Adzenys ER Oral Suspension Dosage

Pre-Treatment Screening

Prior to treating patients with ADZENYS ER, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)] .

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for ADZENYS ER use [see Warnings and Precautions (5.1), and Drug Abuse and Dependence (9)] .

Dosing Considerations for All Patients

Administer ADZENYS ER orally once daily in the morning with or without food. The dose should be individualized according to the therapeutic needs and response of the patient.

Shake the bottle of ADZENYS ER before administering the dose. Do not add ADZENYS ER to food or mix ADZENYS ER with other liquids before consuming.

Pediatric Patients

The recommended starting dose for patients 6 to 17 years of age is 6.3 mg (5 mL) once daily in the morning. Increase in increments of 3.1 mg (2.5 mL) or 6.3 mg (5 mL) at weekly intervals. The maximum dose is 18.8 mg (15 mL) daily for patients 6 to 12 years, and 12.5 mg (10 mL) daily for patients 13 to 17 years.

Adults

The recommended dose of ADZENYS ER for adults is 12.5 mg (10 mL) daily.

Switching from Other Amphetamine Products

Patients taking ADDERALL XR may be switched to ADZENYS ER at the equivalent dose taken once daily [see Clinical Pharmacology (12)] . Refer to Table 1 for equivalent doses of ADZENYS ER and ADDERALL XR. ADDERALL XR (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, and amphetamine sulfate extended-release capsules) is also referred to as mixed salts of a single-entity amphetamine product extended-release capsules (MAS ER).

If switching from any other amphetamine products, discontinue that treatment, and titrate with ADZENYS ER using the titration schedule [see Dosage and Administration (2.3, 2.4)] .

Do not substitute for other amphetamine products on a milligram-per-milligram basis because of different amphetamine salt compositions and differing pharmacokinetic profiles [see Warnings and Precautions (5.8)] .

Dosage Modifications Due to Drug Interactions

Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine. Acidifying agents (e.g., ascorbic acid) decrease blood levels, while alkalinizing agents (e.g., sodium bicarbonate) increase blood levels. Adjust ADZENYS ER dosage accordingly [see Drug Interactions (7.1)] .