Clomicalm: Product Information (Page 2 of 4)

Efficacy:

Dose Establishment: A 12 week, placebo-controlled, multi-site clinical trial was conducted in the US and Europe to establish an effective dose of CLOMICALM Tablets in dogs. Treatment with CLOMICALM Tablets, at 2 — 4 mg/kg/day divided twice daily, in conjunction with behavioral modification (desensitization and counterconditioning) was more effective than behavior modification alone in reducing the signs of separation anxiety in dogs.

Dose Confirmation: In another placebo-controlled, multi-site clinical trial, CLOMICALM Tablets at 2 — 4 mg/kg/day given either once daily or divided twice daily showed significant improvement in resolving signs of separation anxiety when tested against behavioral modification alone (desensitization and counterconditioning). In this 8 week study, the rate of improvement of the dogs receiving CLOMICALM Tablets with behavioral modification was significantly faster than the rate of improvement of the dogs receiving behavioral modification alone. After one week on trial, 47% of the dogs receiving CLOMICALM Tablets once or twice (divided dose) daily in conjunction with behavioral modification showed clinical improvement compared to improvement in 29% of the dogs receiving behavioral modification alone.

Safety:

CLOMICALM Tablets were demonstrated to be well-tolerated in dogs at the recommended label dose of 2-4 mg/kg/day. In a six month target animal safety study, beagle dogs were dosed daily at 4 (1X), 12 (3X), and 20 (5X) mg/kg/day. Emesis was seen in all groups including the dogs receiving placebo, but occurred more frequently in dogs receiving 12 and 20 mg/kg. Decreased activity was also seen in dogs receiving the 12 and 20 mg/kg. There were no apparent treatment-related alterations in the following: body weights, physical examination findings, electrocardiograph examinations, hematology or biochemistry parameters, ophthalmoscopic examinations, macroscopic or microscopic organ examinations and organ weights. Average food and water consumption over the 26 week period was similar for control and treated groups. In a one year study, pure bred dogs were dosed daily at 12.5 (3X), 50 (12.5X), and 100 (25X) mg/kg/day. Emesis and mydriasis were observed within 15 minutes to one hour after dosing in dogs receiving 12.5, 50, and 100 mg/kg/day and lethargy was observed within 1 hour of dosing in dogs receiving 50 and 100 mg/kg. Testicular hypoplasia was seen in dogs receiving 50 mg/kg. At 100 mg/kg/day (25X) convulsions and eventual death occurred in five out of the eight dogs.

Adverse Reactions:

Frequency and category of adverse reactions observed in dogs dosed with CLOMICALM Tablets or placebo were observed in multisite clinical studies as follows.

*These dogs displayed growling behavior towards either humans or other dogs.

Adverse Reactions Reported in Placebo-Controlled Clinical Field Trials
CLOMICALM N=180 Placebo N=88
Emesis 36 (20%) 8 (9%)
Lethargy 26 (14%) 7 (8%)
Diarrhea 17 (9%) 4 (5%)
Polydipsia 6 (3%) 0
Decreased Appetite 6 (3%) 3 (3%)
Aggression* 3 (2%) 1 (1%)
Seizure 2 (1%) 0
Dry Mouth 1 (0.5%) 1 (1%)
Tremors 1 (0.5%) 0
Constipation 1 (0.5%) 0
Anisocoria 1 (0.5%) 0
Polyuria 1 (0.5%) 0
Hyperthermia 1 (0.5%) 0

Post-Approval Experience: Although not all adverse reactions are reported, the following adverse reactions are based on voluntary postapproval adverse drug experience reporting: lethargy/depression, anorexia, elevation in liver enzymes, vomiting and diarrhea. Hepatobiliary disease has occurred, especially in the presence of pre-existing conditions or with concurrent administration of drugs metabolized via the hepatic system. Additionally, in an overdose situation, the following signs have been reported: ataxia, convulsion(s), anticholinergic effects (e.g., mydriasis, bradycardia, tachycardia, and arrhythmia) and vocalization.

To report suspected adverse reactions or in case of accidental human ingestion, call 1-888-545-5973.

Dosage and Administration:

The recommended daily dose of CLOMICALM Tablets is 2 to 4 mg/kg/day (0.9 -1.8 mg/lb/day) (see dosing table below). It can be administered as a single daily dose or divided twice daily based on patient response and/ or tolerance of the side effects. It may be prudent to initiate treatment in divided doses to minimize side effects by permitting tolerance to side effects to develop or allowing the patient time to adapt if tolerance does not develop. To reduce the incidence of vomiting that may be experienced by some dogs, CLOMICALM Tablets may be given with a small amount of food.

Dog Weight (lbs.) CLOMICALM per Day No. Tablets per Day Tablet Strength
2.75-5.5 5 mg 1 5 mg
5.6-10.9 10 mg 2 5 mg
11-22 20 mg 1 20 mg
22.1-44 40 mg 1 40 mg
44.1-88 80 mg 1 80 mg
88.1-176 160 mg 2 80 mg

The specific methods of behavioral modification used in clinical trials involved desensitization and counterconditioning techniques. Since the manifestation of separation anxiety can vary according to the individual dog, it is advised that a specific behavior modification plan be developed based on a professional assessment of each individual case.

Once the desired clinical effect is achieved and the owners have successfully instituted the appropriate behavioral modification, the dose of CLOMICALM Tablets may be reduced to maintain the desired effect or discontinued. Withdrawal side effects were not reported in studies with CLOMICALM Tablets in dogs. However, in clinical practice, it is recommended to taper the individual patient dose while continuing to monitor the dog’s behavior and clinical status through the dose reduction or withdrawal period. Continued behavioral modification is recommended to prevent recurrence of the clinical signs.

The effectiveness and clinical safety of CLOMICALM Tablets for long-term use (i.e., for more than 12 weeks) has not been evaluated.

Professional judgment should be used in monitoring the patient’s clinical status, response to therapy and tolerance to side effects to determine the need to continue treatment with CLOMICALM Tablets and to continue to rule-out physiological disorders which may complicate the diagnosis and treatment of separation anxiety.

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