Clonidine Hydrochloride Oral
Generic Name: clonidine hydrochloride oral
Brand Names:
Javadin
11 DESCRIPTION JAVADIN (clonidine hydrochloride) oral solution is a central alpha-2 adrenergic agonist hypotensive agent available as a 0.02 mg/mL solution for oral administration. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. Its molecular formula is C 9 H 9 Cl 2 N 3 , HCl which corresponds to a molecular weight of 266.5.
Overview
11 DESCRIPTION JAVADIN (clonidine hydrochloride) oral solution is a central alpha-2 adrenergic agonist hypotensive agent available as a 0.02 mg/mL solution for oral administration. Clonidine hydrochloride is an imidazoline derivative and exists as a mesomeric compound. The chemical name is 2-(2,6-dichlorophenylamino)-2-imidazoline hydrochloride. Its molecular formula is C 9 H 9 Cl 2 N 3 , HCl which corresponds to a molecular weight of 266.5.
Uses
1 INDICATIONS AND USAGE JAVADIN is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating risk reduction with JAVADIN. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.
Dosage
2 DOSAGE AND ADMINISTRATION Initial dosage is 0.1 mg orally twice daily with or without food (morning and bedtime) ( 2.1 ) Titrate in increments of 0.1 mg per day at weekly intervals if necessary until the desired response is achieved. ( 2.1 ) The therapeutic doses most commonly used have ranged from 0.2 mg to 0.6 mg per day, given in divided doses. ( 2.1 ) Maximum recommended daily dose is 2.4 mg. ( 2.1 ) 2.1 Recommended Dosage Dosage should be individualized based on response. The recommended initial dosage is 0.1 mg orally twice daily (morning and bedtime). Dosage can be titrated in increments of 0.1 mg per day at weekly intervals as necessary. Doses should be taken twice a day, with either an equal or higher split dosage being given at bedtime.
Side Effects
6 ADVERSE REACTIONS 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 Pharmaceuticals, Inc., at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
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 1: Clinically Important Drug Interactions with JAVADIN. Antihypertensive drugs Clinical Implication Concomitant use of antihypertensive drugs with clonidine potentiates the hypotensive effects of clonidine [see Warnings and Precautions ( 5.1 )].
Warnings
5 WARNINGS AND PRECAUTIONS 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 administration up to 4 hours before surgery and resume promptly postoperatively; monitor blood pressure closely. ( 5.2 ) Sedation and Somnolence: Clonidine may cause sedation; caution patients who operate machinery or drive. 4 CONTRAINDICATIONS 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 )
Pregnancy
8.1 Pregnancy Risk Summary Prolonged experience with clonidine in pregnant women over several decades, based on published literature, including controlled trials, a retrospective cohort study and case reports, have not identified a drug associated risk of major birth defects, miscarriage, adverse maternal or fetal outcomes. In animal embryofetal studies, increased resorptions were seen in rats and mice administered oral clonidine hydrochloride from implantation through organogenesis at approximately 2 times the maximum recommended human dose (MRHD) (see Data) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied JAVADIN (clonidine hydrochloride) is a clear, colorless solution supplied in a high-density polyethylene (HDPE) bottle with child-resistant closure. The 0.02 mg/mL oral solution is available in bottles of 250 mL (NDC 24338-115-01).
Frequently Asked Questions
What is Clonidine Hydrochloride Oral used for?▼
1 INDICATIONS AND USAGE JAVADIN is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. There are no controlled trials demonstrating risk reduction with JAVADIN. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals.
What are the side effects of Clonidine Hydrochloride Oral?▼
6 ADVERSE REACTIONS 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 Pharmaceuticals, Inc., at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Clonidine Hydrochloride Oral during pregnancy?▼
8.1 Pregnancy Risk Summary Prolonged experience with clonidine in pregnant women over several decades, based on published literature, including controlled trials, a retrospective cohort study and case reports, have not identified a drug associated risk of major birth defects, miscarriage, adverse maternal or fetal outcomes. In animal embryofetal studies, increased resorptions were seen in rats and mice administered oral clonidine hydrochloride from implantation through organogenesis at approximately 2 times the maximum recommended human dose (MRHD) (see Data) .
What are the important warnings for Clonidine Hydrochloride Oral?▼
5 WARNINGS AND PRECAUTIONS 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 administration up to 4 hours before surgery and resume promptly postoperatively; monitor blood pressure closely. ( 5.2 ) Sedation and Somnolence: Clonidine may cause sedation; caution patients who operate machinery or drive. 4 CONTRAINDICATIONS 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 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.