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Drug overview for DURACLON (PF) (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 selective 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 selective alpha2-adrenergic agonist.
No enhanced Uses information available for this drug.
DRUG IMAGES
DURACLON 100 MCG/ML VIAL
The following indications for DURACLON (PF) (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 (PF) (clonidine hcl/pf):
To avoid the possibility of precipitating the withdrawal syndrome, clonidine therapy should not be discontinued abruptly. (See Cautions: Withdrawal Effects.)
For the management of hypertension, the usual initial oral dosage of clonidine hydrochloride (as conventional tablets) in adults is 0.1 mg twice daily. Geriatric patients may benefit from a lower initial dosage of 0.05
mg twice daily. Dosage may be increased by 0.1 mg at weekly intervals until the desired response is achieved.
In clinical studies, the most commonly used dosages have ranged from 0.2-0.6 mg daily, administered in divided doses.
Some experts state that the usual dosage range for adults is 0.1-0.8 mg daily, administered in 2 divided doses.
The maximum effective dosage in adults is 2.4 mg daily.
For information on overall principles and expert recommendations for treatment of hypertension in pediatric patients, see Uses: Hypertension in Pediatric Patients, in the Thiazides General Statement 40:28.20.
Smaller than usual dosages of clonidine hydrochloride may be adequate in patients who are also receiving diuretics or other hypotensive drugs.
When transdermal clonidine therapy is used for the management of hypertension in adults, transdermal therapy is initiated with one system delivering 0.1 mg/24 hours applied once every 7 days. Because of interpatient variability in transdermal absorption, it is recommended that this initial dosage be used in all patients, including those who had been receiving oral clonidine hydrochloride therapy, and that dosage subsequently be titrated according to individual requirements; the relationship between the effective dosage of oral clonidine hydrochloride and that of transdermal clonidine is not predictable.
If the desired reduction in blood pressure is not achieved after 1 or 2 weeks with the initial dosage, dosage may be increased by using 2 systems delivering 0.1 mg/24 hours or a larger dosage system. Subsequent dosage adjustments may be made at weekly intervals.
Some experts state that the usual dosage range for transdermal clonidine is 0.1-0.3 mg/24 hours applied once every 7 days.
Transdermal dosages exceeding 0.6 mg/24 hours (2 systems each delivering 0.3 mg/24 hours) are usually not associated with additional efficacy. In patients who develop localized skin irritation during the intended period of use (7 days), it may be necessary to move the transdermal system to a different site or replace it with another system at shorter intervals (e.g., every 3-5 days).
Replacement of the transdermal system following a duration of less than 7 days may be required rarely to maintain blood pressure control.
When transdermal therapy is initiated in patients who have been receiving low dosages of oral clonidine hydrochloride, some clinicians recommend continuing the usual oral dosage the first day the initial transdermal system is applied. When transdermal clonidine therapy is administered to patients already receiving other hypotensive agents, dosage of the other hypotensive agents should be gradually reduced when transdermal therapy is initiated since the hypotensive effect of transdermal clonidine may not begin until 2-3 days after application of the initial system; the other hypotensive agents may have to be continued, particularly in patients with more severe hypertension.
When used for the relief of severe, intractable cancer pain that is unresponsive to epidural or spinal opiate analgesia or other more conventional methods of analgesia, the recommended initial epidural dosage of clonidine hydrochloride in adults is 30 mcg/hour, administered by continuous epidural infusion. The dosage may be adjusted based on clinical response and tolerance; however, clinical experience with infusion rates exceeding 40 mcg/hour is limited. Patients should be closely monitored, particularly during the first few days of epidural clonidine therapy.
The recommended initial dosage of epidural clonidine hydrochloride in pediatric patients is 0.5 mcg/kg of body weight per hour. The dosage of epidural clonidine in pediatric patients should be cautiously adjusted based on clinical response.
Oral clonidine hydrochloride dosages of 0.025-0.2 mg twice daily (as conventional tablets) have been employed in the management of vasomotor symptoms (e.g., hot flashes) associated with menopause+.
While comparative efficacy of various transdermal clonidine dosages have not been established, patients in clinical studies have received one transdermal system delivering 0.1 mg/24 hours applied once every 7 days.
For symptomatic relief of opiate withdrawal in opiate-dependent individuals+, various dosage regimens of oral clonidine hydrochloride (as conventional tablets) have been used. Some experts state that the usual clonidine hydrochloride dosage for opiate withdrawal management is 0.1-0.3
mg every 6-8 hours, with dosage guided by withdrawal symptoms and adverse effects. Other experts recommend administration of an initial 0.1-mg test dose of clonidine hydrochloride; a 0.2-mg
test dose may be considered for patients with severe manifestations of opiate withdrawal or for those weighing more than 200 pounds (91 kg). If blood pressure remains adequate (generally systolic and diastolic blood pressures of least 90 and 60 mm Hg, respectively) following the test dose, a clonidine hydrochloride dosage of 0.1-0.2
mg may be administered every 4-6 hours as needed; scheduled dosing may be considered in patients with severe withdrawal. Under this dosing method, the total dose administered during the initial 24 hours of treatment is tabulated to establish the patient's daily dosage requirement and is administered in 3 or 4 divided doses.
Doses of clonidine hydrochloride should be reduced, delayed, or omitted in individuals demonstrating greater sensitivity to the drug's adverse effects (e.g., hypotension, orthostasis, bradycardia). Individuals treated in the outpatient setting should be capable of performing self-monitoring for these adverse effects, and some experts suggest that lower dosages may be appropriate in this setting. As opiate withdrawal symptoms wane, clonidine hydrochloride dosage may be reduced gradually (e.g., by 0.1 mg per dose every 1-2 days).
Other tapering schedules also have been used to discontinue therapy (e.g., dosage has been reduced by decrements of 50% per day for 3 days and then discontinued, or reduced by 0.1-0.2 mg daily ). Clinicians should consult published protocols for more specific information.
For use in the cessation of smoking+, the initial adult oral dosage of clonidine hydrochloride is typically 0.1 mg twice daily (as conventional tablets). Therapy with the drug is initiated on the day set as the date of cessation of smoking or shortly before this date (e.g., up to 3 days prior).
Dosage may be increased each week by 0.1 mg daily, if needed. In clinical studies, oral dosages varied from 0.15-0.75
mg daily without a clear relationship to achievement of cessation of smoking. The duration of oral therapy with clonidine hydrochloride also varied in these studies, ranging from 3-10 weeks.
When transdermal clonidine is used for the cessation of smoking+, therapy is initiated typically in adults with one system delivering 0.1 mg/24 hours applied once every 7 days. Therapy with the drug is initiated on the day set as the date of cessation of smoking or shortly before this date (e.g., up to 3 days prior).
Dosage may be increased at weekly intervals by 0.1 mg/24 hours, if needed. In clinical studies, the transdermal dosage varied from 0.1-0.2
mg/24 hours without a clear relationship to achievement of cessation of smoking. The duration of transdermal clonidine therapy also varied in these studies, ranging from 3-10 weeks.
Smaller than usual dosages of clonidine or clonidine hydrochloride may be adequate in patients with renal impairment. Dosage should be adjusted according to the degree of renal impairment. Some clinicians suggest that adjustment of clonidine hydrochloride dosage is not necessary in patients with creatinine clearances of 10 mL/minute or greater, but those with lower clearances can receive 50-75% of the usual dosage. Supplemental doses after hemodialysis are not necessary.
For the management of hypertension, the usual initial oral dosage of clonidine hydrochloride (as conventional tablets) in adults is 0.1 mg twice daily. Geriatric patients may benefit from a lower initial dosage of 0.05
mg twice daily. Dosage may be increased by 0.1 mg at weekly intervals until the desired response is achieved.
In clinical studies, the most commonly used dosages have ranged from 0.2-0.6 mg daily, administered in divided doses.
Some experts state that the usual dosage range for adults is 0.1-0.8 mg daily, administered in 2 divided doses.
The maximum effective dosage in adults is 2.4 mg daily.
For information on overall principles and expert recommendations for treatment of hypertension in pediatric patients, see Uses: Hypertension in Pediatric Patients, in the Thiazides General Statement 40:28.20.
Smaller than usual dosages of clonidine hydrochloride may be adequate in patients who are also receiving diuretics or other hypotensive drugs.
When transdermal clonidine therapy is used for the management of hypertension in adults, transdermal therapy is initiated with one system delivering 0.1 mg/24 hours applied once every 7 days. Because of interpatient variability in transdermal absorption, it is recommended that this initial dosage be used in all patients, including those who had been receiving oral clonidine hydrochloride therapy, and that dosage subsequently be titrated according to individual requirements; the relationship between the effective dosage of oral clonidine hydrochloride and that of transdermal clonidine is not predictable.
If the desired reduction in blood pressure is not achieved after 1 or 2 weeks with the initial dosage, dosage may be increased by using 2 systems delivering 0.1 mg/24 hours or a larger dosage system. Subsequent dosage adjustments may be made at weekly intervals.
Some experts state that the usual dosage range for transdermal clonidine is 0.1-0.3 mg/24 hours applied once every 7 days.
Transdermal dosages exceeding 0.6 mg/24 hours (2 systems each delivering 0.3 mg/24 hours) are usually not associated with additional efficacy. In patients who develop localized skin irritation during the intended period of use (7 days), it may be necessary to move the transdermal system to a different site or replace it with another system at shorter intervals (e.g., every 3-5 days).
Replacement of the transdermal system following a duration of less than 7 days may be required rarely to maintain blood pressure control.
When transdermal therapy is initiated in patients who have been receiving low dosages of oral clonidine hydrochloride, some clinicians recommend continuing the usual oral dosage the first day the initial transdermal system is applied. When transdermal clonidine therapy is administered to patients already receiving other hypotensive agents, dosage of the other hypotensive agents should be gradually reduced when transdermal therapy is initiated since the hypotensive effect of transdermal clonidine may not begin until 2-3 days after application of the initial system; the other hypotensive agents may have to be continued, particularly in patients with more severe hypertension.
When used for the relief of severe, intractable cancer pain that is unresponsive to epidural or spinal opiate analgesia or other more conventional methods of analgesia, the recommended initial epidural dosage of clonidine hydrochloride in adults is 30 mcg/hour, administered by continuous epidural infusion. The dosage may be adjusted based on clinical response and tolerance; however, clinical experience with infusion rates exceeding 40 mcg/hour is limited. Patients should be closely monitored, particularly during the first few days of epidural clonidine therapy.
The recommended initial dosage of epidural clonidine hydrochloride in pediatric patients is 0.5 mcg/kg of body weight per hour. The dosage of epidural clonidine in pediatric patients should be cautiously adjusted based on clinical response.
Oral clonidine hydrochloride dosages of 0.025-0.2 mg twice daily (as conventional tablets) have been employed in the management of vasomotor symptoms (e.g., hot flashes) associated with menopause+.
While comparative efficacy of various transdermal clonidine dosages have not been established, patients in clinical studies have received one transdermal system delivering 0.1 mg/24 hours applied once every 7 days.
For symptomatic relief of opiate withdrawal in opiate-dependent individuals+, various dosage regimens of oral clonidine hydrochloride (as conventional tablets) have been used. Some experts state that the usual clonidine hydrochloride dosage for opiate withdrawal management is 0.1-0.3
mg every 6-8 hours, with dosage guided by withdrawal symptoms and adverse effects. Other experts recommend administration of an initial 0.1-mg test dose of clonidine hydrochloride; a 0.2-mg
test dose may be considered for patients with severe manifestations of opiate withdrawal or for those weighing more than 200 pounds (91 kg). If blood pressure remains adequate (generally systolic and diastolic blood pressures of least 90 and 60 mm Hg, respectively) following the test dose, a clonidine hydrochloride dosage of 0.1-0.2
mg may be administered every 4-6 hours as needed; scheduled dosing may be considered in patients with severe withdrawal. Under this dosing method, the total dose administered during the initial 24 hours of treatment is tabulated to establish the patient's daily dosage requirement and is administered in 3 or 4 divided doses.
Doses of clonidine hydrochloride should be reduced, delayed, or omitted in individuals demonstrating greater sensitivity to the drug's adverse effects (e.g., hypotension, orthostasis, bradycardia). Individuals treated in the outpatient setting should be capable of performing self-monitoring for these adverse effects, and some experts suggest that lower dosages may be appropriate in this setting. As opiate withdrawal symptoms wane, clonidine hydrochloride dosage may be reduced gradually (e.g., by 0.1 mg per dose every 1-2 days).
Other tapering schedules also have been used to discontinue therapy (e.g., dosage has been reduced by decrements of 50% per day for 3 days and then discontinued, or reduced by 0.1-0.2 mg daily ). Clinicians should consult published protocols for more specific information.
For use in the cessation of smoking+, the initial adult oral dosage of clonidine hydrochloride is typically 0.1 mg twice daily (as conventional tablets). Therapy with the drug is initiated on the day set as the date of cessation of smoking or shortly before this date (e.g., up to 3 days prior).
Dosage may be increased each week by 0.1 mg daily, if needed. In clinical studies, oral dosages varied from 0.15-0.75
mg daily without a clear relationship to achievement of cessation of smoking. The duration of oral therapy with clonidine hydrochloride also varied in these studies, ranging from 3-10 weeks.
When transdermal clonidine is used for the cessation of smoking+, therapy is initiated typically in adults with one system delivering 0.1 mg/24 hours applied once every 7 days. Therapy with the drug is initiated on the day set as the date of cessation of smoking or shortly before this date (e.g., up to 3 days prior).
Dosage may be increased at weekly intervals by 0.1 mg/24 hours, if needed. In clinical studies, the transdermal dosage varied from 0.1-0.2
mg/24 hours without a clear relationship to achievement of cessation of smoking. The duration of transdermal clonidine therapy also varied in these studies, ranging from 3-10 weeks.
Smaller than usual dosages of clonidine or clonidine hydrochloride may be adequate in patients with renal impairment. Dosage should be adjusted according to the degree of renal impairment. Some clinicians suggest that adjustment of clonidine hydrochloride dosage is not necessary in patients with creatinine clearances of 10 mL/minute or greater, but those with lower clearances can receive 50-75% of the usual dosage. Supplemental doses after hemodialysis are not necessary.
Clonidine hydrochloride is administered orally or by epidural infusion, and clonidine is administered percutaneously by topical application of a transdermal system. To ensure overnight blood pressure control with oral administration, the last dose of the day should be administered immediately before retiring. If oral clonidine therapy is to be discontinued, dosage of the drug should be slowly reduced over a period of 2-4 days to avoid the possibility of precipitating a withdrawal syndrome. (See Cautions: Withdrawal Effects.)
| 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 (PF) (clonidine hcl/pf):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Clonidine/Beta-Blockers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. 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, BISOPROLOL FUMARATE, BISOPROLOL-HYDROCHLOROTHIAZIDE, BREVIBLOC, BRIMONIDINE TARTRATE-TIMOLOL, BYSTOLIC, CARTEOLOL HCL, CARVEDILOL, CARVEDILOL ER, COMBIGAN, COREG, COREG CR, CORGARD, 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 |
There are 1 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, PRUDOXIN, REMERON, SILENOR, TRIMIPRAMINE MALEATE, ZONALON |
The following contraindication information is available for DURACLON (PF) (clonidine hcl/pf):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
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 (PF) (clonidine hcl/pf):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
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 (PF) (clonidine hcl/pf):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
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.
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.
Since clonidine is distributed into milk, the drug should be used with caution in nursing women. The manufacturer of parenteral clonidine states that because of the potential for serious adverse reactions to clonidine in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for DURACLON (PF) (clonidine hcl/pf):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for DURACLON (PF) (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 |
| R10.3 | 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 |
| R10.9 | Unspecified abdominal pain |
| R52 | Pain, unspecified |
| R68.84 | Jaw pain |
Formulary Reference Tool