Drug: Duraclon

Duraclon (clonidine hydrochloride injection) is a centrally-acting analgesic solution for use in continuous epidural infusion devices. Clonidine Hydrochloride, USP, is an imidazoline derivative and exists as a mesomeric compound. The chemical names are Benzenamine, 2,6-dichloro-N-2-imidazolidinylidene monohydrochloride and 2-[(2,6-dichlorophenyl) imino]imidazolidine monohydrochloride. The following is the structural formula:
C9H9Cl2N3• HCl      Mol. Wt. 266.56 Duraclon (clonidine hydrochloride injection) is supplied as a clear, colorless, preservative-free, pyrogen-free, aqueous sterile solution (pH 5 to 7) in single-dose, 10 mL vials. Each mL of the 100 μg/mL (0.1 mg/mL) concentration contains 100 μg of 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. Each 10 mL vial contains 1 mg (1000 μg) of clonidine hydrochloride. Each mL of the 500 μg/mL (0.5 mg/mL) concentration contains 500 μg of 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. Each 10 mL vial contains 5 mg (5000 μg) of clonidine hydrochloride.Last reviewed on RxList: 8/18/2010
This monograph has been modified to include the generic and brand name in many instances.

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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 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 Duraclon (clonidine injection) or morphine. Incidence of Adverse Events in the Two-Week Trial
Adverse Events Clonidine
N = 38
n(%) Placebo
N = 47
n(%) Total Number of Patients Who Experienced at Least One Adverse Event 37 (97.4) 38 (80.5) Hypotension 17 (44.8) 5 (10.6) Postural Hypotension 12 (31.6) 0 (0) Dry Mouth 5 (13.2) 4 (8.5) Nausea 5 (13.2) 10 (21.3) Somnolence 5 (13.2) 10 (21.3) Dizziness 5 (13.2) 2 (4.3) Confusion 5 (13.2) 5 (10.6) Vomiting 4 (10.5) 7 (14.9) Nausea/Vomiting 3 (7.9) 1 (2.1) Sweating 2 (5.3) 0 (0) Chest Pain 2 (5.3) 0 (0) Hallucination 2 (5.3) 1 (2.1) Tinnitus 2 (5.3) 0 (0) Constipation 1 (2.6) 2 (4.3) Tachycardia 1 (2.6) 2 (4.3) Hypoventilation 1 (2.6) 2 (4.3) An open label long-term extension of the above trial was performed. Thirty-two subjects received epidural clonidine and morphine for up to 94 weeks with a median dosing period of 10 weeks. The following adverse events (and percent incidence) were reported: hypotension/postural hypotension (47%); nausea (13%); anxiety/confusion (38%); somnolence (25%); urinary tract infection (22%); constipation, dyspnea, fever, infection (6% each); asthenia, hyperaesthesia, pain, skin ulcer, and vomiting (5% each). Eighteen percent of subjects discontinued this study as a result of catheter-related problems (infections, accidental dislodging, etc.), and one subject developed meningitis, possibly as a result of a catheter-related infection. In this study, rebound hypertension was not assessed, and ECG and laboratory data were not systematically sought. The following adverse reactions have also been reported with the use of any dosage form of clonidine. In many cases patients were receiving concomitant medication and a causal relationship has not been established: Body as a Whole: Weakness, 10%; fatigue, 4%; headache and withdrawal syndrome, each 1%. Also reported were pallor, a weakly positive Coomb's test, and increased sensitivity to alcohol. Cardiovascular: Palpitations and tachycardia, and bradycardia, each 0.5%. Syncope, Raynaud's phenomenon, congestive heart failure, and electrocardiographic abnormalities (i.e., sinus node arrest, functional bradycardia, high degree AV block) have been reported rarely. Rare cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis. Central Nervous System: Nervousness and agitation, 3%; mental depression, 1%; insomnia, 0.5%. Cerebrovascular accidents, other behavioral changes, vivid dreams or nightmares, restlessness, and delirium have been reported rarely. Dermatological: Rash, 1%; pruritus, 0.7%; hives, angioneurotic edema and urticaria, 0.5%; alopecia, 0.2%. Gastrointestinal: Anorexia and malaise, each 1%; mild transient abnormalities in liver function tests, 1%; hepatitis, parotitis, ileus and pseudo obstruction, and abdominal pain, rarely. Genitourinary: Decreased sexual activity, impotence, and libido, 3%; nocturia, about 1%; difficulty in micturition, about 0.2%; urinary retention, about 0.1%. Hematologic: Thrombocytopenia, rarely. Metabolic: Weight gain, 0.1%; gynecomastia, 1%; transient elevation of glucose or serum phosphatase, rarely. Musculoskeletal: Muscle or joint pain, about 0.6%; leg cramps, 0.3%. Oro-otolaryngeal: Dryness of the nasal mucosa was rarely reported. Ophthalmological: Dryness of the eyes, burning of the eyes and blurred vision were rarely reported. Read the Duraclon (clonidine injection) Side Effects Center for a complete guide to possible side effectsLearn More »

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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

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Clonidine may potentiate the CNS-depressive effect of alcohol, barbiturates or other sedating drugs. Narcotic analgesics may potentiate the hypotensive effects of clonidine. Tricyclic antidepressants may antagonize the hypotensive effects of clonidine. The effects of tricyclic antidepressants on clonidine's analgesic actions are not known. Beta-blockers may exacerbate the hypertensive response seen with clonidine withdrawal. Also, due to the potential for additive effects such as bradycardia and AV block, caution is warranted in patients receiving clonidine with agents known to affect sinus node function or AV nodal conduction, e.g., digitalis, calcium channel blockers, and beta-blockers. There is one reported case of a patient with acute delirium associated with the simultaneous use of fluphenazine and oral clonidine. Symptoms resolved when clonidine was withdrawn and recurred when the patient was rechallenged with clonidine. Epidural clonidine may prolong the duration of pharmacologic effects of epidural local anesthetics, including both sensory and motor blockade.Last reviewed on RxList: 8/18/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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).

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Duraclon (clonidine 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 Duraclon (clonidine injection) above the C4 dermatome is contraindicated since there are no adequate safety data to support such use. (see WARNINGS). Last reviewed on RxList: 4/30/2007
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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 μg 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.

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

Source: http://www.rxlist.com

General Cardiac Effects Epidural clonidine frequently causes decreases in heart rate. Symptomatic bradycardia can be treated with atropine. Rarely, atrioventricular block greater than first degree has been reported. Clonidine does not alter the hemodynamic response to exercise, but may mask the increase in heart rate associated with hypovolemia. Respiratory Depression and Sedation Clonidine administration may result in sedation through the activation of alpha-adrenoceptors in the brainstem. High doses of clonidine cause sedation and ventilatory abnormalities that are usually mild. Tolerance to these effects can develop with chronic administration. These effects have been reported with bolus doses that are significantly larger than the infusion rate recommended for treating cancer pain. Depression Depression has been seen in a small percentage of patients treated with oral or transdermal clonidine. Depression commonly occurs in cancer patients and may be exacerbated by treatment with clonidine. Patients, especially those with a known history of affective disorders, should be monitored for the signs and symptoms of depression. Pain of Visceral or Somatic Origin: In the clinical investigations, at doses tested, Duraclon (clonidine injection) was most effective in well-localized, “neuropathic” pain that was characterized as electrical, burning, or shooting in nature, and which was localized to a dermatomal or peripheral nerve distribution. Duraclon (clonidine injection) may be less effective, or possibly ineffective in the treatment of pain that is diffuse, poorly localized, or visceral in origin. Carcinogenesis, Mutagenesis, Impairment of Fertility In a 132-week study in rats, clonidine hydrochloride administered as a dietary admixture at 5-8 times (based on body surface area) the 50 μg/kg maximum recommended daily human dose (MRDHD) for hypertension did not show any carcinogenic potential. Clonidine was inactive in the Ames test of mutagenicity. Fertility of male or female rats was unaffected by oral clonidine hydrochloride doses as high as 150 μg/kg, or about 0.5 times the MRDHD. Fertility of female rats did, however, appear to be affected in another experiment at oral dose levels of 500-2000 μg/kg, or 2-7 times the MRDHD. Usage in Pregnancy/Teratogenic Effects Pregnancy Category C: Reproduction studies in rabbits at clonidine hydrochloride doses up to approximately the MRDHD revealed no evidence of teratogenic or embryotoxic potential. In rats, however, doses as low as one-third the MRDHD were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. Increased resorptions were not associated with treatment with the same or higher doses up to 0.5 times the MRDHD when dams were treated on days 6-15 of gestation. Increased resorptions were observed at higher levels (7times the MRDHD) in rats and mice treated on days 1-14 of gestation. Clonidine readily crosses the placenta and its concentrations are equal in maternal and umbilical cord plasma; amniotic fluid concentrations can be 4-times those found in serum. There are no adequate and well-controlled studies in pregnant women during early gestation when organ formation takes place. Studies using epidural clonidine during labor have demonstrated no apparent adverse effects on the infant at the time of delivery. However, these studies did not monitor the infants for hemodynamic effects in the days following delivery. Clonidine hydrochloride injection should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Labor and Delivery There are no adequate controlled clinical trials evaluating the safety, efficacy, and dosing of Duraclon (clonidine injection) in obstetrical settings. Because maternal perfusion of the placenta is critically dependent on blood pressure, use of Duraclon (clonidine injection) as an analgesic during labor and delivery is not indicated (see WARNINGS). Nursing Mothers Concentrations of clonidine in human breast milk are approximately twice those found in maternal plasma. Caution should be exercised when clonidine is administered to a nursing woman. Because of the potential for severe adverse reactions in nursing infants, a decision should be made to either discontinue nursing or to discontinue clonidine. Pediatric Use The safety and effectiveness of Duraclon (clonidine injection) in this limited indication and clinical population have been established in patients old enough to tolerate placement and management of an epidural catheter, based on evidence from adequate and well controlled studies in adults and experience with the use of clonidine in the pediatric age group for other indications. The use of Duraclon (clonidine injection) should be restricted to pediatric patients with severe intractable pain from malignancy that is unresponsive to epidural or spinal opiates or other more conventional analgesic techniques. The starting dose of Duraclon (clonidine injection) should be selected on per kilogram basis (0.5 μg per kg per hour) and cautiously adjusted based on the clinical response.Last reviewed on RxList: 8/18/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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