Dexdomitor RX

Dexdomitor RX  is used for clinical procedures, minor surgical procedures, and minor dental procedures as a sedative and analgesic for dogs and cats.

DEXDOMITOR® (dexmedetomidine hydrochloride) Injectable

Description
Injectable sedative and analgesic for dogs (IM or IV) and cats (IM)
Injectable preanesthetic for dogs (IM)
Non-opioid synthetic alpha 2 adrenoreceptor agonist produces dose-dependent sedation and analgesia.

Approved Uses
DEXDOMITOR is approved for:
Use as a sedative and analgesic in dogs and cats to facilitate clinical examinations, clinical procedures, minor surgical procedures, and minor dental procedures. DEXDOMITOR is also indicated for use as a preanesthetic in dogs prior to general anesthesia.

Examples of actual uses of DEXDOMITOR as a sedative and analgesic in dogs include:

Oral exam, treatment
Radiographs
Skin treatments (biopsies, scrapings, etc.)
Ear exam, treatment
Grooming (bathing, nail trims)
Ophthalmic exam, treatment
Anal gland treatment
Other (orthopedic, bandage change, enemas) 

Examples of actual uses of DEXDOMITOR as a sedative and analgesic in cats include:

Oral exam, treatment
Grooming and bathing
Abscess treatment, suture removal, or skin biopsy
Radiography and ultrasound
Ear examination and treatment of otitis
Other diagnostic procedures or treatment
Key Features
FDA-approved for sedation and analgesia in dogs
Proven safe and effective in dogs as young as 16 weeks of age
Effects observed within 5 minutes
Peak effects observed at 15 minutes (IV) and 30 minutes (IM)
Recovery without  Antisedan  (atipamezole hydrochloride) occurred by 180 minutes (IV) and +180 minutes (IM)
FDA-approved for sedation and analgesia in cats
Proven safe and effective in cats as young as 12 weeks of age
Effects observed within 5 minutes
Peak effects observed at 15 - 60 minutes
Recovery occurred by 180 minutes 
FDA-approved as a preanesthetic in dogs
Approved for concurrent use with commonly used induction and anesthetic agents
Markedly reduces anesthetic requirements (30% – 60%)
based on DEXDOMITOR dose and type of induction or inhalant agent
The concurrent use of DEXDOMITOR prior to or with an anesthetic or its use in the presence of other sedatives has not been evaluated in cats
Reversible with Antisedan
Antisedan is FDA-approved for use in dogs only
Packaging

10 mL multidose vials containing 0.5 mg of dexmedetomidine hydrochloride per mL.

Dosage and Administration
Same dose volume as DOMITOR
Flexible dosing options:
Sedative and analgesic dose in dogs
375 mcg/m2 IV
500 mcg/ m2 IM
Sedative and analgesic dose in cats
40 mcg/kg IM
Preanesthetic dose in dogs
125 mcg/m2 IM
375 mcg/m2 IM

The choice of preanesthetic dose depends on:
Patient disposition
Severity of procedure
Duration of procedure
Anesthetic protocol

Caution
See label instructions for complete cautions, contraindications, warnings and precautions.
Federal law restricts this drug to use by or on the order of a licensed veterinarian

Contraindications
DEXDOMITOR should not be used in dogs and cats with cardiovascular disease, respiratory disorders, liver or kidney diseases, shock, severe debilitation or in dogs and cats under stress due to extreme heat, cold or fatigue

As with all alpha2-adrenoceptor agonists, the potential for isolated cases of hypersensitivity, including paradoxical response (excitation), exists

Warnings
Not for human use. Keep out of reach of children.

DEXDOMITOR can be absorbed by humans and may cause irritation following direct exposure to skin, eyes or mouth. In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing.

Appropriate precaution should be taken while handling and using filled syringes. In case of accidental topical exposure, oral exposure or exposure by injection, seek medical attention.

Users with cardiovascular disease (e.g., hypertension or ischemic heart disease) should take special precautions to avoid any exposure to this product

Caution should be exercised when handling sedated animals. Handling or any other sudden stimuli may cause a defense reaction in an animal that is sedated.

Precautions
The use of DEXDOMITOR prior to or with anesthetic or other sedatives has not been evaluated in cats. DEXDOMITOR sedation is not recommended for cats with respiratory disease.

Only clinically healthy dogs and cats should be treated. Animals should be frequently monitored for cardiovascular function and body temperature during sedation and analgesia.

Nervous or excited animals with high levels of endogenous catecholamines may exhibit a reduced pharmacological response to alpha2–adrenoceptor agonists like DEXDOMITOR or DOMITOR. In agitated animals, the onset of sedative/analgesic effects could be slowed, or the depth and duration of effects could be diminished or non-existent.

Allow dogs and cats to rest quietly for 10-15 minutes after injection. Repeat dosing has not been evaluated.

The use of DEXDOMITOR as a preanesthetic significantly reduces the amount of induction and maintenance anesthetic requirements. Careful patient monitoring during anesthetic induction and maintenance is necessary to avoid anesthetic overdose.

The routine use of anticholinergics simultaneously with or after DEXDOMITOR administration in dogs is not recommended as it could lead to adverse cardiovascular effects. An anticholinergic drug may be administered at least 10 minutes before DEXDOMITOR to prevent DEXDOMITOR-induced bradycardia. The use of anticholinergics in the presence of DEXDOMITOR has not been evaluated in cats.

DEXDOMITOR has not been evaluated for use in breeding, pregnant or lactating dogs or cats.

Related Products

The first generation alpha2-agonist, DOMITOR® (medetomidine hydrochloride) is FDA-approved as a sedative and analgesic in dogs.

Companion product  Antisedan following IM administration produces rapid reversal of sedative and analgesic effects in dogs

Important Safety Information

As with other a2-agonists, bradycardia with occasional atrioventricular blockade can occur along with decreased respiratory rates. In approximately 10% of treated dogs, vomiting may occur between 5 and 10 minutes post-treatment with DOMITOR. Refer to the full prescribing information for additional details.

Occasional vomiting may occur with  Antisedan use. Rarely, brief state of excitement or apprehensiveness may be seen in treated dogs. Other potential side effects of a2-antagonists include hypersalivation, diarrhea, and tremors.

Prescriptions items are NONREFUNDABLE and NONRETURNABLE.