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CLOMICALM® (Clomipramine Hydrochloride) Tablets

By: Novartis Animal Health

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

Description

CLOMICALM (clomipramine hydrochloride) Tablets belong to the dibenzazepine class of tricyclic antidepressants. Clomipramine hydrochloride is 3-chloro-5 [3-(dimethyl-amino) propyl]-10, 11-dihydro-5H-dibenz[b,f] azepine monohydrochloride. CLOMICALM Tablets are oblong, light brown in color and contain clomipramine hydrochloride formulated together with meat components. CLOMICALM Tablets are available in 20, 40 and 80 mg tablet strengths in color-coded packaging for oral administration to dogs. The molecular weight of clomipramine hydrochloride is 351.3. The structural formula is: (see image.)

Clinical Pharmacology

Clomipramine hydrochloride reduces the clinical signs of separation anxiety by affecting serotonergic and noradrenergic neuronal transmission in the central nervous system.

While clomipramine hydrochloride can cause lethargy in dogs (see Adverse Reactions), its mode of action is not as a sedative. Clomipramine hydrochloride's capacity to inhibit reuptake of serotonin in the central nervous system is believed to be the primary mechanism of action.

Clomipramine hydrochloride is rapidly absorbed when administered orally. A single-dose crossover study involving 12 dogs evaluated clomipramine hydrochloride bioavailability after IV (2 mg/kg) and oral (4 mg/kg) administration in either a fed or fasted state. The administration of clomipramine hydrochloride in the presence of food resulted in an increase in the rate and extent of drug absorption as shown below (mean ±SD):

..........AUCO–inf (nmol/L)        Cmax (nmol/L)        Tmax (hr)        Absolute Bioavailability (F)
Fed............1670±575...................601±286...........1.18±0.32...................0.21±0.07
Fasted........1350±447...................379±154...........1.31±154....................0.17±0.05

The absolute bioavailability is approximately 25% greater in fed dogs. The apparent terminal plasma half-life ranges from approximately 2 to 9 hours in fed and 3 to 21 hours in fasted dogs. The difference and variability in apparent half-life estimates may be attributable to prolonged drug absorption in the fasted state. The relatively large volume of distribution (3.8 ± 0.8 L/kg) suggests that the drug is widely distributed throughout the body.

Indications and Usage

CLOMICALM Tablets are to be used as part of a comprehensive behavioral management program to treat separation anxiety in dogs greater than 6 months of age. Inappropriate barking or destructive behavior, as well as inappropriate elimination (urination or defecation) may be alleviated by the use of CLOMICALM Tablets in conjunction with behavior modification.

Separation anxiety is a complex behavior disorder displayed when the owner (or other attachment figure) leaves the dog. The signs of separation anxiety evaluated in controlled trials were vocalization, destructive behavior, excessive salivation and inappropriate elimination. In the absence of the owner or attachment figure, dogs with separation anxiety may exhibit one or more of these clinical signs. Although the owner (attachment figure) may inadvertently misinterpret this behavior, which only happens in their absence, as spiteful, it is thought to be the result of anxiety experienced by the dog.

  • Punishment is not considered appropriate for a dog with separation anxiety.

  • Proper recognition of clinical signs, including a complete patient history and assessment of the patient's household environment, is essential to accurately diagnose and treat separation anxiety.

  • The use of CLOMICALM Tablets should not replace appropriate behavioral and environmental management but should be used to facilitate a comprehensive behavioral management program.

    Contraindications

    CLOMICALM Tablets are contraindicated in dogs with known hypersensitivity to clomipramine or other tricyclic antidepressants.

    CLOMICALM Tablets should not be used in male breeding dogs. Testicular hypoplasia was seen in dogs treated for 1 year at 12.5 times the maximum daily dose.

    CLOMICALM Tablets should not be given in combination, or within 14 days before or after treatment with a monoamine oxidase inhibitor [e.g., selegiline hydrochloride (L-deprenyl), amitraz].

    CLOMICALM Tablets are contraindicated for use in dogs with a history of seizures or concomitantly with drugs which lower the seizure threshold.

    Human Warnings

    Not for use in humans. Keep out of reach of children. In case of accidental ingestion seek medical attention immediately. In children, accidental ingestion should be regarded as serious. There is no specific antidote for clomipramine. Overdose in humans causes anticholinergic effects including effects on the central nervous (e.g., convulsions) and cardiovascular (e.g., arrhythmia, tachycardia) systems. People with known hypersensitivity to clomipramine should administer the product with caution.

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