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Precedex (Dexmedetomidine Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Intensive Care Unit Sedation

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 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.

1.2Procedural Sedation

Precedex is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

DOSAGE AND ADMINISTRATION

Dosing Guidelines

  • Precedex dosing should be individualized and titrated to desired clinical response.

  • Precedex is not indicated for infusions lasting longer than 24 hours

  • Precedex 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 patients over 65 years of age: a dose reduction should be considered [ see Use in Specific Populations (8.5) ].

For patients with impaired hepatic or renal function: a dose reduction should be considered [ see Use in Specific Populations (8.5, 8.6, 8.7), Clinical Pharmacology (12.3) ].

Maintenance of Intensive Care Unit Sedation For adult patients: 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.

For patients over 65 years of age: a dose reduction should be considered [ see Use in Specific Populations (8.5) ].

For patients with impaired hepatic or renal function: a dose reduction should be considered [ see Use in Specific Populations (8.5, 8.6, 8.7), Clinical Pharmacology (12.3) ].

Initiation of Procedural Sedation For adult patients: a loading infusion of one mcg/kg over 10 minutes. For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 mcg/kg given over 10 minutes may be suitable.

For awake fiberoptic intubation patients: a loading infusion of one mcg/kg over 10 minutes.

For patients over 65 years of age: a loading infusion of 0.5 mcg/kg over 10 minutes [ see Use in Specific Populations (8.5) ].

For patients with impaired hepatic or renal function: a dose reduction should be considered [ see Use in Specific Populations (8.5, 8.6, 8.7), Clinical Pharmacology (12.3) ].

Maintenance of Procedural Sedation For adult patients: the maintenance infusion is generally initiated at 0.6 mcg/kg/hr and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/hr. The rate of the maintenance infusion should be adjusted to achieve the targeted level of sedation.

For awake fiberoptic intubation patients: a maintenance infusion of 0.7 mcg/kg/hr is recommended until the endotracheal tube is secured.

For patients over 65 years of age: a dose reduction should be considered [ see Use in Specific Populations (8.5) ].

For patients with impaired hepatic or renal function: a dose reduction should be considered [ see Use in Specific Populations (8.5, 8.6, 8.7), Clinical Pharmacology (12.3) ].

2.3Dosage Adjustment

Due to possible pharmacodynamic interactions, a reduction in dosage of Precedex or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered [ see Drug Interactions (7.1) ].

Dosage reductions may need to be considered for patients with renal or hepatic impairment, and geriatric patients [ see Warnings and Precautions (5.6), Use in Specific Populations (8.5, 8.6, 8.7), Clinical Pharmacology (12.3) ].

2.4Preparation of Solution

Precedex must be diluted in 0.9% sodium chloride solution to achieve required concentration (4 mcg/mL) prior to administration. Preparation of solutions is the same, whether for the loading dose or maintenance infusion.

Strict aseptic technique must always be maintained during handling of Precedex.

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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

2.5Administration with Other Fluids

Precedex infusion should not be co-administered through the same intravenous catheter with blood or plasma because physical compatibility has not been established.

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

Precedex has been shown to be compatible when administered with the following intravenous fluids and drugs:

0.9% sodium chloride in water, 5% dextrose 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 hydrochloride, 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.

2.6Compatibility with Natural Rubber

Compatibility studies have demonstrated the potential for absorption of Precedex 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.

DOSAGE FORMS AND STRENGTHS

200 mcg/2 mL (100 mcg/mL) in a glass vial

HOW SUPPLIED/STORAGE AND HANDLING

Precedex (dexmedetomidine hydrochloride) injection, 200 mcg/2 mL (100 mcg/mL) is available in 2 mL clear glass vial. Vials are intended for single use only.

NDC No. Container Size

0409-1638-02

Vial

2 mL

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

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