DEXMEDETOMIDINE OROMUCOSAL GEL SUMMARY

Brand Name: Sileo^®
Manufacturer: Zoetis

Source: https://www.sileodogus.com

Available Dosage Forms

• Dexmedetomidine Oromucosal Gel 0.09 mg/mL (equivalent to 0.1 mg/mL dexmedetomidine HCl) in 3-mL dosing syringes; Sileo^® (Rx). FDA-approved for use in dogs.

Dosage by Species

• Dogs: 125 mcg/m² BSA administered onto the oral mucosa between the dog’s cheek and gum. The first dose should be administered approximately 30 to 60 minutes before the fear and/or anxiety-eliciting noise stimulus, immediately after the dog shows the first signs of anxiety or fear related to noise, or when the owner detects a typical noise stimulus (eg, sound of fireworks) eliciting anxiety or fear in the dog. Dosing should only be performed by an adult who is wearing disposable, impermeable gloves. The gel must be administered using the accompanying syringe (Sileo^® dot syringe).

Pharmacokinetic Parameters

Contraindications/Warnings

• Do not use dexmedetomidine in dogs or cats that are hypersensitive to dexmedetomidine.
• Do not use dexmedetomidine in patients with cardiovascular disease, respiratory disorders, or liver or kidney diseases, or in conditions of shock, severe debilitation, or stress caused by extreme heat, cold, or fatigue.
• Use with caution in animals that have or are prone to developing seizures as dexmedetomidine has been shown to lower seizure threshold.
• Do not use the oromucosal product for dogs younger than 16 weeks of age or in dogs with dental or gingival diseases.
• It should not be swallowed as it may not be effective. If swallowed, the dose should not be repeated for at least 2 hours to eliminate the risk for overdose.

Pregnancy Category

• Safe use in breeding or lactating animals has not been determined.

Drug Interactions

• Synergistic sedative effects with anesthetics, opioids, sedatives, and hypnotics.
• Use with atropine increases risk for arrhythmias.

Storage/Stability

• Store at controlled room temperature of 20°C to 25°C (68°F-77°F), with excursions permitted to 15°C to 30°C (59°F-86°F). Use syringe contents within 2 weeks after opening the syringe. 

Regulatory Considerations

• New Animal Drug Application (NADA) #141-456

MIRTAZAPINE TRANSDERMAL SUMMARY

Brand Name: Mirataz^™
Manufacturer: Kindred Bio, Inc.

Source: https://kindredbio.com/wp-content/uploads/2018/10/Tube_Box_TM.jpg

Available Dosage Forms

• 100 mg/tube in 5-gram tube (20 mg per 1 gram); Mirataz^™, (Rx).

Dosage by Species

• Cats: Management of Weight Loss (FDA-approved): Using transdermal ointment, apply 1.5-inch ribbon (~2 mg/cat) to inner pinna of cat’s ear every 24 hours for 14 days. Person applying medication should wear gloves. Alternate application of ointment between the left and right inner pinna of the ears. A dry cloth or towel may be used to wipe the surface of the pinna clean prior to administration.

Pharmacokinetic Parameters

Contraindications/Warnings

• Mirtazapine is contraindicated in patients with hypersensitivity to mirtazapine or that have received monoamine oxidase inhibitors (eg, selegiline) in the past 14 days
• Use with caution in patients with known cardiac disease or cerebrovascular disease that could be exacerbated by hypotension
• Patients with renal impairment, renal failure, or hepatic disease may require lower doses of mirtazapine, and should be monitored while on mirtazapine therapy
• Use with caution in patients with urinary retention; prostatic hypertrophy; acute, untreated closed-angle glaucoma or increased intraocular pressure; or GI obstruction or ileus due to mirtazapine’s anticholinergic effects.
• Mirataz has not been evaluated in cats < 2 kg or less than 6 months of age.

Pregnancy Category

• Safe use has not been evaluated in cats that are intended for breeding, pregnant, or lactating cats.

Drug Interactions

Storage/Stability

• Store below 25°C (77°F). Multi-use tube. Discard within 30 days of first use.

Regulatory Considerations

• New Animal Drug Application (NADA) #141-481

IMEPITOIN SUMMARY

Brand Name: Pexion^®
Manufacturer: Boehringer Ingelheim, Inc.

Source: https://www.animeddirect.co.uk/media/catalog/product//d/s/dsc_3485.jpg

Available Dosage Forms

• Imepitoin Oral Tablets (scored): 100 mg & 400 mg; Pexion^®; (Rx).

Dosage by Species

• Dogs: Treatment of noise aversion (FDA-approved): 30 mg/kg PO every 12 hours. Initiate therapy starting 2 days prior to the day of the expected noise event and continue through the noise event.

Pharmacokinetic Parameters

Contraindications/Warnings

• Imepitoin is contraindicated in patients hypersensitive to it or in patients with severely impaired hepatic function or with severe renal or cardiovascular disorders.
• Do not use as a primary treatment for dogs with status epilepticus or cluster seizures.
• Use with caution if at all in dogs weighing less than 5 kg or in dogs with renal, liver, cardiac, gastrointestinal, or other disease.
• Withdrawal (behavioral or muscular signs) may be observed in dogs upon abrupt termination of treatment, consider withdrawing the drug gradually if appropriate.

Pregnancy Category

• Safe use in breeding or lactating animals has not been determined.

Drug Interactions

• Flumazenil could reverse the effects of imepitoin.

Storage/Stability

• Store at or below 30°C (86°F) and keep out of reach of children and pets.

Regulatory Considerations

• New Animal Drug Application (NADA) #141-509

CAPROMORELIN SUMMARY

Brand Name: Entyce^®
Manufacturer: Aratana Animal Health

Source: https://entyce.aratana.com/wp-content/uploads/2018/04/entyce-package.png

Available Dosage Forms

• 30 mg/mL oral solution, supplied in 10 mL, 15 mL, and 30 mL bottles with a dosing syringe

Dosage by Species

• Dogs: 3 mg/kg orally once daily for 4 days.
• Cats: 1-3 mg/kg orally once daily (extra-label)

 Pharmacokinetic Parameters

Contraindications/Warnings

• Capromorelin should not be used in dogs or cats that are hypersensitive to it or its components.
• Use with caution in patients with renal insufficiency or hepatic dysfunction.
• Drug interactions are possible with CYP3A4 and CYP3A5 inducers and inhibitors, but specific interactions have not been reported to date.

Pregnancy Category

• Safe use in breeding or lactating animals has not been determined.

Drug Interactions

Storage/Stability

• Store at or below 30°C (86°F) and keep out of reach of children and pets.

Regulatory Considerations

• New Animal Drug Application (NADA) #141-457.

Diethylstilbestrol (DES) Summary

Dosage by Species

• Dogs: Tapered administration starting with0.02 mg/kg (not to exceed 1 mg) orally every 24 hours for 3–5 days initially, then decreased to every other day, and finally decreased to the longest dosing interval that controls incontinence (once weekly for most dogs).

Pharmacokinetic Parameters

Contraindications/Warnings

• Do not administer concurrently with other estrogens (e.g., estriol).
• Not for use in cats.
• Carcinogenic and teratogenic in humans.

Pregnancy Category

• Category X.

Drug Interactions

Storage/Stability

• Store compounded capsules in a moisture-resistant and light-resistant container at room temperature (59°F–86°F).

Estriol Summary

Brand Name: Incurin
Manufacturer: Merck Animal Health

Source: http://www.merck-animal-health-usa.com/products/96-59930-4/productdetails_130_163463.aspx

Available Dosage Forms

• Scored tablets: 1 mg supplied in blister packs of 30 tablets

Dosage by Species

• Dogs: Tapered dosage starting with2 mg orally every 24 hours for 14 days, then 1 mg orally every 24 hours for 7 days, then 0.5 mg orally every 24 hours for 7 days. When the lowest effective dose is determined, it can be administered every 48 hours or as infrequently as possible to control incontinence.

Pharmacokinetic Parameters

Contraindications/Warnings

• Do not administer concurrently with other estrogens (e.g., diethylstilbestrol).
• Not for use in cats.

Pregnancy Category

• Safe use in breeding or lactating animals has not been determined.

Drug Interactions

Storage/Stability

• Store at or below 77°F, with excursions permitted to 104°F.

Regulatory Considerations

• New Animal Drug Application (NADA) #141-325.

Phenylpropanolamine Summary

Brand Name: Proin
Manufacturer: PRN Pharmacal

Source: https://www.valleyvet.com/ct_detail.html?pgguid=3709570e-ae33-4dbb-ac22-aa599889c086

Available Dosage Forms

• Chewable liver-flavored scored tablets: 25 mg, 50 mg, 75 mg

Dosage by Species

• Dogs: 2 mg/kg orally every 8–24 hours.
• Cats: 1–2.2 mg/kg orally every 8–24 hours; not recommended for use in cats.

Pharmacokinetic Parameters

Contraindications/Warnings

• Use with caution (if at all) in animals with glaucoma, prostatic hypertrophy, hyperthyroidism, diabetes mellitus, cardiovascular disorders, renal insufficiency, or hypertension.
• Do not use in dogs with urinary tract infections; important clinical signs may be masked.
• Do not administer to dogs undergoing food allergy trials or known to be allergic to liver, garlic, or whey.

Pregnancy Category

• Safe use in breeding or lactating animals has not been determined.

Drug Interactions

Storage/Stability

• Store at controlled room temperature (68°F–77°F). Excursions are permitted between 59°F and 104°F.

Regulatory Considerations

• New Animal Drug Application (NADA) #141-324.

Trilostane Summary

Brand Name: Vetoryl
Manufacturer: Dechra

Source: https://www.google.com/url?q=http%3A%2F%2Fwww.dechra-us.com%2Fproducts%2Fdetails%2Fvetoryl%25C2%25AE-capsules-%28trilostane%29-5-mg&usg=AFQjCNF_dZtbTrE1nFoe6Ksm7WYzSqgBFA

Available Dosage Forms

• Capsules: 5 mg, 10 mg, 30 mg, 60 mg

Dosage by Species

• Dogs (hyperadrenocorticism): 2.2–6.7 mg/kg orally every 24 hour; therapy may be initiated with ~1 mg/kg orally every 12 hours to minimize adverse effects.
• Dogs (Alopecia X): 3 mg/kg orally every 12 hours for 4–6 months.
• Cats: 0.5–12 mg/kg orally every 24 hours or every 12 hours.
• Horses: 120–240 mg orally every 24 hours.

Pharmacokinetic Parameters

Contraindications/Warnings

• Do not use in pregnant animals.
• Do not use in animals with primary hepatic disease or renal insufficiency.
• Intolerance to trilostane therapy or overdosage has resulted in death. Pet owners should consult a veterinarian immediately if any signs of possible toxicity are observed.

Pregnancy Category

• Category X: inhibition of progesterone synthesis can result in miscarriage.

Drug Interactions

Storage/Stability

• Store at controlled room temperature (77°F). Excursions are permitted between 59°F and 86°F.

Regulatory Considerations

• New Animal Drug Application (NADA) #141-291.

Pergolide Mesylate Summary

Brand Name: Prascend
Manufacturer: Boehringer Ingelheim

Source: https://www.valleyvet.com/ct_detail.html?pgguid=e0f4888c-86de-4ce9-9013-6d947df697a8

Available Dosage Forms

• Scored oral tablet: 1 mg

Compounded Formulations

• Pergolide Compounded Oral Suspension, Veterinary, USP (1 mg/mL)

Dosage by Species

• Horses: 2–4 µg/kg orally every 24 hours, rounded to the nearest 0.5 mg (½ tablet).

Pharmacokinetic Parameters

Contraindications/Warnings

• Contraindicated in horses with allergy to ergot derivatives.

Pregnancy Category

• Safe use in breeding or lactating animals has not been determined.

Drug Interactions

Storage/Stability

• Store at or below 77°F.

Regulatory Considerations

• New Animal Drug Application (NADA) #141-331.
• ARCI (Association of Racing Commissioners International) has classified pergolide mesylate as a Class 3 substance.

Domperidone Summary

Brand Name: Equidone
Manufacturer: Dechra Animal Products

Source: http://www.dechra-us.com/products/horse/equidone-gel

Available Dosage Forms

• Oral gel: 110 mg/mL in a 26-mL oral dosing syringe (approximately 5 doses for the average adult mare)

Dosage by Species

• Horses (prevention of fescue toxicosis): 1.1 mg/kg orally every 24 hours, starting 10–15 days before expected foaling date. Treatment may continue for up to 5 days after foaling.
• Horses (diagnosis of PPID): 2.5 mg/kg orally as a single dose; ACTH level 4 hours post dosing.

Pharmacokinetic Parameters

Contraindications/Warnings

• Accurate breeding date and expected foaling date are needed for safe use. Domperidone may lead to premature birth, low birth weight foals, or foal morbidity if administered more than 15 days before the expected foaling date.
• Domperidone causes false positives on the milk calcium test used to predict foaling.
• Do not use in horses with gastrointestinal obstruction (domperidone is a prokinetic agent).

Pregnancy Category

• Safe use in breeding, pregnant, or lactating mares has not been determined (other than in last 45 days of pregnancy and first 15 days of lactation).

Drug Interactions

Storage/Stability

• Store at controlled room temperature (77°F). Excursions are permitted between 59°F and 86°F.
• Recap dosing syringe after each use.

Regulatory Considerations

• New Animal Drug Application (NADA) #141-314.
• ARCI (Association of Racing Commissioners International) has not classified this drug.

Oclacitinib Maleate Summary

Brand Name: Apoquel
Manufacturer: Zoetis Animal Health

Source: http://www.veterinarypracticenews.com/May-2014/Shortage-Of-Apoquel-Allergy-Drug-To-Last-Into-2015/

Available Dosage Forms

• Oral film-coated tablets: 3.6 mg, 5.4 mg, 16 mg

Dosage by Species

• Dogs: 0.4–0.6 mg/kg orally every 12 hours for 14 days, then every 24 hours (often accomplished by administering half of the dose in the morning and half in the evening, rather than the whole dose once daily).
• Cats: 0.4–0.6 mg/kg orally every 12 hours; not labeled for use in cats.

Pharmacokinetic Parameters

Contraindications/Warnings

• Not for use in breeding dogs or pregnant or lactating bitches.
• Do not use in dogs younger than 12 months of age.
• Do not use in dogs with serious infections or neoplasia.
• Concurrent use with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents has not been evaluated and may increase risks from immunosuppression.

Pregnancy Category

• Category X.

Drug Interactions

• No drug interactions were observed when oclacitinib was administered concurrently with endoparasiticides, ectoparasiticides, antimicrobial agents, or anti-inflammatory agents during field studies.13
• Although not evaluated directly, it is possible that concurrent use with glucocorticoids, cyclosporine, or other systemic immunosuppressive agents could increase risks from immunosuppression.

Storage/Stability

• Store at controlled room temperature between 68°F and 77°F. Excursions are permitted between 59F° and 104°F.

Regulatory Considerations

• New Animal Drug Application (NADA) #141-345.
• ARCI (Association of Racing Commissioners International) has not classified this drug.

Maropitant Summary

Brand Name: Cerenia
Manufacturer: Zoetis Animal Health

Source: https://www.zoetisus.com/products/dogs/cerenia.aspx

Available Dosage Forms

• Oral scored tablets: 16 mg, 24 mg, 60 mg, 160 mg
• Injectable solution: 10 mg/mL

Dosage by Species

• Dogs (acute vomiting): 2 mg/kg orally or 1 mg/kg by subcutaneous or intravenous injection every 24 hours.
• Dogs (motion sickness): 8 mg/kg orally every 24 hours for a total of two doses. Dogs must be fasted 1 hour before administration; administration must occur 2 hours before travel (owner must remove access to food 3 hours before travel).
• Cats: 1 mg/kg by subcutaneous or intravenous injection every 24 hours.

Pharmacokinetic Parameters

Contraindications/Warnings

• Do not use in puppies younger than 16 weeks of age because of a higher risk of myelosuppression.
• Use with caution in animals with cardiovascular disease; maropitant can prolong the QT interval.
• Use with caution in animals with compromised hepatic function.
• Keep potential toxins away from pets treated with maropitant. It is not possible to induce vomiting in animals receiving maropitant.

Pregnancy Category

• Safe use in breeding or lactating animals has not been determined.

Drug Interactions

Storage/Stability

• Store tablets at controlled room temperature (68°F–77°F). Excursions are permitted between 59°F and 86°F.
• Store injectable solution at controlled room temperature (68°F–77°F). Excursions are permitted between 59°F and 86°F. After first vial puncture, store solution at refrigerated temperature (36°F–46°F). Use within 90 days of first vial puncture; stopper may be punctured a maximum of 25 times.

Regulatory Considerations

• New Animal Drug Application (NADA) #141-262 (tablets), #141-263 (injection).
• ARCI (Association of Racing Commissioners International) has not classified this drug.

Cisapride Summary

Compounded Formulations

• Cisapride Compounded Oral Suspension, Veterinary, USP (10 mg/mL)
• Cisapride Compounded Injection, Veterinary, USP (3 mg/mL)

Dosage by Species

• Dogs: 0.5–1 mg/kg orally or by intravenous injection every 8 hours.
• Cats: 2.5–7.5 mg (not weight-based) orally every 8–12 hours; 1 mg/kg by intravenous injection every 8–12 hours.
• Horses: 0.1–0.4 mg/kg by intravenous injection every 8–12 hours.17
• Mice, Rats, Gerbils, Hamsters, Guinea Pigs, Chinchillas, Rabbits: 0.1–0.5 mg/kg orally every 12 hours.18

Pharmacokinetic Parameters

Contraindications/Warnings

• Contraindicated in animals with gastrointestinal obstruction, hemorrhage, or perforation.

Pregnancy Category

• Category C.

Drug Interactions

Storage/Stability

• Store compounded oral suspension and injection in the refrigerator (36°F–46°F).
• Shake oral suspension well before administering.

Regulatory Considerations

• ARCI (Association of Racing Commissioners International) has not classified this drug.

Potassium Bromide Summary

Compounded Formulations

• Potassium Bromide Compounded Oral Solution, Veterinary, USP (250mg/mL)

Dosage by Species

• Dogs (loading dose): 400–600 mg/kg orally, administered as several daily doses over 1–5 days. Administer with food.
• Dogs (maintenance dose): 30–35 mg/kg orally every 24 hours or divided into 2 equal doses. Administer with food.

Pharmacokinetic Parameters

Contraindications/Warnings

• Bromide toxicity (bromism) may occur at blood levels exceeding 2.5 mg/mL.
• Do not administer solution with evidence of precipitation (bromide crystals) to avoid bromide toxicity.
• Hyperkalemia is possible during the initial loading period. Foods and supplements that contain potassium—as well as potassium-sparing diuretics—should be avoided.
• Bromides usually are administered as oral liquids. Solid dosage forms—especially large gelatin capsules—could lodge in the esophagus and cause erosion.

Pregnancy Category

• Safe use in breeding or lactating animals has not been determined.

Drug Interactions

Storage/Stability

• Store potassium bromide in a moisture-resistant container at room temperature (59°F–86°F) or in the refrigerator (36°F–46°F).

Regulatory Considerations

• ARCI (Association of Racing Commissioners International) has not classified this drug.

Pimobendan Summary

Brand Name: Vetmedin
Manufacturer: Boehringer Ingelheim

Source: http://www.vetmedin.com/safety_and_dosing/dosage.aspx

Available Dosage Forms

• Oral beef-flavored scored tablets: 1.25 mg, 2.5 mg, 5 mg, 10 mg

Dosage by Species

• Dogs: 0.25 mg/kg orally every 12 hours (labeled dose); 0.3 mg/kg orally every 8 hours (ACVIM).
• Cats: 0.25 mg/kg orally every 12 hours; typical dose per cat is 1.25 mg.

Pharmacokinetic Parameters

Contraindications/Warnings

• For use in dogs diagnosed with congestive heart failure only. Laboratory studies in normal dogs showed cardiovascular pathology when pimobendan was administered at higher doses.
• Do not administer to animals with hypertrophic cardiomyopathy, aortic stenosis, or any other clinical condition in which an augmentation of cardiac output is inappropriate for functional or anatomical reasons.
• Safe use of pimobendan has not been evaluated in dogs younger than 6 months of age or dogs with diabetes or other serious metabolic disease.

Pregnancy Category

• Safe use in breeding or lactating animals has not been determined.

Drug Interactions

Storage/Stability

• Store at room temperature (68°F–77°F). Excursions are permitted between 59°F and 86°F.

Regulatory Considerations

• New Animal Drug Application (NADA) #141-273.
• ARCI (Association of Racing Commissioners International) has not classified this drug.

Clenbuterol Summary

Brand Name: Ventipulmin
Manufacturer: Boehringer Ingelheim

Source: https://www.valleyvet.com/ct_detail.html?pgguid=2e87bed2-7b6a-11d5-a192-00b0d0204ae5

Available Dosage Forms

• Oral solution: 72.5 µg/mL

Dosage by Species

• Horses (airway obstruction): 0.8 µg/kg orally every 12 hours.
• Horses (pregnant mares with dystocia): 10 mL orally as a single dose.

Pharmacokinetic Parameters

Contraindications/Warnings

• Use in food-producing animals is prohibited.
• Use with caution in horses with cardiac disease because of risk of tachycardia.

Pregnancy Category

• Safe use in breeding or lactating animals has not been determined.

Drug Interactions

Storage/Stability

• Store at or below 77°F. Avoid freezing.

Regulatory Considerations

• New Animal Drug Application (NADA) #140-973.
• ARCI (Association of Racing Commissioners International) has classified clenbuterol as a Class 3 substance.

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