javadin

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. The therapeutic doses most commonly employed have ranged from 0.2 mg to 0.6 mg per day, given in divided doses. Maximum recommended daily dose is 2.4 mg, but doses as high as this have rarely been employed. 2.2 Administration Instructions A calibrated measuring device, such as an oral dosing syringe or oral dosing cup, is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. Administer JAVADIN (clonidine hydrochloride) oral solution with or without food. [see Clinical Pharmacology ( 12.3 )] JAVADIN may be administered up to 4 hours before surgery and resume as soon as possible…

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. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth (40%), drowsiness (33%); dizziness (16%); constipation and sedation (10%, respectively). The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established. Body as a Whole: Fatigue, headache, pallor,…

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 )

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 pediatric patients 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. Dialysis is not likely to significantly enhance the elimination of clonidine.

U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.

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 )]. Intervention Monitor blood pressure and heart rate, and adjust dosage of JAVADIN accordingly in patients treated concomitantly with antihypertensives CNS depressants Clinical Implication Concomitant use of CNS depressants with clonidine potentiates the sedating effects [see Warnings and Precautions ( 5.3 )]. Intervention Avoid concomitant use of CNS depressants with JAVADIN. Drugs that affect sinus node function or AV node conduction (e.g., digitalis, calcium channel blockers, beta blockers) Clinical Implication Concomitant use of drugs that affect sinus node function or AV node conduction with clonidine potentiate bradycardia and risk of AV block [see Warnings and Precautions ( 5.1 )]. Intervention Avoid concomitant use of drugs that affect sinus node function or AV node conduction with JAVADIN. Tricyclic antidepressants Clinical Implication Concomitant use of tricyclic antidepressants with clonidine can increase blood pressure and may counteract the hypotensive effects of clonidine. Intervention Monitor blood pressure and adjust dosage of JAVADIN as needed. 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 )