First of Its Kind. The Only FDA-Approved, Immediate-Release, Ready-to-Use (RTU) Oral Liquid Clonidine Made for Hypertension Control.1-3
Javadin™: RTU Liquid Clonidine
- RTU oral liquid form of clonidine indicated for the treatment of hypertension and may be employed alone or concomitantly with other antihypertensive agents1
- Available as a clear, colorless oral solution (0.02 mg/mL) in a 250 mL bottle1
- Blood pressure lowers typically within 30 to 60 minutes after administration, with maximum decrease occurring within 2 to 4 hours1
No Pills, No Compounding, No Transdermal Delivery Systems
- Javadin™ RTU oral solution may streamline hypertension care as the only immediate-release liquid clonidine—no tablet cutting, compounding, or applying a transdermal delivery system1,a
aBioequivalence to clonidine tablets was established in a bioequivalence study conducted with healthy subjects; however, Javadin™ has not been studied for safety and efficacy in a clinical trial.4
Dosing
- Initial dose is 0.1 mg (5 mL) twice daily (in the morning and at bedtime), with or without food1
- Dose may be increased 0.1 mg (5 mL) per day at weekly intervals, as necessary1
- Maximum effective daily dose is 2.4 mg; however, such high doses are rarely used1
Dosage of Javadin™ should be individualized based on response. For additional dosing recommendations, please refer to Section 2.1 of the Full Prescribing Information.
Refrigeration Free, Dye Free, Berry Flavored
- Javadin™ is available as a berry-flavored, clear, colorless oral solution1
- Javadin™ should be stored at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F) (see USP Controlled Room Temperature)1
- Discard unused portion 60 days after first opening1
Safety
- Javadin™ is contraindicated in patients with known hypersensitivity to clonidine1
- Clinically significant adverse reactions include bradycardia, cardiac conduction abnormalities, symptomatic hypotension, rebound hypertension, sedation, and somnolence1
Javadin™ Is Ready-to-Use Oral Liquid Clonidine1
Difficulty swallowing solid dosage forms is common in adults and can complicate medication adherence.5
Javadin™ oral solution may be appropriate for adult patients who have difficulty swallowing tablets or require a liquid formulation.1
32% of adults have difficulty swallowing tablets or capsules.6
Study design: This cross-sectional study involved 152 adults aged 19 to 66 years who were invited to participate. Participants completed a self-administered questionnaire consisting of both closed multi-response and open-ended questions. The questionnaire explored their perceptions of difficulties swallowing tablets or capsules, memories of choking incidents involving food or medication, and coping strategies used to facilitate swallowing.6
About 59% of patients with difficulty swallowing solid oral dosage forms modified their medication to facilitate swallowing, including splitting or crushing tablets or opening capsules, potentially compromising their efficacy and safety.5
Study design: Based on a quantitative study conducted in 11 general practices and consecutive patients (n=1051, median age=61.8 years) taking ≥1 solid dosage form for ≥4 weeks. A questionnaire, assessed at the practice and at home, evaluated the severity of swallowing difficulties, potential causes, and whether the patients skipped doses due to these issues.5
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Focus on the Patient, Not the Prep
- Javadin™, the first and only RTU oral liquid clonidine for hypertension management, offers dosing without the challenges of compounding, cutting, transdermal system variability, or swallowing tablets.1-3,b
bBioequivalence to clonidine tablets was established in a bioequivalence study conducted with healthy subjects; however, Javadin™ has not been studied for safety and efficacy in a clinical trial.4
Lowers Blood Pressure Within 30 to 60 Minutes, Not Days1,7
- Patients taking Javadin™ may experience blood pressure declines within 30 to 60 minutes after an oral dose, with the maximum decrease occurring within 2 to 4 hours.1
- Unlike other antihypertensive agents that act peripherally, Javadin™ acts centrally by stimulating alpha-adrenoreceptors in the brain.1,8 Javadin™ decreases peripheral resistance, renal vascular resistance, heart rate, and blood pressure.1
The Safety Profile of Javadin™ Oral Solution Is Consistent With That of Clonidine Tablets1,10,c
The most frequent adverse reactions are dry mouth, drowsiness, 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.
cBioequivalence to clonidine tablets was established in a bioequivalence study conducted with healthy subjects; however, Javadin™ has not been studied for safety and efficacy in a clinical trial.4
Javadin™ Dosing
Javadin™ can be taken with or without food1
Javadin™ oral solution provides a 0.1 mg dose of clonidine in 5 mL (0.02 mg/mL)1
The dose of Javadin™ must be adjusted according to the patient's individual blood pressure response1,d
| Recommended Dose of Clonidine | Volume of Javadin™ | |
|---|---|---|
Initial Starting Dose (twice daily; in the morning and bedtime) | 0.1 mg (twice daily) | 5 mL (twice daily) |
Incremental Dose Adjustment (increase at weekly intervals, as necessary)a | 0.1 mg | 5 mL |
dDoses should be taken twice a day, with either an equal or higher split dosage being given at bedtime.1
- Most common therapeutic doses range from 0.2 mg to 0.6 mg per day given in divided doses1
- Maximum recommended daily dose is 2.4 mg; however, such high doses are rarely used1
For additional dosing recommendations, please refer to Section 2.1 of the Full Prescribing Information.
Javadin™ Resources
Javadin™ Tradesheet
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