How Long Is Clonidine Good For

What is Catapres and how is it used?

Catapres is a prescription medicine used to treat symptoms high blood pressure, attention deficit hyperactivity disorder (ADHD) and cancer pain. Catapres may be used alone or with other medications.

Catapres belongs to a class of drugs called Alpha2 Agonists, Key-Acting, ADHD Agents.

It is non known if Catapres is condom and effective in children younger than 12 years of age.

What are the possible side effects of Catapres?

Catapres may cause serious side effects including:

• withdrawal symptoms,
• nervousness,
• agitation,
• headache,
• tremor, and
• rapid rise in blood pressure

Get medical help correct away, if yous take any of the symptoms listed above.

The most mutual side effects of Catapres include:

• dry oral fissure,
• dizziness,
• drowsiness,
• fatigue,
• constipation,
• headache,
• nausea, and
• problem sleeping (insomnia)

Tell the dr. if you accept whatever side effect that bothers yous or that does non go away.

These are not all the possible side effects of Catapres. For more data, ask your doctor or pharmacist.

Phone call your doctor for medical advice about side effects. You may report side effects to FDA at i-800-FDA-1088.

DESCRIPTION

Catapres® (clonidine hydrochloride, USP) is a centrally acting blastoff-agonist hypotensive agent available equally 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 inactive ingredients are colloidal silicon dioxide, corn starch, dibasic calcium phosphate, FD&C Yellow No. vi, gelatin, glycerin, lactose, and magnesium stearate. The Catapres 0.1 mg tablet likewise contains FD&C Blue No.1 and FD&C Cerise No.3.

Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical proper noun is 2-(ii,6-dichlorophenylamino)-2-imidazoline hydrochloride. The post-obit is the structural formula:

C_nineH_ixCl_twoNorth₃ · HCl     Mol. Wt. 266.56

Clonidine hydrochloride is an odorless, bitter, white, crystalline substance soluble in water and booze.

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INDICATIONS

CATAPRES tablets are indicated in the treatment of hypertension. CATAPRES tablets may be employed lonely or concomitantly with other antihypertensive agents.

DOSAGE AND Assistants

Adults

The dose of Catapres® (clonidine hydrochloride, USP) tablets must be adapted according to the patient's individual blood pressure level response. The following is a general guide to its administration.

Initial Dose

0.1 mg tablet twice daily (morning and bedtime). Elderly patients may do good from a lower initial dose.

Maintenance Dose

Further increments of 0.1 mg per day may be made at weekly intervals if necessary until the desired response is accomplished. Taking the larger portion of the oral daily dose at bedtime may minimize transient aligning effects of dry oral fissure and drowsiness. The therapeutic doses most ordinarily employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses. Studies take indicated that 2.4 mg is the maximum effective daily dose, merely doses every bit high as this accept rarely been employed.

Renal Impairment

Patients with renal damage may do good from a lower initial dose. Patients should be carefully monitored. Since but a minimal amount of clonidine is removed during routine hemodialysis, there is no need to requite supplemental clonidine following dialysis.

HOW SUPPLIED

Catapres® (clonidine hydrochloride, USP) tablets are supplied as follows:

Dose (mg)	Color	Marking	Bottle of 100
0.1	Tan	BI 6	NDC 0597-0006-01
0.2	Orange	BI 7	NDC 0597-0007-01
0.iii	Peach	BI eleven	NDC 0597-0011-01

Shop at 25°C (77°F); excursions permitted to xv°-30°C (59°-86°F) [come across USP Controlled Room Temperature].

Dispense in tight, calorie-free-resistant container.

Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. Manufactured by: Boehringer Ingelheim Promeco S.A. de C.Five., United mexican states City, Mexico. Licensed from: Boehringer Ingelheim, International GmbH,Address medical inquiries to: (800) 542-6257 or (800) 459-9906. Revised: May 2012

SLIDESHOW

How to Lower Blood Pressure level: Practise Tips See Slideshow

SIDE EFFECTS

Most adverse effects are balmy and tend to diminish with continued therapy. The almost frequent (which appear to be dose-related) are dry out mouth, occurring in about twoscore of 100 patients; drowsiness, almost 33 in 100; dizziness, about 16 in 100; constipation and sedation, each nigh 10 in 100.

The post-obit less frequent adverse experiences accept also been reported in patients receiving CATAPRES tablets, but in many cases patients were receiving concomitant medication and a causal relationship has non been established.

Body as a Whole: Fatigue, fever, headache, pallor, weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs' test and increased sensitivity to booze.

Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.due east., sinus node arrest, junctional bradycardia, loftier caste AV block and arrhythmias), orthostatic symptoms, palpitations, Raynaud'south miracle, syncope, and tachycardia. Cases of sinus bradycardia and atrioventricular block accept been reported, both with and without the apply of concomitant digitalis.

Central Nervous Organisation: Agitation, anxiety, delirium, delusional perception, hallucinations (including visual and auditory), insomnia, mental depression, nervousness, other behavioral changes, paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares.

Dermatological: Baldness, angioneurotic edema, hives, pruritus, rash, and urticaria.

Gastrointestinal: Intestinal pain, anorexia, constipation, hepatitis, malaise, mild transient abnormalities in liver function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstacle), salivary gland hurting, and vomiting.

Genitourinary: Decreased sexual practice, difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and urinary retention.

Hematologic: Thrombocytopenia.

Metabolic: Gynecomastia, transient tiptop of blood glucose or serum creatine phosphokinase, and weight proceeds.

Musculoskeletal: Leg cramps and muscle or joint pain.

Oro-otolaryngeal: Dryness of the nasal mucosa.

Ophthalmological: Adaptation disorder, blurred vision, burning of the optics, decreased lacrimation, and dryness of eyes.

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.g., orthostatic hypotension, dizziness, fatigue) may be induced or exacerbated.

Monitor centre rate in patients receiving clonidine concomitantly with agents known to affect sinus node office or AV nodal conduction, east.grand., digitalis, calcium channel blockers and beta-blockers. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in clan 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 increment the arrhythmogenic potential (QTprolongation, ventricular fibrillation) of high intravenous doses of haloperidol. Causal relationship and relevance for clonidine oral tablets take not been established.

WARNINGS

Withdrawal

Patients should be instructed not to discontinue therapy without consulting their doctor. Sudden cessation of clonidine treatment has, in some cases, resulted in symptoms such equally nervousness, agitation, headache, and tremor accompanied or followed by a rapid ascent in blood force per unit area 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 brash in these situations. Rare instances of hypertensive encephalopathy, cerebrovascular accidents and death accept been reported subsequently clonidine withdrawal. When discontinuing therapy with CATAPRES tablets, the medico should reduce the dose gradually over 2 to four days to avoid withdrawal symptomatology.

An excessive ascent in blood pressure following discontinuation of CATAPRES tablets therapy tin 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 CATAPRES tablets.

Because children ordinarily take gastrointestinal illnesses that lead to vomiting, they may exist particularly susceptible to hypertensive episodes resulting from sharp inability to take medication.

PRECAUTIONS

Full general

In patients who have adult localized contact sensitization to Catapres-TTS® (clonidine), continuation of Catapres-TTS or substitution of oral clonidine hydrochloride therapy may exist associated with the development of a generalized skin rash.

In patients who develop an allergic reaction to Catapres-TTS, substitution of oral clonidine hydrochloride may likewise 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. There are post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol and temporary cardiac pacing while taking clonidine.

In hypertension caused past pheochromocytoma, no therapeutic effect of CATAPRES tablets tin can be expected.

Perioperative Utilise

Administration of Catapres® (clonidine hydrochloride, USP) tablets should exist continued to within 4 hours of surgery and resumed every bit soon as possible thereafter. Claret pressure should be advisedly monitored during surgery and additional measures to control blood pressure should exist available if required.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Chronic dietary administration of clonidine was not carcinogenic to rats (132 weeks) or mice (78 weeks) dosed, respectively, at upwards to 46 or seventy times the maximum recommended daily human dose equally mg/kg (9 or 6 times the MRDHD on a mg/m² footing). At that place was no evidence of genotoxicity in the Ames test for mutagenicity or mouse micronucleus exam for clastogenicity.

Fertility of male or female rats was unaffected by clonidine doses every bit high as 150 μg/kg (approximately 3 times MRDHD). In a separate experiment, fertility of female rats appeared to be affected at dose levels of 500 to 2000 μg/kg (10 to 40 times the oral MRDHD on a mg/kg basis; 2 to 8 times the MRDHD on a mg/m² ground).

Pregnancy

Teratogenic Effects

Pregnancy Category C

Reproduction studies performed in rabbits at doses up to approximately iii times the oral maximum recommended daily human being dose (MRDHD) of Catapres® (clonidine hydrochloride, USP) tablets produced no prove of a teratogenic or embryotoxic potential in rabbits. In rats, however, doses as depression as 1/3 the oral MRDHD (1/15 the MRDHD on a mg/thou² 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 aforementioned time or at college dose levels (up to 3 times the oral MRDHD) when the dams were treated on gestation days half dozen to 15. Increases in resorption were observed at much college dose levels (40 times the oral MRDHD on a mg/kg footing; 4 to 8 times the MRDHD on a mg/one thousand² footing) in mice and rats treated on gestation days 1 to fourteen (lowest dose employed in the study was 500 μg/kg).

No adequate, well-controlled studies have been conducted in pregnant women. Clonidine crosses the placental barrier (meet CLINICAL PHARMACOLOGY, Pharmacokinetics). Because animal reproduction studies are non always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

Every bit clonidine hydrochloride is excreted in homo milk, caution should be exercised when CATAPRES tablets are administered to a nursing woman.

Pediatric Employ

Safety and effectiveness in pediatric patients have not been established in adequate and wellcontrolled trials (see WARNINGS, Withdrawal).

Overdose & Contraindications

OVERDOSE

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 low may exist higher in children than adults. Large overdoses may outcome in reversible cardiac conduction defects or dysrhythmias, apnea, blackout and seizures. Signs and symptoms of overdose generally occur inside 30 minutes to ii hours after exposure. As niggling as 0.ane 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 evolution of CNS depression; therefore, consecration of vomiting with ipecac syrup is non recommended. Gastric lavage may be indicated post-obit 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 direction of clonidine-induced respiratory depression, hypotension and/or coma; blood pressure should be monitored since the assistants of naloxone has occasionally resulted in paradoxical hypertension. 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 pulverization. This patient developed hypertension followed by hypotension, bradycardia, apnea, hallucinations, semicoma, and premature ventricular contractions. The patient fully recovered later intensive handling. Plasma clonidine levels were lx ng/ml subsequently ane hour, 190 ng/ml after i.v hours, 370 ng/ml after 2 hours, and 120 ng/ml afterward 5.v and 6.v hours. In mice and rats, the oral LD50 of clonidine is 206 and 465 mg/kg, respectively.

CONTRAINDICATIONS

Catapres® (clonidine hydrochloride, USP) tablets should not be used in patients with known hypersensitivity to clonidine (see PRECAUTIONS).

CLINICAL PHARMACOLOGY

Clonidine stimulates alpha-adrenoreceptors in the brain stem. This action results in reduced sympathetic outflow from the central nervous organization and in decreases in peripheral resistance, renal vascular resistance, heart rate, and blood pressure. CATAPRES tablets human activity relatively rapidly. The patient'due south blood force per unit area declines within thirty to 60 minutes afterward an oral dose, the maximum decrease occurring within ii to 4 hours. Renal claret catamenia and glomerular filtration charge per unit remain essentially unchanged. Normal postural reflexes are intact; therefore, orthostatic symptoms are mild and exceptional.

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 in that location 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 almost patients given clonidine, but the drug does not alter normal hemodynamic response to practice.

Tolerance to the antihypertensive effect may develop in some patients, necessitating a reevaluation of therapy.

Other studies in patients have provided prove of a reduction in plasma renin activity and in the excretion of aldosterone and catecholamines. The verbal relationship of these pharmacologic actions to the antihypertensive consequence of clonidine has not been fully elucidated.

Clonidine acutely stimulates growth hormone release in both children and adults, but does non produce a chronic elevation of growth hormone with long-term apply.

Pharmacokinetics

The pharmacokinetics of clonidine is dose-proportional in the range of 100 to 600 μg. The accented bioavailability of clonidine on oral administration is seventy% to 80%. Pinnacle plasma clonidine levels are attained in approximately i to 3 hours.

Post-obit intravenous administration, clonidine displays biphasic disposition with a distribution one-half-life of about 20 minutes and an elimination one-half-life ranging from 12 to 16 hours. The half-life increases upward to 41 hours in patients with severe impairment of renal function. Clonidine crosses the placental bulwark. Information technology has been shown to cross the blood-brain barrier in rats.

Following oral administration about 40% to 60% of the absorbed dose is recovered in the urine as unchanged drug in 24 hours. About 50% of the absorbed dose is metabolized in the liver. Neither nutrient nor the race of the patient influences the pharmacokinetics of clonidine.

The antihypertensive effect is reached at plasma concentrations betwixt nigh 0.2 and 2.0 ng/mL in patients with normal excretory function. A farther rise in the plasma levels will non enhance the antihypertensive event.

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 vi 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, centre examinations were performed during clinical trials in 908 patients earlier, 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 optics, no drug-related aberrant ophthalmological findings were recorded and, according to specialized tests such as electroretinography and macular dazzle, retinal part was unchanged.

In combination with amitriptyline, clonidine hydrochloride assistants led to the development of corneal lesions in rats inside 5 days.

PATIENT INFORMATION

Patients should be cautioned confronting suspension of CATAPRES tablets therapy without their md's advice.

Since patients may experience a possible sedative result, dizziness, or adaptation disorder with use of clonidine, circumspection patients virtually engaging in activities such equally driving a vehicle or operating appliances or machinery. Also, inform patients that this sedative event may be increased by concomitant utilise of alcohol, barbiturates, or other sedating drugs.

Patients who habiliment contact lenses should be cautioned that treatment with CATAPRES tablets may crusade dryness of eyes.

From

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Report Issues to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or telephone call 1-800-FDA-1088.

Source: https://www.rxlist.com/catapres-drug.htm

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