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Cymbalta

(duloxetine)

Full Prescribing Information DailyMed Drug Information

Forms/Strengths

  •  Capsules: 20 mg, 30 mg, 60 mg

Dosing

  • Age: 7 years for GAD
  • Considerations: Monitor for suicidal thoughts and behaviors, especially during initial treatment or dosage changes. Regularly monitor weight and growth in pediatric patients.
  • Initial Dose:
    • Major Depressive Disorder (MDD): Start with 40–60 mg/day (e.g., 20 mg BID or 30 mg QD).
    • Generalized Anxiety Disorder (GAD):
      • Adults: Start with 60 mg QD.
      • Pediatrics (≥ 7 years): Start with 30 mg QD, increase to 60 mg QD after 1 week.
  • Titration: Increase to 60 mg/day after one week if tolerated
  • Max Dose: 120 mg/day

Quick Facts

  • Inhibits serotonin (5-HT) and norepinephrine (NE) reuptake for mood regulation and pain relief
  • Improves mood, alleviates anxiety, modulates pain
  • Oral capsule; doses >60 mg/day typically divided (e.g., 30 mg BID)
  • Common side effects: nausea, dry mouth, dizziness, constipation, fatigue
  • Dual action on mood and pain symptoms; monitor for suicidal ideation in younger patients

Indications

  •  Generalized Anxiety Disorder (F41.1)

Off-Label Uses

  • Major Depressive Disorder (F32.x)
  • Diabetic Peripheral Neuropathic Pain (G63.2)
  • Chronic Musculoskeletal Pain (M79.1)

How to Take

  • Take once daily, preferably at the same time each day.
  • Can be taken with or without food; taking with food may help reduce nausea.
  • Swallow capsule whole; do not crush, chew, or open.
  • Do not abruptly stop; tapering is required to prevent withdrawal symptoms.

Side Effects

  •  Common: Nausea, diarrhea, decreased weight, dizziness, decreased appetite, vomiting, fatigue
  • Serious: Suicidal thoughts and behaviors, severe skin reactions, activation of mania or hypomania, angle-closure glaucoma, seizures, blood pressure increases, hyponatremia

Monitoring / Labs

  • Monitor for suicidal thoughts and behaviors.
  • Regularly monitor weight and growth.
  • Monitor blood pressure periodically.

Education

  • When to Call the Doctor:

    • Severe mood changes, suicidal thoughts, or unusual behavior.
    • Symptoms of serotonin syndrome (e.g., confusion, rapid heart rate, muscle rigidity, high fever).
    • Signs of liver damage (e.g., yellowing of the skin/eyes, dark urine, persistent nausea).
    • Unusual bruising or bleeding.
    • Severe dizziness, fainting, or difficulty urinating.
  • Safety Tips:

    • Monitor blood pressure regularly, as Cymbalta may increase blood pressure.
    • Use caution when driving or operating machinery, as drowsiness and dizziness may occur.
    • Avoid alcohol, as it may increase the risk of liver toxicity.
    • May cause sexual dysfunction; discuss with provider if problematic.
    • Taper gradually if discontinuing to minimize withdrawal effects (e.g., dizziness, nausea, irritability).
  • Parent Tips for Pediatric Patients:

    • Monitor for suicidal thoughts, mood changes, or behavioral changes, especially during the first few weeks.
    • May cause drowsiness or agitation; observe how the child responds to the medication.
    • Encourage hydration and a balanced diet to help with potential nausea.
    • If taken for chronic pain or fibromyalgia, assess response regularly.

Additional Information

  • Contraindications:

    • Hypersensitivity to duloxetine or formulation components.
    • Use within 14 days of MAOI therapy (risk of serotonin syndrome).
    • Uncontrolled narrow-angle glaucoma.
    • Severe hepatic or renal impairment.
  • Pregnancy:

    • Category C; use only if benefits outweigh risks.
    • May cause withdrawal symptoms in newborns if taken in the third trimester.
  • Lactation:

    • Excreted in breast milk; use with caution as effects on the infant are unknown.
  • Drug Interactions:

    • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs, St. John’s Wort) increase serotonin syndrome risk.
    • CYP1A2 and CYP2D6 inhibitors (e.g., fluvoxamine, quinidine) may increase duloxetine levels.
    • NSAIDs, anticoagulants, and antiplatelets may increase bleeding risk.
    • May enhance the hypertensive effects of stimulants or decongestants.