Precedex

>10%

Hypotension (28%)

1-10%

AFib

Anemia

Bradycardia

Fever

Pleural effusion

Leukocytosis

Pulmonary edema

Postmarketing Reports

Electrocardiogram QT prolonged

Hypernatremia

Polyuria

Acute renal failure

Respiratory distress syndrome

Respiratory failure

Mechanism of Action

Centrally acting alpha2-adrenoceptor agonist that has sedative and anesthetic properties possibly by activating G-proteins in the brainstem, which results in the inhibition of norepinephrine release

Pharmacokinetics

Half-life, elimination: 6 min; 2 hr (terminal)

Peak plasma: 0.3-1.5 ng/mL

Protein bound: 94%

Vd: 118 L

Metabolism: Liver, including glucuronidation and CYP2A6

Metabolites: 3-hydroxy, 3-carboxy, 3-hydroxy N-methyl, 3-carboxy N-methyl, and N-methyl O-glucuronide dexmedetomidine

Total body clearance: 39 L/hr

Excretion: Urine (95%); feces (4%)

Follow the doctor's instructions about any restrictions on food, beverages, or activity.

Dexmedetomidine can interact with other drugs that can cause drowsiness or slowed breathing, leading to dangerous side effects or death. Ask a doctor before giving the patient a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with dexmedetomidine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of the patient's health care providers about all medicines in use now and any medicine the patient starts or stops using.

• Dose-related sedative, anxiolytic, analgesic, and anesthetic-sparing effects;2 3 5 6 8 13 does not appear to reduce dosage requirements of skeletal muscle relaxants.3 12

• Helps maintain intraoperative hemodynamic stability by blunting sympathetic response to surgery.2 3 5 6 8 13

• Does not cause respiratory depression in healthy individuals when given by IV infusion in recommended dosages.1

• Compared with clonidine, dexmedetomidine has a shorter half-life2 3 5 (about 2 versus 8–12 hours)2 3 6 and greater α2-selectivity, with potential for reduced incidence of undesirable α1-adrenergic effects (e.g., hypotension, bradycardia).3

• Exhibits α2-selectivity when given by slow IV infusion in low to moderate doses (10–300 mcg/kg); selectivity diminishes at 12 high doses (e.g., 1000 mcg/kg) or with rapid IV administration.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant diseases.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing patients of other important precautionary information. (See Cautions.)1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

• It is used to cause sleep during care.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Trouble breathing, slow breathing, or shallow breathing.
• Slow heartbeat.
• A heartbeat that does not feel normal.
• Fever.
• Feeling agitated.
• Feeling nervous and excitable.
• Headache.
• Call your doctor right away if you have any of these signs within 48 hours after getting Precedex: Change in thinking clearly and with logic, constipation, diarrhea, dizziness, salt cravings, stomach pain, sweating, weakness, or weight loss.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

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.

Precedex is indicated for short-term intravenous sedation. Dosage must be individualized and titrated to the desired clinical effect. Blood pressure, heart rate and oxygen levels will be monitored both continuously during the infusion of Precedex and as clinically appropriate after discontinuation.

Manufactured and Distributed by:
Hospira, Inc.
Lake Forest, IL 60045 USA

Licensed from:
Orion Corporation
Espoo, Finland
                                                                                       EN-4272
Hospira, Inc., Lake Forest, IL 60045 USA                                                                                                          

Applies to dexmedetomidine: parenteral injection concentrate

Side effects include:

Hypotension, hypertension, nausea, bradycardia, fever, vomiting, hypoxia, tachycardia, anemia.