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Precedex

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Precedex

SIDE EFFECTS

Clinical Studies 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 clinical trials of another drug and may not reflect the rates observed in practice.

Use of Precedex has been associated with the following serious adverse reactions:

Most common treatment-emergent adverse reactions, occurring in greater than 2% of patients in both Intensive Care Unit and procedural sedation studies include hypotension, bradycardia and dry mouth.

Intensive Care Unit Sedation

Adverse reaction information is derived from the continuous infusion trials of Precedex for sedation in the Intensive Care Unit setting in which 1007 adult patients received Precedex. The mean total dose was 7.4 mcg/kg (range: 0.8 to 84.1), mean dose per hour was 0.5 mcg/kg/hr (range: 0.1 to 6.0) and the mean duration of infusion of 15.9 hours (range: 0.2 to 157.2). The population was between 17 to 88 years of age, 43% ≥ 65 years of age, 77% male and 93% Caucasian. Treatment-emergent adverse reactions occurring at an incidence of > 2% are provided in Table 2. The most frequent adverse reactions were hypotension, bradycardia and dry mouth [see WARNINGS AND PRECAUTIONS].

Table 2: Adverse Reactions With an Incidence > 2%—Adult Intensive Care Unit Sedation Population < 24 hours*

Adverse Event All Precedex
(N = 1007) (%)
Randomized Precedex
(N = 798) (%)
Placebo
(N = 400) (%)
Propofol
(N = 188) (%)
Hypotension 25% 24% 12% 13%
Hypertension 12% 13% 19% 4%
Nausea 9% 9% 9% 11%
Bradycardia 5% 5% 3% 0
Atrial fibrillation 4% 5% 3% 7%
Pyrexia 4% 4% 4% 4%
Dry mouth 4% 3% 1% 1%
Vomiting 3% 3% 5% 3%
Hypovolemia 3% 3% 2% 5%
Atelectasis 3% 3% 3% 6%
Pleural effusion 2% 2% 1% 6%
Agitation 2% 2% 3% 1%
Tachycardia 2% 2% 4% 1%
Anemia 2% 2% 2% 2%
Hyperthermia 2% 2% 3% 0
Chills 2% 2% 3% 2%
Hyperglycemia 2% 2% 2% 3%
Hypoxia 2% 2% 2% 3%
Post-procedural hemorrhage 2% 2% 3% 4%
Pulmonary edema 1% 1% 1% 3%
Hypocalcemia 1% 1% 0 2%
Acidosis 1% 1% 1% 2%
Urine output decreased 1% 1% 0 2%
Sinus tachycardia 1% 1% 1% 2%
Ventricular tachycardia < 1% 1% 1% 5%
Wheezing < 1% 1% 0 2%
Edema peripheral < 1% 0 1% 2%
* 26 subjects in the all Precedex group and 10 subjects in the randomized Precedex group had exposure for greater than 24 hours.

Adverse reaction information was also derived from the placebo-controlled, continuous infusion trials of Precedex for sedation in the surgical intensive care unit setting in which 387 adult patients received Precedex for less than 24 hours. The most frequently observed treatment-emergent adverse events included hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia and anemia (see Table 3).

Table 3: Treatment-Emergent Adverse Events Occurring in > 1% Of All Dexmedetomidine-Treated Adult Patients in the Randomized Placebo-controlled Continuous Infusion < 24 Hours ICU Sedation Studies

Adverse Event Randomized Dexmedetomidine
(N = 387)
Placebo
(N = 379)
Hypotension 28% 13%
Hypertension 16% 18%
Nausea 11% 9%
Bradycardia 7% 3%
Fever 5% 4%
Vomiting 4% 6%
Atrial Fibrillation 4% 3%
Hypoxia 4% 4%
Tachycardia 3% 5%
Hemorrhage 3% 4%
Anemia 3% 2%
Dry Mouth 3% 1%
Rigors 2% 3%
Agitation 2% 3%
Hyperpyrexia 2% 3%
Pain 2% 2%
Hyperglycemia 2% 2%
Acidosis 2% 2%
Pleural Effusion 2% 1%
Oliguria 2% < 1%
Thirst 2% < 1%

In a controlled clinical trial, Precedex was compared to midazolam for ICU sedation exceeding 24 hours duration in adult patients. Key treatment emergent adverse events occurring in dexmedetomidine or midazolam treated patients in the randomized active comparator continuous infusion long-term intensive care unit sedation study are provided in Table 4. The number (%) of subjects who had a dose-related increase in treatment-emergent adverse events by maintenance adjusted dose rate range in the Precedex group is provided in Table 5.

Table 4: Key Treatment-Emergent Adverse Events Occurring in Dexmedetomidine- or Midazolam-Treated Adult Patients in the Randomized Active Comparator Continuous Infusion Long-Term Intensive Care Unit Sedation Study*

Adverse Event Dexmedetomidine
(n=244)
Midazolam
(n=122)
Hypotension1 56% 56%
Hypotension requiring intervention 28% 27%
Bradycardia2 42% 19%
Bradycardia requiring intervention 5% 1%
Systolic Hypertension3 28% 42%
Tachycardia4 25% 44%
Tachycardia requiring intervention 10% 10%
Diastolic Hypertension3 12% 15%
Hypertension3 11% 15%
Hypertension requiring intervention† 19% 30%
Hypokalemia 9% 13%
Pyrexia 7% 2%
Agitation 7% 6%
Hyperglycemia 7% 2%
Constipation 6% 6%
Hypoglycemia 5% 6%
Respiratory Failure 5% 3%
Renal Failure Acute 2% 1%
Acute Respiratory Distress Syndrome 2% 1%
Generalized edema 2% 6%
Hypomagnesemia 1% 7%
† Includes any type of hypertension.
1Hypotension was defined in absolute terms as Systolic blood pressure of < 80 mmHg or Diastolic blood pressure of < 50 mmHg or in relative terms as < 30% lower than pre-study drug infusion value.
2Bradycardia was defined in absolute terms as < 40 bpm or in relative terms as < 30% lower than pre-study drug infusion value.
3Hypertension was defined in absolute terms as Systolic blood pressure > 180 mmHg or Diastolic blood pressure of > 100 mmHg or in relative terms as > 30% higher than pre-study drug infusion value.
4Tachycardia was defined in absolute terms as > 120 bpm or in relative terms as > 30% greater than pre-study drug infusion value.

The following adverse events occurred between 2 and 5% for Precedex and Midazolam, respectively: renal failure acute (2.5%, 0.8%), acute respiratory distress syndrome (2.5%, 0.8%), and respiratory failure (4.5%, 3.3%).

Table 5: Number (%) of adult subjects who had a dose-related increase in Treatment Emergent Adverse Events by maintenance adjusted dose rate range in the Precedex group

Adverse Event Precedex mcg/kg/hr
≤ 0.7*
N = 95
> 0.7 to ≤ 1.1*
N = 78
> 1.1*
N = 71
Constipation 6% 5% 14%
Agitation 5% 8% 14%
Anxiety 5% 5% 9%
Oedema peripheral 3% 5% 7%
Atrial fibrillation 2% 4% 9%
Respiratory failure 2% 6% 10%
Acute Respiratory Distress Syndrome 1% 3% 9%
*Average maintenance dose over the entire study drug administration

Procedural Sedation

Adverse reaction information is derived from the two trials for procedural sedation in which 318 adult patients received Precedex. The mean total dose was 1.6 mcg/kg (range: 0.5 to 6.7), mean dose per hour was 1.3 mcg/kg/hr (range: 0.3 to 6.1) and the mean duration of infusion of 1.5 hours (range: 0.1 to 6.2). The population was between 18 to 93 years of age, 30% ≥ 65 years of age, 52% male and 61% Caucasian.

Treatment-emergent adverse reactions occurring at an incidence of > 2% are provided in Table 6. The most frequent adverse reactions were hypotension, bradycardia, and dry mouth [see WARNINGS AND PRECAUTIONS]. Pre-specified criteria for the vital signs to be reported as adverse reactions are footnoted below the table. The decrease in respiratory rate and hypoxia was similar between Precedex and comparator groups in both studies.

Table 6: Adverse Reactions With an Incidence > 2%—Procedural Sedation Population

Adverse Event Precedex
N = 318 (%)
Placebo
N = 113 (%)
Hypotension1 54% 30%
Respiratory depression2 37% 32%
Bradycardia3 14% 4%
Hypertension4 13% 24%
Tachycardia5 5% 17%
Nausea 3% 2%
Dry mouth 3% 1%
Hypoxia6 2% 3%
Bradypnea 2% 4%
1Hypotension was defined in absolute and relative terms as Systolic blood pressure of < 80 mmHg or < 30% lower than pre-study drug infusion value, or Diastolic blood pressure of < 50 mmHg.
2Respiratory depression was defined in absolute and relative terms as respiratory rate (RR) < 8 beats per minute or > 25% decrease from baseline.
3Bradycardia was defined in absolute and relative terms as < 40 beats per minute or < 30% lower than pre-study drug infusion value.
4Hypertension was defined in absolute and relative terms as Systolic blood pressure > 180 mmHg or > 30% higher than pre-study drug infusion value or Diastolic blood pressure of > 100 mmHg.
5Tachycardia was defined in absolute and relative terms as > 120 beats per minute or > 30% greater than pre-study drug infusion value.
6Hypoxia was defined in absolute and relative terms as SpO2 < 90% or 10% decrease from baseline.

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Precedex. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypotension and bradycardia were the most common adverse reactions associated with the use of Precedex during post approval use of the drug.

Table 7: Adverse Reactions Experienced During Post-approval Use of Precedex

Body System Preferred Term
Body as a Whole Fever, hyperpyrexia, hypovolemia, light anesthesia, pain, rigors
Cardiovascular Disorders, General Blood pressure fluctuation, heart disorder, hypertension, hypotension, myocardial infarction
Central and Peripheral Nervous System Disorders Dizziness, headache, neuralgia, neuritis, speech disorder, convulsion
Gastrointestinal System Disorders Abdominal pain, diarrhea, vomiting, nausea
Heart Rate and Rhythm Disorders Arrhythmia, ventricular arrhythmia, bradycardia, hypoxia, atrioventricular block, cardiac arrest, extrasystoles, atrial fibrillation, heart block, t wave inversion, tachycardia, supraventricular tachycardia, ventricular tachycardia
Liver and Biliary System Disorders Increased gamma-glutamyl transpepsidase, hepatic function abnormal, hyperbilirubinemia, alanine transaminase, aspartate aminotransferase
Metabolic and Nutritional Disorders Acidosis, respiratory acidosis, hyperkalemia, increased alkaline phosphatase, thirst, hypoglycemia
Psychiatric Disorders Agitation, confusion, delirium, hallucination, illusion
Red Blood Cell Disorders Anemia
Renal Disorders Blood urea nitrogen increased, oliguria
Respiratory System Disorders Apnea, bronchospasm, dyspnea, hypercapnia, hypoventilation, hypoxia, pulmonary congestion
Skin and Appendages Disorders Increased sweating
Vascular Disorders Hemorrhage
Vision Disorders Photopsia, abnormal vision

Read the Precedex (dexmedetomidine hydrochloride) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Anesthetics, Sedatives, Hypnotics, Opioids

Co-administration of Precedex 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 Precedex and isoflurane, propofol, alfentanil and midazolam have been demonstrated. However, due to possible pharmacodynamic interactions, when co-administered with Precedex, a reduction in dosage of Precedex or the concomitant anesthetic, sedative, hypnotic or opioid may be required.

Neuromuscular Blockers

In one study of 10 healthy adult volunteers, administration of Precedex for 45 minutes at a plasma concentration of one ng/mL resulted in no clinically meaningful increases in the magnitude of neuromuscular blockade associated with rocuronium administration.

Drug Abuse And Dependence

Controlled Substance

Precedex (dexmedetomidine hydrochloride) is not a controlled substance.

Dependence

The dependence potential of Precedex has not been studied in humans. However, since studies in rodents and primates have demonstrated that Precedex exhibits pharmacologic actions similar to those of clonidine, it is possible that Precedex may produce a clonidine-like withdrawal syndrome upon abrupt discontinuation [see WARNINGS AND PRECAUTIONS].

Last reviewed on RxList: 7/2/2013
This monograph has been modified to include the generic and brand name in many instances.

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