JAVADIN

Median time to peak clonidine plasma concentrations (C max ) occurred at approximately 2.8 hours (range: 1 to 6 hours) following 0.3 mg oral dose of JAVADIN in healthy adult subjects under fasting conditions. The pharmacokinetics of clonidine is dose-proportional in the range of 0.1 to 0.6 mg.

AbsorptionThe absolute bioavailability of clonidine on oral administration is 70% to 80%. Effect of Food Food had no effect on plasma exposures of clonidine after administration of JAVADIN. Distribution F...

The following clinically significant adverse reactions are discussed elsewhere in the labeling: Bradycardia, Cardiac Conduction Abnormalities, and Symptomatic Hypotension [see Warnings and Precautions ( 5.1 )] Rebound Hypertension [see Warnings and Precautions ( 5.2 )] Sedation and Somnolence [see Warnings and Precautions ( 5.3 )] The most frequent adverse reactions are dry mouth, drowsiness, dizziness, constipation and sedation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pha...

JAVADIN is contraindicated in patients with known hypersensitivity to clonidine. [see Adverse Reactions ( 6 )].

• JAVADIN is contraindicated in patients with known hypersensitivity to clonidine ( 4 )

Bradycardia, Cardiac Conduction Abnormalities, and Symptomatic Hypotension: Clonidine may cause bradycardia, conduction abnormalities, and hypotension. Titrate slowly in patients with syncope, heart block, or vascular disease. Monitor blood pressure and heart rate. Avoid drugs affecting sinus or AV node function. ( 5.1 ) Rebound Hypertension: Abrupt discontinuation of JAVADIN may cause rebound hypertension, especially with high doses or beta-blocker use. Taper gradually over 2–4 days. Continue a...

7 DRUG INTERACTIONS The interactions of JAVADIN with co-administration of other drugs have not been studied. The drug interaction data provided in this section is based on oral immediate-release clonidine formulations. Table 1 displays clinically important drug interactions with JAVADIN.

Table 1Clinically Important Drug Interactions with JAVADIN. Antihypertensive drugs Clinical Implication Conco...