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Side Effects & Adverse Reactions
Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
WARNINGS: Not for use in humans. Keep this and all drugs out of reach of children.
Adverse reactions associated with humans ingesting dirlotapide include: abdominal distention, abdominal pain, diarrhea, flatulence, headache, increased serum transaminases, nausea, and vomiting.
SLENTROL may cause eye-irritation. If accidental eye exposure occurs, flush the eyes immediately with clean water.
In some cases aggression has been reported in dogs being treated with SLENTROL. In case of aggression SLENTROL treatment should be discontinued until a veterinarian is consulted.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INDICATIONS: SLENTROL (dirlotapide) Oral Solution is indicated for the management of obesity in dogs.
History
There is currently no drug history available for this drug.
Other Information
DESCRIPTION: Slentrol (dirlotapide) is a solution formulated at a concentration of 5 mg/mL of dirlotapide for oral administration to dogs. Dirlotapide is a selective microsomal triglyceride transfer protein inhibitor that blocks the assembly and release of lipoprotein particles into the bloodstream (via the lymphatic system) in dogs.1
The empirical formula is C40H33F3N4O3 and the molecular weight is 674.73. The chemical name is (S)-N-{2-[Benzyl(methyl)amino]-2-oxo-1-phenylethyl}-1-methyl-5-[4'-(trifluoromethyl)[1,1'-biphenyl]-2-carboxamido]-1H-indole-2-carboxamide.
The chemical structure of dirlotapide is:
Sources
Slentrol Manufacturers
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Zoetis Inc.
Slentrol | Zoetis Inc.
DOSAGE AND ADMINISTRATION: SLENTROL should be prescribed as part of an overall weight management program that incorporates a complete and balanced canine diet and physical activity.
Dietary Considerations: SLENTROL should only be used with a commercial maintenance diet. Any diet changes should be made gradually and prior to initiating SLENTROL treatment. Better appetite control may be achieved in diets that are not restricted in fat content. Changing the diet while initiating treatment with SLENTROL should be avoided.
The dog will need to be weighed at the start of treatment and then at monthly intervals so that the dosing regimen can be adjusted according to the prescribing instructions below.
During the first month of therapy, the dosing regimen for SLENTROL consists of two fixed dose rates (number of mL administered per unit of body weight) in all dogs. In subsequent months of therapy, the recommended dosing regimen prescribed for SLENTROL varies for each individual dog and the dose volume must be specifically calculated each month, based on the amount of weight lost (expressed as a percent) during the previous month of therapy.
With regard to dosing it is important to note that:
Initial body weight is used to calculate the dose that is first administered. Subsequent dose adjustments are made by adjusting the volume of solution administered. Dose adjustments are determined at monthly intervals. A diet change at the time of a dose escalation should be avoided.The dose should not exceed a maximum daily dose of 0.2 mL/kg (0.09 mL/lb), based on the dog's current body weight, during any part of treatment.
Dose Preparation and Administration: To prepare for oral administration, remove the bottle cap and insert the supplied oral dosing syringe through the membrane into the bottle. Invert the bottle and withdraw the appropriate volume required using the graduation marks on the side of the oral dosing syringe.
The 1 mL dosing syringe provided with SLENTROL can not accurately measure the dosage required to treat dogs that weigh less than 12.5 lb (5.7 kg).
A veterinarian or veterinary technician should instruct the pet owner/caregiver on how to measure the amount of SLENTROL to be administered to ensure accurate dosing.
SLENTROL can be administered directly into the dog's mouth or on a small amount of food. It can be given with a meal or at a different time of day.
Wipe the oral dosing syringe clean after each use with a clean dry cloth or disposable towel. Do not introduce water into the oral dosing syringe or the SLENTROL solution.
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