Clomicalm® Tablets

CLOMICALM (clomipramine hydrochloride) 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.

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

Please follow your pet’s individual treatment plan, which may include a combination of medications and behavioral modification strategies, as recommended by your veterinarian or animal behaviorist.

CLOMICALM (clomipramine hydrochloride) tablets: For use in dogs only. Keep out of reach of children. In children, accidental ingestion should be regarded as serious. Do not administer to dogs with hypersensitivity to clomipramine or other tricyclic antidepressants. CLOMICALM tablets should not be used in: 1) male breeding dogs; 2) combination or within 14 days before or after treatment with a monoamine oxidase inhibitor; 3) dogs with a history of seizures or concomitantly with drugs which lower the seizure threshold. CLOMICALM tablets are not recommended for other behavior problems such as aggression. Effectiveness and clinical safety for long-term use (i.e., for >12 weeks) has not been evaluated. To reduce the incidence of vomiting that may be experienced by some dogs, CLOMICALM tablets may be given with a small amount of food. For full prescribing information, contact Virbac at 1-800-338-3659 or download the product insert.

Dogs

Clomipramine hydrochloride

Tricyclic antidepressant

CLOMICALM Tablets are “beef” flavored.*

CLOMICALM tablets are available in 5 mg, 20 mg, and 80 mg tablet strengths.

Please ensure the selected product and quantity are appropriate for your pet, as recommended by your veterinarian. For current availability, please refer to the product selection above.

CLOMICALM Tablets should be administered as directed by your veterinarian. Do not discontinue abruptly. Please consult your veterinarian before making any changes or discontinuing the prescribed dosing schedule.

If you have questions about your pet’s prescribed dosing schedule (e.g., timing, interval), please contact your veterinarian.

The recommended daily dose of CLOMICALM tablets is 2 to 4 mg/kg/day (0.9 – 1.8 mg/lb/day). Your veterinarian will instruct you to give the drug either once a day or divide the daily dose into 2 separate doses depending on your dog’s response to the drug or tolerance to any side effects. CLOMICALM tablets may be given with a small amount of food in an attempt to reduce the incidence of vomiting that may be experienced by some dogs.

If a dose is missed, the next dose should be administered (without doubling) at the next scheduled dosing time.

Store in a cool, dry place at a controlled room temperature, between 59° and 77°F. Store unused tablets in the original closed container. Keep this and all other medications in a secure location out of the reach of children and animals.

Exposure to extreme temperatures, light, or moisture can affect the integrity and effectiveness of medications. Always store this medication properly (e.g., away from the bathroom, kitchen sink, or other damp places), as outlined on the product label.

The most common side effects of this medication are vomiting, lethargy, diarrhea, increased thirst, and decreased appetite.

Contact your veterinarian immediately if your pet experiences severe vomiting or diarrhea, convulsions or seizures, trouble urinating, extreme behavioral changes (e.g., overexcitement, aggression), weakness, or decreased coordination.

The information provided above may not encompass all possible side effects. Please notify your veterinarian if your pet experiences any side effects, including those listed above, or if you notice anything unusual.

For oral use in dogs only.

Not for use in humans. Keep this and all medications out of reach of children and animals. In case of accidental ingestion, seek medical attention immediately.

People with known hypersensitivity to clomipramine should administer the product with caution.

Do NOT use this medication in male breeding dogs.

Do NOT use this medication in dogs with a history of seizures.

Clomipramine should not be given in combination, or within 14 days before or after treatment with a monoamine oxidase inhibitor (e.g., amitraz, selegiline). Therefore, it is NOT compatible with flea and tick collars that contain amitraz as an active ingredient. If your pet is currently using one of these collars, consult your veterinarian before starting this medication.

Use with caution in dogs with cardiovascular disease, preexisting liver disease, urinary retention, glaucoma, or reduced GI motility.

The safety and efficacy of CLOMICALM tablets have not been established in dogs less than 6 months of age or in pregnant or lactating female dogs. Discuss the risks of using this medication with your veterinarian prior to use if your pet falls into one of these categories.

Do not administer this medication to animals with a known or suspected allergy/hypersensitivity to any tricyclic antidepressant, including clomipramine, or to any other ingredient in the formulation. Allergic reactions to medications may occur. Please inform Vetsource and your veterinarian if your pet has any known sensitivities or allergies, especially to medications and supplements.

If your pet displays symptoms of an allergic reaction, discontinue therapy and call your veterinarian immediately or seek emergency veterinary attention. Symptoms may include (but are not limited to): swollen lips, tongue, face, or airways; difficulty breathing; agitation; profuse salivation; and widespread hives or itching.

The following drugs* may have potential interactions with this medication: acepromazine (PromAce), anticholinergic drugs (e.g., amantadine, atropine), antihistamines (e.g., hydroxyzine), blood pressure medications (e.g., enalapril, sildenafil, telmisartan), dexmedetomidine (Sileo), levothyroxine, MAOIs (e.g., amitraz, selegiline), methocarbamol, metoclopramide, mirtazapine, ondansetron, phenobarbital, phenylpropanolamine (Proin), sotalol, SSRIs (e.g., fluoxetine), tramadol, and trazodone.

*NOTE: This may not be a comprehensive list. As with all medications, please consult your veterinarian if you have any questions or concerns prior to use. Contact your veterinarian if your pet experiences any unusual reactions when multiple medications and/or supplements are given together.

Please ensure your veterinarian is aware of all medications, supplements, and over-the-counter (OTC) products that your pet is currently using. Your veterinarian may prescribe multiple medications, even if a potential drug interaction may occur. In these instances, your veterinarian may adjust the dosages or monitor your pet more closely.

If you are concerned that your pet has experienced an adverse reaction to this medication, please contact Virbac at 1-800-338-3659 or Vetsource Pet Owner Care at 877-738-4443.

If you have any reason to suspect accidental ingestion or overdose, call your doctor/veterinarian or the appropriate poison control resource immediately.

The national toll-free Poison Help line, 1-800-222-1222, will connect you to your local poison center in case of emergency. This service is available nationwide and in most U.S. territories.

The ASPCA Animal Poison Control Center is available 24 hours a day, 365 days a year at 888-426-4435.

Pet Poison Helpline also provides a 24/7 animal poison control service at 855-764-7661.

All content, including the images and product description above, is intended for general informational purposes only and should not be considered a substitute for professional veterinary consultation, diagnosis, or treatment.

For additional information about this product and how it fits into your pet's individual treatment plan, please consult your veterinarian.