).
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with LUVOX CR Capsules and should counsel them in the appropriate use. A patient Medication Guide discussing antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions and other important information about LUVOX CR Capsules is available for LUVOX CR Capsules. The prescriber or health professional should instruct patients, their families, and their caregivers to read both sections of the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking LUVOX CR Capsules.
17.1 Clinical Worsening and Suicide Risk Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate the need for very close monitoring and possibly changes in the medication (see BOXED WARNING and WARNINGS AND PRECAUTIONS [5.1]).
17.2 Contraindicated Medications Patients should be advised that the following medications should not be used while taking LUVOX CR Capsules:
• Monoamine oxidase inhibitors (MAOIs): See CONTRAINDICATIONS (4.1) and WARNINGS AND PRECAUTIONS (5.2).
• Thioridazine: See CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.4).
• Tizanidine: See CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.5).
• Pimozide: See CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.6).
• Alosetron: See CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.7).
• Ramelteon: See CONTRAINDICATIONS (4) and WARNINGS AND PRECAUTIONS (5.8).
In addition, MAOIs should not be taken within 14 days (2 weeks) after stopping LUVOX CR Capsules, and LUVOX CR Capsules should not be taken within two weeks after stopping treatment with an MAOI (see CONTRAINDICATIONS [4.1] and WARNINGS AND PRECAUTIONS [5.2]).
17.3 Other Potentially Hazardous Drug Interactions Patients should be advised that the use of LUVOX CR Capsules with any of the following medications may produce clinically significant adverse reactions. Patients should inform their physician if they are taking any of these medications before starting treatment with LUVOX CR Capsules. Patients should also inform their physici |
