ONYDA XR

Immediate-release clonidine hydrochloride, extended-release clonidine hydrochloride tablets, and ONYDA XR have different pharmacokinetic characteristics. Dose substitution on a milligram for milligram basis will result in differences in exposures [see Dosage and Administration ( 2.3 )] .

AbsorptionFollowing a single 0.2 mg dose of ONYDA XR in 20 healthy adult subjects under fasting conditions in a crossover study, the median (range) time to peak plasma concentrations (T max ) for clonidine was ...

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 t...

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 mo...

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 )

Hypotension/bradycardia: Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease, or chronic renal failure. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Avoid concomitant use of drugs with additive effects unless clinically indicated. Advise patients to avoid becoming dehydrated or...

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 5Clinically Important Drug Interactions with ONYDA XR Antihypertensive drugs Clinical Implication Con...