adverse reactions in the RECONCILE chewable tablet group only. Resumption of the full dose of RECONCILE chewable tablets resulted in a return of the initial adverse reactions in approximately half of the affected dogs. The majority of these adverse reactions were intermittent and mild. However, one dog experienced recurrence of severe adverse reactions, which necessitated withdrawal from the study for that dog.

Additionally, two dogs required a second dose reduction of RECONCILE chewable tablets. Effectiveness was maintained in a majority of those dogs in which a dose reduction was necessary.

The following adverse events are based on post-approval adverse drug experience reporting with Reconcile® chewable tablets. Not all adverse reactions are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using this data.

The following adverse events are listed in decreasing order of reported frequency: decreased appetite, depression/lethargy, shaking/shivering/tremor, vomiting, restlessness and anxiety, seizures, aggression, diarrhea, mydriasis, vocalization, weight loss, panting, confusion, incoordination, and hypersalivation.


For a complete listing of adverse reactions for Reconcile® (fluoxetine hydrochloride) Chewable Tablets reported to the CVM see: http://www.fda.gov/AnimalVeterinary/SafetyHealth/ProductSafetyInformation/ucm055394.htm


Effectiveness


In one randomized multi-centered, double-blinded, vehicle-controlled study of 8 weeks duration, 229 dogs were evaluated at 34 investigative sites in the United States and Canada. One hundred seventeen dogs were randomized to 1-2 mg/kg/day of RECONCILE chewable tablets and 112 dogs were randomized to the control group. Both groups underwent concurrent behavior modification. In seven of the eight weeks, the percentage of dogs with improved overall separation anxiety scores was significantly higher (p ≤ 0.05) among dogs treated with RECONCILE chewable tablets compared to dogs that received the control tablet. At the end of the study, 73% of dogs treated with RECONCILE chewable tablets showed significant improvement (p=0.010) as compared to 51% of dogs treated with behavior modification alone.


Dogs treated with RECONCILE chewable tablets also showed improvement in destructive behavior, excessive vocalization, and restlessness over dogs that received the control tablet. In addition, dogs in both groups experienced improvement in inappropriate urination, inappropriate defecation, excessive salivation, excessive licking/grooming, shaking/shivering and depression. Overall separation anxiety severity scores improved more rapidly for dogs taking RECONCILE chewable tablets than those dogs receiving the control tablet. The same effect was also noted for the individual scores for excessive vocalization and depression.


Storage Information:

Store at 20-25°C (68-77°F). Excursions permitted between 15-30°C (59-86°F).

Do not remove desiccant canister from the bottle. Completely close bottle between uses.

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