Sign Out
Advise the patient to read patient labeling (Medication Guide).
Abuse, Misuse, and Addiction: Educate patients and their families about the risks of abuse, misuse, and addiction of CONCERTA, which can lead to overdose and death, and proper disposal of any unused drug [see Precautions and Overdosage]. Advise patients to store CONCERTA in a safe place, preferably locked, and instruct patients to not give CONCERTA to anyone else.
Risks to Patients with Serious Cardiac Disease: Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with CONCERTA use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Precautions].
Increased Blood Pressure and Heart Rate: Advise patients that CONCERTA can cause elevations in blood pressure and heart rate [see Precautions].
Psychiatric Risks: Advise patients that CONCERTA, at recommended doses, can cause psychotic or manic symptoms, even in patients without a prior history of psychotic symptoms or mania [see Precautions].
Priapism: Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism [see Precautions].
Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, including Raynaud's Phenomenon]: Instruct patients beginning treatment with CONCERTA about the risk of peripheral vasculopathy, including Raynaud's phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.
Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.
Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking CONCERTA.
Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.
Suppression of Growth: Advise patients, caregivers, and family members that CONCERTA may cause slowing of growth and weight loss [see Precautions].
Increased Intraocular Pressure (IOP) and Glaucoma: Advise patients that IOP and glaucoma may occur during treatment with CONCERTA [see Precautions].
Motor and Verbal Tics, and Worsening of Tourette's Syndrome: Advise patients that motor and verbal tics and worsening of Tourette's Syndrome may occur during treatment with CONCERTA. Instruct patients to notify their healthcare provider if emergence of new tics or worsening of tics or Tourette's syndrome occurs [see Precautions].
Administration Instructions: Patients should be informed that CONCERTA should be swallowed whole with the aid of liquids. Tablets should not be chewed, divided, or crushed. The medication is contained within a nonabsorbable shell designed to release the drug at a controlled rate. The tablet shell, along with insoluble core components, is eliminated from the body; patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.
