Cymbalta


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duloxetine hydrochloride

Cymbalta, Yentreve (UK)

Pharmacologic class: Selective serotonin and norepinephrine reuptake inhibitor

Therapeutic class: Antidepressant

Pregnancy risk category C

FDA Box Warning

• Drug may increase risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder and other psychiatric disorders, especially during first few months of therapy. Risk must be balanced with clinical need, as depression itself increases suicide risk. With patient of any age, observe closely for clinical worsening, suicidality, and unusual behavior changes when therapy begins. Advise family and caregivers to observe patient closely and communicate with prescriber as needed.

• Drug isn't approved for use in children.

Action

Unknown. May potentiate serotonergic and noradrenergic activity in CNS.

Availability

Capsules (delayed-release): 20 mg, 30 mg, 60 mg

Indications and dosages

Major depressive disorder

Adults: 40 mg/day (20 mg b.i.d.) P.O. to 60 mg/day (once daily or as 30 mg b.i.d.) P.O. If needed, start at 30 mg P.O. once daily for 1 week so patient can adjust to drug before increasing to 60 mg/day. If dosage is increased above 60 mg/day, use increments of 30 mg/day. Some patients may require maintenance dosage of 60 mg once daily for several months or longer.

Generalized anxiety disorder

Adults: For most patients, recommended starting dose is 60 mg P.O. once daily. If needed, start at 30 mg P.O. once daily for 1 week so patient can adjust to drug before increasing to 60 mg/day. If dosage is increased above 60 mg/day, use increments of 30 mg/day.

Diabetic peripheral neuropathic pain

Adults: 60 mg P.O. once daily. For patients with unknown tolerance, consider starting at lower dosage.

Fibromyalgia, chronic musculoskeletal pain

Adults: Initially, 30 mg P.O. daily for 1 week so patient can adjust to drug before increasing to 60 mg P.O. once daily. Some patients may respond to starting dosage. Base continued therapy on patient response.

Dosage adjustment

• Renal impairment

Contraindications

• MAO inhibitor use within past 14 days
• Uncontrolled narrow-angle glaucoma

Precautions

Use cautiously in:
• hepatic insufficiency, severe renal impairment, or chronic hepatic disease (use not recommended)
• hyponatremia, seizure disorder, controlled narrow-angle glaucoma, conditions that slow gastric emptying, urinary hesitancy and frequency
• history of mania
• concurrent use of potent CYP1A2 inhibitors (such as fluoroquinolones, thioridazine, or serotonin precursors) (avoid use)
• concurrent use of 5-hydroxytryptamine receptor agonist (triptan) or other CNS-acting drugs
• heavy alcohol use
• pregnant patients
• breastfeeding patients (use not recommended)
• children, adolescents, and young adults.

Administration

• Assess blood pressure before starting therapy.
• Give without regard to meals.
• Make sure patient swallows capsule whole without chewing or crushing it. Don't sprinkle contents onto food or mix with liquids.

Don't give within 14 days of MAO inhibitors; don't give MAO inhibitors within 5 days of duloxetine withdrawal.

Adverse reactions

CNS: fatigue, somnolence, dizziness, asthenia, headache, agitation, abnormal dreams, tremor, insomnia, anxiety, worsening of depression, increased risk of suicide or suicidal ideation (especially in child or adolescent)

CV: orthostatic hypotension, syncope

EENT: blurred vision, mydriasis, nasopharyngitis, laryngopharyngeal pain

GI: nausea, vomiting, diarrhea, constipation, dyspepsia, dysgeusia, dry mouth

GU: abnormal orgasm, erectile or ejaculatory dysfunction, delayed ejaculation, decreased libido, frequent daytime urination

Hematologic: abnormal bleeding (ecchymoses, hematomas, epistaxis, petechiae, life-threatening hemorrhage)

Hepatic: hepatotoxicity

Musculoskeletal: muscle cramp, pain, and spasms

Respiratory: cough, upper respiratory tract infection

Skin: increased sweating, hot flashes, rash, pruritus

Other: pyrexia, seasonal allergy, yawning, decreased appetite, weight loss, serotonin syndrome

Interactions

Drug-drug.Aspirin, NSAIDs, other drugs that affect coagulation: increased risk of bleeding

Drugs metabolized by CYP2D6 (such as phenothiazines, tricyclic antidepressants, type 1C antiarrhythmics): increased blood levels of these drugs

Highly protein-bound drugs: increased free concentrations of these drugs, potentially causing adverse reactions

MAO inhibitors: serious and potentially fatal interactions

Potent CYP1A2 inhibitors (such as cimetidine, fluvoxamine, quinolone antibiotics), potent CYP2D6 inhibitors (such as fluoxetine, paroxetine, quinidine): increased duloxetine blood level

Serotonergic drugs (such as linezolid, lithium, tramadol, triptans): increased risk of serotonin syndrome

Thioridazine: increased risk of serious ventricular arrhythmias and sudden death

Warfarin: altered anticoagulant effect, including increased bleeding

Drug-diagnostic tests.ALP, ALT, AST, creatine kinase: increased levels

Sodium: decreased level

Drug-herbs.St. John's wort: increased risk of serotonin syndrome

Drug-behaviors.Alcohol use: increased risk of hepatic damage

Smoking: decreased duloxetine bioavailability

Patient monitoring

Monitor patient's mental status carefully. Stay alert for mood changes and signs of suicidal ideation, especially in child or adolescent.
• Monitor liver function test results and creatinine level for evidence of hepatic impairment.

Watch for potentially life-threatening serotonin syndrome, especially with concomitant use of serotonergic drugs (including triptans) or drugs that impair serotonin metabolism (including MAO inhibitors). Signs and symptoms may include mental status changes (agitation, hallucinations, coma), autonomic instability (tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (hyperreflexia, incoordination) and GI upset (nausea, vomiting, diarrhea).
• Monitor blood pressure periodically during therapy.
• Watch for signs and symptoms of hyponatremia, such as headache, poor concentration, memory impairment, confusion, weakness, and unsteadiness. If these occur, consider discontinuing drug and provide treatment as appropriate.
• Know that in diabetic patients, small increases in fasting blood glucose, glycosylated hemoglobin, and total cholesterol levels may occur.
• If concurrent triptan use is warranted, observe patient closely, especially at start of therapy and during dosage increases.
• Carefully monitor patient receiving warfarin when duloxetine is begun or discontinued.

Don't stop drug abruptly. Taper dosage gradually.

Patient teaching

• Advise patient to take drug without regard to meals.
• Instruct patient to swallow capsules whole without chewing or crushing. Tell patient not to sprinkle contents onto food or mix with liquids.

Advise patient (and parent or significant other as appropriate) to monitor mental status carefully and immediately report increased depression or suicidal thoughts or behavior (especially in child or adolescent).

Instruct patient to report signs and symptoms of liver damage (unexplained flulike symptoms, itching, right upper abdominal tenderness, dark urine, or yellow skin).

Tell patient not to stop taking drug abruptly and that dosage will be tapered gradually when drug is discontinued.
• Caution patient to avoid driving and other hazardous activities until drug's effects on concentration and alertness are known.
• Advise patient to rise slowly from a sitting or lying position to avoid sudden blood pressure drop.
• Instruct patient to avoid heavy alcohol use during therapy because of increased risk of liver damage.
• Caution patient to avoid NSAIDs, aspirin, and other drugs that affect coagulation unless prescriber approves.
• Instruct patient not to use herbs, especially St. John's wort, without consulting prescriber.
• Tell female patient to notify prescriber if she is pregnant or breastfeeding or plans to become pregnant or to breastfeed.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.

DULoxetine

(do-lox-e-teen) ,

Cymbalta

(trade name)

Classification

Therapeutic: antidepressants
Pharmacologic: selective serotonin norepinephrine reuptake inhibitors
Pregnancy Category: C

Indications

Major depressive disorder.Diabetic peripheral neuropathic pain.Generalized anxiety disorder.Fibromyalgia.Chronic musculoskeletal pain (including chronic lower back pain and chronic pain from osteoarthritis).Stress urinary incontinence.

Action

Inhibits serotonin and norepinephrine reuptake in the CNS. Both antidepressant and pain inhibition are centrally mediated.

Therapeutic effects

Decreased depressive symptomatology.
Decreased neuropathic pain.
Decreased symptoms of anxiety.
Decreased pain.

Pharmacokinetics

Absorption: Well absorbed following oral administration.
Distribution: Unknown.
Protein Binding: Highly (> 90%) protein-bound.
Metabolism and Excretion: Mostly metabolized, primarily by the CYP2D6 and CYP1A2 enzyme pathways.
Half-life: 12 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
POunknown6 hr12 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Concurrent use of MAO inhibitors or MAO-like drugs (linezolid or methylene blue);Uncontrolled angle-closure glaucoma;End-stage renal disease;Chronic hepatic impairment or substantial alcohol use (↑ risk of hepatitis); Lactation: May enter breast milk; discontinue or bottle-feed.
Use Cautiously in: History of suicide attempt or ideation;History of mania (may activate mania/hypomania);Concurrent use of other centrally acting drugs (↑ risk of adverse reactions);History of seizure disorder;Controlled angle-closure glaucoma;Diabetic patients and those with renal impairment (consider lower initial dose with gradual increase); Obstetric: Use during 3rd trimester may result in neonatal serotonin syndrome requiring prolonged hospitalization, respiratory and nutritional support; Pediatric: May ↑ risk of suicide attempt/ideation especially during dose early treatment or dose adjustment; risk may be greater in children or adolescents (safe use in children/adolescents not established).

Adverse Reactions/Side Effects

Central nervous system

  • neuroleptic malignant syndrome (life-threatening)
  • seizures (life-threatening)
  • suicidal thoughts (life-threatening)
  • fatigue (most frequent)
  • drowsiness (most frequent)
  • insomnia (most frequent)
  • activation of mania
  • dizziness
  • nightmares

Ear, Eye, Nose, Throat

  • blurred vision
  • ↑ intraocular pressure

Cardiovascular

  • ↑ BP

Gastrointestinal

  • hepatotoxicity (life-threatening)
  • ↓ appetite (most frequent)
  • constipation (most frequent)
  • dry mouth (most frequent)
  • nausea (most frequent)
  • diarrhea
  • ↑ liver enzymes
  • gastritis
  • vomiting

Fluid and Electrolyte

  • hyponatremia

Genitourinary

  • dysuria (most frequent)
  • abnormal orgasm
  • erectile dysfunction
  • ↓ libido
  • urinary retention

Dermatologic

  • erythema multiforme (life-threatening)
  • stevens-johnson syndrome (life-threatening)
  • ↑ sweating (most frequent)
  • pruritus
  • rash

Neurologic

  • tremor

Miscellaneous

  • serotonin syndrome (life-threatening)

Interactions

Drug-Drug interaction

Concurrent use with MAO inhibitors may result in serious potentially fatal reactions (Do not use within 14 days of discontinuing MAOI. Wait at least 5 days after stopping duloxetine to start MAOI).Concurrent use with MAO-inhibitor-like drugs, such as linezolid or methylene blue may ↑ risk of serotonin syndrome; concurrent use contraindicated; do not start therapy in patients receiving linezolid or methylene blue ; if linezolid or methylene blue need to be started in a patient receiving duloxetine, immediately discontinue duloxetine and monitor for signs/symptoms of serotonin syndrome for 5 days or until 24 hr after last dose of linezolid or methylene blue, whichever comes first (may resume duloxetine therapy 24 hr after last dose of linezolid or methylene blue)↑ risk of hepatotoxicity with alcohol use disorder/alcohol abuse.Drugs that affect serotonergic neurotransmitter systems, including tricyclic antidepressants, SSRIs, fentanyl, buspirone, tramadol, and triptans ↑ risk of serotonin syndrome.Drugs that inhibit CYP1A2, including fluvoxamine and some fluoroquinolones, ↑ levels of duloxetine and should be avoided.Drugs that inhibit CYP2D6, including paroxetine, fluoxetine, and quinidine ↑ levels of duloxetine and may increase the risk of adverse reactions.Duloxetine also inhibits CYP2D6 and may ↑ levels of drugs metabolized by CYP2D6, including tricyclic antidepressants, phenothiazines, and class Ic antiarrhythmics (propafenone and flecainide ); concurrent use should be undertaken with caution.↑ risk of serious arrhythmias with thioridazine ; avoid concurrent use.↑ risk of bleeding with aspirin, NSAIDs, or warfarin.Use with St. John's wort ↑ serotonin syndrome.

Route/Dosage

Oral (Adults) Major depressive disorder—40–60 mg/day (as 20 mg or 30 mg twice daily or as 60 mg once daily) as initial therapy, then 60 mg once daily as maintenance therapy; Generalized anxiety disorder—30–60 mg once daily as initial therapy (if initiated on 30 mg once daily, should titrate to 60 mg once daily after 1 wk), then 60–120 mg once daily as maintenance therapy; Neuropathic pain—60 mg once daily; Fibromyalgia—30 mg once daily for 1 wk, then ↑ to 60 mg once daily; Chronic musculoskeletal pain—60 mg once daily (may also be started on 30 mg once daily and ↑ to 60 mg once daily after 1 wk.

Renal Impairment

Oral (Adults) Start with lower dose and ↑ gradually.

Availability

Capsules: 20 mg, 30 mg, 60 mg Cost: 20 mg $437.15 / 60, 30 mg $473.58 / 60, 60 mg $478.64 / 60

Nursing implications

Nursing assessment

  • Assess for sexual dysfunction (erectile dysfunction; decreased libido).
  • Monitor BP before and periodically during therapy. Sustained hypertension may be dose related; decrease dose or discontinue therapy if this occurs.
  • Monitor appetite and nutritional intake. Weigh weekly. Report continued weight loss. Adjust diet as tolerated to support nutritional status.
  • Monitor closely for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression, especially in early therapy or during dose changes. Risk may be increased in children, adolescents, and adults ≤24 yr. Restrict amount of drug available to patient.
  • Assess for serotonin syndrome (mental changes [agitation, hallucinations, coma], autonomic instability [tachycardia, labile BP, hyperthermia], neuromuscular aberrations [hyperreflexia, incoordination], and/or GI symptoms [nausea, vomiting, diarrhea]), especially in patients taking other serotonergic drugs (SSRIs, SNRIs, triptans).
  • Assess for rash periodically during therapy. May cause Stevens-Johnson syndrome. Discontinue therapy if severe or if accompanied with fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia.
  • Depression: Assess mental status (orientation, mood, and behavior). Inform health care professional if patient demonstrates significant increase in anxiety, nervousness, or insomnia.
  • Pain and Fibromyalgia: Assess intensity, quality, and location of pain periodically during therapy. May require several weeks for effects to be seen.
  • Lab Test Considerations: May cause ↑ ALT, AST, bilirubin, CPK, and alkaline phosphatase.
    • May cause hyponatremia.
    • Monitor blood sugar and hemoglobin A1c. May cause slight ↑ in blood glucose.

Potential Nursing Diagnoses

Ineffective coping (Indications)
Risk for suicide (Adverse Reactions)
Chronic pain (Indications)

Implementation

  • Do not confuse duloxetine with fluoxetine or paroxetine. Do not confuse Cymbalta with Symbyax.
  • Oral: May be administered without regard to meals. Capsules should be swallowed whole. Do not crush, chew, or open and sprinkle contents on food or liquids; may affect enteric coating .

Patient/Family Teaching

  • Instruct patient to take duloxetine as directed at the same time each day. Take missed doses as soon as possible unless time for next dose. Do not stop abruptly; may cause dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue; must be decreased gradually.
  • Encourage patient and family to be alert for emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, mania, worsening of depression and suicidal ideation, especially during early antidepressant therapy. If these symptoms occur, notify health care professional.
  • May cause drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Instruct patient to notify health care professional if signs of serotonin syndrome (mental status changes: agitation, hallucinations, coma; autonomic instability: tachycardia, labile BP, hyperthermia; neuromuscular aberrations: hyperreflexia, incoordination; and/or gastrointestinal symptoms: nausea, vomiting, diarrhea), liver damage (pruritus, dark urine, jaundice, right upper quadrant tenderness, unexplained "flu-like" symptoms) or rash occur.
  • Advise patient to avoid taking alcohol during duloxetine therapy.
  • Instruct patient to notify health care professional if pregnancy is planned or suspected or if breast feeding. Encourage any patient exposed to duloxetine during pregnancy to register with the Cymbalta Pregnancy Registry at 1-866-814-6975 or www.cymbaltapregnancyregistry.com.

Evaluation/Desired Outcomes

  • Increased sense of well-being.
    • Renewed interest in surroundings. Need for therapy should be periodically reassessed. Patients may notice improvement within 1–4 wk, but should be advised to continue therapy as directed. Therapy is usually continued for several months.
  • Decrease in neuropathic pain associated with diabetic peripheral neuropathy.
  • Decrease in chronic musculoskeletal pain and pain and soreness associated with fibromyalgia.
  • Decrease in anxiety.

Cymbalta

(sĭm-bôl′tə)
A trademark for the drug duloxetine hydrochloride.

Cymbalta

a trademark for duloxetine.

Patient discussion about Cymbalta

Q. I have been told by my doctor that I may have fibromyalgia.He is giving me Cymbalta,what is an alternative med I have almost all of the symptoms associated with fibromyalgia. I need help with a natural teatment.

A. there are all kinds of alternative treatments that helps in Fibromyalgia...acupuncture, magnesium supplements,chiropractic care,
hypnosis and so on.
not all of them are helpful, and as always in alternative treatments- it's hard to know what is helpful and what is just a waste of money. there's a site that might give you some idea about alternative treatment in FM:
http://nccam.nih.gov/health/pain/fibromyalgia.htm
it's very reliable.

More discussions about Cymbalta
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