Duloxetine Delayed-Release

Duloxetine delayed-release capsules 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 neuropathic pain in adults Fibromyalgia in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: Major depressive disorder (MDD) in adults ( 1 ) Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older ( 1 ) Diabetic peripheral neuropathic pain (DPNP) in …

• Take Duloxetine delayed-release capsules once daily, with or without food
• Swallow whole; do not crush, chew, or open capsule Indication Starting Dose Target Dose Maximum Dose MDD 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
• 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 60 mg/day 60 mg/day (once daily) 60 mg/day FM
• Adults and Pediatrics (13 to 17 years of age) 30 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoskeletal Pain 30 mg/day 60 mg/day (once daily) 60 mg/day Discontinuing Duloxetine delayed-release capsules: Gradually reduce dosage to avoid discontinuation symptoms Important Administration Instructions Administer Duloxetine delayed-release capsules orally (with or without meals) and swallow whole
• Do not chew or crush, and do not open the delayed-release capsule and sprinkle its contents on food or mix with liquids because these actions might affect the enteric coating
• If a dose of Duloxetine delayed-release capsules is missed, take the missed dose as soon as it is remembered
• If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time
• Do not take two doses of Duloxetine delayed-release capsules at the same time. …

Duloxetine delayed-release capsules, USP are available as: 20 mg opaque ochre capsules imprinted with "B" on the cap and "746" on the body 30 mg opaque green (cap) /opaque white (body) capsules imprinted with "B" on the cap and "747" on the body. 40 mg opaque blue (cap) /opaque orange (body) capsules imprinted with "B" on the cap and "750" on the body. …

• The safety and effectiveness of Duloxetine delayed-release capsules have been established for treatment of generalized anxiety disorder (GAD) in patients 7 to 17 years of age and for treatment of juvenile fibromyalgia syndrome in patients 13 to 17 years of age
• The safety and effectiveness of Duloxetine delayed-release capsules have not been established
• In pediatric patients with major depressive disorder (MDD), diabetic peripheral neuropathic pain, or chronic musculoskeletal pain
• Antidepressants increased the risk of suicidal thoughts and behavior
• In pediatric patients. …

Geriatric Exposure in Premarketing Clinical Trials of Duloxetine delayed-release capsules Of the 2,418 patients in MDD trials, 6% (143) were 65 years of age or over. Of the 1,041 patients in CLBP trials, 21% (221) were 65 years of age or over. Of the 487 patients in OA trials, 41% (197) were 65 years of age or over. Of the 1,074 patients in the DPNP trials, 33% (357) were 65 years of age or over. …

• 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 Boxed Warning and Warnings and Precautions ]
• Administration — Advise patients to swallow Duloxetine delayed-release capsules whole and to not chew, crush, or open the capsule (do not sprinkle contents on food or mixed with liquids) because these actions might affect the enteric coating. …

• The use of MAOIs intended to treat psychiatric disorders with Duloxetine delayed-release capsules or within 5 days of stopping treatment with Duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome
• The use of Duloxetine delayed-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is contraindicated [see Dosage and Administration and Warnings and Precautions ]. …

Both CYP1A2 and CYP2D6 are responsible for duloxetine metabolism. Potent inhibitors of CYP1A2 should be avoided ( 7.1 ) Potent inhibitors of CYP2D6 may increase Duloxetine delayed-release capsules concentrations ( 7.2 ) Duloxetine delayed-release capsules is a moderate inhibitor of CYP2D6 ( 7.9 ) 7.1 Inhibitors of CYP1A2 When duloxetine 60 mg was co-administered with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to male subjects (n=14) duloxetine AUC was increased approximately 6-fold, the C max was increased about 2.5-fold, and duloxetine t 1/2 was increased approximately 3-fold. …

Hepatotoxicity : Hepatic failure, sometimes fatal, has been reported. Discontinue Duloxetine delayed-release capsules 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 ( 5.2 ) Orthostatic Hypotension, Falls and Syncope : Consider dosage reduction or discontinuation if these events occur ( 5.3 ) Serotonin Syndrome : Increased risk when co-administered with other serotonergic agents, but also when taken alone. …

The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Orthostatic Hypotension, Falls and Syncope [see Warnings and Precautions (5.3) ] Serotonin Syndrome [see Warnings and Precautions (5.4) ] Increased Risk of Bleeding [see Warnings and Precautions (5.5) ] Severe Skin Reactions [see Warnings and Precautions (5.6) ] Discontinuation Syndrome [see Warnings and Precautions (5.7) ] Activation of Mania/Hypomania [see Warnings and Precautions (5.8) ] Angle-Closure Glaucoma [see War …

8.1 Pregnancy Risk Summary Data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage. Data from published literature and from a postmarketing retrospective cohort study have not identified a clear drug-associated risk of major birth defects or other adverse developmental outcomes (see Data ) . …

10.1 Signs and Symptoms In postmarketing experience, fatal outcomes have been reported for acute duloxetine overdoses, primarily with mixed overdoses, but also with duloxetine only, including 1000 mg of duloxetine (approximately 8.3 times the maximum recommended dosage). Signs and symptoms of overdose (duloxetine alone or with mixed drugs) included somnolence, coma, serotonin syndrome, seizures, syncope, tachycardia, hypotension, hypertension, and vomiting. …

9.2 Abuse In animal studies, duloxetine did not demonstrate barbiturate-like (depressant) abuse potential. While Duloxetine delayed-release capsules have not been systematically studied in humans for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials. However, it is not possible to predict on the basis of premarketing experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. …

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.