Adzenys XR-ODT Disease Interactions

The use of amphetamines and amphetamine-like drugs is contraindicated in patients with advanced arteriosclerosis, symptomatic or unstable cardiac or cerebrovascular disease, moderate to severe hypertension, or hyperthyroidism. Like other sympathomimetic amines, amphetamines may cause cardiovascular adverse effects such as palpitation, tachycardia, cardiac arrhythmias, and elevation of blood pressure. Rarely, cardiomyopathy manifested as ventricular hypertrophy and/or congestive heart failure has been reported during chronic amphetamine use. In addition, sudden death has been reported in association with amphetamine therapy at usual dosages in children with structural cardiac abnormalities. In general, amphetamines should not be used in patients with structural cardiac abnormalities. If not otherwise contraindicated, therapy with amphetamines should be administered cautiously in patients with a current or past history of cardiovascular or cerebrovascular disease.

The use of amphetamines and amphetamine-like drugs is contraindicated in patients with narrow-angle glaucoma or anatomically narrow angles. Like other sympathomimetic amines, amphetamines can induce transient mydriasis. In patients with narrow angles, pupillary dilation can provoke an acute attack of angle-closure glaucoma. If possible, these agents should also be avoided in patients with other forms of glaucoma, since mydriasis may occasionally increase intraocular pressure.

The use of CNS stimulants is contraindicated in patients with marked agitation and/or anxiety since these symptoms may be aggravated. CNS stimulants may also exacerbate symptoms of behavior disturbance and thought disorder in psychotic patients, particularly children. Therapy with CNS stimulants should be administered cautiously in patients with a history of psychosis or a predisposition to agitated states.

The use of CNS stimulants is contraindicated in patients with significant cardiovascular impairment such as uncompensated heart failure, severe coronary disease, severe hypertension (including that associated with hyperthyroidism or pheochromocytoma), cardiac structural abnormalities, serious arrhythmias, etc. Sudden death has been reported in adults and children taking CNS stimulant treatment. Additionally, stroke, myocardial infarction, chest pain, syncope, arrhythmias, and other symptoms have been reported in adults under treatment. A careful assessment of the cardiovascular status should be done in patients being considered for treatment. This includes family history, physical exam, and further cardiac evaluation (EKG and echocardiogram). Patients who develop symptoms should have a detailed cardiac evaluation and if needed, treatment should be suspended.

The use of most CNS stimulants is contraindicated in patients with glaucoma, as these agents exhibit sympathomimetic activity and may induce mydriasis provoking an increase in intraocular pressure.

CNS stimulants have been shown to increase blood pressure, and their use might be contraindicated in patients with severe/uncontrolled hypertension. Caution should be used when administering to patients with preexisting high blood pressure and other cardiovascular conditions. All patients under treatment should be regularly monitored for changes in blood pressure and heart rate.

In general, CNS stimulants are extensively metabolized by the liver. Their plasma clearance may be decreased and their half-life prolonged in patients with impaired hepatic function. Therapy with CNS stimulants should be administered cautiously in patients with moderate to severe liver disease, and the dosage should be adjusted accordingly. Additionally, postmarketing reports have shown that atomoxetine can cause severe liver injury. Laboratory testing should be done at the first sign or symptom of liver dysfunction (jaundice, dark urine, upper quadrant tenderness) and treatment should be discontinued in patients with evidence of liver injury.

The use of CNS stimulants can cause psychotic or manic symptoms, suicidal ideation, and aggression, and can exacerbate symptoms of behavior disturbance and thought disorder. Psychiatric symptoms have been reported in patients with and without history of psychiatric disorders, and all patients should be monitored closely, especially during treatment initiation and at times of dose changes. Extreme caution should be exercised when CNS stimulants are given to patients with a history of psychosis, depression, mania, or bipolar disorder. All patients receiving treatment should be screened for bipolar disease prior to initiation. If any psychiatric symptoms emerge or are exacerbated, treatment suspension should be considered. CNS stimulants are contraindicated in patients with marked agitation or anxiety.

CNS stimulants (especially amphetamines) have significant potential for habituation and abuse. Tolerance, psychological dependence, and severe social dysfunction can develop after prolonged use. Frank psychotic episodes may also occur in association with chronic intoxication. Therapy with CNS stimulants should be administered cautiously, if at all, in patients with a history of alcohol or substance abuse. The use of amphetamines is considered by manufacturers to be contraindicated in such patients.

CNS stimulants have been reported to exacerbate Tourette's syndrome and other motor and phonic tics. Therapy with CNS stimulants, if necessary, should be administered cautiously in patients with tic disorders or family history of Tourette's syndrome. The manufacturers of the CNS stimulants, methylphenidate (racemic) and dexmethylphenidate (the more pharmacologically active d-enantiomer), consider their use to be contraindicated in such patients.

CNS stimulants may induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, and depression). Close monitoring is recommended when using these agents in patients with bipolar disorders.

CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a preexisting psychotic disorder. Close monitoring is recommended when using these agents in patients with psychotic disorders.

Overall CNS stimulants should be administered with caution in patients with significantly impaired renal function as the reduction in the rate of elimination may alter the therapeutic response. The dosage should be adjusted accordingly.

Due to general central nervous system stimulation, therapy with CNS stimulant drugs may cause seizures. These drugs may lower the convulsive threshold in patients with prior history of seizures or EEG abnormalities, and very rarely in patients with no previous history of seizures. Therapy with CNS stimulants should be used with caution in patients with or predisposed to seizures. If seizures appear, therapy should be discontinued.

Obese, type 2 diabetic patients who achieve weight loss may demonstrate improved metabolic control of their disease as a result of their reduced weight. Therefore, patients with type 2 diabetes mellitus should be monitored during weight-reduction therapy (or therapy that may be expected to induce significant weight loss as a secondary effect) for hypoglycemia and reduced need for oral hypoglycemic medication or insulin, and the dosages of these agents adjusted accordingly. Patients should be apprised of the risk of hypoglycemia and be alert to potential signs and symptoms such as headache, dizziness, drowsiness, nervousness, confusion, tremor, hunger, weakness, perspiration, and palpitation.