Drizalma Sprinkle (Duloxetine)

Drizalma SprinkleTM (duloxetine) delayed-release capsules are indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients aged 7 to 17 years Diabetic Peripheral Neuropathic Pain (DPNP) in adults Chronic musculoskeletal pain in adults Fibromyalgia (FM) in adults

Cautions

WARNINGS AND PRECAUTIONS Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported. Discontinue Drizalma Sprinkle™ in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Avoid use in patients with substantial alcohol use or evidence of chronic liver disease. Orthostatic Hypotension, Falls, and Syncope: Consider dosage reduction or discontinuation if these events occur. Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRIs, SNRIs, triptans), but also when taken alone. If it occurs, discontinue Drizalma SprinkleTM and initiate supportive treatment. Increased Risk of Bleeding: May increase the risk of bleeding events. Concomitant use of antiplatelet drugs and anticoagulants may increase this risk. Severe Skin Reactions: Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome, can occur with duloxetine. Discontinue at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified. Discontinuation Syndrome: Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias, such as electric shock sensations), tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible. Activation of Mania or Hypomania: In patients with bipolar disorder, treating a depressive episode with duloxetine or another antidepressant may precipitate a mixed/manic episode. Use cautiously in patients with bipolar disorder. Prior to initiating treatment with Drizalma SprinkleTM, screen patients for any personal or family history of bipolar disorder, mania, or hypomania. Angle-Closure Glaucoma: Has occurred in patients with untreated, anatomically narrow angles treated with antidepressants. Seizures: Drizalma SprinkleTM should be prescribed with care in patients with a history of seizure disorder. Blood Pressure Increase: Monitor blood pressure prior to initiating treatment and periodically throughout treatment. Hyponatremia: Can occur in association with SIADH; consider discontinuation. Glucose Control in Diabetes: In diabetic peripheral neuropathic pain patients, increases in fasting blood glucose and HbA1c have been observed. Condition that Slow Gastric Emptying: Use cautiously in these patients. Sexual Dysfunction: Drizalma SprinkleTM may cause symptoms of sexual dysfunction.

Side Effects

The most common adverse reactions (=5% and at least twice the incidence of placebo treated patients) were: Adults: nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis. Pediatric Patients: nausea, diarrhea, decreased weight.