Dexmedetomidine Hydrochloride Injection 100 mcg/mL

1.1 Intensive Care Unit Sedation Dexmedetomidine injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine injection should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine injection has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue dexmedetomidine injection prior to extubation. 1.2 Procedural Sedation Dexmedetomidine injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. …

• Dosing Guidelines • Dexmedetomidine injection dosing should be individualized and titrated to desired clinical response. • Dexmedetomidine injection is not indicated for infusions lasting longer than 24 hours. • Dexmedetomidine injection should be administered using a controlled infusion device
• Dosage Information Table 1: Dosage Information INDICATION DOSAGE AND ADMINISTRATION Initiation of Intensive Care Unit Sedation For adult patients: a loading infusion of one mcg/kg over 10 minutes
• For adult patients being converted from alternate sedative therapy: a loading dose may not be required
• For patients over 65 years of age: a dose reduction should be considered [see Use in Specific Populations ]
• For adult patients with impaired hepatic function: a dose reduction should be considered [see Use in Specific Populations , Clinical Pharmacology ]
• Maintenance of Intensive Care Unit Sedation For adult patients: a maintenance infusion of 0.2 to 0.7 mcg/kg/hour
• The rate of the maintenance infusion should be adjusted to achieve the desired level of sedation
• For patients over 65 years of age: a dose reduction should be considered [see Use in Specific Populations ]
• For adult patients with impaired hepatic function: a dose reduction should be considered [see Use in Specific Populations , Clinical Pharmacology ]
• Initiation of Procedural Sedation For adult patients: a loading infusion of one mcg/kg over 10 minutes. …

Dexmedetomidine Injection, USP is clear and colorless and is available as follows. Dexmedetomidine Injection, USP 200 mcg/2 mL (100 mcg/mL) in a glass vial with pink cap. To be used after dilution. Dexmedetomidine Injection, USP 200 mcg/2 mL (100 mcg/mL) in a glass vial with pink cap. To be used after dilution. ( 3 )

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7.1 Anesthetics, Sedatives, Hypnotics, Opioids Co-administration of dexmedetomidine injection with anesthetics, sedatives, hypnotics, and opioids is likely to lead to an enhancement of effects. Specific studies have confirmed these effects with sevoflurane, isoflurane, propofol, alfentanil, and midazolam. No pharmacokinetic interactions between dexmedetomidine injection and isoflurane, propofol, alfentanil and midazolam have been demonstrated. However, due to possible pharmacodynamic interactions, when co-administered with dexmedetomidine injection, a reduction in dosage of dexmedetomidine injection or the concomitant anesthetic, sedative, hypnotic or opioid may be required. …

5.1 Drug Administration Dexmedetomidine injection should be administered only by persons skilled in the management of patients in the intensive care or operating room setting. Due to the known pharmacological effects of dexmedetomidine injection, patients should be continuously monitored while receiving dexmedetomidine injection. 5.2 Hypotension, Bradycardia, and Sinus Arrest Clinically significant episodes of bradycardia and sinus arrest have been reported with dexmedetomidine injection administration in young, healthy adult volunteers with high vagal tone or with different routes of administration including rapid intravenous or bolus administration. …

The following clinically significant adverse reactions are described elsewhere in the labeling: • Hypotension, bradycardia and sinus arrest [ see Warnings and Precautions ( 5.2 )] • Transient hypertension [see Warnings and Precautions ( 5.3 )] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of dexmedetomidine injection use in pregnant women. In an in vitro human placenta study, placental transfer of dexmedetomidine occurred. In a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. …

The tolerability of dexmedetomidine injection was studied in one study in which healthy adult subjects were administered doses at and above the recommended dose of 0.2 to 0.7 mcg/kg/hr. The maximum blood concentration achieved in this study was approximately 13 times the upper boundary of the therapeutic range. The most notable effects observed in two subjects who achieved the highest doses were first degree atrioventricular block and second degree heart block. No hemodynamic compromise was noted with the atrioventricular block and the heart block resolved spontaneously within one minute. …

9.1 Controlled Substance Dexmedetomidine injection (dexmedetomidine hydrochloride) is not a controlled substance. 9.3 Dependence The dependence potential of dexmedetomidine injection has not been studied in humans. However, since studies in rodents and primates have demonstrated that dexmedetomidine injection exhibits pharmacologic actions similar to those of clonidine, it is possible that dexmedetomidine injection may produce a clonidine-like withdrawal syndrome upon abrupt discontinuation [see …

Tome assim que lembrar, a menos que esteja quase na hora da próxima dose. Nesse caso, pule a dose esquecida. Nunca tome duas doses de uma vez para compensar. Confira a bula, pois alguns medicamentos são diferentes.