Dexmedetomidine Hydrochloride in Sodium Chloride (Page 7 of 7)
16. HOW SUPPLIED/STORAGE AND HANDLING
Dexmedetomidine HCl in 0.9% sodium chloride injection
Dexmedetomidine hydrochloride in 0.9% sodium chloride injection is clear and colorless, and 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, 50 mL, and 100 mL clear glass bottles. The strength is based on the dexmedetomidine base. Containers are intended for single-dose only. Discard unused portion.
NDC | Container | Size |
---|---|---|
68094-047-10 | Vial | 10 × 20 mL |
68094-147-10 | Bottle | 20 × 50 mL |
68094-247-10 | Bottle | 10 × 100 mL |
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
17. PATIENT COUNSELING INFORMATION
Dexmedetomidine HCl 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 HCl in 0.9% sodium chloride injection and as clinically appropriate after discontinuation.
- When dexmedetomidine HCl 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 HCl in 0.9% sodium chloride injection such as: weakness, confusion, excessive sweating, weight loss, abdominal pain, salt cravings, diarrhea, constipation, dizziness, or light-headedness.
- Advise breastfeeding mothers who were exposed to dexmedetomidine HCl in 0.9% sodium chloride injection to monitor breastfed neonates for irritability [see Use in Specific Populations (8.2)].
Manufactured for:
Precision Dose, Inc.
South Beloit, IL 61080
Rev. 04/2023
PRINCIPAL DISPLAY PANEL — 20 mL Vial Label
20 mL
Rx only
NDC 68094-047-01
Single-dose vial. Discard unused portion.
Dexmedetomidine HCl in
0.9% Sodium Chloride Injection
80 mcg/20 mL (4 mcg/mL)*
For Intravenous Infusion
PrecisionDose™
LOTEXP. DATE
PRINCIPAL DISPLAY PANEL — 50 mL Bottle Label
50 mL
Rx only
NDC 68094-147-01
Single-dose bottle. Discard unused portion.
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
200 mcg / 50 mL (4 mcg/mL)*
For Intravenous Infusion
64000063 F.112
LOTEXP. DATE
PRINCIPAL DISPLAY PANEL — 100 mL Bottle Label
100 mL
Rx only
NDC 68094-247-01
Single-dose bottle. Discard unused portion.
Dexmedetomidine HCl in 0.9%
Sodium Chloride Injection
400 mcg / 100 mL (4 mcg/mL)*
For Intravenous Infusion
64000064 F.113
LOTEXP. DATE
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Labeler — Precision Dose, Inc. (035886746) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Corden Pharma SPA | 338725627 | MANUFACTURE (68094-047), MANUFACTURE (68094-147), MANUFACTURE (68094-247), ANALYSIS (68094-047), ANALYSIS (68094-147), ANALYSIS (68094-247), PACK (68094-047), PACK (68094-147), PACK (68094-247), LABEL (68094-047), LABEL (68094-147), LABEL (68094-247) |
Revised: 12/2023 Precision Dose, Inc.
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