Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Suicidal Thoughts and Behaviors: Advise patients, their families, and their caregivers to look for the emergence of suicidal ideation and behavior, especially during treatment and when the dose is adjusted up or down and instruct them to report such symptoms to their healthcare provider [see Warnings and Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults under Precautions].
CYMBALTA should be swallowed whole and should not be chewed or crushed, nor should the capsule be opened and its contents be sprinkled on food or mixed with liquids. All of these might affect the enteric coating.
Hepatotoxicity: Inform patients that severe liver problems, sometimes fatal, have been reported in patients treated with CYMBALTA. Instruct patients to talk to their healthcare provider if they develop itching, right upper belly pain, dark urine, or yellow skin/eyes while taking CYMBALTA, which may be signs of liver problems. Instruct patients to talk to their healthcare provider about their alcohol consumption. Use of CYMBALTA with heavy alcohol intake may be associated with severe liver injury [see Hepatotoxicity under Precautions].
Alcohol: Although CYMBALTA does not increase the impairment of mental and motor skills caused by alcohol, use of CYMBALTA concomitantly with heavy alcohol intake may be associated with severe liver injury. For this reason, CYMBALTA should not be prescribed for patients with substantial alcohol use [see Hepatotoxicity under Precautions and Alcohol under Interactions].
Orthostatic Hypotension, Falls and Syncope: Advise patients of the risk of orthostatic hypotension, falls and syncope, especially during the period of initial use and subsequent dose escalation, and in association with the use of concomitant drugs that might potentiate the orthostatic effect of CYMBALTA [see Orthostatic Hypotension, Falls and Syncope under Precautions].
Serotonin Syndrome: Caution patients about the risk of serotonin syndrome with the concomitant use of CYMBALTA and other serotonergic agents including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, amphetamines, and St. John's Wort [see Contraindications, Serotonin Syndrome under Precautions, and Serotonergic Drugs under Interactions].
Advise patients of the signs and symptoms associated with serotonin syndrome that may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Caution patients to seek medical care immediately if they experience these symptoms.
Abnormal Bleeding: Caution patients about the concomitant use of CYMBALTA and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [see Increased Risk of Bleeding under Precautions].
Severe Skin Reactions: Caution patients that CYMBALTA may cause serious skin reactions. This may need to be treated in a hospital and may be life-threatening. Counsel patients to call their doctor right away or get emergency help if they have skin blisters, peeling rash, sores in their mouth, hives, or any other allergic reactions [see Severe Skin Reactions under Precautions].
Discontinuation of Treatment: Instruct patients that discontinuation of CYMBALTA may be associated with symptoms such as dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue, and should be advised not to alter their dosing regimen, or stop taking CYMBALTA without consulting their physician [see Discontinuation of Treatment with CYMBALTA under Precautions].
Activation of Mania or Hypomania: Adequately screen patients with depressive symptoms for risk of bipolar disorder (e.g. family history of suicide, bipolar disorder, and depression) prior to initiating treatment with CYMBALTA. Advise patients to report any signs or symptoms of a manic reaction such as greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, talking more or faster than usual, unusually grand ideas, and excessive happiness or irritability [see Activation of Mania/Hypomania under Precautions].
Angle-Closure Glaucoma: Advise patients that taking CYMBALTA can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Angle-Closure Glaucoma under Precautions].
Seizures: Advise patients to inform their physician if they have a history of seizure disorder [see Seizures under Precautions].
Effects on Blood Pressure: Caution patients that CYMBALTA may cause an increase in blood pressure [see Effect on Blood Pressure under Precautions].
Concomitant Medications: Advise patients to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter medications, since there is a potential for interactions [see Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders and Use of CYMBALTA with Other MAOIs such as Linezolid or Methylene Blue under Dosage & Administration, Contraindications, Serotonin Syndrome and Clinically Important Drug Interactions under Precautions, and Interactions].
Hyponatremia: Advise patients that hyponatremia has been reported as a result of treatment with SNRIs and SSRIs, including CYMBALTA. Advise patients of the signs and symptoms of hyponatremia [see Hyponatremia under Precautions].
Concomitant Illnesses: Advise patients to inform their physicians about all of their medical conditions [see Use in Patients with Concomitant Illness under Precautions].
CYMBALTA is in a class of medicines that may affect urination. Instruct patients to consult with their healthcare provider if they develop any problems with urine flow [see Urinary Hesitation and Retention under Precautions].
Pregnancy: Advise pregnant women to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with CYMBALTA.
Advise patients that CYMBALTA use during the month before delivery may lead to an increased risk for postpartum hemorrhage and may increase the risk of neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding.
Advise pregnant women that there is a risk of relapse with discontinuation of antidepressants.
Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to duloxetine during pregnancy [see Use in Pregnancy & Lactation].
Lactation: Advise breastfeeding women using CYMBALTA to monitor infants for sedation, poor feeding and poor weight gain and to seek medical care if they notice these signs [see Use in Pregnancy & Lactation].
Interference with Psychomotor Performance: Any psychoactive drug may impair judgment, thinking, or motor skills. Although in controlled studies CYMBALTA has not been shown to impair psychomotor performance, cognitive function, or memory, it may be associated with sedation and dizziness. Therefore, caution patients about operating hazardous machinery including automobiles, until they are reasonably certain that CYMBALTA therapy does not affect their ability to engage in such activities.