Calmedrag®

Oral tablet.

Anxiolytic.

Dogs

Clomipramine Hydrochloride is a tricyclic antidepressant that inhibits the presynaptic reuptake of Serotonin and Norepinephrine and thus produces anxiolytic, anticompulsive, antiaggressive and antidepressant effects. As a result, significant changes can be seen in the behavior of dogs subjected to Clomipramine therapies.

Each tablet contains:
Clomipramine Hydrochloride…………………………..……. 20 mg
(Equivalent to 17.9 mg of Clomipramine base)
Excipients c.s.p…………….…………………………… 1 comp.

Indicated as a treatment for separation anxiety.
Treatment with Calmedrag® should be supported with behavioral management therapy.

• Oral route.
• Place the tablet as far back as possible in the dog’s snout, keep the snout closed and encourage swallowing.
• It is recommended at the beginning of therapy to administer the product together with food to reduce the possibility of side effects such as vomiting.

2 mg of Clomipramine Hydrochloride per kilogram of body weight (2 mg/Kg) every 12 hours for 2-3 months

1 tablet of Calmedrag® per 10 kg of body weight (1 tablet/10 kg) every 12 hours for 2-3 months.
It is advisable to discontinue therapy gradually.

Administer with caution to dogs with a history of seizures, gastrointestinal hypomotility, urinary retention, heart rhythm abnormalities, or increased intraocular pressure.

• The most frequently observed adverse symptoms and signs include nausea, vomiting, and transient lethargy or drowsiness.
• Sedation typically occurs at the beginning of therapy and is usually self-limiting as soon as dogs become tolerant to it.
• Vomiting has been reported especially in dogs that have received Clomipramine on an empty stomach, so it is recommended to administer it with food.
• There may be, although unlikely, anorexia, diarrhea, overactivity of liver enzymes, and some anticholinergic effects (e.g., dry mouth).

Clomipramine in general is a fairly safe medication and tolerated by dogs. In this species, lethal doses are approximately between 50 and 100 mg/Kg per day orally, that is, 12.5 to 25 times the recommended therapeutic dose. Notwithstanding the above, overdoses with tricyclic antidepressants are life-threatening (arrhythmias, seizures, cardio-respiratory collapse).
There is no known antidote for Clomipramine.

• Do not administer to animals with known hypersensitivity to tricyclic agents.
• Do not administer to animals weighing less than 2.5 kg.
• Do not administer to male breeding dogs.
• Do not administer to pregnant or lactating females.
• Do not administer to puppies under 6 months of age.
• Do not administer concomitantly with MAO inhibitors (Selegiline, Amitraz).

• Due to additive effects, Clomipramine should be administered with caution when used concomitantly with other anticholinergic or CNS depressant agents.
• Tricyclic antidepressants used with antithyroid agents may increase the potential risk of agranulocytosis.
• Cimetidine may inhibit the metabolism of tricyclic antidepressants and increase the risk of toxicity.
• Use in combination with sympathomimetic agents may increase the risk of cardiac effects (arrhythmias, hypertension, hyperpyrexia).
• Do not administer concomitantly with MAO inhibitors (Selegiline, Amitraz).

• Wash your hands after handling and/or administering the product.
• Keep away from the reach of children and pets.
• Accidental ingestion should be considered dangerous.
• Use with caution by people with known sensitivity to Clomipramine

Empty containers can be discarded as household waste, without any special precautions. Do not dispose of containers with product remains on the ground or in water courses. For expired or unused products, contact the manufacturing laboratory.

Store in a cool, dry place at a temperature between 15 and 30°C.

SALE UNDER RETAINED VETERINARY PRESCRIPTION
URUGUAY: EXCLUSIVE SALE UNDER MSP RECIPE (GREEN RECIPE)
VETERINARY USE
KEEP OUT OF THE REACH OF CHILDREN AND PETS

Chile: Reg. SAG N° 2178
Uruguay: Reg. MGAP N° 2017A00466
Bolivia: Reg. SENASAG PUV- no 009999/21

Laboratorio Drag Pharma Chile Invetec S.A.
Lautaro N° 300. Quilicura. Santiago. Chile.