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AMIODARONE HYDROCHLORIDE injection


  1. Patient Information
  2. Manufactured By:
  3. Distributed By:
  4. Revised: 11/2012document Id:

Patient Information 

Amiodarone has the potential to cause serious side effects that limit its use to life-threatening and hemodynamically unstable cardiac arrhythmias. Advise female patients to discontinue nursing while being treated with amiodarone, as breast-feeding could expose the nursing infant to a significant dose of the drug. Recommend that patients avoid grapefruit juice, over-the-counter cough medicine (which commonly contain dextromethorphan), andSt. John's Wort. Inform patients that most manufacturers of corneal refractive laser surgery devices contraindicate corneal refractive laser surgery in patients taking amiodarone. Discuss the symptoms of hypo- and hyper-thyroidism, particularly if patients will be transitioned to oral amiodarone.

Manufactured By: 

Wockhardt Limited

Mumbai, India.

Distributed By: 

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Rev.171012

LabelCarton
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55648-739
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMIODARONE HYDROCHLORIDE(UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)AMIODARONE HYDROCHLORIDE50 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL(UNII: LKG8494WBH)20.2 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)100 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55648-739-045 in 1 CARTON
13 mL in 1 VIAL
2NDC:55648-739-0210 in 1 CARTON
23 mL in 1 VIAL
3NDC:55648-739-011 in 1 CARTON
33 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07761010/30/2008
AMIODARONE HYDROCHLORIDE
amiodarone hydrochloride injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55648-780
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AMIODARONE HYDROCHLORIDE(UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)AMIODARONE HYDROCHLORIDE50 mg in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL(UNII: LKG8494WBH)20.2 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)100 mg in 1 mL
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55648-780-011 in 1 CARTON
118 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07783410/30/2008
Labeler -Wockhardt Limited (650069115)
Registrant -Wockhardt Limited (650069115)
Establishment
NameAddressID/FEIBusiness Operations
Wockhardt Limited676257570ANALYSIS(55648-739, 55648-780) , MANUFACTURE(55648-739, 55648-780) , PACK(55648-739, 55648-780) , LABEL(55648-739, 55648-780)

Revised: 11/2012document Id: 

e11649f1-cacd-4246-ba5c-c45407d16c93Set id: b0eb6c22-7553-4e3f-a06d-20a186ced99aVersion: 1Effective Time: 20121106Wockhardt Limited



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