LYRICA- pregabalin capsule
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17 PATIENT COUNSELING INFORMATION
See the FDA-approved Medication Guide.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking PROZAC as monotherapy or in combination with olanzapine. When using PROZAC and olanzapine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax.
17.1 General Information
Healthcare providers should instruct their patients to read the Medication Guide before starting therapy with fluoxetine capsules and to reread it each time the prescription is renewed.
Healthcare providers should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with fluoxetine capsules and should counsel them in its appropriate use. Healthcare providers should instruct patients, their families, and their caregivers to read 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.
Patients should be advised of the following issues and asked to alert their healthcare provider if these occur while taking PROZAC.
When using PROZAC and olanzapine in combination, also refer to the Medication Guide for Symbyax.
17.2 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 a need for very close monitoring and possibly changes in the medication [see Box Warning and Warnings and Precautions ( 5.1)].
17.3 Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-Like Reactions
Patients should be cautioned about the risk of serotonin syndrome or NMS-like reactions with the concomitant use of fluoxetine and triptans, tramadol, or other serotonergic agents [see Warnings and Precautions ( 5.2) and Drug Interactions ( 7.3)].
Patients should be advised of the signs and symptoms associated with serotonin syndrome or NMS-like reactions that may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form can resemble neuroleptic malignant syndrome, in which the symptoms may include hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be cautioned to seek medical care immediately if they experience these symptoms.
17.4 Allergic Reactions and Rash
Patients should be advised to notify their physician if they develop a rash or hives [see Warnings and Precautions ( 5.3)]. Patients should also be advised of the signs and symptoms associated with a severe allergic reaction, including swelling of the face, eyes, or mouth, or have trouble breathing. Patients should be cautioned to seek medical care immediately if they experience these symptoms.
17.5 Abnormal Bleeding
Patients should be cautioned about the concomitant use of fluoxetine and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents have been associated with an increased risk of bleeding [see Warnings and Precautions ( 5.7) and Drug Interactions ( 7.6)]. Patients should be advised to call their doctor if they experience any increased or unusual bruising or bleeding while taking PROZAC.
17.6 Hyponatremia
Patients should be advised that hyponatremia has been reported as a result of treatment with SNRIs and SSRIs, including PROZAC. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to falls. More severe and/or acute cases have been associated with hallucination, syncope, seizure, coma, respiratory arrest, and death [see Warnings and Precautions ( 5.8)].
17.7 Potential for Cognitive and Motor Impairment
PROZAC may impair judgment, thinking, or motor skills. Patients should be advised to avoid driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected [see Warnings and Precautions ( 5.11)].
17.8 Use of Concomitant Medications
Patients should be advised to inform their physician if they are taking, or plan to take, any prescription medication, including Symbyax®, Sarafem®, or over-the-counter drugs, including herbal supplements or alcohol. Patients should also be advised to inform their physicians if they plan to discontinue any medications they are taking while on PROZAC.
17.9 Discontinuation of Treatment
Patients should be advised to take PROZAC exactly as prescribed, and to continue taking fluoxetine as prescribed even after their symptoms improve. Patients should be advised that they should not alter their dosing regimen, or stop taking PROZAC without consulting their physician [see Warnings and Precautions ( 5.13)]. Patients should be advised to consult with their healthcare provider if their symptoms do not improve with PROZAC.
17.10 Use in Specific Populations
Pregnancy — Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy. Fluoxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations ( 8.1)].
Nursing Mothers — Patients should be advised to notify their physician if they intend to breast-feed an infant during therapy. Because PROZAC is excreted in human milk, nursing while taking fluoxetine is not recommended [see Use in Specific Populations ( 8.3)].
Pediatric Use — PROZAC is approved for use in pediatric patients with MDD and OCD [see Box Warning and Warnings and Precautions ( 5.1)]. Limited evidence is available concerning the longer-term effects of fluoxetine on the development and maturation of children and adolescent patients. Height and weight should be monitored periodically in pediatric patients receiving fluoxetine.Safety and effectiveness of PROZAC and olanzapine in combination in patients less than 18 years of age have not been established [see Warnings and Precautions ( 5.6) and Use in Specific Populations ( 8.4)].
Literature revised October 29, 2009
Eli Lilly and Company, Indianapolis, IN 46285, USA
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