Duraclon (Clonidine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

Duraclon 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 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 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.

The 500 mcg/mL (0.5 mg/mL) strength product must be diluted prior to use in 0.9% Sodium Chloride for Injection, U.S.P., to a final concentration of 100 mcg/mL:

Volume of Duraclon 500 mcg/mL	Volume of 0.9% Sodium Chloride for Injection, U.S.P.	Resulting Final Duraclon Concentration (100 mcg/mL)
1 mL	4 mL	500 mcg/5 mL
2 mL	8 mL	1000 mcg/10 mL
3 mL	12 mL	1500 mcg/15 mL
4 mL	16 mL	2000 mcg/20 mL
5 mL	20 mL	2500 mcg/25 mL
6 mL	24 mL	3000 mcg/30 mL
7 mL	28 mL	3500 mcg/35 mL
8 mL	32 mL	4000 mcg/40 mL
9 mL	36 mL	4500 mcg/45 mL
10 mL	40 mL	5000 mcg/50 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.

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.

HOW SUPPLIED

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

NDC 67457-219-10, 500 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 licensed registered trademark.

Manufactured for:
Mylan Institutional LLC
Rockford, IL 61103 U.S.A.

Manufactured by:
Mylan Institutional
Galway, Ireland

0764L102
REVISED JUNE 2012
MI:DURAIJ:R2

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