ncreased by 20 mg increments, at approximately weekly intervals. Elvanse Adult should be administered orally at the lowest effective dosage.
The maximum recommended dose is 70 mg/day; higher doses have not been studied. In patients with severe renal insufficiency (GFR 15 to <30 mL/min/1.73 m2 or CrCl <30 mL/min) the maximum dose should not exceed 50 mg/day. Further dosage reduction should be considered in patients undergoing dialysis (see section 5.2).
Treatment must be stopped if the symptoms do not improve after appropriate dosage adjustment over a 1 month period. If paradoxical aggravation of symptoms or other intolerable adverse events occur, the dosage should be reduced or discontinued.
Method of administration
Elvanse Adult may be taken with or without food.
Elvanse Adult may be swallowed whole, or the capsule opened and the entire contents emptied and mixed with a soft food such as yogurt or in a glass of water or orange juice. If the contents include any compacted powder, a spoon may be used to break apart the powder in the soft food or liquid. The contents should be stirred until completely dispersed. The patient should consume the entire mixture of soft food or liquid immediately; it should not be stored. The active ingredient dissolves completely once dispersed; however, a film containing the inactive ingredients may remain in the glass or container once the mixture is consumed.
The patient should not take anything less than one capsule per day and a single capsule should not be divided.
In the event of a missed dose, Elvanse Adult dosing can resume the next day. Afternoon doses should be avoided because of the potential for insomnia.
Pre-treatment eva luation
Prior to prescribing, it is necessary to conduct a baseline eva luation of a patient's cardiovascular status including blood pressure and heart rate. A comprehensive history should document concomitant medications, past and present co-morbid medical and psychiatric disorders or symptoms, family history of sudden cardiac/unexplained death, and accurate recording of pre treatment weight (see section 4.4).
Consistent with other stimulants, the potential for abuse, misuse or diversion of Elvanse Adult should be considered prior to prescribing (see section 4.4).
Ongoing monitoring
Psychiatric, and cardiovascular status should be continually monitored (see also section 4.4).
• Blood pressure and pulse should be recorded at each adjustment of dose and at least every six months.
• Development of de novo or worsening of pre-existing psychiatric disorders should be monitored at every adjustment of dose and then at least every six months and at every visit.
Patients should be monitored for the risk of diversion, misuse, and abuse of Elvanse Adult.
Long-term use
Pharmacological treatment of ADHD may be needed for extended periods. The physician who elects to use Elvanse Adult for extended periods (over 12 months) should re-eva luate the usefulness of Elvanse Adult at least yearly, and consider trial periods off medication to assess the patient's functioning without pharmacotherapy.
Older people
Dexamfetamine clearance is reduced in the elderly, therefore dose adjustment may be required (see section 5.2).
Patients with renal impairment
Due to reduced clearance in patients with severe renal insufficiency (GFR 15 to <30 mL/min/1.73 m2 or CrCl <30 mL/min) the maximum dose should not exceed 50 mg/day. Further dosage reduction should be considered in patie |
