Prescription Drug Information: DEXMEDETOMIDINE HYDROCHLORIDE (Page 5 of 5)

14.2 Procedural Sedation

The safety and efficacy of dexmedetomidine hydrochloride in 0.9% sodium chloride injection for sedation of non-intubated patients prior to and/or during surgical and other procedures was evaluated in two randomized, double-blind, placebo-controlled multicenter clinical trials. Study 1 evaluated the sedative properties of dexmedetomidine hydrochloride in 0.9% sodium chloride injection in patients having a variety of elective surgeries/procedures performed under monitored anesthesia care. Study 2 evaluated dexmedetomidine hydrochloride in 0.9% sodium chloride injection in patients undergoing awake fiberoptic intubation prior to a surgical or diagnostic procedure.

In Study 1, the sedative properties of dexmedetomidine hydrochloride in 0.9% sodium chloride injection were evaluated by comparing the percent of patients not requiring rescue midazolam to achieve a specified level of sedation using the standardized Observer’s Assessment of Alertness/Sedation Scale (see Table 12).

Table 12: Observer’s Assessment of Alertness/Sedation

Assessment Categories
Responsiveness Speech Facial Expression Eyes Composite Score
Responds readily to name spoken in normal tone Normal Normal Clear, no ptosis 5 (alert)
Lethargic response to name spoken in normal tone Mild slowing or thickening Mild relaxation Glazed or mild ptosis (less than half the eye) 4
Responds only after name is called loudly and/or repeatedly Slurring or prominent slowing Marked relaxation (slack jaw) Glazed and marked ptosis (half the eye or more) 3
Responds only after mild prodding or shaking Few recognizable words 2
Does not respond to mild prodding or shaking 1 (deep sleep)

Patients were randomized to receive a loading infusion of either dexmedetomidine hydrochloride in 0.9% sodium chloride injection 1 mcg/kg, dexmedetomidine hydrochloride in 0.9% sodium chloride injection 0.5 mcg/kg, or placebo (normal saline) given over 10 minutes and followed by a maintenance infusion started at 0.6 mcg/kg/hr. The maintenance infusion of study drug could be titrated from 0.2 mcg/kg/hr to 1 mcg/kg/hr to achieve the targeted sedation score (Observer’s Assessment of Alertness/Sedation Scale ≤4). Patients were allowed to receive rescue midazolam as needed to achieve and/or maintain an Observer’s Assessment of Alertness/Sedation Scale ≤4. After achieving the desired level of sedation, a local or regional anesthetic block was performed. Demographic characteristics were similar between the dexmedetomidine hydrochloride in 0.9% sodium chloride injection and comparator groups. Efficacy results showed that dexmedetomidine hydrochloride in 0.9% sodium chloride injection was more effective than the comparator group when used to sedate non-intubated patients requiring monitored anesthesia care during surgical and other procedures (see Table 13).

In Study 2, the sedative properties of dexmedetomidine hydrochloride in 0.9% sodium chloride injection were evaluated by comparing the percent of patients requiring rescue midazolam to achieve or maintain a specified level of sedation using the Ramsay Sedation Scale score ≥2 (see Table 9).

Patients were randomized to receive a loading infusion of dexmedetomidine hydrochloride in 0.9% sodium chloride injection 1 mcg/kg or placebo (normal saline) given over 10 minutes and followed by a fixed maintenance infusion of 0.7 mcg/kg/hr. After achieving the desired level of sedation, topicalization of the airway occurred. Patients were allowed to receive rescue midazolam as needed to achieve and/or maintain a Ramsay Sedation Scale ≥2. Demographic characteristics were similar between the dexmedetomidine hydrochloride in 0.9% sodium chloride injection and comparator groups. For efficacy results see Table 13.

Table 13: Key Efficacy Results of Procedural Sedation Studies

Study Loading Infusion Treatment Arm Number of Patients Enrolleda % Not Requiring Midazolam Rescue Confidenceb Interval on the Difference vs. Placebo Mean (SD) Total Dose (mg) of Rescue Midazolam Required Confidenceb Intervals of the Mean Rescue Dose
Study 1 Dexmedetomidine0.5 mcg/kg 134 40 37 (27, 48) 1.4 (1.7) -2.7 (-3.4, -2.0)
Dexmedetomidine 1 mcg/kg 129 54 51 (40, 62) 0.9 (1.5) -3.1 (-3.8, -2.5)
placebo 63 3 4.1 (3.0)
Study 2 Dexmedetomidine 1 mcg/kg 55 53 39 (20, 57) 1.1 (1.5) -1.8 (-2.7, -0.9)
placebo 50 14 2.9 (3.0)

a Based on ITT population defined as all randomized and treated patients.

b Normal approximation to the binomial with continuity correction.

16 HOW SUPPLIED/STORAGE AND HANDLING

Dexmedetomidine hydrochloride in 0.9% Sodium Chloride Injection Dexmedetomidine hydrochloride in 0.9% Sodium Chloride injection is a clear colorless solution available as 80 mcg/20 mL (4 mcg/mL), 200 mcg/50 mL (4 mcg/mL) and 400 mcg/100 mL (4 mcg/mL) in 20 mL clear single-dose vial, 50 mL and 100 mL clear single-dose bottles, respectively. Containers are intended for single use only.

NDC No. Strength Vial/Bottle Size
71225-126-01 4 mcg/mL 20 mL Single-dose vial
71225-126-04 4 mcg/mL 20 mL Single-dose vial packaged in a carton containing 10 vials
71225-126-02 4 mcg/mL 50 mL Single-dose bottle
71225-126-05 4 mcg/mL 50 mL Single-dose bottle packaged in a carton containing 20 bottles
71225-126-03 4 mcg/mL 100 mL Single-dose bottle
71225-126-06 4 mcg/mL 100 mL Single-dose bottle packaged in a carton containing 10 bottles

Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Discard unused portion.

17 PATIENT COUNSELING INFORMATION

Dexmedetomidine hydrochloride in 0.9% Sodium Chloride 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 in 0.9% Sodium Chloride injection and as clinically appropriate after discontinuation.

  • When dexmedetomidine hydrochloride in 0.9% Sodium Chloride 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 in 0.9% Sodium Chloride injection such as: weakness, confusion, excessive sweating, weight loss, abdominal pain, salt cravings, diarrhea, constipation, dizziness or light-headedness.

Manufactured for:

Slayback Pharma LLC,

Princeton, NJ 08540.

Manufactured at:

Corden Pharma S.p.A,

Caponago, Italy.

Revised: 12/2019

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

20 mL VIAL LABEL
NDC 71225-126-01
Single-dose vial. Discard unused portion.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
80 mcg/20 mL
(4 mcg/mL)
For Intravenous Infusion Rx Only

Dexmed 20ml vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mL CARTON LABEL
10 x 20 mL Single-Dose vial
NDC 71225-126-04
Single-dose vial. Discard unused portion.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
80 mcg/20 mL
(4 mcg/mL)
For Intravenous Infusion Rx Only

Dexmed 20 mL Carton label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mL BOTTLE LABEL
NDC 71225-126-02
Single-dose bottle. Discard unused portion.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
200 mcg/50 mL
(4 mcg/mL)
For Intravenous Infusion Rx Only

Dexmed 50mL Container Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mL CARTON LABEL
20 Units x 50 mL
NDC 71225-126-05
Single-dose bottle. Discard unused portion.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
200 mcg/50 mL
(4 mcg/mL)
For Intravenous Infusion Rx Only

Dexmed 50 mL Carton label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mL BOTTLE LABEL
NDC 71225-126-03
Single-dose bottle. Discard unused portion.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
400 mcg/100 mL
(4 mcg/mL)
For Intravenous Infusion Rx Only

Dexmed 100mL container label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mL CARTON LABEL
10 Units x 100 mL
NDC 71225-126-06
Single-dose bottle. Discard unused portion.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
400 mcg/100 mL
(4 mcg/mL)
For Intravenous Infusion Rx Only

Dexmed 100mL Carton label
(click image for full-size original)
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71225-126
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMEDETOMIDINE HYDROCHLORIDE (DEXMEDETOMIDINE) DEXMEDETOMIDINE 4 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9 mg in 1 mL
METHIONINE 1 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71225-126-05 20 BOTTLE in 1 CARTON contains a BOTTLE (71225-126-02)
1 NDC:71225-126-02 50 mL in 1 BOTTLE This package is contained within the CARTON (71225-126-05)
2 NDC:71225-126-06 10 BOTTLE in 1 CARTON contains a BOTTLE (71225-126-03)
2 NDC:71225-126-03 100 mL in 1 BOTTLE This package is contained within the CARTON (71225-126-06)
3 NDC:71225-126-04 10 VIAL in 1 CARTON contains a VIAL (71225-126-01)
3 NDC:71225-126-01 20 mL in 1 VIAL This package is contained within the CARTON (71225-126-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212791 12/06/2019
Labeler — Slayback Pharma LLC (967770848)
Establishment
Name Address ID/FEI Operations
Corden Pharma SpA 338725627 ANALYSIS (71225-126), LABEL (71225-126), MANUFACTURE (71225-126), PACK (71225-126)

Revised: 05/2020 Slayback Pharma LLC

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