WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
– Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.
– Monitor for worsening and emergence of suicidal thoughts and behaviors.
Duloxetine delayed release 30mg (Duloxetine delayed-release (DR) capsules USP ) are a prescription medication used to treat or manage:
– Major Depressive Disorder
– Generalized Anxiety Disorder
– Diabetic Peripheral Neuropathic Pain
– Chronic Musculoskeletal Pain
SELECT IMPORTANT SAFETY INFORMATION
Patients should NOT take Duloxetine if:
– They are currently on or have stopped treatment with a monoamine oxidase inhibitor (MAOI) within the last 14 days. Patients should not be treated with an MAOI within 5 days of stopping treatment with duloxetine, as this could cause serious or life-threatening side effects
– They are currently being treated with linezolid or intravenous methylene blue
– They are currently being treated with inhibitors of CYP1A2 or thioridazine.
SELECT ADDITIONAL WARNINGS & PRECAUTIONS:
Avoid use in patients with chronic liver disease or cirrhosis as hepatic failure, sometimes fatal, has been reported in patients treated with duloxetine. Duloxetine should be discontinued in patients who develop right, upper abdominal pain, jaundice or other evidence of clinically significant liver dysfunction. Duloxetine should be avoided in patients with severe renal impairment, and should not be prescribed to patients with substantial alcohol use.
Cases of orthostatic hypotension, falls and syncope have been reported with duloxetine therapy.
Serotonin Syndrome has been reported with SSRIs and SNRIs, including with duloxetine, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St. John’s Wort). Patients should be monitored for the emergence of Serotonin Syndrome and if symptoms occur, discontinue duloxetine and initiate supportive treatment.
Duloxetine delayed release 30mg may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding associated with the concomitant use of duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation.
Severe skin reactions can occur with duloxetine. Duloxetine delayed release 30mg should be discontinued at the first appearance of blisters, peeling rash, mucosal erosions or any other sign of hypersensitivity if no other etiology can be identified.
Discontinuation of Duloxetine delayed release 30mg may result in symptoms, including dizziness, headache, nausea, diarrhea, parasthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue.
Activation of mania or hypomania has occurred in patients treated with duloxetine.
Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with anti-depressants.
Duloxetine should be prescribed with care in patients with a history of seizure disorder, and blood pressure should be monitored prior to initiating treatment and periodically throughout treatment.
Cases of hyponatremia have been reported in patients treated with duloxetine.
Duloxetine may worsen glucose control in diabetes. In diabetic peripheral neuropathic pain patients, small increases in fasting blood glucose, and HbA have been observed.
The most common adverse reactions include: dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis.
Duloxetine may cause fetal harm, so talk to your patients if they are or plan to become pregnant. Caution should be exercised when duloxetine is administered to nursing mothers.