Onyda XR (clonidine ER — regional product)

Onyda XR (clonidine hydrochloride)

Is a centrally acting alpha2-adrenergic agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.

What Are Side Effects of Onyda XR?

Side effects of Onyda XR include:

• drowsiness,
• fatigue,
• irritability,
• nightmares,
• insomnia,
• constipation,
• dry mouth,
• decreased appetite,
• dizziness,
• headache, and
• abdominal pain.

Seek medical care or call 911 at once if you have the following serious side effects:

• Serious eye symptoms such as sudden vision loss, blurred vision,tunnel vision,eye painor swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
• Severe headache,confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Onyda XR

The starting dosage is 0.1 mg of Onyda XR orally once daily at bedtime with or without food. The dosage of Onyda XR may be increased in increments of 0.1 mg per day at weekly intervals. The maximum recommended dosage of Onyda XR is 0.4 mg once daily at bedtime.

Onyda XR In Children

The safety and efficacy of Onyda XR in the treatment of ADHD have been established in pediatric patients 6 to 17 years of age.

Safety and efficacy of Onyda XR in pediatric patients below the age of 6 years has not been established.

What Drugs, Substances, or Supplements Interact with Onyda XR?

Onyda XR may interact with other medicines such as:

• CNS depressants (e.g., alcohol, barbiturates or other sedating drugs),
• tricyclic antidepressants,
• drugs known to affect sinus node function or AV nodal conduction (e.g., digitalis, calcium channel blockers and beta-blockers), and
• antihypertensive drugs.

Tell your doctor all medications and supplements you use.

Onyda XR During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Onyda XR; it is unknown how it might affect a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to ADHD medications, including Onyda XR, during pregnancy. Onyda XR passes into breast milk. In most cases, there are no adverse effects on breastfed infants. If an infant is exposed to Onyda XR through breast milk, they should be monitored for symptoms of low blood pressure (hypotension) and slow heart rate, such as sedation, lethargy, rapid breathing, and poor feeding. Consult your doctor before breastfeeding.

Additional Information

Our Onyda XR (clonidine hydrochloride) Extended-Release Oral Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.