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DEXMEDETOMIDINE HYDROCHLORIDE injection, solution


  1. Patient Information
  2. Revised: 3/2017document Id:

Patient Information 

Dexmedetomidine Hydrochloride Injection 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 Dexmedetomidine Hydrochloride Injection and as clinically appropriate after discontinuation.

  • When Dexmedetomidine Hydrochloride Injection is infused for more than 6 hours, patients should be informed to report nervousness, agitation, and headaches that may occur for up to 48 hours.
  • Additionally, patients should be informed to report symptoms that may occur within 48 hours after the administration of Dexmedetomidine Hydrochloride Injection such as: weakness, confusion, excessive sweating, weight loss, abdominal pain, salt cravings, diarrhea, constipation, dizziness or light-headedness.

PremierProRxis a registered trademark of Premier Healthcare Alliance, L.P., used under license.

Manufactured by:
Fresenius Kabi
Lake Zurich, IL 60047

www.fresenius-kabi.us

451484B
Revised: March 2017
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PACKAGE LABEL - PRINCIPAL DISPLAY - Dexmedetomidine Hydrochloride 2 mL Vial Label
DexmedetomidineHCl Injection

200 mcg (base) per 2 mL

(100 mcg (base) per mL)

For intravenous infusion.

MUST BE DILUTED.
Discard unused portion.

2 mLSingle Dose Vial

Rx only

prx462102


PACKAGE LABEL - PRINCIPAL DISPLAY - Dexmedetomidine Hydrochloride 2 mL Vial Tray Label

DexmedetomidineHCl Injection

200 mcg* per 2 mL

(100 mcg per mL)

For intravenous infusion.

MUST BE DILUTED.
Discard unused portion.
Preservative free.

25 x 2 mLSingle Dose Vials

Rx only

prx462102

DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63323-421
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXMEDETOMIDINE HYDROCHLORIDE(UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO)DEXMEDETOMIDINE100 ug in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
SODIUM ACETATE(UNII: 4550K0SC9B)597 ug in 1 mL
ACETIC ACID(UNII: Q40Q9N063P)27 ug in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63323-421-1625 in 1 TRAY09/18/2015
12 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20107209/18/2015
Labeler -Fresenius Kabi USA, LLC (608775388)
Establishment
NameAddressID/FEIBusiness Operations
Fresenius Kabi USA, LLC840771732MANUFACTURE(63323-421)

Revised: 3/2017document Id: 

391cc5f3-af8f-4ead-922d-105dbaf38217Set id: 50fa2e23-0740-41bf-b518-e34bda628b6dVersion: 3Effective Time: 20170331Fresenius Kabi USA, LLC



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