When added to stimulant therapy, clonidine XR showed up to 37% improvement over placebo in ADHD-RS-IV scores. ONYDA XR can improve ADHD symptom control in patients treated with stimulants.
Baseline stimulant medication
+ clonidine XR
Baseline stimulant medication
+ placebo
During the 8 week study, patients took either clonidine XR or a placebo, in addition to their regular stimulant medication. The clonidine XR dose was gradually titrated based on patients' response to treatment.
Each week, researchers measured changes in the child's inattention and hyperactivity/impulsivity using a standard ADHD rating scale (ADHD-RS-IV)
At week 5, patients in the stimulant + clonidine XR group had significantly greater improvement in inattention and hyperactivity/impulsivity scores from baseline than those taking stimulant + placebo.
The most common adverse events in the study were somnolence, fatigue, headache, upper abdominal pain, nasal congestion, pharyngolaryngeal pain, cough, irritability, insomnia, dizziness, and increased body temperature.
Adding clonidine XR to a stimulant improved ADHD symptoms more than a stimulant alone
Studies of clonidine XR showed improvement over placebo in ADHD-RS-IV scores. ONYDA XR can improve symptom control in patients.
Clonidine XR
0.2 mg/day
Clonidine XR
0.4 mg/day
Placebo
No active medicine
During the 8 week study, patients took either clonidine XR or a placebo. The clonidine XR dose was slowly increased over time until each patient reached their assigned dose.
Each week, researchers measured changes in the child's inattention and hyperactivity/impulsivity using a standard ADHD rating scale (ADHD-RS-IV)
At week 5, patients in the clonidine XR groups had significantly greater improvement in inattention and hyperactivity/impulsivity scores from baseline than those in the placebo group.
The most common adverse events in the study were somnolence, fatigue, irritability, pharyngolaryngeal pain, increased body temperature, ear pain, emotional disorder, nightmare, insomnia, constipation and dry mouth.
Studies of clonidine XR showed improvement over placebo in ADHD-RS-IV scores
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REFERENCES: 1. ONYDA XR [package insert]. Tris Pharma, Inc., Monmouth Junction, NJ. 2. Jain R, Segal S, Kollins SH, Khayrallah M. Clonidine extended-release tablets for pediatric patients with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2011 Feb;50(2):171-9. 3. Kollins SH, Jain R, Brams M, Segal S, Findling RL, Wigal SB, Khayrallah M. Clonidine extended-release tablets as add-on therapy to psychostimulants in children and adolescents with ADHD. Pediatrics. 2011 Jun;127(6):e1406-13.
ONYDA XR is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) alone or with certain other ADHD medicines in children 6 years of age and older.
It is not known if ONYDA XR is safe and effective in children under 6 years of age.
ONYDA® XR (clonidine HCI) is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD), alone or with certain other ADHD medicines, in children 6 years of age and older. It is not known if ONYDA XR is safe and effective in children under 6 years of age.
Do not take ONYDA XR if you are allergic to clonidine.
Before taking ONYDA XR, tell your healthcare provider if you have kidney problems; low or high blood pressure; a history of passing out (syncope); heart problems (including slow heart rate or rhythm problems); had a stroke or stroke symptoms; or had an allergic reaction after taking clonidine through the skin (patch). Tell your healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding. It is not known if ONYDA XR may harm an unborn baby. ONYDA XR passes into breast milk and may cause sleepiness, floppy muscles, or breathing problems in breastfed babies. A pregnancy registry is available at 1-866-961-2388 or womensmentalhealth.org/adhdmedications.
Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ONYDA XR may interact with medicines for depression, ADHD, heart or blood pressure conditions, medicines that cause sleepiness, or other clonidine-containing medicines.
What to avoid while taking ONYDA XR?
Avoid dehydration and overheating, which may increase the risk of passing out.
Do not drive, operate machinery, or perform dangerous activities until you know how ONYDA XR affects you, because it may cause sleepiness and tiredness that can slow reaction times.
Avoid alcohol or other medicines that cause sleepiness or dizziness unless discussed with your healthcare provider.
Do not suddenly stop ONYDA XR. Stopping suddenly may cause rebound high blood pressure and withdrawal symptoms. Contact your healthcare provider before stopping treatment. If vomiting prevents you from taking ONYDA XR, contact your healthcare provider because rebound hypertension may occur.
Possible side effects
ONYDA XR may cause serious side effects including:
Low blood pressure and slow heart rate, which may increase the risk of passing out. Your healthcare provider should check your heart rate and blood pressure before and during treatment.
Sleepiness and tiredness that may slow reaction times.
Rebound high blood pressure and withdrawal symptoms after sudden stop (including headache, increased heart rate, nausea, flushing or warm feeling, lightheadedness, chest tightness, nervousness, or anxiety).
Allergic reactions. Stop taking ONYDA XR and seek medical help immediately if you develop rash, hives, or swelling of the eyes, face, lips, or tongue, especially if you previously had an allergic reaction to clonidine patch.
ONYDA XR may cause fertility problems in females and males, which may affect the ability to have a child. Talk to your healthcare provider if this is a concern.
Most common side effects when used alone:
Sleepiness/tiredness, nightmare, constipation, irritability, trouble sleeping, and dry mouth.
Most common side effects when used with other ADHD medicines:
Sleepiness/tiredness, decreased appetite, and dizziness.
These are not all possible side effects of ONYDA XR. Call your healthcare provider for medical advice about side effects. Report side effects to Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088.
Please see Full Prescribing Information and Patient Information, including Instructions for Use.
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