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Drug overview for DURACLON (clonidine hcl/pf):
Generic name: CLONIDINE HCL/PF (KLON-i-deen)
Drug class: Central Adrenolytics
Therapeutic class: Analgesic, Anti-inflammatory or Antipyretic
Clonidine hydrochloride, an imidazoline-derivative hypotensive agent, is a centrally acting alpha2-adrenergic agonist.
No enhanced Uses information available for this drug.
Generic name: CLONIDINE HCL/PF (KLON-i-deen)
Drug class: Central Adrenolytics
Therapeutic class: Analgesic, Anti-inflammatory or Antipyretic
Clonidine hydrochloride, an imidazoline-derivative hypotensive agent, is a centrally acting alpha2-adrenergic agonist.
No enhanced Uses information available for this drug.
DRUG IMAGES
DURACLON 100 MCG/ML VIAL
The following indications for DURACLON (clonidine hcl/pf) have been approved by the FDA:
Indications:
Severe pain
Professional Synonyms:
None.
Indications:
Severe pain
Professional Synonyms:
None.
The following dosing information is available for DURACLON (clonidine hcl/pf):
Regardless of the route of administration, to avoid the possibility of precipitating the withdrawal syndrome, clonidine therapy should not be discontinued abruptly.
Dosage of clonidine is expressed in terms of clonidine and clonidine hydrochloride.
Dosage of clonidine is expressed in terms of clonidine and clonidine hydrochloride.
Clonidine hydrochloride is administered orally or by epidural infusion; clonidine is administered orally or percutaneously by topical application of a transdermal system.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| DURACLON 100 MCG/ML VIAL | Maintenance | Adults infuse 0.03 mg/hour by continuous epidural route |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CLONIDINE 1,000 MCG/10 ML VIAL | Maintenance | Adults infuse 0.03 mg/hour by continuous epidural route |
The following drug interaction information is available for DURACLON (clonidine hcl/pf):
There are 0 contraindications.
There are 0 severe interactions.
There are 2 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Clonidine/Tricyclic Compounds; Mirtazapine SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Clonidine decreases blood pressure via alpha-2 agonism.(1) Tricyclic compounds(2) and mirtazapine(3) antagonize alpha-2, which may result in a loss of effect of clonidine. CLINICAL EFFECTS: The concurrent use of clonidine and tricyclic compounds(1,3,4-16) and mirtazapine(3,17) may result in decreased effectiveness of clonidine and hypertensive crisis. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: If possible, avoid concurrent use of clonidine with tricyclic compounds or mirtazapine. Consider using an alternative agent in patients maintained on clonidine. If concurrent administration is warranted, blood pressure should be carefully monitored, particularly in the first two weeks of therapy, when this interaction is most likely to occur. The dosage of clonidine may need to be adjusted or the tricyclic compound or mirtazapine may need to be discontinued. DISCUSSION: This interaction has been reported in patients receiving amitriptyline,(6) clomipramine,(7,8) desipramine,(2,9-11) imipramine(12-16), and protriptyline.(11) In one patient, a hypertensive crisis resulted. Other patients experienced a decrease in blood pressure control. A controlled trial demonstrated a decrease in anti-hypertensive effect when desipramine was added to a clonidine regimen. This decrease in hypertensive-control may be overcome by increasing the dose of clonidine and monitoring blood pressure closely. Cyclobenzaprine is structurally related to the tricyclic antidepressants and, especially at higher dosages, has similar effects.(18) Therefore, it is prudent to consider cyclobenzaprine in this interaction. Hypertensive crisis has been reported during concurrent clonidine and mirtazapine therapy.(3,17) Mianserin(19,20) and maprotiline,(21) tetracyclic antidepressants, have been shown not to affect the antihypertensive effects of clonidine. |
AMITRIPTYLINE HCL, AMOXAPINE, AMRIX, ANAFRANIL, CHLORDIAZEPOXIDE-AMITRIPTYLINE, CLOMIPRAMINE HCL, CYCLOBENZAPRINE HCL, CYCLOBENZAPRINE HCL ER, CYCLOPAK, CYCLOTENS, DESIPRAMINE HCL, DOXEPIN HCL, FEXMID, IMIPRAMINE HCL, IMIPRAMINE PAMOATE, MIRTAZAPINE, MIRTAZAPINE ANHYDROUS, NORPRAMIN, NORTRIPTYLINE HCL, PAMELOR, PERPHENAZINE-AMITRIPTYLINE, PROTRIPTYLINE HCL, REMERON, SILENOR, TONMYA, TRIMIPRAMINE MALEATE |
| Clonidine/Beta-Blockers SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Withdrawal of clonidine triggers increased catecholamine release. Beta-blockers inhibit the vasodilation mediated by the beta 2 receptor, leaving the vasoconstriction mediated by the alpha 2 receptor unopposed. In addition, concurrent use is expected to produce additive effects on blood pressure and heart rate requiring standard monitoring precautions. CLINICAL EFFECTS: Severe hypertension may occur upon abrupt discontinuation of clonidine in patients receiving both clonidine and beta-blockers. In addition, concurrent use is expected to produce additive effects on blood pressure and heart rate requiring standard monitoring precautions. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: In a patient receiving both drugs, discontinuation of the beta-blocker prior to clonidine may decrease the occurrence of rebound hypertension. If clonidine is discontinued first, rebound hypertension can be treated by restarting the clonidine or by the IV administration of phentolamine, phenoxybenzamine or prazosin. When adding either of these agents to the drug regimen of the patient, monitor blood pressure. Since labetalol has both alpha and beta activity, administration of labetalol may prevent rebound hypertension in patients undergoing clonidine withdrawal, although conflicting reports exist. In addition, concurrent use is expected to produce additive effects on blood pressure and heart rate requiring standard monitoring precautions. DISCUSSION: Increased blood pressure has been observed in patients following: 1) the discontinuation of clonidine in patients receiving beta-blockers, 2) the replacement of clonidine therapy with beta-blockers, 3) the simultaneous discontinuation of both drugs. Conflicting reports exist on the development of increased blood pressure after clonidine withdrawal in patients receiving labetalol. Patients receiving labetalol who are being withdrawn from clonidine should still be closely monitored. |
ACEBUTOLOL HCL, ATENOLOL, ATENOLOL-CHLORTHALIDONE, BETAPACE, BETAPACE AF, BETAXOLOL HCL, BETIMOL, BETOPTIC S, BIMATOPROST-DORZOLAMID-TIMOLOL, BISOPROLOL FUMARATE, BISOPROLOL-HYDROCHLOROTHIAZIDE, BREVIBLOC, BRIMONIDINE TARTRATE-TIMOLOL, BYSTOLIC, CARTEOLOL HCL, CARVEDILOL, CARVEDILOL ER, COMBIGAN, COREG, COREG CR, COSOPT, COSOPT PF, DORZOLAMIDE-TIMOLOL, ESMOLOL HCL, ESMOLOL HCL-SODIUM CHLORIDE, ESMOLOL HCL-WATER, HEMANGEOL, INDERAL LA, INDERAL XL, INNOPRAN XL, ISTALOL, KAPSPARGO SPRINKLE, LABETALOL HCL, LABETALOL HCL-WATER, LEVOBUNOLOL HCL, LOPRESSOR, METOPROLOL SUCCINATE, METOPROLOL TARTRATE, METOPROLOL-HYDROCHLOROTHIAZIDE, NADOLOL, NEBIVOLOL HCL, PINDOLOL, PROPRANOLOL HCL, PROPRANOLOL HCL ER, PROPRANOLOL-HYDROCHLOROTHIAZID, RAPIBLYK, SOTALOL, SOTALOL AF, SOTALOL HCL, SOTYLIZE, TENORETIC 100, TENORETIC 50, TENORMIN, TIMOLOL, TIMOLOL MALEATE, TIMOLOL-BIMATOPROST, TIMOLOL-BRIMONI-DORZOL-BIMATOP, TIMOLOL-BRIMONIDIN-DORZOLAMIDE, TIMOLOL-DORZOLAMIDE-BIMATOPRST, TIMOPTIC OCUDOSE, TOPROL XL |
The following contraindication information is available for DURACLON (clonidine hcl/pf):
Drug contraindication overview.
*Clonidine is contraindicated in patients with known hypersensitivity to the drug or to any ingredient or component in the formulation. *Administration of epidural clonidine is contraindicated in patients receiving anticoagulant therapy, in those with a bleeding diathesis, and in the presence of an injection site infection. *Administration of epidural clonidine above the C4 dermatome is contraindicated because of inadequate safety data supporting such use. *Administration of epidural clonidine also is not recommended in most patients with severe cardiovascular disease or in patients who are hemodynamically unstable.
*Clonidine is contraindicated in patients with known hypersensitivity to the drug or to any ingredient or component in the formulation. *Administration of epidural clonidine is contraindicated in patients receiving anticoagulant therapy, in those with a bleeding diathesis, and in the presence of an injection site infection. *Administration of epidural clonidine above the C4 dermatome is contraindicated because of inadequate safety data supporting such use. *Administration of epidural clonidine also is not recommended in most patients with severe cardiovascular disease or in patients who are hemodynamically unstable.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Increased risk of bleeding due to coagulation disorder |
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Bradycardia |
| Hypotension |
| Perioperative care |
| Respiratory depression |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Cerebrovascular disorder |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
| Myocardial ischemia |
The following adverse reaction information is available for DURACLON (clonidine hcl/pf):
Adverse reaction overview.
Most adverse effects with clonidine are mild in nature and tend to decrease with continuation of therapy. The most common, dose-related adverse effects include dry mouth, drowsiness, dizziness, constipation, and sedation. Adverse effects with transdermal clonidine are generally similar to those with oral therapy.
The most frequent adverse effects with transdermal clonidine were dry mouth, drowsiness, and local adverse dermatologic effects. The most frequent adverse effects occurring with clonidine hydrochloride epidural infusion for severe intractable cancer pain were hypotension, postural hypotension, dizziness, anxiety, and dry mouth; asymptomatic bradycardia was also observed in 1 patient. Mean heart rate and blood pressure reductions were also observed in patients receiving clonidine hydrochloride epidural infusion.
Upon withdrawal of clonidine, 4 patients also experienced rebound hypertension, of which 1 suffered a cerebrovascular accident. Adverse effects occurring in >=5% of patients receiving clonidine as monotherapy for ADHD include somnolence, fatigue, irritability, nightmares, insomnia, constipation, and dry mouth. When used as adjunctive therapy to stimulants in ADHD, adverse effects reported in >=5% of patients include somnolence, fatigue, decreased appetite, and dizziness.
Most adverse effects with clonidine are mild in nature and tend to decrease with continuation of therapy. The most common, dose-related adverse effects include dry mouth, drowsiness, dizziness, constipation, and sedation. Adverse effects with transdermal clonidine are generally similar to those with oral therapy.
The most frequent adverse effects with transdermal clonidine were dry mouth, drowsiness, and local adverse dermatologic effects. The most frequent adverse effects occurring with clonidine hydrochloride epidural infusion for severe intractable cancer pain were hypotension, postural hypotension, dizziness, anxiety, and dry mouth; asymptomatic bradycardia was also observed in 1 patient. Mean heart rate and blood pressure reductions were also observed in patients receiving clonidine hydrochloride epidural infusion.
Upon withdrawal of clonidine, 4 patients also experienced rebound hypertension, of which 1 suffered a cerebrovascular accident. Adverse effects occurring in >=5% of patients receiving clonidine as monotherapy for ADHD include somnolence, fatigue, irritability, nightmares, insomnia, constipation, and dry mouth. When used as adjunctive therapy to stimulants in ADHD, adverse effects reported in >=5% of patients include somnolence, fatigue, decreased appetite, and dizziness.
There are 11 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bradycardia Hypotension |
Chest pain Depression Fever Hallucinations Tachycardia Vomiting |
| Rare/Very Rare |
|---|
|
Accidental fall Atrioventricular block Respiratory depression |
There are 23 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute cognitive impairment Dizziness Drowsy Nausea Orthostatic hypotension Symptoms of anxiety Xerostomia |
Anorexia Constipation Dyspnea Fatigue General weakness Headache disorder Hyperhidrosis Libido changes Sedation Skin rash Tinnitus |
| Rare/Very Rare |
|---|
|
Dysuria Insomnia Palpitations Pruritus of skin Urticaria |
The following precautions are available for DURACLON (clonidine hcl/pf):
The safety and efficacy of extended-release clonidine tablets and extended-release oral suspension (Onyda(TM) XR) for the treatment of ADHD have been established in pediatric patients 6-17 years of age. Use for this indication is based on evidence from 3 adequate, well-controlled studies, a short-term, placebo-controlled monotherapy study, a short-term, adjunctive therapy study, and a long-term randomized monotherapy study. Safety and efficacy of oral clonidine hydrochloride, extended-release clonidine (Nexiclon(TM) XR), and clonidine transdermal system for the management of hypertension in children have not been established.
The safety and efficacy of clonidine hydrochloride epidural infusion have been established in pediatric patients who are old enough to tolerate placement and management of an epidural catheter, based on evidence from adequate, well-controlled studies in adults and experience with the use of clonidine in pediatric patients for other indications. Epidural clonidine should be used only in pediatric patients with severe, intractable cancer pain that is unresponsive to epidural or spinal opiates and to other conventional analgesic therapy. Children may be more likely to experience CNS depression associated with clonidine overdosage than adults.
In children, signs of toxicity have occurred with clonidine doses as low as 0.1 mg. Rare cases of clonidine toxicity (many involving children) associated with accidental or deliberate mouthing or ingestion of clonidine transdermal systems have been reported. The manufacturer of oral clonidine states that because children frequently experience vomiting associated with GI illnesses, they may be particularly susceptible to hypertensive episodes resulting from sudden inability to ingest the drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
The safety and efficacy of clonidine hydrochloride epidural infusion have been established in pediatric patients who are old enough to tolerate placement and management of an epidural catheter, based on evidence from adequate, well-controlled studies in adults and experience with the use of clonidine in pediatric patients for other indications. Epidural clonidine should be used only in pediatric patients with severe, intractable cancer pain that is unresponsive to epidural or spinal opiates and to other conventional analgesic therapy. Children may be more likely to experience CNS depression associated with clonidine overdosage than adults.
In children, signs of toxicity have occurred with clonidine doses as low as 0.1 mg. Rare cases of clonidine toxicity (many involving children) associated with accidental or deliberate mouthing or ingestion of clonidine transdermal systems have been reported. The manufacturer of oral clonidine states that because children frequently experience vomiting associated with GI illnesses, they may be particularly susceptible to hypertensive episodes resulting from sudden inability to ingest the drug.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Reproduction studies in rabbits using oral clonidine hydrochloride dosages up to about 3 times the maximum recommended human dosage have not revealed evidence of teratogenicity or embryotoxicity. However, in female rats receiving the drug continuously for 2 months prior to mating, an increased incidence of fetal resorptions occurred with oral dosages as low as one-third the maximum recommended human dosage (1/15th the maximum recommended human dosage on a mg/m2 basis); resorptions were not increased when these or higher dosages (up to 3 times the maximum recommended human dosage) were administered during days 6-15 of gestation. An increased incidence of fetal resorptions was observed when much higher dosages (40 times the maximum recommended human dosage on a mg/kg basis and 4-8 times the maximum recommended human dosage on a mg/m2 basis) were administered to mice and rats during days 1-14 of gestation; the lowest dosage used in the study was 0.5
mg/kg. There are no adequate and controlled studies to date using clonidine in pregnant women, and the drug should be used during pregnancy only when clearly needed. There is a pregnancy exposure registry available that monitors pregnancy outcomes in women exposed to ADHD medications, including clonidine, during pregnancy.
Patients can register by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or by visiting https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/ .
mg/kg. There are no adequate and controlled studies to date using clonidine in pregnant women, and the drug should be used during pregnancy only when clearly needed. There is a pregnancy exposure registry available that monitors pregnancy outcomes in women exposed to ADHD medications, including clonidine, during pregnancy.
Patients can register by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or by visiting https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/ .
Since clonidine is distributed into milk, the drug should be used with caution in nursing women. The drug is excreted into milk at relative infant doses ranging from 4.1-8.4%
of the maternal weight-adjusted dosage. Although in most cases, there were no reported adverse effects in breast-fed infants exposed to clonidine, one infant developed sedation, hypotonia, and apnea after clonidine exposure through breast milk. Monitor infants exposed to clonidine through breast milk for symptoms of hypotension and bradycardia, such as sedation, lethargy, tachypnea and poor feeding. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for the drug and any potential adverse effects on the breast-fed infant from exposure to clonidine or the underlying maternal condition.
of the maternal weight-adjusted dosage. Although in most cases, there were no reported adverse effects in breast-fed infants exposed to clonidine, one infant developed sedation, hypotonia, and apnea after clonidine exposure through breast milk. Monitor infants exposed to clonidine through breast milk for symptoms of hypotension and bradycardia, such as sedation, lethargy, tachypnea and poor feeding. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for the drug and any potential adverse effects on the breast-fed infant from exposure to clonidine or the underlying maternal condition.
Geriatric patients may benefit from lower initial dosages of clonidine.
The following prioritized warning is available for DURACLON (clonidine hcl/pf):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for DURACLON (clonidine hcl/pf)'s list of indications:
| Severe pain | |
| G89 | Pain, not elsewhere classified |
| G89.1 | Acute pain, not elsewhere classified |
| G89.11 | Acute pain due to trauma |
| G89.12 | Acute post-thoracotomy pain |
| G89.18 | Other acute postprocedural pain |
| G89.2 | Chronic pain, not elsewhere classified |
| G89.21 | Chronic pain due to trauma |
| G89.22 | Chronic post-thoracotomy pain |
| G89.28 | Other chronic postprocedural pain |
| G89.29 | Other chronic pain |
| G89.3 | Neoplasm related pain (acute) (chronic) |
| G89.4 | Chronic pain syndrome |
| M25.5 | Pain in joint |
| M25.50 | Pain in unspecified joint |
| M25.51 | Pain in shoulder |
| M25.511 | Pain in right shoulder |
| M25.512 | Pain in left shoulder |
| M25.519 | Pain in unspecified shoulder |
| M25.52 | Pain in elbow |
| M25.521 | Pain in right elbow |
| M25.522 | Pain in left elbow |
| M25.529 | Pain in unspecified elbow |
| M25.53 | Pain in wrist |
| M25.531 | Pain in right wrist |
| M25.532 | Pain in left wrist |
| M25.539 | Pain in unspecified wrist |
| M25.54 | Pain in joints of hand |
| M25.541 | Pain in joints of right hand |
| M25.542 | Pain in joints of left hand |
| M25.549 | Pain in joints of unspecified hand |
| M25.55 | Pain in hip |
| M25.551 | Pain in right hip |
| M25.552 | Pain in left hip |
| M25.559 | Pain in unspecified hip |
| M25.56 | Pain in knee |
| M25.561 | Pain in right knee |
| M25.562 | Pain in left knee |
| M25.569 | Pain in unspecified knee |
| M25.57 | Pain in ankle and joints of foot |
| M25.571 | Pain in right ankle and joints of right foot |
| M25.572 | Pain in left ankle and joints of left foot |
| M25.579 | Pain in unspecified ankle and joints of unspecified foot |
| M25.59 | Pain in other specified joint |
| M26.62 | Arthralgia of temporomandibular joint |
| M54.5 | Low back pain |
| M54.50 | Low back pain, unspecified |
| M54.51 | Vertebrogenic low back pain |
| M54.59 | Other low back pain |
| M54.6 | Pain in thoracic spine |
| M79.6 | Pain in limb, hand, foot, fingers and toes |
| M79.60 | Pain in limb, unspecified |
| M79.601 | Pain in right arm |
| M79.602 | Pain in left arm |
| M79.603 | Pain in arm, unspecified |
| M79.604 | Pain in right leg |
| M79.605 | Pain in left leg |
| M79.606 | Pain in leg, unspecified |
| M79.609 | Pain in unspecified limb |
| M79.62 | Pain in upper arm |
| M79.621 | Pain in right upper arm |
| M79.622 | Pain in left upper arm |
| M79.629 | Pain in unspecified upper arm |
| M79.63 | Pain in forearm |
| M79.631 | Pain in right forearm |
| M79.632 | Pain in left forearm |
| M79.639 | Pain in unspecified forearm |
| M79.64 | Pain in hand and fingers |
| M79.641 | Pain in right hand |
| M79.642 | Pain in left hand |
| M79.643 | Pain in unspecified hand |
| M79.644 | Pain in right finger(s) |
| M79.645 | Pain in left finger(s) |
| M79.646 | Pain in unspecified finger(s) |
| M79.65 | Pain in thigh |
| M79.651 | Pain in right thigh |
| M79.652 | Pain in left thigh |
| M79.659 | Pain in unspecified thigh |
| M79.66 | Pain in lower leg |
| M79.661 | Pain in right lower leg |
| M79.662 | Pain in left lower leg |
| M79.669 | Pain in unspecified lower leg |
| M79.67 | Pain in foot and toes |
| M79.671 | Pain in right foot |
| M79.672 | Pain in left foot |
| M79.673 | Pain in unspecified foot |
| M79.674 | Pain in right toe(s) |
| M79.675 | Pain in left toe(s) |
| M79.676 | Pain in unspecified toe(s) |
| R07.82 | Intercostal pain |
| R10.0 | Acute abdomen |
| R10.1 | Pain localized to upper abdomen |
| R10.10 | Upper abdominal pain, unspecified |
| R10.11 | Right upper quadrant pain |
| R10.12 | Left upper quadrant pain |
| R10.2 | Pelvic and perineal pain |
| R10.20 | Pelvic and perineal pain unspecified side |
| R10.21 | Pelvic and perineal pain right side |
| R10.22 | Pelvic and perineal pain left side |
| R10.23 | Pelvic and perineal pain bilateral |
| R10.24 | Suprapubic pain |
| R10.3 | Pain localized to other parts of lower abdomen |
| R10.30 | Lower abdominal pain, unspecified |
| R10.31 | Right lower quadrant pain |
| R10.32 | Left lower quadrant pain |
| R10.33 | Periumbilical pain |
| R10.8 | Other abdominal pain |
| R10.84 | Generalized abdominal pain |
| R10.85 | Abdominal pain of multiple sites |
| R10.9 | Unspecified abdominal pain |
| R10.A | Pain localized to flank |
| R10.A0 | Flank pain, unspecified side |
| R10.A1 | Flank pain, right side |
| R10.A2 | Flank pain, left side |
| R10.A3 | Flank pain, bilateral |
| R52 | Pain, unspecified |
| R68.84 | Jaw pain |
Formulary Reference Tool