Dexmedetomidine Hcl Recall
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Questions & Answers
Side Effects & Adverse Reactions
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 1-866-683-0660.
Note to physician: This product contains an alpha2-adrenergic agonist.
Animal safety: Dexmedetomidine hydrochloride should not be administered in the presence of preexisting hypotension, hypoxia, or bradycardia. Due to the pronounced cardiovascular effects of dexmedetomidine hydrochloride, 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 hydrochloride sedation is not recommended for cats with respiratory disease.
The use of dexmedetomidine hydrochloride 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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
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.
There is currently no usage information available for this product. We apologize for any inconvenience.
There is currently no drug history available for this drug.
DESCRIPTION: Dexmedetomidine HCl (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:
Each mL of Dexmedetomidine HCl 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.