Anipryl 15 mg (30 Tablets)

Anipryl is an oral tablet prescribed by veterinarians to control the clinical signs of canine cognitive dysfunction syndrome (CDS) and of uncomplicated pituitary-dependent Addison's Disease (PDH). Since this medication is a selective monoamine oxidase -B inhibitor, it may enhance catecholamine neuroactivity and increase dopamine levels in dogs.

Key Benefits

• First and only FDA-approved drug used to control clinical signs associated with Canine Cognitive Dysfunction Syndrome
• First and only product approved to control uncomplicated PDH (pituitary-dependent hyperadrenocorticism) Cushing's disease
• Is a selective monoamine oxidase -B inhibitor, which could enhance catecholamine neuronactivity and increases dopamine levels in dogs.
• No specific laboratory tests required for treatment.
• Can be given with food.
• Available in multiple dosage sizes.

How It Works

Anipryl increases the concentration of a nervous system messenger chemical called dopamine. Higher levels of dopamine improve many cognitive processes. Treating Cushing's Disease has traditionally been centered on suppressing the adrenal gland's production and release of cortisone. However, this approach has a high potential for side effects. Selegiline has allowed for a new approach by suppressing the pituitary gland directly.

Indications

Anipryl tablets are indicated for the control of clinical signs associated with canine cognitive dysfunc-tion syndrome (CDS) and control of clinical signs associ-ated withuncomplicated canine pituitary dependent hyperadrenocorticism (PDH).

View Anipryl Drug Facts Sheet.

Dosage & Administration:

CDS: The recommended dosage for oral administration for the control of clinical signs associated with CDS is 0.5-1.0mg/kg once daily, preferably administered in the morning. Initially, dogs should be dosed to the nearest whole tablet. Adjustments should then be made based on response and tolerance to the drug.

PDH: The recommended dosage for the control of clinical signs associated with canine PDH is 1.0 mg/kg once daily, preferably administered in the morning. If no improvement is observed after 2 months of therapy, dosage may be increased to a maximum of 2.0 mg/kg once daily. If no improvement is seen after 1 month at the higher dose or ifat any time clinical signs progress, the dog should be re-evaluated. In dogs whose clinical signs of PDH progress despite Anipryl therapy in the absence of con-current disease, alternate therapy should be considered.

Dogs should be monitored closely for possible adverse events associated with any increase in dose.

Clinical Use of Anipryl in CDS: CDS is an age-related deterioration of cognitive abilities characterized by behav-ioral changes not wholly attributable to a general medical condition such as neoplasia, infection, or organ failure. CDS is typified by multiple cognitive impairments which affect the dog's function. In clinical trials, the observed behavioral changes associated with CDS in older dogs included: disorientation, decreased activity level, abnormal sleep/wake cycles, loss of housetraining, decreased or altered responsiveness to family members, and decreased or altered greeting behavior. In clinical trials, Anipryl was shown to be effective in controlling clinical signs associatedwith CDS. After 4 weeks of treatment, dogs treated with Anipryl showed significant improvement when compared to placebo-treated controlsin sleeping patterns, house-training,and activity level. Some dogs showed increased improvement up to 3 months, however, onset, duration and magnitude of response varied with individual dogs.

The diagnosis of CDS in dogs is a diagnosis of exclusion, based on thorough behavioral and medical histories, in con-junction with appropriate diagnostic work-up and testing.11Periodic patient monitoring to evaluate the response and tolerance to the drug and for the presence of concurrent or new disease is recommended.

Clinical Use of Anipryl in PDH: Clinical signs of PDH seen in clinical trials included panting, reduced activity, poly-dipsia, polyuria, changes in sleep patterns, altered appetite, obesity, alopecia, abdominal distention, reduced skin elasticity, thin skin, poor hair growth, pyoderma, decreased responsiveness to attention, and decreased enthusiasm of greeting. In clinical studies involving 125evaluable cases of naturally occurring PDH, Anipryl was shown to be effective in controlling clinical signs associated with the disease.On physical examination, abdominal distention was the parameter which most con-sistently improved following treatment with Anipryl. Based on owner assessments, activity level was the parameter most consistently evaluated as "improved." Approximately 60% of the dogs were evaluated by the veterinarians and owners to be "slightly improved" to "improved" after 1month of Anipryl therapy. By month 2, veterinarians reported that approximately 77% were "slightly improved" to "improved." Approximately 20% of dogs did not respond to Anipryl and were deemed treatment failures.

Those dogs that responded to Anipryl tended to do so within 1-2 months after treatment was initiated. Response to therapy varied between patients with some dogs show-ing improvement in all presenting clinical signs and others showing improvement in only 1-2 parameters. Duration of response was also variable, with some dogs continuing on Anipryl for over 1 year with good control of clinical signs and others showing an initial response to therapy only to be followed within several months by recurrence of clini-cal signs of PDH. There was no correlation demonstrated between an individual dog's clinical response to Anipryl and that dog's low dose dexamethasone suppression test results, therefore, monitoring should be based on history and physical examination findings.

Caution:

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

Contraindications:

Anipryl is contraindicated in patients with known hypersensitivity to this drug.

In humans, selegiline is contraindicated for use with meperidine and this contraindication is often extended to other opioids.

Warnings:

Keep out of reach of children. Not for human use.

Anipryl should not be administered at doses exceeding those recommended (0.5-2.0 mg/kg once daily).

In humans, concurrent use of MAO inhibitors with alpha-2 agonists has resulted in extreme fluctuations of blood pressure; therefore, blood pressure monitoring is recommended with concurrent use in dogs. Also, in humans, severe CNS toxicity including death has been reported with the combination of selegiline and tricyclic antide pressants, and selegiline and selective serotonin reuptake inhibitors. Although no suchadverse drug interactions were reported in the clinical trials in dogs, it seems prudent to avoid the combination of Anipryl and selective serotonin reuptake inhibitors (e.g., fluoxetine) as well as Anipryl and tricyclic (e.g., clomipramine, amitriptyline, imipramine) or other anti depressants.

At least 14 days should elapse between discontinuation of Anipryl and initiation of treatment with a tricyclic anti-depressant or selective serotonin reuptake inhibitor. Because of the long half-life of fluoxetine and its active metabolites, at least 5 weeks should elapse between discontinuation of fluoxetine and initiation of treatment with Anipryl.

Concurrent use of Anipryl with ephedrine or potential MAO inhibitors, such as amitraz, is not recommended.

Precautions:

General: Anipryl is not recommended for other behavior problems such as aggression. In the clinical trials, 3 dogs showed an increase in aggression while on this drug. The safety and effi cacy of Anipryl has not been evaluated in dogs with debilitating systemic diseases other than PDH.

The decision to prescribe Anipryl should take into consideration that the MAO system of enzymes is complex and incompletely understood and there is only a limited amount of carefully documented clinical experience with selegiline. Consequently, the full spectrum of possible responses to selegiline may not have been observed in pre-marketing evaluation of the drug. It is advisable, therefore, to observe patients carefully for atypical responses.

Endocrine function testing to confirm pituitary dependent hyperadreno-corticism should be performed prior to Anipryl administration for that condition. Anipryl is not recommended for treatment of patients with hyperadreno-corticism not of pituitary origin such as those due to an adrenal tumor or administration of glucocorticoids. If complications of PDH are evident at the time of diagnosis or emerge during Anipryl therapy, the patient should be evaluated and, if warranted, alternative therapy considered. Concurrent use of Anipryl in conjunction with other therapies of canine PDH has not been evaluated.

Laboratory Test: No specific laboratory tests are deemed essential for the management of patients on Anipryl, as response to therapy should be based on the history and physical examinations for both PDH and CDS. In clinical trials for PDH, no correlation was found between an individual patient's clinical response and results of the low dose dexamethasone suppression (LDDS) test. There was no evidence of adrenal insufficiency in these trials.

In the 12 weekclinical trial for CDS, a small number of dogs had a drop in hematocrit; some dropping within the normal range and some dropping below 37%. The clinical significance of this is unknown at this time. It is advisable to conduct a thorough physical examination and to consider appropriate laboratory tests to establish hemato logical and serum biochemical baseline data prior to administration of Anipryl.

Reproductive Safety: The safety of Anipryl in breeding, pregnant and lactating bitches, and breeding dogs has not been determined.

Storage:

Store at controlled room temperature 20°-25°C (68°-77°F).