Drug Interactions between modafinil and naldemedine

Grapefruit juice can increase the blood levels of naldemedine. This may increase side effects and withdrawal symptoms such as sweating, tearing, runny nose, chills, diarrhea, abdominal pain, anxiety, insomnia, irritability, restlessness, and yawning. You should limit the consumption of grapefruit and grapefruit juice during treatment with naldemedine. Talk to your doctor or pharmacist if you have questions on how to take this or other medications you are prescribed. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Information for this minor interaction is available on the professional version.

The use of CNS stimulants can cause psychotic symptoms, suicidal ideation, and aggression, and can exacerbate symptoms of behavior disturbance and thought disorder; CNS stimulants may induce a manic or mixed episode in patients with bipolar disorder. Psychiatric symptoms have been reported in patients with and without history of psychiatric disorders. All patients (particularly those with psychotic or bipolar disorders) 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. Prior to initiating therapy, all patients should be screened for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or family history of suicide, bipolar disease, or depression). If any psychiatric symptoms emerge or are exacerbated, treatment suspension should be considered. Some CNS stimulants are contraindicated in patients with marked agitation or anxiety.

Peripheral opioid receptor antagonists are contraindicated in patients with known or suspected gastrointestinal obstruction, and in patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation. Cases of gastrointestinal perforation have been reported in patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structure integrity in the wall of the GI tract such as peptic ulcer, diverticular disease, Crohn's disease, infiltrative GI tract malignancies or peritoneal metastases. It is recommended to monitor for the development of severe, persistent, or worsening abdominal pain and to discontinue treatment in patients who develop symptoms. The overall risk- benefit profile should be carefully evaluated before using these agents in patients with these conditions.

Peripheral opioid receptor antagonists are contraindicated in patients with known or suspected gastrointestinal obstruction, and in patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation. Cases of gastrointestinal perforation have been reported in patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structure integrity in the wall of the GI tract such as peptic ulcer, diverticular disease, Crohn's disease, infiltrative GI tract malignancies or peritoneal metastases. It is recommended to monitor for the development of severe, persistent, or worsening abdominal pain and to discontinue treatment in patients who develop symptoms. The overall risk- benefit profile should be carefully evaluated before using these agents in patients with these conditions.

CNS stimulants increase blood pressure and heart rate; the use of some agents may be contraindicated in patients with severe/uncontrolled hypertension. Caution should be used when administering to patients with preexisting high blood pressure (even mild hypertension) and other cardiovascular conditions. All patients under treatment should be regularly monitored for potential tachycardia and hypertension.

Peripheral opioid receptor antagonists are contraindicated in patients with known or suspected gastrointestinal obstruction, and in patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation. Cases of gastrointestinal perforation have been reported in patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structure integrity in the wall of the GI tract such as peptic ulcer, diverticular disease, Crohn's disease, infiltrative GI tract malignancies or peritoneal metastases. It is recommended to monitor for the development of severe, persistent, or worsening abdominal pain and to discontinue treatment in patients who develop symptoms. The overall risk- benefit profile should be carefully evaluated before using these agents in patients with these conditions.

The use of naldemedine should be avoided in patients with severe hepatic impairment. No dose adjustment is required in patients with mild or moderate hepatic impairment.

Peripheral opioid receptor antagonists are contraindicated in patients with known or suspected gastrointestinal obstruction, and in patients at increased risk of recurrent obstruction, due to the potential for gastrointestinal perforation. Cases of gastrointestinal perforation have been reported in patients with opioid-induced constipation and advanced illness with conditions that may be associated with localized or diffuse reduction of structure integrity in the wall of the GI tract such as peptic ulcer, diverticular disease, Crohn's disease, infiltrative GI tract malignancies or peritoneal metastases. It is recommended to monitor for the development of severe, persistent, or worsening abdominal pain and to discontinue treatment in patients who develop symptoms. The overall risk- benefit profile should be carefully evaluated before using these agents in patients with these conditions.

The use of CNS stimulants can cause psychotic symptoms, suicidal ideation, and aggression, and can exacerbate symptoms of behavior disturbance and thought disorder; CNS stimulants may induce a manic or mixed episode in patients with bipolar disorder. Psychiatric symptoms have been reported in patients with and without history of psychiatric disorders. All patients (particularly those with psychotic or bipolar disorders) 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. Prior to initiating therapy, all patients should be screened for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or family history of suicide, bipolar disease, or depression). If any psychiatric symptoms emerge or are exacerbated, treatment suspension should be considered. Some CNS stimulants are contraindicated in patients with marked agitation or anxiety.

Patients with a history of drug and/or stimulant abuse should be closely followed during treatment with modafinil. Observe patients for signs of misuse and abuse. Clinical studies indicate modafinil produces psychoactive and euphoric effects/feelings consistent with other CNS stimulants.

Modafinil is not recommended for use in patients with a history of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use. Increased monitoring of heart rate and blood pressure is recommended in patients taking modafinil. Caution is advised in patients with known cardiovascular disease and increased monitoring is recommended in patients with a recent history of myocardial infarction or unstable angina.

Modafinil is not recommended for use in patients with a history of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use. Increased monitoring of heart rate and blood pressure is recommended in patients taking modafinil. Caution is advised in patients with known cardiovascular disease and increased monitoring is recommended in patients with a recent history of myocardial infarction or unstable angina.

Modafinil is not recommended for use in patients with a history of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use. Increased monitoring of heart rate and blood pressure is recommended in patients taking modafinil. Caution is advised in patients with known cardiovascular disease and increased monitoring is recommended in patients with a recent history of myocardial infarction or unstable angina.

Patients with a history of drug and/or stimulant abuse should be closely followed during treatment with modafinil. Observe patients for signs of misuse and abuse. Clinical studies indicate modafinil produces psychoactive and euphoric effects/feelings consistent with other CNS stimulants.

Modafinil is not recommended for use in patients with a history of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use. Increased monitoring of heart rate and blood pressure is recommended in patients taking modafinil. Caution is advised in patients with known cardiovascular disease and increased monitoring is recommended in patients with a recent history of myocardial infarction or unstable angina.

Naldemedine is not removed from the blood by hemodialysis. Plasma concentrations of naldemedine in subjects with ESRD requiring hemodialysis were similar when the drug was administered either pre- or post-hemodialysis.

Modafinil is not recommended for use in patients with a history of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use. Increased monitoring of heart rate and blood pressure is recommended in patients taking modafinil. Caution is advised in patients with known cardiovascular disease and increased monitoring is recommended in patients with a recent history of myocardial infarction or unstable angina.

Modafinil is not recommended for use in patients with a history of left ventricular hypertrophy or ischemic ECG changes, chest pain, arrhythmia or other clinically significant manifestations of mitral valve prolapse in association with central nervous system stimulant use. Increased monitoring of heart rate and blood pressure is recommended in patients taking modafinil. Caution is advised in patients with known cardiovascular disease and increased monitoring is recommended in patients with a recent history of myocardial infarction or unstable angina.

Exposure to modafinil is increased in patients with liver dysfunction. In patients with severe liver dysfunction, reduce the dose of modafinil to one-half the dose recommended dose.