Select therapeutic use:

Anxiety/OCD:

Indications for: DRIZALMA SPRINKLE

Generalized anxiety disorder (GAD).

Adult Dosage:

Swallow whole. If unable to swallow caps, can open and sprinkle contents onto applesauce; consume immediately. May be given via NG tube. Initially 60mg once daily (may start at 30mg once daily for 1 week then increase to 60mg once daily); usual target 60mg/day (doses up to 120mg/day have been given; if needed, may increase by increments of 30mg/day). Elderly: Initially 30mg once daily for 2 weeks then increase to 60mg once daily; if needed, may increase by increments of 30mg/day; max 120mg/day.

Children Dosage:

<7yrs: not established. Swallow whole. If unable to swallow caps, can open and sprinkle contents onto applesauce; consume immediately. May be given via NG tube. 7–17yrs: Initially 30mg once daily for 2 weeks then increase to 60mg once daily; usual target 30–60mg/day; if needed, may increase by increments of 30mg/day; max 120mg/day.

DRIZALMA SPRINKLE Contraindications:

During or within 14 days of MAOIs. Concomitant MAOIs within 5 days of discontinuing duloxetine. Concomitant linezolid or IV methylene blue; see full labeling.

Boxed Warning:

Suicidal thoughts and behaviors.

DRIZALMA SPRINKLE Warnings/Precautions:

Increased risk of suicidal thoughts and behavior in children, adolescents and young adults; monitor for clinical worsening and unusual changes. Screen for bipolar disorder, mania, or hypomania. Monitor for emergence of serotonin syndrome; discontinue if occurs. Consider dose reduction or discontinuation if orthostatic hypotension, falls and/or syncope occur. Discontinue at 1st sign of blisters, peeling rash, or mucosal erosions. Monitor BP prior to and during therapy. History of seizure disorders, drug abuse. Angle-closure glaucoma. Decreased GI motility. Cardiac disease. Diabetes. Monitor weight and growth in children. Severe renal impairment (GFR <30mL/min), end stage renal disease, hepatic insufficiency, evidence of chronic liver disease, or substantial alcohol use: not recommended. Avoid abrupt cessation. Reevaluate periodically. Elderly. Pregnancy (esp. 3rd trimester). Neonates. Labor & delivery: increased risk of postpartum hemorrhage. Nursing mothers: monitor infants.

DRIZALMA SPRINKLE Classification:

SNRI.

DRIZALMA SPRINKLE Interactions:

See Contraindications. Concomitant thioridazine (may cause arrhythmias): not recommended. Increased risk of serotonin syndrome with other serotonergic drugs (eg, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Potentiated by potent CYP1A2 inhibitors (eg, cimetidine, fluvoxamine, quinolones, enoxacin): avoid. May potentiate or be potentiated by CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) or substrates (eg, tricyclics, phenothiazines, type 1C antiarrhythmics) or other highly protein-bound drugs. Caution with CYP1A2 substrates (eg, theophylline, caffeine), antihypertensives, CNS-acting drugs, other drugs that induce orthostatic hypotension or raise gastric pH (eg, PPIs, famotidine). Increased risk of bleeding with aspirin, NSAIDs, warfarin, or others that affect coagulation; monitor.

Adverse Reactions:

Nausea, dry mouth, somnolence, fatigue, insomnia, constipation, dizziness, diarrhea, decreased appetite, hyperhidrosis, abdominal pain; mania/hypomania, urinary hesitation/retention, increased BP, orthostatic hypotension, hyponatremia, hepatotoxicity (eg, elevated liver transaminases, cholestatic jaundice), sexual dysfunction; rare: seizures, serious skin reactions (eg, erythema multiforme, Stevens-Johnson Syndrome).

Metabolism:

Hepatic (CYP1A2, CYP2D6).

Drug Elimination:

Renal (70%), fecal (20%). Half-life: 12.4 hours (range: 7.8–22.2 hour).

Generic Drug Availability:

NO

How Supplied:

Caps—30, 60, 90, 1000

Fibromyalgia:

Indications for: DRIZALMA SPRINKLE

Fibromyalgia.

Adult Dosage:

Swallow whole. If unable to swallow caps, can open and sprinkle contents onto applesauce; consume immediately. May be given via NG tube. Initially 30mg once daily for 1 week, then increase to 60mg once daily.

Children Dosage:

<13yrs: not established.

DRIZALMA SPRINKLE Contraindications:

During or within 14 days of MAOIs. Concomitant MAOIs within 5 days of discontinuing duloxetine. Concomitant linezolid or IV methylene blue; see full labeling.

Boxed Warning:

Suicidal thoughts and behaviors.

DRIZALMA SPRINKLE Warnings/Precautions:

Increased risk of suicidal thoughts and behavior in children, adolescents and young adults; monitor for clinical worsening and unusual changes. Screen for bipolar disorder, mania, or hypomania. Monitor for emergence of serotonin syndrome; discontinue if occurs. Consider dose reduction or discontinuation if orthostatic hypotension, falls and/or syncope occur. Discontinue at 1st sign of blisters, peeling rash, or mucosal erosions. Monitor BP prior to and during therapy. History of seizure disorders, drug abuse. Angle-closure glaucoma. Decreased GI motility. Cardiac disease. Diabetes. Monitor weight and growth in children. Severe renal impairment (GFR <30mL/min), end stage renal disease, hepatic insufficiency, evidence of chronic liver disease, or substantial alcohol use: not recommended. Avoid abrupt cessation. Reevaluate periodically. Elderly. Pregnancy (esp. 3rd trimester). Neonates. Labor & delivery: increased risk of postpartum hemorrhage. Nursing mothers: monitor infants.

DRIZALMA SPRINKLE Classification:

SNRI.

DRIZALMA SPRINKLE Interactions:

See Contraindications. Concomitant thioridazine (may cause arrhythmias): not recommended. Increased risk of serotonin syndrome with other serotonergic drugs (eg, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Potentiated by potent CYP1A2 inhibitors (eg, cimetidine, fluvoxamine, quinolones, enoxacin): avoid. May potentiate or be potentiated by CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) or substrates (eg, tricyclics, phenothiazines, type 1C antiarrhythmics) or other highly protein-bound drugs. Caution with CYP1A2 substrates (eg, theophylline, caffeine), antihypertensives, CNS-acting drugs, other drugs that induce orthostatic hypotension or raise gastric pH (eg, PPIs, famotidine). Increased risk of bleeding with aspirin, NSAIDs, warfarin, or others that affect coagulation; monitor.

Adverse Reactions:

Nausea, dry mouth, somnolence, fatigue, insomnia, constipation, dizziness, diarrhea, decreased appetite, hyperhidrosis, abdominal pain; mania/hypomania, urinary hesitation/retention, increased BP, orthostatic hypotension, hyponatremia, hepatotoxicity (eg, elevated liver transaminases, cholestatic jaundice), sexual dysfunction; rare: seizures, serious skin reactions (eg, erythema multiforme, Stevens-Johnson Syndrome).

Metabolism:

Hepatic (CYP1A2, CYP2D6).

Drug Elimination:

Renal (70%), fecal (20%). Half-life: 12.4 hours (range: 7.8–22.2 hour).

Generic Drug Availability:

NO

How Supplied:

Caps—30, 60, 90, 1000

Mood disorders:

Indications for: DRIZALMA SPRINKLE

Major depressive disorder (MDD).

Adult Dosage:

Swallow whole. If unable to swallow caps, can open and sprinkle contents onto applesauce; consume immediately. May be given via NG tube. Initially 40mg/day (given as 20mg twice daily) to 60mg/day (given either once daily or as 30mg twice daily); may start at 30mg once daily for 1 week, if needed; usual target 60mg once daily (doses up to 120mg/day have been given).

Children Dosage:

<18yrs: not established.

DRIZALMA SPRINKLE Contraindications:

During or within 14 days of MAOIs. Concomitant MAOIs within 5 days of discontinuing duloxetine. Concomitant linezolid or IV methylene blue; see full labeling.

Boxed Warning:

Suicidal thoughts and behaviors.

DRIZALMA SPRINKLE Warnings/Precautions:

Increased risk of suicidal thoughts and behavior in children, adolescents and young adults; monitor for clinical worsening and unusual changes. Screen for bipolar disorder, mania, or hypomania. Monitor for emergence of serotonin syndrome; discontinue if occurs. Consider dose reduction or discontinuation if orthostatic hypotension, falls and/or syncope occur. Discontinue at 1st sign of blisters, peeling rash, or mucosal erosions. Monitor BP prior to and during therapy. History of seizure disorders, drug abuse. Angle-closure glaucoma. Decreased GI motility. Cardiac disease. Diabetes. Monitor weight and growth in children. Severe renal impairment (GFR <30mL/min), end stage renal disease, hepatic insufficiency, evidence of chronic liver disease, or substantial alcohol use: not recommended. Avoid abrupt cessation. Reevaluate periodically. Elderly. Pregnancy (esp. 3rd trimester). Neonates. Labor & delivery: increased risk of postpartum hemorrhage. Nursing mothers: monitor infants.

DRIZALMA SPRINKLE Classification:

SNRI.

DRIZALMA SPRINKLE Interactions:

See Contraindications. Concomitant thioridazine (may cause arrhythmias): not recommended. Increased risk of serotonin syndrome with other serotonergic drugs (eg, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Potentiated by potent CYP1A2 inhibitors (eg, cimetidine, fluvoxamine, quinolones, enoxacin): avoid. May potentiate or be potentiated by CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) or substrates (eg, tricyclics, phenothiazines, type 1C antiarrhythmics) or other highly protein-bound drugs. Caution with CYP1A2 substrates (eg, theophylline, caffeine), antihypertensives, CNS-acting drugs, other drugs that induce orthostatic hypotension or raise gastric pH (eg, PPIs, famotidine). Increased risk of bleeding with aspirin, NSAIDs, warfarin, or others that affect coagulation; monitor.

Adverse Reactions:

Nausea, dry mouth, somnolence, fatigue, insomnia, constipation, dizziness, diarrhea, decreased appetite, hyperhidrosis, abdominal pain; mania/hypomania, urinary hesitation/retention, increased BP, orthostatic hypotension, hyponatremia, hepatotoxicity (eg, elevated liver transaminases, cholestatic jaundice), sexual dysfunction; rare: seizures, serious skin reactions (eg, erythema multiforme, Stevens-Johnson Syndrome).

Metabolism:

Hepatic (CYP1A2, CYP2D6).

Drug Elimination:

Renal (70%), fecal (20%). Half-life: 12.4 hours (range: 7.8–22.2 hour).

Generic Drug Availability:

NO

How Supplied:

Caps—30, 60, 90, 1000

Musculoskeletal pain:

Indications for: DRIZALMA SPRINKLE

Chronic musculoskeletal pain.

Adult Dosage:

Swallow whole. If unable to swallow caps, can open and sprinkle contents onto applesauce; consume immediately. May be given via NG tube. Initially 30mg once daily for 1 week, then increase to 60mg once daily.

Children Dosage:

Not established.

DRIZALMA SPRINKLE Contraindications:

During or within 14 days of MAOIs. Concomitant MAOIs within 5 days of discontinuing duloxetine. Concomitant linezolid or IV methylene blue; see full labeling.

Boxed Warning:

Suicidal thoughts and behaviors.

DRIZALMA SPRINKLE Warnings/Precautions:

Increased risk of suicidal thoughts and behavior in children, adolescents and young adults; monitor for clinical worsening and unusual changes. Screen for bipolar disorder, mania, or hypomania. Monitor for emergence of serotonin syndrome; discontinue if occurs. Consider dose reduction or discontinuation if orthostatic hypotension, falls and/or syncope occur. Discontinue at 1st sign of blisters, peeling rash, or mucosal erosions. Monitor BP prior to and during therapy. History of seizure disorders, drug abuse. Angle-closure glaucoma. Decreased GI motility. Cardiac disease. Diabetes. Monitor weight and growth in children. Severe renal impairment (GFR <30mL/min), end stage renal disease, hepatic insufficiency, evidence of chronic liver disease, or substantial alcohol use: not recommended. Avoid abrupt cessation. Reevaluate periodically. Elderly. Pregnancy (esp. 3rd trimester). Neonates. Labor & delivery: increased risk of postpartum hemorrhage. Nursing mothers: monitor infants.

DRIZALMA SPRINKLE Classification:

SNRI.

DRIZALMA SPRINKLE Interactions:

See Contraindications. Concomitant thioridazine (may cause arrhythmias): not recommended. Increased risk of serotonin syndrome with other serotonergic drugs (eg, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Potentiated by potent CYP1A2 inhibitors (eg, cimetidine, fluvoxamine, quinolones, enoxacin): avoid. May potentiate or be potentiated by CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) or substrates (eg, tricyclics, phenothiazines, type 1C antiarrhythmics) or other highly protein-bound drugs. Caution with CYP1A2 substrates (eg, theophylline, caffeine), antihypertensives, CNS-acting drugs, other drugs that induce orthostatic hypotension or raise gastric pH (eg, PPIs, famotidine). Increased risk of bleeding with aspirin, NSAIDs, warfarin, or others that affect coagulation; monitor.

Adverse Reactions:

Nausea, dry mouth, somnolence, fatigue, insomnia, constipation, dizziness, diarrhea, decreased appetite, hyperhidrosis, abdominal pain; mania/hypomania, urinary hesitation/retention, increased BP, orthostatic hypotension, hyponatremia, hepatotoxicity (eg, elevated liver transaminases, cholestatic jaundice), sexual dysfunction; rare: seizures, serious skin reactions (eg, erythema multiforme, Stevens-Johnson Syndrome).

Metabolism:

Hepatic (CYP1A2, CYP2D6).

Drug Elimination:

Renal (70%), fecal (20%). Half-life: 12.4 hours (range: 7.8–22.2 hour).

Generic Drug Availability:

NO

How Supplied:

Caps—30, 60, 90, 1000

Nonnarcotic analgesics:

Indications for: DRIZALMA SPRINKLE

Diabetic peripheral neuropathic pain.

Adult Dosage:

Swallow whole. If unable to swallow caps, can open and sprinkle contents onto applesauce; consume immediately. May be given via NG tube. 60mg once daily (may start at lower dose if 60mg not tolerated); renal impairment: consider lower starting dose and slow titration.

Children Dosage:

Not established.

DRIZALMA SPRINKLE Contraindications:

During or within 14 days of MAOIs. Concomitant MAOIs within 5 days of discontinuing duloxetine. Concomitant linezolid or IV methylene blue; see full labeling.

Boxed Warning:

Suicidal thoughts and behaviors.

DRIZALMA SPRINKLE Warnings/Precautions:

Increased risk of suicidal thoughts and behavior in children, adolescents and young adults; monitor for clinical worsening and unusual changes. Screen for bipolar disorder, mania, or hypomania. Monitor for emergence of serotonin syndrome; discontinue if occurs. Consider dose reduction or discontinuation if orthostatic hypotension, falls and/or syncope occur. Discontinue at 1st sign of blisters, peeling rash, or mucosal erosions. Monitor BP prior to and during therapy. History of seizure disorders, drug abuse. Angle-closure glaucoma. Decreased GI motility. Cardiac disease. Diabetes. Monitor weight and growth in children. Severe renal impairment (GFR <30mL/min), end stage renal disease, hepatic insufficiency, evidence of chronic liver disease, or substantial alcohol use: not recommended. Avoid abrupt cessation. Reevaluate periodically. Elderly. Pregnancy (esp. 3rd trimester). Neonates. Labor & delivery: increased risk of postpartum hemorrhage. Nursing mothers: monitor infants.

DRIZALMA SPRINKLE Classification:

SNRI.

DRIZALMA SPRINKLE Interactions:

See Contraindications. Concomitant thioridazine (may cause arrhythmias): not recommended. Increased risk of serotonin syndrome with other serotonergic drugs (eg, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, meperidine, methadone, tryptophan, buspirone, amphetamines, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Potentiated by potent CYP1A2 inhibitors (eg, cimetidine, fluvoxamine, quinolones, enoxacin): avoid. May potentiate or be potentiated by CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) or substrates (eg, tricyclics, phenothiazines, type 1C antiarrhythmics) or other highly protein-bound drugs. Caution with CYP1A2 substrates (eg, theophylline, caffeine), antihypertensives, CNS-acting drugs, other drugs that induce orthostatic hypotension or raise gastric pH (eg, PPIs, famotidine). Increased risk of bleeding with aspirin, NSAIDs, warfarin, or others that affect coagulation; monitor.

Adverse Reactions:

Nausea, dry mouth, somnolence, fatigue, insomnia, constipation, dizziness, diarrhea, decreased appetite, hyperhidrosis, abdominal pain; mania/hypomania, urinary hesitation/retention, increased BP, orthostatic hypotension, hyponatremia, hepatotoxicity (eg, elevated liver transaminases, cholestatic jaundice), sexual dysfunction; rare: seizures, serious skin reactions (eg, erythema multiforme, Stevens-Johnson Syndrome).

Metabolism:

Hepatic (CYP1A2, CYP2D6).

Drug Elimination:

Renal (70%), fecal (20%). Half-life: 12.4 hours (range: 7.8–22.2 hour).

Generic Drug Availability:

NO

How Supplied:

Caps—30, 60, 90, 1000