Generic Name
Clonidine
Brand Names
ONYDA, Clonidine Transdermal, Catapres-TTS-2, Catapres-TTS-1, Clonidine HCI, Duraclon, Catapres-TTS-3, Nexiclon
FDA approval date: January 03, 1995
Classification: Central alpha-2 Adrenergic Agonist
Form: Patch, Injection, Tablet, Suspension
What is ONYDA (Clonidine)?
Clonidine hydrochloride extended-release tablets are indicated for the treatment of attention deficit hyperactivity disorder as monotherapy and as adjunctive therapy to stimulant medications. Clonidine hydrochloride is a centrally acting alpha 2 -adrenergic agonist indicated for the treatment of attention deficit hyperactivity disorder as monotherapy or as adjunctive therapy to stimulant medications.
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Brand Information
ONYDA XR (Clonidine hydrochloride)
1INDICATIONS AND USAGE
ONYDA XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older
2DOSAGE FORMS AND STRENGTHS
Extended-release oral suspension: Light beige to tan viscous suspension containing 0.1 mg clonidine hydrochloride per mL.
3CONTRAINDICATIONS
ONYDA XR is contraindicated in patients with a history of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, and angioedema
4ADVERSE REACTIONS
The following serious adverse reactions are described in greater detail elsewhere in labeling:
- Hypotension/bradycardia
- Sedation and somnolence
- Rebound hypertension
- Allergic reactions
- Cardiac Conduction Abnormalities
4.1Clinical 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.
The safety of ONYDA XR for the treatment of ADHD in pediatric patients 6 years and older is based upon adequate and well-controlled studies of clonidine hydrochloride extended-release tablets (referred to as “clonidine hydrochloride extended-release” in this section). The safety results of these adequate and well-controlled studies of clonidine hydrochloride extended-release tablets are presented below.
Two clonidine hydrochloride extended-release ADHD clinical studies (Study 1 and Study 2) evaluated 256 patients in two 8-week placebo-controlled studies.
A third clonidine hydrochloride extended-release ADHD clinical study (Study 3) evaluated 135 pediatric patients 6 to 17 years of age in a 40-week placebo-controlled randomized‑withdrawal study.
Study 1: Fixed-dose clonidine hydrochloride extended-release Monotherapy
Study 1 was a short-term, multi-center, randomized, double-blind, placebo-controlled study of two fixed doses (0.2 mg/day or 0.4 mg/day) of clonidine hydrochloride extended-release in pediatric patients 6 to 17 years of age who met DSM-IV criteria for ADHD hyperactive or combined inattentive/hyperactive subtypes.
Most Common Adverse Reactions (incidence of ≥ 5% and at least twice the rate of placebo): somnolence, fatigue, irritability, insomnia, nightmare, constipation, dry mouth.
Adverse Reactions Leading to Discontinuation of clonidine hydrochloride extended-release: Five patients (7%) in the low dose group (0.2 mg), 15 patients (20%) in the high dose group (0.4 mg), and 1 patient in the placebo group (1%) reported adverse reactions that led to discontinuation. The most common adverse reactions that led to discontinuation were somnolence and fatigue.
Commonly observed adverse reactions (incidence of ≥2% in either active treatment group and greater than the rate on placebo) during the treatment period are listed in
Table 1: Common Adverse Reactions Occurring in ≥2%of Patients Treated with Clonidine Hydrochloride Extended-Release Tablets and Greater than the Rate of Placebo in the Fixed-Dose Monotherapy Trial -Treatment Period (Study 1)
* Somnolence includes the terms "somnolence" and "sedation".
† Fatigue includes the terms "fatigue" and "lethargy".
Commonly observed adverse reactions (incidence of ≥2% in either active treatment group and greater than the rate on placebo) during the taper period are listed in
Table 2: Common Adverse Reactions Occurring in ≥2% of Patients Treated with Clonidine Hydrochloride Extended-Release Tablets and Greater than the Rate of Placebo in the Fixed-Dose Monotherapy Trial -Taper Period* (Study 1)
* Taper Period: 0.2 mg dose, week 8; 0.4 mg dose, weeks 6-8; Placebo dose, weeks 6-8
Study 2: Flexible-dose clonidine hydrochloride extended-release as Adjunctive Therapy to Psychostimulants
Study 2 was a short-term, randomized, double-blind, placebo-controlled study of a flexible dose of clonidine hydrochloride extended-release as adjunctive therapy to a psychostimulant in pediatric patients 6 to 17 years of age who met DSM-IV criteria for ADHD hyperactive or combined inattentive/hyperactive subtypes, during which clonidine hydrochloride extended‑release was initiated at 0.1 mg/day and titrated up to 0.4 mg/day over a 3-week period. Most clonidine hydrochloride extended-release treated patients (75.5%) were escalated to the maximum dose of 0.4 mg/day.
Most Common Adverse Reactions (incidence of ≥ 5% and at least twice the rate of placebo): somnolence, fatigue, decreased appetite, dizziness.
Adverse Reactions Leading to Discontinuation: There was one patient in the clonidine hydrochloride extended-release + stimulant (group (1%) who discontinued because of an adverse event (severe bradyphrenia, with severe fatigue).
Commonly observed adverse reactions (incidence of ≥2% in the treatment group and greater than the rate on placebo) during the treatment period are listed in
Table 3: Common Adverse Reactions Occurring in ≥2% of Patients Treated with Clonidine Hydrochloride Extended-Release Tablets and Greater than the Rate of Placebo in the Flexible-Dose Adjunctive to Stimulant Therapy Trial -Treatment Period (Study 2)
+Somnolence includes the terms: "somnolence" and "sedation"
† Fatigue includes the terms "fatigue" and "lethargy"
Commonly observed adverse reactions (incidence of ≥2% in the treatment group and greater than the rate on placebo) during the taper period are listed in
Table 4: Common Adverse Reactions Occurring in ≥2% of Patients Treated with Clonidine Hydrochloride Extended-Release Tablets and Greater than the Rate of Placebo in the Flexible-Dose Adjunctive to Stimulant Therapy Trial -Taper Period
+Taper Period: weeks 6-8
Adverse Reactions Leading to Discontinuation
Thirteen percent (13%) of patients receiving clonidine hydrochloride extended-release discontinued from the pediatric monotherapy study due to adverse reactions, compared to 1% in the placebo group. The most common adverse reactions leading to discontinuation of clonidine hydrochloride extended-release monotherapy treated patients were somnolence/sedation (5%) and fatigue (4%).
Effect on Blood Pressure and Heart Rate
In patients that completed 5 weeks of treatment in a controlled, fixed-dose monotherapy study in pediatric patients, during the treatment period the maximum placebo-subtracted mean change in systolic blood pressure was -4.0 mmHg on clonidine hydrochloride extended-release 0.2 mg/day and -8.8 mmHg on clonidine hydrochloride extended-release 0.4 mg/day. The maximum placebo-subtracted mean change in diastolic blood pressure was -4.0 mmHg on clonidine hydrochloride extended-release 0.2 mg/day and -7.3 mmHg on clonidine hydrochloride extended-release 0.4 mg/day. The maximum placebo-subtracted mean change in heart rate was ‑4.0 beats per minute on clonidine hydrochloride extended-release 0.2 mg/day and -7.7 beats per minute on clonidine hydrochloride extended-release 0.4 mg/day.
During the taper period of the fixed-dose monotherapy study the maximum placebo-subtracted mean change in systolic blood pressure was +3.4 mmHg on clonidine hydrochloride extended‑release 0.2 mg/day and -5.6 mmHg on clonidine hydrochloride extended-release 0.4 mg/day. The maximum placebo-subtracted mean change in diastolic blood pressure was +3.3 mmHg on clonidine hydrochloride extended-release 0.2 mg/day and -5.4 mmHg on clonidine hydrochloride extended-release 0.4 mg/day. The maximum placebo-subtracted mean change in heart rate was -0.6 beats per minute on clonidine hydrochloride extended-release 0.2 mg/day and -3.0 beats per minute on clonidine hydrochloride extended-release 0.4 mg/day.
4.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of clonidine hydrochloride extended-release tablets (and excludes those already mentioned in Section
Psychiatric: hallucinations
Cardiovascular: Q-T prolongation
5DRUG INTERACTIONS
The interactions of ONYDA XR 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 5 displays clinically important drug interactions with ONYDA XR.
Table 5: Clinically Important Drug Interactions with ONYDA XR
6OVERDOSAGE
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.
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
7DESCRIPTION
ONYDA XR contains clonidine hydrochloride, a centrally acting alpha
The molecular formula of clonidine hydrochloride is C
Clonidine hydrochloride is an odorless, bitter, white to almost white, crystalline powder soluble in water and alcohol. The pH of a 5% solution in water is between 3.5 and 5.5.
ONYDA XR is an extended-release suspension for oral administration. Each mL of ONYDA XR contains 0.09 mg clonidine equivalent to 0.1 mg clonidine hydrochloride (0.095 mg clonidine hydrochloride complexed with sodium polystyrene sulfonate and 0.005 mg clonidine hydrochloride). The pH of ONYDA XR is between 2.8 and 4.
The inactive ingredients are anhydrous citric acid, edetate disodium, glycerin, modified starch, methylparaben, orange flavor, polyvinyl acetate dispersion 30%, povidone, polysorbate 80, propylparaben, purified water, sucrose, sodium polystyrene sulfonate, triacetin, xanthan gum.
8CLINICAL STUDIES
The efficacy of ONYDA XR for the treatment of ADHD in pediatric patients 6 years of age and older is based upon adequate and well-controlled studies of clonidine hydrochloride extended-release tablets (referred to as “clonidine hydrochloride extended-release” in this section). The efficacy results of these adequate and well-controlled studies of clonidine hydrochloride extended-release tablets are presented below.
Efficacy of clonidine hydrochloride extended-release in the treatment of ADHD was established in pediatric patients 6 to 17 years in:
- One short-term, placebo-controlled monotherapy trial (Study 1)
- One short-term adjunctive therapy to psychostimulants trial (Study 2)
- One randomized withdrawal trial as monotherapy (Study 3)
Short-term Monotherapy and Adjunctive Therapy to Psychostimulant Studies for ADHD
The efficacy of clonidine hydrochloride extended-release in the treatment of ADHD was established in 2 (one monotherapy and one adjunctive therapy) placebo-controlled trials in pediatric patients aged 6 to 17 years, who met DSM-IV criteria of ADHD hyperactive or combined hyperactive/inattentive subtypes. Signs and symptoms of ADHD were evaluated using the investigator administered and scored ADHD Rating Scale-IV-Parent Version (ADHDRS-IV) total score including hyperactive/impulsivity and inattentive subscales. Study 1 was an 8-week randomized, double-blind, placebo-controlled, fixed dose study of pediatric patients 6 to 17 years (N=236) with a 5-week primary efficacy endpoint. Patients were randomly assigned to one of the following three treatment groups: clonidine hydrochloride extended-release 0.2 mg/day (N=78), clonidine hydrochloride extended-release 0.4 mg/day (N=80), or placebo (N=78). Dosing for the clonidine hydrochloride extended-release groups started at 0.1 mg/day and was titrated in increments of 0.1 mg/week to their respective dose (as divided doses). Patients were maintained at their dose for a minimum of 2 weeks before being gradually tapered down to 0.1 mg/day at the last week of treatment. At both doses, improvements in ADHD symptoms were statistically significantly superior in clonidine hydrochloride extended-release-treated patients compared with placebo-treated patients at the end of 5 weeks as measured by the ADHDRS-IV total score (
Table 6: Short-Term Trials
a Difference (drug minus placebo) in least-squares mean change from baseline. SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: unadjusted confidence interval.
Maintenance Monotherapy for ADHD
Study 3 was a double-blind, placebo-controlled, randomized-withdrawal study in pediatric patients 6 to 17 years (n=253) with DSM-IV-TR diagnosis of ADHD. The study consisted of a 10-week, open-label phase (4 weeks of dose optimization and 6 weeks of dose maintenance), a 26-week double-blind phase, and a 4-week taper-down and follow-up phase. All patients were initiated at 0.1 mg/day and increased at weekly intervals in increments of 0.1 mg/day until reaching personalized optimal dose (0.1, 0.2, 0.3 or 0.4 mg/day, as divided doses). Eligible patients had to demonstrate treatment response as defined by ≥ 30% reduction in ADHD-RS-IV total score and a Clinical Global Impression-Improvement score of 1 or 2 during the open label phase. Patients who sustained treatment response (n=135) until the end of the open label phase were randomly assigned to one of the two treatment groups, clonidine hydrochloride extended-release (N=68) and Placebo (N=67), to evaluate the long-term efficacy of maintenance dose of clonidine hydrochloride extended-release in the double-blind phase. The primary efficacy endpoint was the percentage of patients with treatment failure defined as a ≥ 30% increase (worsening) in ADHD-RS-IV total score and ≥ 2 points increase (worsening) in Clinical Global Impression – Severity Scale in 2 consecutive visits or early termination for any reason. A total of 73 patients experienced treatment failure in the double-blind phase: 31 patients (45.6%) in the clonidine hydrochloride extended-release group and 42 patients (62.7%) in the placebo group, with a statistically significant difference in the primary endpoint favoring clonidine (
Table 7: Treatment Failure: Double-Blind Full Analysis Set (Study 3)
ADHD-RS-IV = Attention Deficit Hyperactivity Disorder-Rating Scale-4th edition; CGI-S = Clinical Global Impression-Severity
a At the same 2 consecutive visits a (1) 30% or greater reduction in ADHD-RS-IV, and (2) 2-point or more increase in CGI-S.
bTwo patients (1 placebo and 1 clonidine hydrochloride extended-release tablets) withdrew consent, but met the clinical criteria for treatment failure.
cThree patients (all placebo) discontinued the study due to treatment failure, but met only the criterion for ADHD-RS-IV.
Figure 2: Kaplan-Meier Estimation of Cumulative Proportion of Pediatric Patients (6 to 17 Years) with Treatment Failure (Study 3)
9HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
ONYDA XR (clonidine hydrochloride) extended-release oral suspension 0.1 mg/mL is a light beige to tan viscous suspension.
ONYDA XR is supplied in a carton. Each carton contains one bottle with a child resistant closure, an oral dosing dispenser(s), and a press in bottle adapter(s).
Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.
Store and dispense ONYDA XR in the original bottle. Dispense with bottle adapter and oral dosing dispenser supplied in the carton.
For the bottles of 30 mL and 60 mL, discard any unused ONYDA XR 30 days after first opening the bottle.
For the 120 mL bottle, discard any unused ONYDA XR 60 days after first opening the bottle.
10PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Dosage and Administration
Advise patients that ONYDA XR may be taken with or without food. When initiating treatment, provide titration instructions
Administration Instructions
Instruct patients to read the “Instructions for Use” for complete administration instructions
Advise patients to:
- firmly insert the bottle adapter into the bottle and do not remove the bottle adapter once inserted. Use the oral dispenser provided with ONYDA XR.
- gently shake ONYDA XR with a smooth up and down motion (to avoid foaming) for at least 10 seconds before each administration.
- For the bottles of 30 mL and 60 mL, discard any unused ONYDA XR 30 days after first opening the bottle.
- For the 120 mL bottle, discard any unused ONYDA XR 60 days after first opening the bottle.
Missed Dose
If patients miss a dose of ONYDA XR, advise them to skip the dose and take the next dose as scheduled and not to take more than the prescribed total daily amount of ONYDA XR in any 24‑hour period
Hypotension/Bradycardia
Advise patients who have a history of syncope or may have a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia, or dehydration, to avoid becoming dehydrated or overheated
Sedation and Somnolence
Instruct patients to use caution when driving a car or operating heavy equipment until they know how they will respond to treatment with ONYDA XR. Also advise patients to avoid the use of ONYDA XR with other centrally active depressants and with alcohol
Rebound Hypertension
Advise patients not to discontinue ONYDA XR abruptly. Inform patients and caregivers that pediatric patients with gastrointestinal illnesses that lead to vomiting may be at increased risk for rebound hypertension
Allergic Reactions
Advise patients to discontinue ONYDA XR and seek immediate medical attention if any signs or symptoms of a hypersensitivity reaction occur, such as generalized rash, urticaria, or angioedema
Pregnancy Registry
Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ONYDA XR during pregnancy
Lactation
Advise breastfeeding women using ONYDA XR to monitor infants for excess sedation, decreased muscle tone, and respiratory depression and to seek medical care if they notice these signs
Fertility
Advise females and males of reproductive potential that ONYDA XR may impair fertility
Manufactured by/Distributed by:
Tris Pharma, Inc.
Monmouth Junction, NJ 08852
LB8735
Rev. 05
11PATIENT INFORMATION
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised:04/2025
12INSTRUCTIONS FOR USE
ONYDA
(clonidine hydrochloride)
extended-release oral suspension
This Instructions for Use contains information on how to take ONYDA XR.
Important Information You Need to Know Before Taking ONYDA XR:
- ONYDA XR is for oral use only (taken by mouth).
- Take ONYDA XR with or without food.
- Use only the oral dosing syringe and bottle adapter that come with ONYDA XR to measure and take a dose of ONYDA XR.
- Shake the ONYDA XR bottle gently.
- Check the expiration date (EXP) on the carton label. Do not take ONYDA XR after the expiration date has passed. Call your healthcare provider or pharmacist if your medicine is expired.
- For the bottles of 30 mL and 60 mL, throw away (discard of) any remaining ONYDA XR if you have not used it 30 days after first opening the bottle.
- For the 120 mL bottle, throw away (discard of) any remaining ONYDA XR if you have not used it 60 days after first opening the bottle.
Supplies included in the ONYDA XR carton:
Figure A
Disposing of ONYDA XR:
- Throw away any unused or expired ONYDA XR in your household trash.
- For the bottles of 30 mL and 60 mL, throw away (discard of) any remaining ONYDA XR if you have not used it 30 days after first opening the bottle.
- For the 120 mL bottle, throw away (discard of) any remaining ONYDA XR if you have not used it 60 days after first opening the bottle.
Storing ONYDA XR:
- Store ONYDA XR at room temperature between 68°F to 77°F (20°C to 25°C).
- Protect from light and keep ONYDA XR in the original container. Tightly close the child-resistant cap.
Keep ONYDA XR and all medicines out of the reach of children.
Manufactured by/Distributed by:
Tris Pharma, Inc.
Monmouth Junction, NJ 08852
LB8730 Rev. 03
This Instructions for Use has been approved by the U.S. Food and Drug Administration
Revised: 02/2025
13PRINCIPAL DISPLAY PANEL
NDC 24478-148-01
(clonidine hydrochloride) extended-release oral suspension
0.1 mg
7 mL Rx only
14PRINCIPAL DISPLAY PANEL
NDC 24478-148-01
(clonidine hydrochloride) extended-release oral suspension
0.1 mg
15PRINCIPAL DISPLAY PANEL
NDC 24478-148-03
(clonidine hydrochloride) extended-release oral suspension
0.1 mg
16PRINCIPAL DISPLAY PANEL
NDC 24478-148-03
(clonidine hydrochloride) extended-release oral suspension
0.1 mg