Drizalma Sprinkle Prescribing Information
- Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies.
Warnings and Precautions (5.4, 5.5) 08/2023
DRIZALMA SPRINKLE is indicated for the treatment of:
• Major Depressive Disorder in adults• Generalized Anxiety Disorder in adults and pediatric patients 7 years of age and older• Diabetic Peripheral Neuropathy in adults• Fibromyalgia in adults• Chronic Musculoskeletal Pain in adults
• Take DRIZALMA SPRINKLE with or without food (2.1)• DRIZALMA SPRINKLE may be: swallowed whole (do not crush or chew capsule); opened and sprinkled over applesauce; or administered via nasogastric tube (2.1)• Take a missed dose as soon as it is remembered. Do not take two doses of DRIZALMA SPRINKLE at the same time (2.1)
Indication | Starting Dose | Target Dose | Maximum Dose |
MDD (2.2) Adults | 40 mg/day to 60 mg/day | Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance Treatment: 60 mg/day | 120 mg/day |
GAD (2.3) | |||
Adults | 60 mg/day | 60 mg/day (once daily) | 120 mg/day |
Geriatric | 30 mg/day | 60 mg/day (once daily) | 120 mg/day |
Pediatrics (7 to 17 years of age) | 30 mg/day | 30 to 60 mg/day (once daily) | 120 mg/day |
DPNP (2.4) | 60 mg/day | 60 mg/day (once daily) | 60 mg/day |
FM (2.5) Adults | 30 mg/day | 60 mg/day (once daily) | 60 mg/day |
Chronic Musculoskeletal Pain (2.6) Adults | 30 mg/day | 60 mg/day (once daily) | 60 mg/day |
• There is no evidence that doses greater than 60 mg/day confers additional benefit, while some adverse reactions were observed to be dose-dependent (2)• Discontinuing DRIZALMA SPRINKLE: Gradually reduce dosage to avoid discontinuation symptoms (2.8, 5.7)
20 mg: hard gelatin capsules with green cap imprinted with “
30 mg: hard gelatin capsules with blue cap imprinted with “
40 mg: hard gelatin capsules with white cap imprinted with “
60 mg: hard gelatin capsules with blue cap imprinted with “
• Pregnancy: Third trimester use may increase risk for symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate (8.1)• Hepatic Impairment: Avoid use in patients with chronic liver disease or cirrhosis (5.14)• Renal Impairment: Avoid use in patients with severe renal impairment, GFR <30 mL/minute (5.14)