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Duraclon

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Duraclon

Indications
Dosage
How Supplied

INDICATIONS

Duraclon (clonidine injection) 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 (clonidine injection) for continuous epidural infusion is 30 μg/hr. Although dosage may be titrated up or down depending on pain relief and occurrence of adverse events, experience with dosage rates above 40 μg/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 μg/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 μg/mL:

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

The 500 μg/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 μg/mL:

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

HOW SUPPLIED

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

NDC 67457-219-10, 500 μg/mL solution in 10 mL vials, packaged individually.

Store at 25°C (77°F); excursions are permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Preservative Free. Discard unused portion.

Marketed by: Bioniche Pharma USA LLC, Lake Forest, IL 60045. Revised: 05/2010. To request medical information or to report suspected adverse reactions, contact Drug Safety at 1888-875-1671 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Last reviewed on RxList: 8/18/2010
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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