A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Precedex Indications, Dosage, Storage, Stability - Dexmedetomidine hydrochloride
Precedex Indications, Dosage, Storage, Stability - Dexmedetomidine hydrochloride
INDICATIONS
AND USAGE
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.
DOSAGE AND ADMINISTRATION
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 or hepatic impairment (see CLINICAL PHARMACOLOGY,
Pharmacokinetics & 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 coadministration 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:
Lactated Ringers
5% dextrose in water, 0.9% sodium chloride in water, 20% mannitol,
thiopental sodium, etomidate, vecuronium bromide, pancuronium bromide, succinylcholine,
atracurium besylate, mivacurium chloride, glycopyrrolate bromide, phenylephrine
HCl, atropine sulfate, midazolam, morphine sulfate, fentanyl citrate, and a
plasma-substitute.
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. Ampules and vials are intended
for single use only.
Compatibility studies have demonstrated the potential for adsorption
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 or maintenance infusion (see
DOSAGE AND ADMINISTRATION
).
HOW SUPPLIED
PRECEDEX (dexmedetomidine hydrochloride injection), 100 mcg/mL
as the base is available in 2 mL clear glass vials and 2 mL clear glass ampules.
2 mL vial
2 mL ampule
Store at controlled room temperature, 25oC (77o
F) with excursions allowed from 15o to 30oC (59oto
86oF).
Manufactured and Distributed by: Abbott Laboratories,
North Chicago, IL 60064
Licensed from: Orion Corporation ,Espoo, Finland,RAO5979-R1-Rev.
Dec., 1998
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