CLONIDINE HCI 100 ug/mL
CLONIDINE HCI · INJECTION, SOLUTION · HF Acquisition Co LLC, DBA HealthFirst
CLONIDINE HCI is a injection, solution containing clonidine hci at 100 ug/mL, taken intravenous. Manufactured by HF Acquisition Co LLC, DBA HealthFirst.
Key Facts
- Brand Name
- CLONIDINE HCI
- Generic Name
- CLONIDINE HCI
- NDC Code (Product)
51662-1346- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- 100 ug/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA200300
- Marketing Start
- 12/23/2018
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
INDICATIONS & USAGE Clonidine hydrochloride is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see CLINICAL PHARMACOLOGY : Clinical Trials). The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS ).
Dosage & Administration
DOSAGE & ADMINISTRATION The recommended starting dose of clonidine hydrochloride injection for continuous epidural infusion is 30 mcg/hr. Although dosage may be titrated up or down depending on pain relief and occurrence of adverse events, experience with dosage rates above 40 mcg/hr is limited. Familiarization with the continuous epidural infusion device is essential. Patients receiving epidural clonidine from a continuous infusion device should be closely monitored for the first few days to assess their response. The 500 mcg/mL (0.5mg/mL) strength product must be diluted prior to use in 0.9% Sodium Chloride for Injection, USP, to a final concentration of 100 mcg/mL: Renal Impairment: Dosage should be adjusted according to the degree of renal impairment, and patients should be carefully monitored. Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis. Clonidine hydrochloride injection must not be used with a preservative. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. DOSAGE
Warnings
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. Vital signs should be monitored frequently, especially during the first few days of epidural clonidine therapy. When clonidine is infused into the upper thoracic spinal segments, more pronounced decreases in the blood pressure may be seen. Clonidine decreases sympathetic outflow from the central nervous system resulting in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. However, in the absence of profound hypotension,…
Contraindications
CONTRAINDICATIONS Clonidine hydrochloride injection is contraindicated in patients with a history of sensitization or allergic reactions to clonidine. Epidural administration is contraindicated in the presence of an injection site infection, in patients on anticoagulant therapy, and in those with a bleeding diathesis. Administration of clonidine hydrochloride injection above the C4 dermatome is contraindicated since there are no adequate safety data to support such use (see WARNINGS ).
Adverse Reactions
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 inadver…
Frequently Asked Questions
What is CLONIDINE HCI used for?
CLONIDINE HCI contains CLONIDINE HCI. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is CLONIDINE HCI a controlled substance?
CLONIDINE HCI is not classified as a controlled substance by the DEA.
What is the generic name for CLONIDINE HCI?
The generic name for CLONIDINE HCI is CLONIDINE HCI. There are no other listed brand versions of CLONIDINE HCI.
What is the NDC code for CLONIDINE HCI 100 ug/mL?
The NDC (National Drug Code) for CLONIDINE HCI 100 ug/mL is 51662-1346, listed by HF Acquisition Co LLC, DBA HealthFirst.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)