Clonidine Hydrochloride 0.2 MG Oral Tablet
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.
When discontinuing therapy with clonidine hydrochloride tablets, the physician should reduce the dose gradually over 2 to 4 days to avoid withdrawal symptomatology.
An excessive rise in blood pressure following discontinuation of clonidine hydrochloride tablets 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is to be discontinued in patients receiving a beta-blocker and clonidine concurrently, the beta-blocker should be withdrawn several days before the gradual discontinuation of clonidine hydrochloride tablets.
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.
OVERDOSAGE
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 50 of clonidine is 206 and 465 mg/kg, respectively.
DESCRIPTION
Clonidine hydrochloride, USP 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&C yellow #10 Aluminum Lake, FD&C yellow #6 Aluminum Lake (Sunset Yellow Lake), lactose monohydrate, magnesium stearate, and sodium starch glycolate.
Clonidine hydrochloride, USP 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, USP is an odorless, bitter, white, crystalline substance soluble in water and alcohol.
836600d0-figure-01
HOW SUPPLIED
Clonidine hydrochloride tablets, USP are supplied as follows: 0.2 mg — Each orange, round tablet imprinted with on one side and 128 and bisect on the other side contains 0.2 mg of clonidine hydrochloride USP.
Bottle of 30 – 68788-9213-3 Bottle of 60 – 68788-9213-6 Bottle of 90 – 68788-9213-9 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) [See USP Controlled Room Temperature].
Manufactured by: Actavis Elizabeth LLC Elizabeth, NJ 07207 USA Distributed by: Actavis Pharma, Inc.
Parsippany, NJ 07054 USA 40-9183 Revised — October 2015 Repackaged by Preferred Pharmaceuticals, Inc.
0.2mg image
INDICATIONS AND USAGE
Clonidine hydrochloride tablets, USP are indicated in the treatment of hypertension.
Clonidine hydrochloride tablets may be employed alone or concomitantly with other antihypertensive agents.
DOSAGE AND ADMINISTRATION
Adults: The dose of clonidine hydrochloride tablets, USP must be adjusted according to the patient’s individual blood pressure response.
The following is a general guide to its administration.
Initial Dose: 0.1 mg tablet twice daily (morning and bedtime).
Elderly patients may benefit 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 achieved.
Taking the larger portion of the oral daily dose at bedtime may minimize transient adjustment effects of dry mouth and drowsiness.
The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day given in divided doses.
Studies have indicated that 2.4 mg is the maximum effective daily dose, but doses as high as this have rarely been employed.
Renal Impairment: Patients with renal impairment may benefit from a lower initial dose.
Patients should be carefully monitored.
Since only a minimal amount of clonidine is removed during routine hemodialysis, there is no need to give supplemental clonidine following dialysis.
For questions regarding this product call Actavis at 1-800-432-8534.