ONYDA Extended-release oral suspension Ref.[110276] Active ingredients: Clonidine

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 complete administration instructions.

• Use the oral dosing dispenser and bottle adapter provided with ONYDA XR.
• Ensure that the bottle adapter is firmly inserted into the bottle before first use and keep the adapter in place for the duration of the usage of the bottle.
• Gently shake ONYDA XR with a smooth up and down motion (to avoid foaming) for at least 10 seconds before each administration.
• Discard any unused ONYDA XR remaining in the bottle after 60 days of first opening the bottle.

2.3 Switching from Other Clonidine Products

For patients switching from another clonidine product, discontinue that treatment, and titrate with ONYDA XR using the titration schedule [see Dosage and Administration (2.1)]. Do not substitute for other clonidine products on a milligram-per-milligram basis because of differing pharmacokinetic profiles [see Clinical Pharmacology (12.3)].

2.4 Discontinuation

When discontinuing ONYDA XR, taper the total daily dose in decrements of no more than 0.1 mg every 3 to 7 days to avoid rebound hypertension [see Warnings and Precautions (5.3)].

2.5 Missed Doses

If a dose of ONYDA XR is missed, skip that dose and take the next dose as scheduled. Do not take more than the prescribed total daily amount of ONYDA XR in any 24-hour period.

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.

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. Discard any unused ONYDA XR remaining in the bottle after 60 days of first opening the bottle.