CLOMICALM- clomipramine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOMIPRAMINE HYDROCHLORIDE (UNII: 2LXW0L6GWJ) (CLOMIPRAMINE - UNII:NUV44L116D)

Available from:

Virbac AH, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

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.

Product summary:

CLOMICALM tablets are available in 5, 20, 40 and 80 mg tablet strengths in color-coded packaging for oral administration to dogs. Keep this and all drugs out of reach of children.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

CLOMICALM- CLOMIPRAMINE HYDROCHLORIDE TABLET
VIRBAC AH, INC.
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CLOMICALM
(CLOMIPRAMINE HYDROCHLORIDE)
CAUTION
Federal 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]-10,11dihydro-5H dibenz[b,f]azepine monohydrochloride.
CLOMICALM
tablets are oblong, light brown in color and contain clomipramine
hydrochloride
formulated together with meat components. The molecular weight of
clomipramine
hydrochloride is 351.3.
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
re-uptake 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 in the following table (mean ±SD):
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. CLOMIPRAMINE IS PRIMARILY METABOLIZ