Precedex® is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Precedex® should be administered by continuous infusion not to exceed 24 hours.

Precedex® should be administered using a controlled infusion device.

Precedex® dosing should be individualized and titrated to the desired clinical effect. For adult patients, Precedex® is generally initiated with a loading infusion of 1 (one) mcg/kg over 10 minutes, followed by a maintenance infusion of 0.2 to 0.7 mcg/kg/hr. The rate of the maintenance infusion should be adjusted to achieve the desired level of sedation. Dexmedetomidine is not indicated for infusions lasting longer than 24 hours.

Precedex® has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue Precedex® prior to extubation provided the infusion does not exceed 24 hours.

Dosage Adjustment

Dosage reductions may need to be considered for patients with renal impairment and hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics and PRECAUTIONS, Hepatic Impairment).

Dilution Prior to Administration

Precedex® must be diluted in 0.9% sodium chloride solution prior to administration.

Preparation of solutions is the same, whether for the loading dose or maintenance infusion.

To prepare the infusion, withdraw 2 mL of Precedex® and add to 48 mL of 0.9% sodium chloride injection to a total of 50 mL. Shake gently to mix well.

Administration With Other Fluids

Compatibility of Precedex® with co-administration of blood, serum, or plasma has not been established. Precedex® has been shown to be compatible when administered with the following intravenous fluids and drugs:

5% dextrose in water, 0.9% sodium chloride in water, 20% mannitol, alfentanil hydrochloride, amikacin sulfate, aminophylline, amiodarone hydrochloride, ampicillin sodium, ampicillin sodium-sulbactam sodium, atracurium besylate, atropine sulfate, azithromycin, aztreonam, bretylium tosylate, bumetanide, butorphanol tartrate, calcium gluconate, cefazolin sodium, cefepime hydrochloride, cefoperazone sodium, cefotaxime sodium, cefotetan sodium, cefoxitin sodium, ceftazidime, ceftizoxime sodium, ceftriaxone sodium, cefuroxime sodium, chlorpromazine hydrochloride, cimetidine hydrochloride, ciprofloxacin, cisatracurium besylate, clindamycin phosphate, dexamethasone sodium phosphate, digoxin, diltiazem hydrochloride, diphenhydramine hydrochloride, dobutamine hydrochloride, dolasetron mesylate, dopamine hydrochloride, doxycycline hyclate, droperidol, enalaprilat, ephedrine hydrochloride, epinephrine hydrochloride, erythromycin lactobionate, esmolol, etomidate, famotidine, fenoldopam mesylate, fentanyl citrate, fluconazole, furosemide, gatifloxacin, gentamicin sulfate, glycopyrrolate bromide, granisetron hydrochloride, haloperidol lactate, heparin sodium, hydrocortisone sodium succinate, hydromorphone hydrochloride, hydroxyzine hydrochloride, inamrinone lactate, isoproterenol hydrochloride, ketorolac tromethamine, labetalol, lactated Ringer's solution, levofloxacin, lidocaine hydrochloride, linezolid, lorazepam, magnesium sulfate, meperidine hydrochloride, methylprednisolone sodium succinate, metoclopramide hydrochloride, metronidazole, midazolam, milrinone lactate, mivacurium chloride, morphine sulfate, nalbuphine hydrochloride, nitroglycerin, norepinephrine bitartrate, ofloxacin, ondansetron hydrochloride, pancuronium bromide, phenylephrine HCl, piperacillin sodium, piperacillin sodium-tazobactam sodium, potassium chloride, procainamide hydrochloride, prochlorperazine edisylate, promethazine hydrochloride, propofol, ranitidine hydrochloride, rapacuronium bromide, remifentanil hydrochloride, rocuronium bromide, sodium bicarbonate, sodium nitroprusside, succinylcholine, sufentanil citrate, sulfamethoxazole-trimethoprim, theophylline, thiopental sodium, ticarcillin disodium, ticarcillin disodium-clavulanate potassium, tobramycin sulfate, vancomycin hydrochloride, vecuronium bromide, verapamil hydrochloride, and a plasma-substitute.

Precedex® has been shown to be incompatible when administered with the following drugs: amphotericin B, diazepam.

Handling Procedures

Parenteral products should be inspected visually for particulate matter and discoloration prior to administration. Strict aseptic technique must always be maintained during handling of Precedex. Vials are intended for single use only.

Compatibility studies have demonstrated the potential for absorption of dexmedetomidine to some types of natural rubber. Although Precedex is dosed to effect, it is advisable to use administration components made with synthetic or coated natural rubber gaskets.

Precedex must be diluted in 0.9% sodium chloride solution to achieve the required concentrations prior to administration. Preparation of solutions is the same, whether for the loading dose or maintenance infusion (see DOSAGE AND ADMINISTRATION).

Precedex® (dexmedetomidine hydrochloride injection), 100 mcg/mL as the base is available in 2 mL clear glass vial.

Store at controlled room temperature, 25°C (77°F) with excursions allowed from 15 to 30°C (59 to 86°F). [See USP.]

Revised: April, 2004. Manufactured and Distributed by: Hospira, Inc., Lake Forest, IL 60045, USA. Licensed from: Orion Corporation Espoo, Finland. FDA rev date: 5/8/2001

Bookmark this page: