Duraclon (Page 4 of 4)

OVERDOSAGE

Hypertension may develop early and may be followed by hypotension, bradycardia, respiratory depression, hypothermia, drowsiness, decreased or absent reflexes, irritability, and miosis. With large oral overdoses, reversible cardiac conduction defects or arrhythmias, apnea, coma, and seizures have been reported. As little as 100 mcg of oral clonidine has produced signs of toxicity in pediatric patients.

There is no specific antidote for clonidine overdosage. Supportive care may include atropine sulfate for bradycardia, intravenous fluids and/or vasopressor agents for hypotension. Hypertension associated with overdosage has been treated with intravenous furosemide, diazoxide or alpha-blocking agents such as phentolamine. Naloxone may be a useful adjunct in the treatment of clonidine induced respiratory depression, hypotension, and/or coma; blood pressure should be monitored since the administration of naloxone has occasionally resulted in paradoxical hypertension. Tolazoline administration has yielded inconsistent results and is not recommended as first-line therapy. Dialysis is not likely to significantly enhance the elimination of clonidine.

The largest overdose reported to date involved a 28-year old white male who ingested 100 mg of clonidine hydrochloride powder. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semi-coma, and premature ventricular contractions. The patient fully recovered after intensive treatment. Plasma clonidine levels were 60 ng/mL after 1 hour, 190 ng/mL after 1.5 hours, 370 ng/mL after 2 hours, and 120 ng/mL after 5.5 and 6.5 hours. In mice and rats, the oral LD50 of clonidine is 206 and 465 mg/kg, respectively.

DOSAGE AND ADMINISTRATION

The recommended starting dose of Duraclon 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.

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.

Duraclon 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.

Discard unused portion.

HOW SUPPLIED

NDC 67457-218-10, 100 mcg/mL solution in
10 mL vials, packaged individually.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Preservative Free. Discard unused portion.

Duraclon® is a registered trademark of Astellas US LLC, licensed to the Viatris Companies.

Manufactured for:
Mylan Institutional LLC
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Institutional
Galway, Ireland

0919L103

Revised: 3/2021
MI:DURAIJ:R6

To request medical information or to report suspected adverse reactions, contact Drug Safety at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PRINCIPAL DISPLAY PANEL – 100 mcg/mL

NDC 67457-218-10 10 mL

Duraclon®
(clonidine HCl
injection, USP)

1000 mcg/10 mL
(100 mcg/mL)

For Epidural Injection

Rx only Single-Dose Vial

Preservative Free

Sterile. Non-pyrogenic.

Each mL contains: 100 mcg
clonidine hydrochloride, USP
and 9 mg sodium chloride, USP
in water for injection, USP.

Hydrochloric acid and/or sodium
hydroxide may have been added
for pH adjustment. Discard
unused portion.

Usual Dosage: See
accompanying prescribing
information.

Store at 20° to 25°C (68° to
77°F). [See USP Controlled
Room Temperature.]

Manufactured for:
Mylan Institutional LLC Morgantown, WV 26505 U.S.A.

Made in Ireland

0511C103 MI:218:1C:R6

Duraclon® is a registered trademark of Astellas US LLC, licensed to the Viatris Companies..

Mylan.com

Duraclon (clonidine HCl injection, USP) 1000 mcg/10 mL (100 mcg/mL) -- Carton Label
(click image for full-size original)
DURACLON clonidine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67457-218
Route of Administration EPIDURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONIDINE HYDROCHLORIDE (CLONIDINE) CLONIDINE HYDROCHLORIDE 0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67457-218-10 1 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (67457-218-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020615 01/26/1997
Labeler — Mylan Institutional LLC (790384502)

Revised: 03/2021 Mylan Institutional LLC

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