Drizalma Sprinkle

— THERAPEUTIC CATEGORIES —
  • Anxiety/OCD
  • Fibromyalgia
  • Mood disorders
  • Musculoskeletal pain
  • Nonnarcotic analgesics
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Drizalma Sprinkle Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Duloxetine (as HCl) 20mg, 30mg, 40mg, 60mg; del-rel caps.

    Pharmacological Class

    SNRI.

    How Supplied

    Caps—30, 60, 90, 1000

    Manufacturer

    Sun Pharmaceutical Industries

    Generic Availability

    NO

    Mechanism of Action

    Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.

    Drizalma Sprinkle Indications

    Indications

    Generalized anxiety disorder (GAD).

    Drizalma Sprinkle Dosage and Administration

    Adult

    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

    <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

    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.

    Drizalma Sprinkle Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Drizalma Sprinkle Warnings/Precautions

    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 Pharmacokinetics

    Absorption

    Peak plasma concentration: at 5 hours (after administration).

    Distribution

    Apparent volume of distribution: ~1640 L. Plasma protein bound: >90%.

    Metabolism

    Hepatic (CYP1A2, CYP2D6).

    Elimination

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

    Drizalma Sprinkle Interactions

    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.

    Drizalma Sprinkle Adverse Reactions

    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).

    Drizalma Sprinkle Clinical Trials

    See Literature

    Drizalma Sprinkle Note

    Not Applicable

    Drizalma Sprinkle Patient Counseling

    See Literature

    Drizalma Sprinkle Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Duloxetine (as HCl) 20mg, 30mg, 40mg, 60mg; del-rel caps.

    Pharmacological Class

    SNRI.

    How Supplied

    Caps—30, 60, 90, 1000

    Manufacturer

    Sun Pharmaceutical Industries

    Generic Availability

    NO

    Mechanism of Action

    Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.

    Drizalma Sprinkle Indications

    Indications

    Fibromyalgia.

    Drizalma Sprinkle Dosage and Administration

    Adult

    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

    <13yrs: not established.

    Drizalma Sprinkle Contraindications

    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.

    Drizalma Sprinkle Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Drizalma Sprinkle Warnings/Precautions

    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 Pharmacokinetics

    Absorption

    Peak plasma concentration: at 5 hours (after administration).

    Distribution

    Apparent volume of distribution: ~1640 L. Plasma protein bound: >90%.

    Metabolism

    Hepatic (CYP1A2, CYP2D6).

    Elimination

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

    Drizalma Sprinkle Interactions

    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.

    Drizalma Sprinkle Adverse Reactions

    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).

    Drizalma Sprinkle Clinical Trials

    See Literature

    Drizalma Sprinkle Note

    Not Applicable

    Drizalma Sprinkle Patient Counseling

    See Literature

    Drizalma Sprinkle Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Duloxetine (as HCl) 20mg, 30mg, 40mg, 60mg; del-rel caps.

    Pharmacological Class

    SNRI.

    How Supplied

    Caps—30, 60, 90, 1000

    Manufacturer

    Sun Pharmaceutical Industries

    Generic Availability

    NO

    Mechanism of Action

    Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.

    Drizalma Sprinkle Indications

    Indications

    Major depressive disorder (MDD).

    Drizalma Sprinkle Dosage and Administration

    Adult

    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

    <18yrs: not established.

    Drizalma Sprinkle Contraindications

    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.

    Drizalma Sprinkle Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Drizalma Sprinkle Warnings/Precautions

    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 Pharmacokinetics

    Absorption

    Peak plasma concentration: at 5 hours (after administration).

    Distribution

    Apparent volume of distribution: ~1640 L. Plasma protein bound: >90%.

    Metabolism

    Hepatic (CYP1A2, CYP2D6).

    Elimination

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

    Drizalma Sprinkle Interactions

    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.

    Drizalma Sprinkle Adverse Reactions

    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).

    Drizalma Sprinkle Clinical Trials

    See Literature

    Drizalma Sprinkle Note

    Not Applicable

    Drizalma Sprinkle Patient Counseling

    See Literature

    Drizalma Sprinkle Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Duloxetine (as HCl) 20mg, 30mg, 40mg, 60mg; del-rel caps.

    Pharmacological Class

    SNRI.

    How Supplied

    Caps—30, 60, 90, 1000

    Manufacturer

    Sun Pharmaceutical Industries

    Generic Availability

    NO

    Mechanism of Action

    Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.

    Drizalma Sprinkle Indications

    Indications

    Chronic musculoskeletal pain.

    Drizalma Sprinkle Dosage and Administration

    Adult

    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

    Not established.

    Drizalma Sprinkle Contraindications

    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.

    Drizalma Sprinkle Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Drizalma Sprinkle Warnings/Precautions

    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 Pharmacokinetics

    Absorption

    Peak plasma concentration: at 5 hours (after administration).

    Distribution

    Apparent volume of distribution: ~1640 L. Plasma protein bound: >90%.

    Metabolism

    Hepatic (CYP1A2, CYP2D6).

    Elimination

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

    Drizalma Sprinkle Interactions

    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.

    Drizalma Sprinkle Adverse Reactions

    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).

    Drizalma Sprinkle Clinical Trials

    See Literature

    Drizalma Sprinkle Note

    Not Applicable

    Drizalma Sprinkle Patient Counseling

    See Literature

    Drizalma Sprinkle Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Duloxetine (as HCl) 20mg, 30mg, 40mg, 60mg; del-rel caps.

    Pharmacological Class

    SNRI.

    How Supplied

    Caps—30, 60, 90, 1000

    Manufacturer

    Sun Pharmaceutical Industries

    Generic Availability

    NO

    Mechanism of Action

    Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.

    Drizalma Sprinkle Indications

    Indications

    Diabetic peripheral neuropathic pain.

    Drizalma Sprinkle Dosage and Administration

    Adult

    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

    Not established.

    Drizalma Sprinkle Contraindications

    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.

    Drizalma Sprinkle Boxed Warnings

    Boxed Warning

    Suicidal thoughts and behaviors.

    Drizalma Sprinkle Warnings/Precautions

    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 Pharmacokinetics

    Absorption

    Peak plasma concentration: at 5 hours (after administration).

    Distribution

    Apparent volume of distribution: ~1640 L. Plasma protein bound: >90%.

    Metabolism

    Hepatic (CYP1A2, CYP2D6).

    Elimination

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

    Drizalma Sprinkle Interactions

    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.

    Drizalma Sprinkle Adverse Reactions

    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).

    Drizalma Sprinkle Clinical Trials

    See Literature

    Drizalma Sprinkle Note

    Not Applicable

    Drizalma Sprinkle Patient Counseling

    See Literature

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