ADDITIONAL IMPORTANT SAFETY INFORMATION
Contraindications
JAVADIN is contraindicated in patients with known hypersensitivity to clonidine. [see Adverse Reactions (6)].
Warnings and Precautions
Bradycardia, Cardiac Conduction Abnormalities, and Symptomatic Hypotension: Treatment with clonidine can cause bradycardia, cardiac conduction abnormalities, and symptomatic hypotension [see Adverse Reactions (6.1)]. The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There have been post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring intravenous (IV) atropine, IV isoproterenol, and temporary cardiac pacing while taking clonidine.
Titrate JAVADIN slowly in patients with a history of syncope, cardiac conduction abnormalities, and those with underlying conditions that may be worsened by hypotension and bradycardia; e.g., heart block, bradycardia, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. Monitor blood pressure and heart rate and adjust dosages accordingly in patients treated concomitantly with antihypertensives or other drugs that can reduce blood pressure or heart rate or increase the risk of syncope Avoid the use of drugs that can affect the sinus node function or AV node conduction [see Drug Interactions (7)].
In patients who have a history of syncope or may have a condition that predisposes them to syncope, such as symptomatic hypotension, bradycardia, or dehydration, advise patients to avoid becoming dehydrated or overheated.
Rebound Hypertension: Abrupt discontinuation of JAVADIN can cause rebound hypertension with elevated plasma catecholamines, especially with higher doses or concomitant beta-blocker use. Symptoms of abrupt discontinuation include tachycardia, rapid blood pressure elevation, headache, nervousness, and agitation. Serious cases of hypertensive encephalopathy, stroke, and death have been reported after abrupt clonidine discontinuation. To reduce the risk of rebound hypertension, taper clonidine gradually over 2-4 days. If rebound hypertension occurs, reverse hypertensive crisis with oral clonidine or IV phentolamine. When discontinuing concurrent beta-blocker therapy, withdraw the beta-blocker several days before beginning clonidine taper.
Administration of JAVADIN should be continued up to 4 hours before 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.
Sedation and Somnolence: Clonidine may cause sedation. Patients who engage in potentially hazardous activities, such as operating machinery or driving, should be advised of possible sedative effects of clonidine. Avoid use with other central nervous system (CNS) depressants, as this combination may cause excessive drowsiness or sedation [see Drug Interactions (7)].
Adverse Reactions
The most frequent adverse reactions are dry mouth, drowsiness, dizziness, constipation and sedation.
These are not all the possible side effects of JAVADIN. Please see Adverse Reactions (6) in the Prescribing Information for a full list.
Drug Interactions
Sedating Drugs: Clonidine may potentiate the CNS-depressive effects of alcohol, barbiturates or other sedating drugs. (7)
Tricyclic Antidepressants: May reduce the hypotensive effect of clonidine. (7)
Neuroleptics: May induce or exacerbate the orthostatic regulation disturbances (e.g., orthostatic hypotension, dizziness, fatigue). (7)
Drugs Known to Affect Sinus Node Function or AV Nodal Conduction: 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) due to a potential for additive effects such as bradycardia and AV block. (7)
See full prescribing information for Specific Drugs and Interactions.Use in Specific Populations
Renal Impairment: Patients with renal impairment may require a lower initial dose and should be closely monitored. Clonidine is minimally removed during hemodialysis, so no supplemental dose is needed.
The Important Safety Information does not include all the information needed to use JAVADIN safely and effectively. Please see accompanying full Prescribing Information for JAVADIN.
To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
JAVADIN™ is a trademark of Azurity Pharmaceuticals, Inc.
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