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Clonidine Extended-Release (Clonidine Hydrochloride) - Summary



Clonidine hydrochloride extended-release tablets are a centrally acting alpha2-adrenergic agonist available as a 0.1 mg extended-release tablet for oral administration. Each 0.1 mg tablet is equivalent to 0.087 mg of the free base.

Clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications.

The efficacy of clonidine hydrochloride extended-release tablets in the treatment of ADHD is based on two controlled trials (one monotherapy and one adjunctive to stimulant medication) in children and adolescents ages 6-17 who met DSM-IV criteria for ADHD hyperactive or combined hyperactive/inattentive subtypes [see Clinical Studies]. In the adjunctive study, clonidine hydrochloride extended-release tablets were administered to patients who had been on a stable regimen of either methylphenidate or amphetamine (or their derivatives) and who had not achieved an optimal response. The effectiveness of clonidine hydrochloride extended-release tablets for longer-term use (more than 5 weeks) has not been systematically evaluated in controlled trials.

A diagnosis of ADHD implies the presence of hyperactive-impulsive and/or inattentive symptoms that cause impairment and were present before the age of 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; "on the go"; excessive talking; blurting answers; can't wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but also of special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV® characteristics.

Need for Comprehensive Treatment program

Clonidine hydrochloride extended-release tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, and social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Clonidine hydrochloride extended-release tablets are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational/vocational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe clonidine hydrochloride extended-release tablets will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms and on the level of functional impairment.

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Published Studies Related to Clonidine Extended-Release (Clonidine)

Clonidine Maintenance Prolongs Opioid Abstinence and Decouples Stress From Craving in Daily Life: A Randomized Controlled Trial With Ecological Momentary Assessment. [2015]
CONCLUSIONS: Clonidine, a readily available medication, is useful in opioid

A randomized feasibility trial of clonidine to reduce perioperative cardiac risk in patients on chronic beta-blockade: the EPIC study. [2014]
chronic beta-blockade... CONCLUSION: This pilot randomized trial confirmed the feasibility, safety, and

Effect of oral low dose clonidine premedication on postoperative pain in patients undergoing abdominal hysterectomy: a randomized placebo controlled clinical trial. [2013]
CONCLUSION: A single oral 100 microg dose of clonidine administered 2 hours

Prophylactic midazolam and clonidine for emergence from agitation in children after emergence from sevoflurane anesthesia: a meta-analysis. [2013]
sevoflurane anesthesia... CONCLUSIONS: This meta-analysis suggests that prophylactic administration of

Effect of oral clonidine on acute intraocular pressure rise after cataract extraction under general anaesthesia. [2012]
posterior chamber intraocular lens implantation under general anaesthesia... CONCLUSION: A single dose of oral clonidine (5 g/kg) preoperatively can produce a

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Clinical Trials Related to Clonidine Extended-Release (Clonidine)

Effect of Intrathecal Clonidine in Hypertensive Subjects With Poorly Controlled Blood Pressure [Completed]
The purpose of this study is to determine the acute efficacy of intrathecal clonidine to reduce blood pressure in hypertensive subjects with poor blood pressure control and describe its effects on cardiovascular function.

Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain [Recruiting]
Epidural analgesia has proven to be an effective method for severe pain relief associated with labor and delivery. During labor, a low dose continuous infusion of local anesthetic and narcotic will be administered through an epidural catheter. As labor progresses and the baby's head makes it way through the pelvis, breakthrough pain may emerge and often needs further treatment. The investigators provide pain relief by administering analgesics through the epidural catheter. The patient will be randomly assigned to receive one of two medication mixtures believed to be successful in treating this type of pain associated with advanced labor. After this initial treatment, if pain relief is not attained, the patient may receive the other medication as well. The medications used in this study have been used at this institution for some time and have been found to be safe for mother and baby. The opioid (fentanyl) dose is small and only a small fraction will be transmitted to the baby. The other medication (clonidine) better known as a blood pressure medication has also been used for pain relief. Studies and clinical experience have shown that clonidine when given epidurally in the doses used in this study has minimal if any effect on the blood pressure of the mother or of the baby. The investigators will record medical and obstetric history and labor progress relevant to the patient. The patient will be asked questions regarding labor pain and side effects before and after the analgesic is administered. The primary objective is to determine which treatment regimen is more successful in abolishing breakthrough pain in advanced labor.

Safety of Clonidine in Infants With Hypoxic Ischemic Encephalopathy During Therapeutic Hypothermia [Not yet recruiting]
This research is being done to find out the safety of the investigational study drug,clonidine, in infants who are undergoing whole body cooling for the treatment of hypoxic ischemic encephalopathy (HIE). HIE is the damage that occurs to the cells of the central nervous system (brain and spinal cord) as a result of decreased oxygen supply and blood flow to the fetus due to perinatal asphyxia (inadequate oxygen to the baby during the birth process). HIE is a significant cause of morbidity and mortality in infants. The only known and effective treatment for HIE is therapeutic hypothermia or whole body cooling for72 hours. During the cooling process babies get agitated, shiver and are uncomfortable. To treat these side effects sedative-analgesic medications like morphine are frequently used. Clonidine (Clon), which is another class of sedative-analgesic can be used for the similar purpose but is more effective than morphine in decreasing shivering in adults and children. Furthermore, in some preclinical studies, clonidine has been shown to be neuroprotective (safe for the brain in models of brain injury). Clon (Duraclon®) has been approved by the Food and Drug Administration (FDA)for the treatment of pain in certain cancer patients. It is not approved for treating side effects of therapeutic hypothermia in infants and its use in this study is considered investigational. FDA is allowing for us to use clonidine for this Phase I-II study. In this kind of study clonidine will be started at low dose and slowly increased do determine at what dose the shivering is controlled and the use of clonidine is not associated with any side effects. This means that not all babies in the study will get the same dose of Clon. Doses at the beginning of the study will be lower than doses at the end of the study. Because of the design of the study, some babies may get doses that are too low to have an effect, and other babies will probably might get a doses that could cause side effects. In this Phase I-II study, the investigators will determine the (i) the maximum tolerated dose of clonidine during cooling for HIE, (ii) the effects of clonidine on heart rate, blood pressure, core body temperature and cerebral autoregulation (ability to maintain constant blood flow in the face of blood pressure changes) and (iii) association between blood levels and changes in the above parameters. In this study the investigators hope to find ways to improve sedation, shivering and agitation in newborn infants with HIE on the cooling protocol. Our ultimate goal is determine the potential neuro-protective properties of clonidine in newborn babies with HIE.

Pharmacokinetics and Clinical Effects of Escalating Doses of Clonidine in ICU Patients [Not yet recruiting]

Comparison of Different Doses of Clonidine to Fentanyl as an Adjuvant to Bupivacaine 0.5% for Spinal Anesthesia [Withdrawn]
The purpose of this study is to evaluate the safety, quality and duration of block with the addition of Clonidine in different doses to 0. 5% heavy bupivacaine, and to compare it with addition of Fentanyl to 0. 5% heavy bupivacaine in sub- arachnoid block.

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Page last updated: 2015-08-10

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