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CLONIDINE
Overview
What is CLONIDINE?
Clonidine Hydrochloride is a centrally acting alpha-agonist
hypotensive agent available as tablets for oral administration in three dosage
strengths: 0.1 mg, 0.2 mg, and 0.3 mg. The 0.1 mg tablet is equivalent to 0.087
mg of the free base.
The following inactive ingredients are contained in these products: corn
starch, D and C yellow #10 Aluminum Lake, FD and C yellow #6 Aluminum Lake
(Sunset Yellow Lake), lactose monohydrate, magnesium stearate, and sodium starch
glycolate.
Clonidine hydrochloride is an imidazoline derivative and exists as a
mesomeric compound. The chemical name is
2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. The following is the
structural formula
Clonidine hydrochloride is an odorless, bitter, white, crystalline substance
soluble in water and alcohol.
What does CLONIDINE look like?
What are the available doses of CLONIDINE?
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What should I talk to my health care provider before I take CLONIDINE?
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How should I use CLONIDINE?
Clonidine hydrochloride is indicated in the treatment of
hypertension. Clonidine hydrochloride may be employed alone or concomitantly
with other antihypertensive agents.
Adults:
Initial Dose:
Maintenance Dose:
Renal Impairment:
What interacts with CLONIDINE?
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What are the warnings of CLONIDINE?
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What are the precautions of CLONIDINE?
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What are the side effects of CLONIDINE?
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What should I look out for while using CLONIDINE?
Clonidine hydrochloride tablets should not be used in patients
with known hypersensitivity to clonidine (see ).
What might happen if I take too much CLONIDINE?
Hypertension may develop early and may be followed by
hypotension, bradycardia, respiratory depression, hypothermia, drowsiness,
decreased or absent reflexes, weakness, irritability and miosis. The frequency
of CNS depression may be higher in children than adults. Large overdoses may
result in reversible cardiac conduction defects or dysrhythmias, apnea, coma and
seizures. Signs and symptoms of overdose generally occur within 30 minutes to
two hours after exposure. As little as 0.1 mg of clonidine has produced signs of
toxicity in children.
There is no specific antidote for clonidine overdosage. Clonidine overdosage
may result in the rapid development of CNS depression; therefore, induction of
vomiting with ipecac syrup is not recommended. Gastric lavage may be indicated
following recent and/or large ingestions. Administration of activated charcoal
and/or a cathartic may be beneficial. Supportive care may include atropine
sulfate for bradycardia, intravenous fluids and/or vasopressor agents for
hypotension and vasodilators for hypertension. Naloxone may be a useful adjunct
for the management 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 male who
ingested 100 mg of clonidine hydrochloride powder. This patient developed
hypertension followed by hypotension, bradycardia, apnea, hallucinations,
semicoma, 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 LD of clonidine
is 206 and 465 mg/kg, respectively.
How should I store and handle CLONIDINE?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].Keep out of reach of children.0.1 mg — Each orange, round tablet imprinted with 127 on one side and bisect on the other side contains 0.1 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2127-10) and 500 (NDC 0228-2127-50).0.2 mg — Each orange, round tablet imprinted with 128 and bisect on the other side contains 0.2 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2128-10) and 500 (NDC 0228-2128-50).0.3 mg — Each orange, round tablet imprinted with 129 and bisect on the other side contains 0.3 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2129-10).Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).Manufactured by: Actavis Elizabeth LLC200 Elmora AvenueElizabeth, NJ 07207 USA 40-9009 Revised — January 20080.1 mg — Each orange, round tablet imprinted with 127 on one side and bisect on the other side contains 0.1 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2127-10) and 500 (NDC 0228-2127-50).0.2 mg — Each orange, round tablet imprinted with 128 and bisect on the other side contains 0.2 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2128-10) and 500 (NDC 0228-2128-50).0.3 mg — Each orange, round tablet imprinted with 129 and bisect on the other side contains 0.3 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2129-10).Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).Manufactured by: Actavis Elizabeth LLC200 Elmora AvenueElizabeth, NJ 07207 USA 40-9009 Revised — January 20080.1 mg — Each orange, round tablet imprinted with 127 on one side and bisect on the other side contains 0.1 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2127-10) and 500 (NDC 0228-2127-50).0.2 mg — Each orange, round tablet imprinted with 128 and bisect on the other side contains 0.2 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2128-10) and 500 (NDC 0228-2128-50).0.3 mg — Each orange, round tablet imprinted with 129 and bisect on the other side contains 0.3 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2129-10).Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).Manufactured by: Actavis Elizabeth LLC200 Elmora AvenueElizabeth, NJ 07207 USA 40-9009 Revised — January 20080.1 mg — Each orange, round tablet imprinted with 127 on one side and bisect on the other side contains 0.1 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2127-10) and 500 (NDC 0228-2127-50).0.2 mg — Each orange, round tablet imprinted with 128 and bisect on the other side contains 0.2 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2128-10) and 500 (NDC 0228-2128-50).0.3 mg — Each orange, round tablet imprinted with 129 and bisect on the other side contains 0.3 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2129-10).Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).Manufactured by: Actavis Elizabeth LLC200 Elmora AvenueElizabeth, NJ 07207 USA 40-9009 Revised — January 20080.1 mg — Each orange, round tablet imprinted with 127 on one side and bisect on the other side contains 0.1 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2127-10) and 500 (NDC 0228-2127-50).0.2 mg — Each orange, round tablet imprinted with 128 and bisect on the other side contains 0.2 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2128-10) and 500 (NDC 0228-2128-50).0.3 mg — Each orange, round tablet imprinted with 129 and bisect on the other side contains 0.3 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2129-10).Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).Manufactured by: Actavis Elizabeth LLC200 Elmora AvenueElizabeth, NJ 07207 USA 40-9009 Revised — January 20080.1 mg — Each orange, round tablet imprinted with 127 on one side and bisect on the other side contains 0.1 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2127-10) and 500 (NDC 0228-2127-50).0.2 mg — Each orange, round tablet imprinted with 128 and bisect on the other side contains 0.2 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2128-10) and 500 (NDC 0228-2128-50).0.3 mg — Each orange, round tablet imprinted with 129 and bisect on the other side contains 0.3 mg of Clonidine hydrochloride USP and is supplied in bottles of 100 (NDC 0228-2129-10).Dispense in a tight, light-resistant container as defined in the USP.Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).Manufactured by: Actavis Elizabeth LLC200 Elmora AvenueElizabeth, NJ 07207 USA 40-9009 Revised — January 2008
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Clonidine stimulates alpha-adrenoreceptors in the brain stem.
This action results in reduced sympathetic outflow from the central nervous
system and in decreases in peripheral resistance, renal vascular resistance,
heart rate, and blood pressure. Clonidine hydrochloride, acts relatively
rapidly. The patient’s blood pressure declines within 30 to 60 minutes after an
oral dose, the maximum decrease occurring within 2 to 4 hours. Renal blood flow
and glomerular filtration rate remain essentially unchanged. Normal postural
reflexes are intact, therefore, orthostatic symptoms are mild and
infrequent.
Acute studies with clonidine hydrochloride in humans have demonstrated a
moderate reduction (15% to 20%) of cardiac output in the supine position with no
change in the peripheral resistance: at a 45° tilt there is a smaller reduction
in cardiac output and a decrease of peripheral resistance. During long term
therapy, cardiac output tends to return to control values, while peripheral
resistance remains decreased. Slowing of the pulse rate has been observed in
most patients given clonidine, but the drug does not alter normal hemodynamic
response to exercise.
Tolerance to the antihypertensive effect may develop in some patients,
necessitating a reevaluation of therapy.
Other studies in patients have provided evidence of a reduction in plasma
renin activity and in the excretion of aldosterone and catecholamines. The exact
relationship of these pharmacologic actions to the antihypertensive effect of
clonidine has not been fully elucidated.
Clonidine acutely stimulates growth hormone release in both children and
adults, but does not produce a chronic elevation of growth hormone with
long-term use.
Pharmacokinetics:
Non-Clinical Toxicology
Clonidine hydrochloride tablets should not be used in patients with known hypersensitivity to clonidine (see ).Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.
Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated ; however, the clinical significance of this interaction is not well documented.
In common with other antibiotics, amoxicillin capsules, amoxicillin for oral suspension, or amoxicillin tablets (chewable) may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Withdrawal:
An excessive rise in blood pressure following discontinuation of clonidine therapy can be reversed by administration of oral clonidine hydrochloride or by intravenous phentolamine. If therapy is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine.
Because children commonly have gastrointestinal illnesses that lead to vomiting, they may be particularly susceptible to hypertensive episodes resulting from abrupt inability to take medication.
In patients who have developed localized contact sensitization to transdermal clonidine, continuation of transdermal clonidine or substitution of oral clonidine hydrochloride therapy may be associated with the development of a generalized skin rash.
In patients who develop an allergic reaction to transdermal clonidine, substitution of oral clonidine hydrochloride may also elicit an allergic reaction (including generalized rash, urticaria, or angioedema).
Clonidine hydrochloride should be used with caution in patients with severe coronary insufficiency, conduction disturbances, recent myocardial infarction, cerebrovascular disease or chronic renal failure.
Perioperative Use:
Patients should be cautioned against interruption of clonidine hydrochloride therapy without their physician’s advice.
Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of a possible sedative effect of clonidine. They should also be informed that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs.
Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. If a patient receiving clonidine hydrochloride is also taking tricyclic antidepressants, the hypotensive effect of clonidine may be reduced, necessitating an increase in the clonidine dose.
Due to a potential for additive effects such as bradycardia and AV block, caution is warranted in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e.g. digitalis, calcium channel blockers and beta-blockers.
Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats (see ).
Toxicology:
In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in 908 patients before, and periodically after, the start of clonidine therapy. In 353 of these 908 patients, the eye examinations were carried out over periods of 24 months or longer. Except for some dryness of the eyes, no drug-related abnormal ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal function was unchanged.
In combination with amitriptyline, clonidine hydrochloride administration led to the development of corneal lesions in rats within 5 days.
Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at up to 46 or 70 times the maximum recommended daily human dose as mg/kg (9 or 6 times the MRDHD on a mg/m basis). There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity.
Fertility of male or female rats was unaffected by clonidine doses as high as 150 mcg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 mcg/kg (10 to 40 times the oral MRDHD on a mg/kg basis, 2 to 8 times the MRDHD on a mg/m basis).
Pregnancy Category C
Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (MRDHD) of clonidine hydrochloride produced no evidence of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as low as 1/3 the oral MRDHD (1/15 the MRDHD on a mg/m basis) of clonidine 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 at the same time or at higher dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days 6-15. Increases in resorption were observed at much higher dose levels (40 times the oral MRDHD on a mg/kg basis; 4 to 8 times the MRDHD on a mg/m basis) in mice and rats treated on gestation days 1-14 (lowest dose employed in the study was 500 mcg/kg).
No adequate, well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride is administered to a nursing woman.
Safety and effectiveness in pediatric patients below the age of twelve have not been established (See on ).
Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100.
The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.
Body As A Whole:
Cardiovascular:
Central Nervous System:
Dermatological:
Gastrointestinal:
Genitourinary:
Hematologic:
Metabolic:
Musculoskeletal:
Oro-otolaryngeal:
Ophthalmological:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Interactions
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