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DEXMEDETOMIDINE- dexmedetomidine hydrochloride injection, solution, concentrate


  1. Patient Information
  2. Principal Display Panel Text For Container Label:
  3. Principal Display Panel Text For Carton Label:
  4. Revised: 12/2016document 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.

AKORN
Manufactured by:Akorn, Inc.
Lake Forest, IL 60045
DM00N Rev. 12/16

Principal Display Panel Text For Container Label: 

NDC 17478-055-02

Dexmedetomidine

HCl Injection

200 mcg/2 mL

(100 mcg/mL)

Dexmedetomidine

MUST BE DILUTED

For Intravenous Use Only

2 mL Single-dose Vial

Discard unused portion.

Rx only

Principal Display Panel Text for Container Label

Principal Display Panel Text For Carton Label: 

NDC 17478-055-02

Dexmedetomidine HCl Injection

200 mcg*/2 mL

(100 mcg/mL)

For Intravenous Use Only

MUST BE DILUTED

10 x 2 mL Single-dose Vials

Preservative-Free

Sterile

Rx only Akorn logo

Principal Display Panel Text for Carton Label
DEXMEDETOMIDINE
dexmedetomidine hydrochloride injection, solution, concentrate
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17478-055
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)
Water(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-055-0210 in 1 CARTON11/24/2014
12 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20258511/24/2014
Labeler -Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc063434679PACK(17478-055) , LABEL(17478-055)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc.155135783MANUFACTURE(17478-055) , ANALYSIS(17478-055) , STERILIZE(17478-055)

Revised: 12/2016document Id: 

3b91bc30-bb9c-43ca-9285-ece1b1058a97Set id: 8fb7886c-7762-4b72-989b-0fe8e963b4b8Version: 2Effective Time: 20161230Akorn, Inc.



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