PHENYLEPHRINE HYDROCHLORIDE injection

IMMPHENTIV by

Drug Labeling and Warnings

IMMPHENTIV by is a Prescription medication manufactured, distributed, or labeled by Hikma Pharmaceuticals USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

• HIGHLIGHTS OF PRESCRIBING INFORMATION

  These highlights do not include all the information needed to use PHENYLEPHRINE HYDROCHLORIDE safely and effectively. See full prescribing information for PHENYLEPHRINE HYDROCHLORIDE.
  
  PHENYLEPHRINE HYDROCHLORIDE injection, for intravenous use
  Initial U.S. Approval: 2012

  RECENT MAJOR CHANGES

  Dosage and Administration, Pharmacy Bulk Vials (2.6)            6/2019

  INDICATIONS AND USAGE

  Phenylephrine Hydrochloride is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia. (1)

  DOSAGE AND ADMINISTRATION

  Dilute before administration. (2.1)
  Dosing for Perioperative Hypotension
  Intravenous bolus administration: 50 mcg to 250 mcg (2.4)
  Intravenous continuous infusion: 0.5 mcg/kg/minute to 1.4 mcg/kg/minute titrated to effect (2.4)
  Dosing for Patients with Vasodilatory Shock
  Intravenous continuous infusion: 0.5 mcg/kg/minute to 6 mcg/kg/minute titrated to effect (2.5)

  DOSAGE FORMS AND STRENGTHS

  Injection: 10 mg/mL supplied as a:

     1 mL single dose vial (3,11,16)

     5 mL pharmacy bulk package vial (3,11,16)

     10 mL pharmacy bulk package vial (3,11,16)

  CONTRAINDICATIONS

  • Hypersensitivity to it or any of its components (4)

  WARNINGS AND PRECAUTIONS

  • Severe bradycardia and decreased cardiac output: (5.2)
  • Extravasation: during intravenous administration may cause necrosis or sloughing of tissue (5.4)
  • Concomitant use with oxytocic drugs: pressor effect of sympathomimetic pressor amines is potentiated  (5.5)
  • Allergic-type reactions:  Sulfite (5.6)

  ADVERSE REACTIONS

  Most common adverse reactions:  nausea and vomiting, headache, nervousness (6)
  

  To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  DRUG INTERACTIONS

  • Agonistic effects with monoamine oxidase inhibitors (MAOI), β-adrenergic blocking agents, α-2 adrenergic agonists, steroids, tricyclic antidepressants, norepinephrine transport inhibitors, ergot alkaloids, centrally-acting sympatholytic agents and atropine sulfate (7.1)
  • Antagonistic effects on and by α-adrenergic blocking agents (7.2)

  See 17 for PATIENT COUNSELING INFORMATION.

  Revised: 6/2019

• Table of Contents

  FULL PRESCRIBING INFORMATION: CONTENTS*

  1 INDICATIONS AND USAGE

  2 DOSAGE AND ADMINISTRATION

  2.1 General Administration Instructions

  2.2 Preparing a 100 mcg/mL Solution for Bolus Intravenous Administration

  2.3 Preparing a Solution for Continuous Intravenous Infusion

  2.4 Dosing for Perioperative Setting

  2.5 Dosing for Septic or Other Vasodilatory Shock

  2.6 Directions for Dispensing from Pharmacy Bulk Vial

  3 DOSAGE FORMS AND STRENGTHS

  4 CONTRAINDICATIONS

  5 WARNINGS AND PRECAUTIONS

  5.1 Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension

  5.2 Bradycardia

  5.3 Risk in Patients with Autonomic Dysfunction

  5.4 Skin and Subcutaneous Necrosis

  5.5 Pressor Effect with Concomitant Oxytocic Drugs

  5.6 Allergic Reactions

  5.7 Peripheral and Visceral Ischemia

  5.8 Renal Toxicity

  6 ADVERSE REACTIONS

  7 DRUG INTERACTIONS

  7.1 Agonists

  7.2 Antagonists

  8 USE IN SPECIFIC POPULATIONS

  8.1 Pregnancy

  8.2 Labor and Delivery

  8.3 Nursing Mothers

  8.4 Pediatric Use

  8.5 Geriatric Use

  8.6 Hepatic Impairment

  8.7 Renal Impairment

  10 OVERDOSAGE

  11 DESCRIPTION

  12 CLINICAL PHARMACOLOGY

  12.1 Mechanism of Action

  12.2 Pharmacodynamics

  12.3 Pharmacokinetics

  14 CLINICAL STUDIES

  16 HOW SUPPLIED/STORAGE AND HANDLING

  17 PATIENT COUNSELING INFORMATION

  * Sections or subsections omitted from the full prescribing information are not listed.

1 INDICATIONS AND USAGE

Phenylephrine Hydrochloride is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia.

2 DOSAGE AND ADMINISTRATION

2.1 General Administration Instructions

Phenylephrine hydrochloride must be diluted before administration as bolus intravenous infusion or continuous intravenous infusion. 

Inspect the solution for particulate matter and discoloration prior to administration.  The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions. Discard any unused portion.

During phenylephrine hydrochloride administration:

• Correct intravascular volume depletion.
• Correct acidosis.  Acidosis may reduce the effectiveness of phenylephrine.

2.2 Preparing a 100 mcg/mL Solution for Bolus Intravenous Administration

For bolus intravenous administration, withdraw 10 mg (1 mL of a 10 mg/mL concentration) of phenylephrine hydrochloride injection and dilute with 99 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.  This will yield a final concentration of 100 mcg/mL.  Withdraw an appropriate dose from the 100 mcg/mL solution prior to bolus intravenous administration.

2.3 Preparing a Solution for Continuous Intravenous Infusion

For continuous intravenous infusion, withdraw 10 mg (1 mL of 10 mg/mL concentration) of phenylephrine hydrochloride injection and add to 500 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (providing a final concentration of 20 mcg/mL).

2.4 Dosing for Perioperative Setting

In adult patients undergoing surgical procedures with either neuraxial anesthesia or general anesthesia:

• 50 mcg to 250 mcg by intravenous bolus administration. The most frequently reported initial bolus dose is 50 mcg or 100 mcg.
• 0.5 mcg/kg/min to 1.4 mcg/kg/min by intravenous continuous infusion, titrated to blood pressure goal.

2.5 Dosing for Septic or Other Vasodilatory Shock

In adult patients with septic or other vasodilatory shock:

• No bolus.
• 0.5 mcg/kg/min to 6 mcg/kg/min by intravenous continuous infusion, titrated to blood pressure goal. Doses above 6 mcg/kg/min do not show significant incremental increase in blood pressure.

2.6 Directions for Dispensing from Pharmacy Bulk Vial

The Pharmacy Bulk Vial is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion. Each closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. The Pharmacy Bulk Vial is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Dispensing from a pharmacy bulk vial should be completed within 4 hours after the vial is penetrated.

3 DOSAGE FORMS AND STRENGTHS

Injection: 10 mg/mL phenylephrine hydrochloride is supplied in three vial sizes:

   1 mL single dose vial (10 mg of phenylephrine hydrochloride per vial)

   5 mL Pharmacy Bulk Package vial  (50 mg of phenylephrine hydrochloride per vial) that will provide five 1 mL single doses

   10 mL Pharmacy Bulk Package vial (100 mg of phenylephrine hydrochloride per vial) that will provide ten 1 mL single doses

4 CONTRAINDICATIONS

The use of phenylephrine hydrochloride is contraindicated in patients with:

• Hypersensitivity to it or any of its components

5 WARNINGS AND PRECAUTIONS

5.1 Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension

Because of its pressor effects, phenylephrine hydrochloride can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.

5.2 Bradycardia

Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output.

5.3 Risk in Patients with Autonomic Dysfunction

The pressor response to adrenergic drugs, including phenylephrine, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.

5.4 Skin and Subcutaneous Necrosis

Extravasation of phenylephrine can cause necrosis or sloughing of tissue.

5.5 Pressor Effect with Concomitant Oxytocic Drugs

Oxytocic drugs potentiate the pressor effect of sympathomimetic pressor amines including phenylephrine hydrochloride [see Drug Interactions (7.1)], with the potential for hemorrhagic stroke. 

5.6 Allergic Reactions

This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.  The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. 

5.7 Peripheral and Visceral Ischemia

Phenylephrine hydrochloride can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease. 

5.8 Renal Toxicity

Phenylephrine hydrochloride can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.

6 ADVERSE REACTIONS

The following adverse reactions associated with the use of phenylephrine hydrochloride were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Cardiac disorders: Bradycardia, AV block, ventricular extrasystoles, myocardial ischemia

Gastrointestinal disorders: Nausea, vomiting

General disorders and administrative site conditions: Chest pain, extravasation

Immune system disorders: Sulfite sensitivity

Nervous system disorders: Headache, nervousness, paresthesia, tremor

Psychiatric disorders: Excitability

Respiratory: Pulmonary edema, rales

Skin and subcutaneous tissue disorders: Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation

Vascular disorders: Hypertensive crisis

7 DRUG INTERACTIONS

7.1 Agonists

The pressor effect of phenylephrine hydrochloride is increased in patients receiving:

• Monoamine oxidase inhibitors (MAOI), such as selegiline.
• β-adrenergic blockers
• α-2 adrenergic agonists, such as clonidine
• Steroids
• Tricyclic antidepressants
• Norepinephrine transport inhibitors, such as atomoxetine
• Ergot alkaloids, such as methylergonovine maleate
• Centrally-acting sympatholytic agents, such as guanfacine or reserpine
• Atropine sulfate

7.2 Antagonists

α-adrenergic blocking agents, including phenothiazines (e.g., chlorpromazine) and amiodarone block phenylephrine and are in turn blocked by phenylephrine. 

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with intravenous phenylephrine. It is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed.

8.2 Labor and Delivery

The most common maternal adverse reactions reported in studies of phenylephrine use during neuraxial anesthesia during cesarean delivery include nausea and vomiting, which are commonly associated with hypotension, bradycardia, reactive hypertension, and transient arrhythmias.  Phenylephrine does not appear to cause a decrease in placental perfusion sufficient to alter either the neonate Apgar scores or blood-gas status.

8.3 Nursing Mothers

It is not known whether this drug is excreted in human milk.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of phenylephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

8.6 Hepatic Impairment

In patients with liver cirrhosis [Child Pugh Class A (n=3), Class B (n=5) and Class C (n=1)], dose-response data indicate decreased responsiveness to phenylephrine. Consider using larger doses than usual in hepatic impaired subjects. 

8.7 Renal Impairment

In patients with end stage renal disease (ESRD) undergoing hemodialysis, dose-response data indicates increased responsiveness to phenylephrine. Consider using lower doses of phenylephrine hydrochloride in ESRD patients.

10 OVERDOSAGE

Overdose of phenylephrine hydrochloride can cause a rapid rise in blood pressure.  Symptoms of overdose include headache, vomiting, hypertension, reflex bradycardia, and cardiac arrhythmias including ventricular extrasystoles and ventricular tachycardia, and may cause a sensation of fullness in the head and tingling of the extremities.

Consider using an α-adrenergic antagonist.

11 DESCRIPTION

Phenylephrine hydrochloride is a synthetic sympathomimetic agent in sterile form for parenteral injection.  Chemically, phenylephrine hydrochloride is (-)-m-Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride and has the following structural formula:

Phenylephrine hydrochloride is very soluble in water, freely soluble in ethanol, and insoluble in chloroform and ethyl ether.  Phenylephrine hydrochloride is sensitive to light.

Phenylephrine Hydrochloride Injection, USP is a clear, colorless, aqueous solution that is essentially free of visible foreign matter.  Each mL contains: Phenylephrine Hydrochloride 10 mg; Sodium Chloride 3.5 mg; Sodium Citrate Dihydrate 4 mg; Citric Acid Monohydrate 1 mg; and Sodium Metabisulfite 2 mg in Water for Injection. The pH  may be adjusted in the range of 3.0 to 6.5 with Sodium Hydroxide and/or Hydrochloric Acid, if necessary.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist.

12.2 Pharmacodynamics

Phenylephrine is the active moiety. Metabolites are inactive at both the α-1and α-2 adrenergic receptors. Following parenteral administration of phenylephrine hydrochloride, increases in systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, and total peripheral vascular resistance are observed. The onset of blood pressure increase following an intravenous bolus phenylephrine hydrochloride administration is rapid and the effect may persist for up to 20 minutes. As mean arterial pressure increases following parenteral doses, vagal activity also increases, resulting in reflex bradycardia.

Most vascular beds are constricted, including renal, splanchnic, and hepatic.

12.3 Pharmacokinetics

Following an intravenous infusion of phenylephrine hydrochloride, the effective half-life was approximately 5 minutes. The steady-state volume of distribution (340 L) exceeded the body volume by a factor of 5, suggesting a high distribution into certain organ compartments. The average total serum clearance (2095 mL/min) was close to one-third of the cardiac output.

A mass balance study showed that phenylephrine is extensively metabolized by the liver with only 12% of the dose excreted unchanged in the urine. Deamination by monoamino oxidase is the primary metabolic pathway resulting in the formation of the major metabolite (m-hydroxymandelic acid) which accounts for 57% of the total administered dose.

14 CLINICAL STUDIES

Increases in systolic and mean blood pressure following administration of phenylephrine were observed in 42  literature-based studies in the perioperative setting, including 26 studies where phenylephrine was used in low-risk (ASA 1 and 2) pregnant women undergoing neuraxial anesthesia during cesarean delivery, 3 studies in non-obstetric surgery under neuraxial anesthesia, and 13 studies in patients undergoing surgery under general anesthesia.  Mean arterial blood pressure increases were also observed in two double-blind, active-controlled studies in patients with septic shock.

16 HOW SUPPLIED/STORAGE AND HANDLING

Phenylephrine Hydrochloride Injection, USP, 10 mg/mL, is supplied as follows:

• NDC: 0641-6142-25: 1 mL single dose vials packaged in cartons containing 25 vials per carton
• NDC: 0641-6188-10: 5 mL Pharmacy Bulk Package vials packed in cartons containing 10 vials per carton
  
• NDC: 0641-6189-10: 10 mL Pharmacy Bulk Package vials packed in cartons containing 10 vials per carton

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from light. Keep covered in carton until time of use. The 1 mL vials are for single use only; the 5 and 10 mL vials are pharmacy bulk packages. The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions. Discard any unused portion.

17 PATIENT COUNSELING INFORMATION

Inform patients, families, or caregivers that the primary side effect of phenylephrine is hypertension and, rarely, hypertensive crisis. Patients may experience bradycardia (slow heart rate), which in some cases may produce heart block or other cardiac arrhythmias, extra ventricular beats, myocardial ischemia in patients with underlying cardiac disease, and pulmonary edema (fluid in the lungs) or rales.  Common, less serious symptoms include the following:  

• chest pain
• skin or tissue damage if the drug leaks out of the venous catheter into the surrounding tissue
• headache, nervousness, tremor, numbness/tingling (paresthesias) in hands or feet
• nausea, vomiting
• excitability, dizziness, sweating, flushing

PRINCIPAL DISPLAY PANEL

Manufactured by:

Hikma Pharmaceuticals USA Inc.
Eatontown, NJ 07724 USA

Revised: June 2019

462-664-02

PRINCIPAL DISPLAY PANEL

NDC 0641-6142-01
Phenylephrine
HCl Injection, USP
10 mg/mL
For Intravenous
Use
Dilute before use
Protect from light
1 mL Single Dose Vial

 

NDC 0641-6142-25     Rx only
Phenylephrine
HCl Injection, USP
10 mg/mL
For Intravenous Use
Dilute before use
25 x 1 mL Single Dose Vials
Discard unused portion

PRINCIPAL DISPLAY PANEL

NDC: 0641-6188-01   Rx only
Phenylephrine
HCl Injection, USP
50 mg/5 mL (10 mg/mL)
Pharmacy Bulk Package
Not for Direct Infusion
For Intravenous Use
Must Be Diluted
Protect From Light     5 mL Vial

 

NDC: 0641-6188-10   Rx only
Phenylephrine
HCl Injection, USP
50 mg/5 mL (10 mg/mL)
Pharmacy Bulk Package
Not for Direct Infusion
For Intravenous Use
Must Be Diluted - Protect From Light
Store in carton until time of use
10 x 5 mL Vials

 

 

PRINCIPAL DISPLAY PANEL

NDC: 0641-6189-01   Rx only
Phenylephrine
HCl Injection, USP
100 mg/10 mL (10 mg/mL)
Pharmacy Bulk Package
Not for Direct Infusion
For Intravenous Use
Must Be Diluted
Protect From Light
10 mL Vial

 

 

 

NDC: 0641-6189-10   Rx only
Phenylephrine
HCl Injection, USP
100 mg/10 mL (10 mg/mL)
Pharmacy Bulk Package
Not for Direct Infusion
For Intravenous Use
Must Be Diluted - Protect From Light
Store in carton until time of use
10 x 10 mL vials

 

SERIALIZATION IMAGE

INGREDIENTS AND APPEARANCE

PHENYLEPHRINE HYDROCHLORIDE 
phenylephrine hydrochloride injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0641-6188
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)	3.5 mg  in 1 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	1  mg  in 1 mL
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)	4  mg  in 1 mL
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	2 mg  in 1 mL
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0641-6188-10	10 in 1 CARTON	06/19/2019
1	NDC: 0641-6188-01	5 mL in 1 VIAL, PHARMACY BULK PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA203826	06/19/2019

PHENYLEPHRINE HYDROCHLORIDE 
phenylephrine hydrochloride injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0641-6189
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)	3.5 mg  in 1 mL
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)	4  mg  in 1 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	1  mg  in 1 mL
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	2 mg  in 1 mL
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0641-6189-10	10 in 1 CARTON	06/19/2019
1	NDC: 0641-6189-01	10 mL in 1 VIAL, PHARMACY BULK PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA203826	06/19/2019

PHENYLEPHRINE HYDROCHLORIDE 
phenylephrine hydrochloride injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0641-6142
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)	3.5 mg  in 1 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	1 mg  in 1 mL
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)	4 mg  in 1 mL
WATER (UNII: 059QF0KO0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	2 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0641-6142-25	25 in 1 CARTON	12/18/2012
1	NDC: 0641-6142-01	1 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA203826	12/18/2012

Labeler - Hikma Pharmaceuticals USA Inc. (946499746)

Establishment
Name	Address	ID/FEI	Business Operations
Hikma Pharmaceuticals USA Inc.		946499746	ANALYSIS(0641-6142, 0641-6188, 0641-6189) , LABEL(0641-6142, 0641-6188, 0641-6189) , MANUFACTURE(0641-6142, 0641-6188, 0641-6189)