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The antihypertensive effect is reached at plasma concentrations between about 0. A further rise in the plasma levels will not enhance the antihypertensive effect. Warnings Withdrawal Patients should be instructed not to discontinue therapy without consulting their physician. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such as nervousness, agitation, headache, and tremor accompanied or followed by a rapid rise in blood pressure and elevated catecholamine concentrations in the plasma.

The likelihood of such reactions to discontinuation of clonidine therapy appears to be greater after administration of higher doses or continuation of concomitant beta-blocker treatment and special caution is therefore advised in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death have been reported after clonidine withdrawal.

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. Precautions General In patients who have developed localized contact sensitization to clonidine-TTS, continuation of clonidine-TTS 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 clonidine-TTS, substitution of oral clonidine hydrochloride may also elicit an allergic reaction including generalized rash, urticaria, or angioedema. The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular AV block, especially in patients taking other sympatholytic drugs. Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required.

Since patients may experience a possible sedative effect, dizziness, or accommodation disorder with use of clonidine, caution patients about engaging in activities such as driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative effect may be increased by concomitant use of alcohol, barbiturates, or other sedating drugs. Drug Interactions 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.

If a patient receiving clonidine is also taking neuroleptics, orthostatic regulation disturbances e. Monitor heart rate in patients receiving clonidine concomitantly with agents known to affect sinus node function or AV nodal conduction, e. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concomitantly with diltiazem or verapamil. Amitriptyline in combination with clonidine enhances the manifestation of corneal lesions in rats see Toxicology.

Based on observations in patients in a state of alcoholic delirium it has been suggested that high intravenous doses of clonidine may increase the arrhythmogenic potential QT-prolongation, ventricular fibrillation of high intravenous doses of haloperidol.

Causal relationship and relevance for clonidine oral tablets have not been established. Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid. In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in patients before, and periodically after, the start of clonidine therapy.

In of these 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. There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity.

Reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose MRDHD of clonidine hydrochloride tablets USP produced no evidence of a teratogenic or embryotoxic potential in rabbits. 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 hydrochloride.

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 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 Administration of clonidine hydrochloride should be continued to within four hours of surgery and resumed as soon as possible thereafter.

Blood pressure should be carefully monitored during surgery and additional measures to control blood pressure should be available if required.

Information for Patients Patients should be cautioned against interruption of clonidine 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.

Drug Interactions Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedatives. 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 dosage.

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.

Toxicology In several studies with oral clonidine hydrochloride, a dose-dependent increase in the incidence and severity of spontaneous retinal degeneration was seen in albino rats treated for six months or longer. Tissue distribution studies in dogs and monkeys showed a concentration of clonidine in the choroid.

In view of the retinal degeneration seen in rats, eye examinations were performed during clinical trials in patients before, and periodically after, the start of clonidine therapy. In of these 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. There was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus test for clastogenicity. Usage in Pregnancy Teratogenic Effects 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 teratogenic or embryotoxic potential in rabbits.

Increased resorptions were not associated with treatment at the same or at higher dose levels up to 3 times the oral MRDHD when dams were treated on gestation days 6— 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. Nursing Mothers As clonidine hydrochloride is excreted in human milk, caution should be exercised when clonidine hydrochloride is administered to a nursing woman.

Pediatric Use Safety and effectiveness in pediatric patients below the age of twelve have not been established see Warnings on Withdrawal. The most frequent which appear to be dose-related are dry mouth, occurring in about 40 of patients; drowsiness, about 33 in ; dizziness, about 16 in ; constipation and sedation, each about 10 in 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 causal relationship has not been established.

Body as a Whole: Missed dose If you missed a dose take it as soon as you remember, but if it is almost time of your next dose, just skip the forgotten dose. Do not try to compensate a missed dose by taking an extra one.

Overdose If you suspect that you took too much of Clonidine and your blood pressure first becomes too high severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain and then followed by low blood pressure fainting, cold feeling, slow heart rate seek for immediate medical attention.

Storage Tablets and patches should be stored at room temperature C F in a light- resistant container away from moisture. Disclaimer We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information on the site cannot be used for self-treatment and self-diagnosis.

Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain.

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