Drugplain

ONYDA XR .1 mg/mL

Clonidine hydrochloride · SUSPENSION, EXTENDED RELEASE · NextWave Pharmaceuticals, Inc

No Recall History
Plain English

Onyda XR is a prescription medication containing clonidine, a medication that lowers blood pressure and is commonly used to treat high blood pressure and attention-deficit/hyperactivity disorder (ADHD) in children. It comes as an extended-release liquid suspension that you take by mouth.

Key Facts

Brand Name
ONYDA XR
Generic Name
Clonidine hydrochloride
NDC Code (Product)
24478-148
Manufacturer
NextWave Pharmaceuticals, Inc
Strength
.1 mg/mL
Dosage Form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
NDA217645
Marketing Start
08/13/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

hypertension707 reports
headache659 reports
off label use611 reports
fatigue592 reports
pain574 reports
drug ineffective492 reports
hypersensitivity483 reports
nausea429 reports
infusion related reaction403 reports
hepatic enzyme increased399 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS 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 [see Clinical Studies ( 14 )]. ONYDA XR is a centrally acting alpha 2 -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. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Starting dosage is 0.1 mg of ONYDA XR orally once daily at bedtime with or without food. Dosage may be increased in increments of 0.1 mg per day at weekly intervals. Maximum recommended dosage is 0.4 mg once daily at bedtime. ( 2.1 ) Do not substitute ONYDA XR for other clonidine products on a mg-per-mg basis because of differing pharmacokinetic profiles. ( 2.3 ) When discontinuing, taper the dose in decrements of no more than 0.1 mg every 3 to 7 days to avoid rebound hypertension. ( 2.4 ) 2.1 Recommended Dosage The starting dosage of ONYDA XR is 0.1 mg orally once daily at bedtime with or without food [see Clinical Pharmacology ( 12.3 )] . Titrate the dose of ONYDA XR in increments of 0.1 mg per day at weekly intervals depending on clinical response up to the maximum recommended dosage of 0.4 mg once daily at bedtime. Doses of ONYDA XR higher than 0.4 mg once daily were not evaluated in clinical trials for ADHD and are not recommended. When ONYDA XR is added to a CNS stimulant, adjust the dose of the CNS stimulant depending on the clinical response to ONYDA XR. 2.2 Administration Instructions Instruct patients to read the “Instructions for Use” for comp…

Contraindications

4 CONTRAINDICATIONS ONYDA XR is contraindicated in patients with a history of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, and angioedema [see Warnings and Precautions ( 5.4 ) and Adverse Reactions ( 6 )]. History of a hypersensitivity reaction to clonidine. Reactions have included generalized rash, urticaria, angioedema. ( 4 )

Drug Interactions

7 DRUG 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 Antihypertensive drugs Clinical Implication Concomitant use of antihypertensive drugs with clonidine potentiates the hypotensive effects of clonidine. Intervention Monitor blood pressure and heart rate, and adjust dosage of ONYDA XR accordingly in patients treated concomitantly with antihypertensives [see Warnings and Precautions ( 5.1 )] . CNS depressants Clinical Implication Concomitant use of CNS depressants with clonidine potentiates the sedating effects [see Warnings and Precautions ( 5.2 )] . Intervention Avoid concomitant use of CNS depressants with ONYDA XR. 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 bl…

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described in greater detail elsewhere in labeling: Hypotension/bradycardia [see Warnings and Precautions ( 5.1 )] Sedation and somnolence [see Warnings and Precautions ( 5.2 )] Rebound hypertension [see Warnings and Precautions ( 5.3 )] Allergic reactions [see Warnings and Precautions ( 5.4 )] Cardiac Conduction Abnormalities [see Warnings and Precautions ( 5.5 )] Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as monotherapy in ADHD: somnolence, fatigue, irritability, nightmare, insomnia, constipation, dry mouth. ( 6.1 ) Most common adverse reactions (incidence at least 5% and twice the rate of placebo) as adjunct therapy to psychostimulant in ADHD: somnolence, fatigue, decreased appetite, dizziness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 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 m…

Frequently Asked Questions

What is ONYDA XR used for?

Onyda XR is a prescription medication containing clonidine, a medication that lowers blood pressure and is commonly used to treat high blood pressure and attention-deficit/hyperactivity disorder (ADHD) in children. It comes as an extended-release liquid suspension that you take by mouth.

Is ONYDA XR a controlled substance?

ONYDA XR is not classified as a controlled substance by the DEA.

What is the generic name for ONYDA XR?

The generic name for ONYDA XR is Clonidine hydrochloride. There are 12 other brand versions of Clonidine hydrochloride.

What is the NDC code for ONYDA XR .1 mg/mL?

The NDC (National Drug Code) for ONYDA XR .1 mg/mL is 24478-148, listed by NextWave Pharmaceuticals, Inc.

Product NDC

24478-148

Package NDC

24478-148-01

Other Clonidine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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