Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Adverse reactions seen during continuous epidural clonidine infusion are dose-dependent and typical for a compound of this pharmacologic class.
The adverse events most frequently reported in the pivotal controlled clinical trial of continuous epidural clonidine administration consisted of hypotension, postural hypotension, decreased heart rate, rebound hypertension, dry mouth, nausea, confusion, dizziness, somnolence, and fever.
Hypotension is the adverse event that most frequently requires treatment.
The hypotension is usually responsive to intravenous fluids and, if necessary, appropriate parenterally-administered pressor agents.
Hypotension was observed more frequently in women and in lower weight patients, but no dose-related response was established.
Implantable epidural catheters are associated with a risk of catheter-related infections, including meningitis and/or epidural abscess.
The risk depends on the clinical situation and the type of catheter used, but catheter related infections occur in 5%-20% of patients, depending on the kind of catheter used, catheter placement technique, quality of the catheter care, and length of catheter placement.
The inadvertent intrathecal administration of clonidine has not been associated with a significantly increased risk of adverse events, but there are inadequate safety and efficacy data to support the use of intrathecal clonidine.
Epidural clonidine was compared to placebo in a two week double-blind study of 85 terminal cancer patients with intractable pain receiving epidural morphine.
The following adverse events were reported in two or more patients and may be related to administration of either clonidine hydrochloride injection or morphine.
WARNINGS Use in Postoperative or Obstetrical Analgesia Clonidine hydrochloride injection (epidural clonidine) is not recommended for obstetrical, post-partum, or peri-operative pain management.
The risk of hemodynamic instability, especially hypotension and bradycardia, from epidural clonidine may be unacceptable in these patients.
Hypotension Because severe hypotension may follow the administration of clonidine, it should be used with caution in all patients.
It is not recommended in most patients with severe cardiovascular disease or in those who are otherwise hemodynamically unstable.
The benefit of its administration in these patients should be carefully balanced against the potential risks resulting from hypotension.
Like all medications, Clonidine Hci can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: