Posology : מינונים

5 DOSAGE AND ADMINISTRATION

5.1 Important Information Prior to Initiating Treatment
Prior to initiating treatment with Attent XR capsules, assess for the presence of cardiac disease (e.g., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (7)].

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 for abuse and overdose, and Attent XR 5, 10, 15, 20, 25, 30 mg RC New SmpC 11.2022
periodically re-evaluate the need for Attent XR use [see Warnings and Precautions (7), Drug Abuse and Dependence (11)].

5.2 Dosing Considerations for All Patients
Individualize the dosage according to the therapeutic needs and response of the patient. Administer Attent XR capsules at the lowest effective dosage.

Based on bioequivalence data, patients taking divided doses of MAS IR, (for example, twice daily), may be switched to MAS ER capsules at the same total daily dose taken once daily. Titrate at weekly intervals to appropriate efficacy and tolerability as indicated.

Attent XR may be taken whole, or the capsule may be opened and the entire contents sprinkled on applesauce.
If the patient is using the sprinkle administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing. The dose of a single capsule should not be divided. The contents of the entire capsule should be taken, and patients should not take anything less than one capsule per day.

Attent XR may be taken with or without food.

Attent XR should be given upon awakening. Afternoon doses should be avoided because of the potential for insomnia.

Where possible, Attent XR therapy should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

5.3 Children
In children with ADHD who are 6 to 12 years of age and are either starting treatment for the first time or switching from another medication, start with 10 mg once daily in the morning; daily dosage may be adjusted in increments of 5 mg or 10 mg at weekly intervals. When in the judgment of the clinician a lower initial dose is appropriate, patients may begin treatment with 5 mg once daily in the morning. The maximum recommended dose for children 6 to 12 years of age is 30 mg/day; doses greater than 30 mg/day have not been studied in children. MAS ER capsules have not been studied in children under 6 years of age.

5.4 Adolescents
The recommended starting dose for adolescents with ADHD who are 13 to 17 years of age and are either starting treatment for the first time or switching from another medication is 10 mg/day. The dose may be increased to 20 mg/day after one week if ADHD symptoms are not adequately controlled.

5.5 Adults
In adults with ADHD who are either starting treatment for the first time or switching from another medication, the recommended dose is 20 mg/day.

5.6 Dosage in Patients with Renal Impairment
In adult patients with severe renal impairment (GFR 15 to < 30 mL/min/1.73m2), the recommended dose is 15 mg once daily in the morning. In pediatric patients (6 to 17 years of age) with severe renal impairment, the recommended dose is 5 mg once daily. The maximum dose for children 6 to 12 years of age with severe renal impairment is 20 mg once daily. Attent XR capsules are not recommended in patients with end stage renal disease (ESRD) (GFR < 15 mL/min/1.73m2) [see Use in Specific Populations (10), Clinical Pharmacology (13)].