PRECEDEX 17 PATIENT COUNSELING INFORMATION

(dexmedetomidine hydrochloride injection)

17 PATIENT COUNSELING INFORMATION

PRECEDEX 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 PRECEDEX and as clinically appropriate after discontinuation.

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When PRECEDEX 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.
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Additionally, patients should be informed to report symptoms that may occur within 48 hours after the administration of PRECEDEX 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 PRECEDEX to monitor breastfed neonates for irritability [see Use in Specific Populations (8.2)].

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17 PATIENT COUNSELING INFORMATION

17 PATIENT COUNSELING INFORMATION

PRECEDEX 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 PRECEDEX and as clinically appropriate after discontinuation.

•
When PRECEDEX 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 PRECEDEX 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 PRECEDEX to monitor breastfed neonates for irritability [see Use in Specific Populations (8.2)].
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17 PATIENT COUNSELING INFORMATION

17 PATIENT COUNSELING INFORMATION

PRECEDEX 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 PRECEDEX and as clinically appropriate after discontinuation.

•
When PRECEDEX 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 PRECEDEX 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 PRECEDEX to monitor breastfed neonates for irritability [see Use in Specific Populations (8.2)].

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