DEXMEDETOMIDINE HYDROCHLORIDE (Page 7 of 7)
16 HOW SUPPLIED/STORAGE AND HANDLING
Do not use if product is discolored or if precipitate matter is present.
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection (4 mcg/mL) is clear and colorless. The strength is based on the dexmedetomidine base. Discard unused portion.
Unit of Sale | Concentration |
NDC 67457-924-50 Carton of 20 single-dose clear glass bottles | 200 mcg/50 mL (4 mcg/mL) |
NDC 67457-925-10 Carton of 10 single-dose clear glass bottles | 400 mcg/100 mL (4 mcg/mL) |
- Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not freeze.
17 PATIENT COUNSELING INFORMATION
Dexmedetomidine hydrochloride 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 and as clinically appropriate after discontinuation.
- •
- When dexmedetomidine hydrochloride 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 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 hydrochloride to monitor breastfed neonates for irritability [see Use in Specific Populations (8.2)].
Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.
Manufactured by:
Mylan Laboratories Limited
Bangalore, India
DECEMBER 2022
Package/Label Display Panel
NDC 67457-924-50
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
200 mcg*/50 mL
(4 mcg*/mL)
For Intravenous Infusion
Discard Unused Portion.
Mylan
Rx only
20 Units x 50 mL Single-Dose Bottles
Package/Label Display Panel
NDC 67457-925-10
Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection
400 mcg/100 mL
4 mcg/mL
For Intravenous Infusion
Discard Unused Portion.
Mylan
Rx only
10 Units x 100 mL Single-Dose Bottles
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Labeler — Mylan Institutional LLC (790384502) |
Revised: 12/2022 Mylan Institutional LLC
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