Dexdomitor label

Dexdomitor

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Side Effects & Adverse Reactions

WARNINGS:

Human safety: Not for human use. Keep out of reach of children.

Dexmedetomidine hydrochloride can be absorbed following direct exposure to skin, eyes, or mouth, and may cause irritation. 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 precautions should be taken while handling and using filled syringes. Accidental topical (including ocular) exposure, oral exposure, or exposure by injection could cause adverse reactions, including sedation, hypotension, and bradycardia. Seek medical attention immediately.

Users with cardiovascular disease (for example, 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, including noise, may cause a defense reaction in an animal that appears to be heavily sedated.

The material safety data sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users or to obtain a copy of the MSDS for this product call 1-888-963-8471.

Note to physician: This product contains an alpha2-adrenergic agonist.

Animal safety: Dexmedetomidine should not be administered in the presence of preexisting hypotension, hypoxia, or bradycardia. Due to the pronounced cardiovascular effects of dexmedetomidine, only clinically healthy dogs and cats (ASA classes I and II) should be treated. Animals should be frequently monitored for cardiovascular function and body temperature during sedation or anesthesia. Dexmedetomidine sedation is not recommended for cats with respiratory disease.

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

WARNINGS:

Human safety: Not for human use. Keep out of reach of children.

Dexmedetomidine hydrochloride can be absorbed following direct exposure to skin, eyes, or mouth, and may cause irritation. 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 precautions should be taken while handling and using filled syringes. Accidental topical (including ocular) exposure, oral exposure, or exposure by injection could cause adverse reactions, including sedation, hypotension, and bradycardia. Seek medical attention immediately.

Users with cardiovascular disease (for example, 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, including noise, may cause a defense reaction in an animal that appears to be heavily sedated.

The material safety data sheet (MSDS) contains more detailed occupational safety information. To report adverse reactions in users or to obtain a copy of the MSDS for this product call 1-888-963-8471.

Note to physician: This product contains an alpha2-adrenergic agonist.

Animal safety: Dexmedetomidine should not be administered in the presence of preexisting hypotension, hypoxia, or bradycardia. Due to the pronounced cardiovascular effects of dexmedetomidine, only clinically healthy dogs and cats (ASA classes I and II) should be treated. Animals should be frequently monitored for cardiovascular function and body temperature during sedation or anesthesia. Dexmedetomidine sedation is not recommended for cats with respiratory disease.

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

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

There is currently no usage information available for this product. We apologize for any inconvenience.

History

There is currently no drug history available for this drug.

Other Information

DESCRIPTION: DEXDOMITOR (dexmedetomidine hydrochloride) is a synthetic alpha2-adrenoreceptor agonist with sedative and analgesic properties. The chemical name is (+)-4-[1-(2,3-dimethylphenyl) ethyl]-1H-imidazole monohydrochloride. It is a white, or almost white, crystalline, water soluble substance having a molecular weight of 236.7. The molecular formula is C13 H16 N2 ∙HCl and the structural formula is:

Chemical Structure

Each mL of DEXDOMITOR contains 0.5 mg dexmedetomidine hydrochloride, 1.6 mg methylparaben (NF), 0.2 mg propylparaben (NF), 9.0 mg sodium chloride (USP), and water for injection (USP), q.s.

DESCRIPTION: DEXDOMITOR (dexmedetomidine hydrochloride) is a synthetic alpha2-adrenoreceptor agonist with sedative and analgesic properties. The chemical name is (+)-4-[1-(2,3-dimethylphenyl) ethyl]-1H-imidazole monohydrochloride. It is a white, or almost white, crystalline, water soluble substance having a molecular weight of 236.7. The molecular formula is C13 H16 N2 ∙HCl and the structural formula is:

Chemical Structure

Each mL of DEXDOMITOR contains 0.1 mg dexmedetomidine hydrochloride, 2.0 mg methylparaben (NF), 0.2 mg propylparaben (NF), 9.0 mg sodium chloride (USP), and water for injection (USP), q.s.

Dexdomitor Manufacturers

  • Zoetis Inc
    Dexdomitor | Zoetis Inc
    No Recall

    Dexdomitor | Zoetis Inc

    Dexdomitor | Zoetis Inc

    DOSAGE AND ADMINISTRATION:

    Dogs: Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.

    The choice of preanesthetic dose depends on the duration and severity of the procedure, as well as the anesthetic regime. The following two tables may be used to determine the correct dexmedetomidine dosage. Note that the mcg/kg dosage decreases as body weight increases. For example, dogs weighing 2 kg are dosed at 28.1 mcg/kg dexmedetomidine IV, compared to dogs weighing 80 kg that are dosed at 8.7 mcg/kg. Due to the small volume of administration, accurate dosing is not possible in dogs weighing less than 2 kg (4.4 lb).

    Table 1: CANINE SEDATION/ANALGESIA DOSE TABLE: Intravenous (IV) and intramuscular (IM) dosing on the basis of body weight. DEXDOMITOR 0.5 mg/mL Sedation/analgesia in dogs Dog
    Weight Dexmedetomidine
    375 mcg/m2 IV Dexmedetomidine
    500 mcg/m2 IM lbs Kg mcg/kg mL mcg/kg mL 4.4-7 2-3 28.1 0.12 40 0.15 7.1-9 3.1-4 25 0.15 35 0.2 9.1-11 4.1-5 23 0.2 30 0.3 11.1-22 5.1-10 19.6 0.29 25 0.4 22.1-29 10.1-13 16.8 0.38 23 0.5 29.1-33 13.1-15 15.7 0.44 21 0.6 33.1-44 15.1-20 14.6 0.51 20 0.7 44.1-55 20.1-25 13.4 0.6 18 0.8 55.1-66 25.1-30 12.6 0.69 17 0.9 66.1-73 30.1-33 12 0.75 16 1 73.1-81 33.1-37 11.6 0.81 15 1.1 81.1-99 37.1-45 11 0.9 14.5 1.2 99.1-110 45.1-50 10.5 0.99 14 1.3 110.1-121 50.1-55 10.1 1.06 13.5 1.4 121.1-132 55.1-60 9.8 1.13 13 1.5 132.1-143 60.1-65 9.5 1.19 12.8 1.6 143.1-154 65.1-70 9.3 1.26 12.5 1.7 154.1-176 70.1-80 9 1.35 12.3 1.8 >176 >80 8.7 1.42 12 1.9 Table 2: CANINE PREANESTHESIA DOSE TABLE: Intramuscular (IM) dosing on the basis of body weight. DEXDOMITOR 0.5 mg/mL Preanesthesia in dogs Dog
    Weight Dexmedetomidine
    125 mcg/m2 IM Dexmedetomidine
    375 mcg/m2 IM lbs Kg mcg/kg mL mcg/kg mL 4.4-7 2-3 9.4 0.04 28.1 0.12 7.1-9 3.1-4 8.3 0.05 25 0.15 9.1-11 4.1-5 7.7 0.07 23 0.2 11.1-22 5.1-10 6.5 0.1 19.6 0.29 22.1-29 10.1-13 5.6 0.13 16.8 0.38 29.1-33 13.1-15 5.2 0.15 15.7 0.44 33.1-44 15.1-20 4.9 0.17 14.6 0.51 44.1-55 20.1-25 4.5 0.2 13.4 0.6 55.1-66 25.1-30 4.2 0.23 12.6 0.69 66.1-73 30.1-33 4 0.25 12 0.75 73.1-81 33.1-37 3.9 0.27 11.6 0.81 81.1-99 37.1-45 3.7 0.3 11 0.9 99.1-110 45.1-50 3.5 0.33 10.5 0.99 110.1-121 50.1-55 3.4 0.35 10.1 1.06 121.1-132 55.1-60 3.3 0.38 9.8 1.13 132.1-143 60.1-65 3.2 0.4 9.5 1.19 143.1-154 65.1-70 3.1 0.42 9.3 1.26 154.1-176 70.1-80 3 0.45 9 1.35 >176 >80 2.9 0.47 8.7 1.42

    The use of dexmedetomidine as a preanesthetic markedly reduces anesthetic requirements in dogs. Injectable induction drug requirements for intubation will be reduced between 30% and 60%, depending on the choice of anesthetic and the dexmedetomidine preanesthetic dose. The concentration of inhalation maintenance anesthetic will be reduced between 40% and 60%, depending on the dose of dexmedetomidine. The anesthetic dose should always be titrated against the response of the patient. The choice of anesthetic is left to the discretion of the veterinarian.

    Cats: Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM).

    This dose can also be used as a preanesthetic and has been shown to markedly reduce anesthetic requirements in cats. Injectable anesthetic drug requirements for intubation were reduced up to 49%, depending on the choice of induction drug. The concentration of inhalation maintenance anesthetic was reduced between 35% and 44%, depending on the choice of induction drug. The anesthetic dose should always be titrated against the response of the patient.

    The following table may be used to determine the correct dexmedetomidine dosage for cats based on body weight.

    Table 3: FELINE DOSE TABLE: Intramuscular (IM) dosing on the basis of body weight in cats. DEXDOMITOR 0.5 mg/mL Sedation/analgesia and preanesthesia in cats Cat
    Weight Dexmedetomidine
    40 mcg/kg IM lbs kg mcg/kg mL 2-4 1-2 40 0.1 4.1-7 2.1-3 40 0.2 7.1-9 3.1-4 40 0.3 9.1-13 4.1-6 40 0.4 13.1-15 6.1-7 40 0.5 15.1-18 7.1-8 40 0.6 18.1-22 8.1-10 40 0.7

    It is recommended that dogs and cats be fasted for 12 hours before treatment with DEXDOMITOR. An eye lubricant should be applied to cats to prevent corneal desiccation that may result from a reduction in the blink reflex. Following injection of DEXDOMITOR, the animal should be allowed to rest quietly for 15 minutes; sedation and analgesia occur within 5 to 15 minutes, with peak effects at 30 minutes after dexmedetomidine.

    DOSAGE AND ADMINISTRATION:

    Dogs: Sedation and Analgesia: 500 mcg/m2 intramuscularly (IM) or 375 mcg/m2 intravenously (IV). Preanesthesia: 125 or 375 mcg/m2 IM.

    The choice of preanesthetic dose depends on the duration and severity of the procedure, as well as the anesthetic regime. The following two tables may be used to determine the correct dexmedetomidine dosage. Note that the mcg/kg dosage decreases as body weight increases. For example, dogs weighing 2 kg are dosed at 28.1 mcg/kg dexmedetomidine IV, compared to dogs weighing 80 kg that are dosed at 8.7 mcg/kg. Due to the small volume of administration, accurate dosing is not possible in dogs weighing less than 2 kg (4.4 lb).

    Table 1: CANINE SEDATION/ANALGESIA DOSE TABLE: Intravenous (IV) and intramuscular (IM) dosing on the basis of body weight. DEXDOMITOR 0.1 mg/mL Sedation/analgesia in dogs Dog
    Weight Dexmedetomidine
    375 mcg/m2 IV Dexmedetomidine
    500 mcg/m2 IM lbs Kg mcg/kg mL mcg/kg mL 4.4-7 2-3 28.1 0.6 40 0.75 7.1-9 3.1-4 25 0.75 35 1 9.1-11 4.1-5 23 1 30 1.5 11.1-22 5.1-10 19.6 1.45 25 2 22.1-29 10.1-13 16.8 1.9

    For higher weight ranges, use DEXDOMITOR's higher concentration and its associated dosing chart.

    Table 2: CANINE PREANESTHESIA DOSE TABLE: Intramuscular (IM) dosing on the basis of body weight. DEXDOMITOR 0.1 mg/mL Preanesthesia in dogs Dog
    Weight Dexmedetomidine
    125 mcg/m2 IM Dexmedetomidine
    375 mcg/m2 IM lbs Kg mcg/kg mL mcg/kg mL 4.4-7 2-3 9.4 0.2 28.1 0.6 7.1-9 3.1-4 8.3 0.25 25 0.75 9.1-11 4.1-5 7.7 0.35 23 1 11.1-22 5.1-10 6.5 0.5 19.6 1.45 22.1-29 10.1-13 5.6 0.65 16.8 1.9 29.1-33 13.1-15 5.2 0.75 33.1-44 15.1-20 4.9 0.85

    For higher weight ranges, use DEXDOMITOR's higher concentration and its associated dosing chart.

    The use of dexmedetomidine as a preanesthetic markedly reduces anesthetic requirements in dogs. Injectable induction drug requirements for intubation will be reduced between 30% and 60%, depending on the choice of anesthetic and the dexmedetomidine preanesthetic dose. The concentration of inhalation maintenance anesthetic will be reduced between 40% and 60%, depending on the dose of dexmedetomidine. The anesthetic dose should always be titrated against the response of the patient. The choice of anesthetic is left to the discretion of the veterinarian.

    Cats: Sedation, Analgesia and Preanesthesia: 40 mcg/kg intramuscularly (IM).

    This dose can also be used as a preanesthetic and has been shown to markedly reduce anesthetic requirements in cats. Injectable anesthetic drug requirements for intubation were reduced up to 49%, depending on the choice of induction drug. The concentration of inhalation maintenance anesthetic was reduced between 35% and 44%, depending on the choice of induction drug. The anesthetic dose should always be titrated against the response of the patient.

    The following table may be used to determine the correct dexmedetomidine dosage for cats based on body weight.

    Table 3: FELINE DOSE TABLE: Intramuscular (IM) dosing on the basis of body weight in cats. DEXDOMITOR 0.1 mg/mL Sedation/analgesia and preanesthesia in cats Cat
    Weight Dexmedetomidine
    40 mcg/kg IM lbs kg mcg/kg mL 2-4 1-2 40 0.5 4.1-7 2.1-3 40 1

    For higher weight ranges, use DEXDOMITOR's higher concentration and its associated dosing chart.

    It is recommended that dogs and cats be fasted for 12 hours before treatment with DEXDOMITOR. An eye lubricant should be applied to cats to prevent corneal desiccation that may result from a reduction in the blink reflex. Following injection of DEXDOMITOR, the animal should be allowed to rest quietly for 15 minutes; sedation and analgesia occur within 5 to 15 minutes, with peak effects at 30 minutes after dexmedetomidine.