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:

Elanco US Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

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 sep

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. Manufactured for: Elanco US Inc., Greenfield, IN 46140, USA Approved by FDA under NADA # 141-120. Clomicalm, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. 03/19 PC4498C 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. Manufactured for: Elanco US Inc., Greenfield, IN 46140, USA Approved by FDA under NADA # 141-120. Clomicalm, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

CLOMICALM- CLOMIPRAMINE HYDROCHLORIDE TABLET
ELANCO US INC.
----------
CLOMICALM™
(clomipramine hydrochloride)
CAUTION:
Federal (USA) law restricts this drug to use by or on the order of a
licensed veterinarian.
DES CRIPTION:
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. The structural formula is:
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):
AUC0-inf
(nmol hr/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±0.32
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
prolon