Prescribing information for duloxetine

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Duloxetine is a prescription medication used to treat depression, anxiety, and certain types of chronic pain. It belongs to a class of drugs known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). It works by restoring the balance of certain natural substances in the brain.

Before taking duloxetine, inform your healthcare provider about any medical conditions you have, especially if you have a history of heart, liver, kidney problems, or if you are taking other medications. It is important to follow the prescribed dosage and guidelines provided by your doctor.

Duloxetine may cause side effects such as nausea, dizziness, dry mouth, and constipation. Contact your healthcare provider if you experience any severe or persistent side effects while taking this medication.

Do not stop taking duloxetine abruptly without consulting your doctor, as withdrawal symptoms may occur. If you have any concerns or questions about this medication, discuss them with your healthcare provider.

Indications and Usage

Duloxetine is indicated for the treatment of major depressive disorder (MDD) in adults. It is also approved for the management of generalized anxiety disorder (GAD) in adults and the treatment of diabetic peripheral neuropathic pain in adults. Duloxetine is not recommended for use in pediatric patients.

Depressive Disorder

Major Depressive Disorder: Duloxetine is effective in the acute and maintenance treatment of MDD. It helps improve mood, sleep, appetite, and energy levels.

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Anxiety Disorder

Generalized Anxiety Disorder: Duloxetine can help reduce anxiety symptoms, such as excessive worry and tension, in adults with GAD.

Contraindications and Warnings

It is important to be aware of the contraindications and warnings associated with duloxetine to ensure safe and effective use of the medication.

Duloxetine is contraindicated in patients with a hypersensitivity to the drug or any of its components. It is also contraindicated in patients who are taking a monoamine oxidase inhibitor (MAOI) or have taken an MAOI within the past 14 days due to the risk of serotonin syndrome.

Patients should be cautioned about the potential for an increased risk of suicidal thinking and behavior, particularly in children, adolescents, and young adults taking antidepressants. Close monitoring for any signs of worsening depression or suicidal thoughts is recommended.

Other warnings include the potential for serotonin syndrome when duloxetine is used in combination with other serotonergic drugs such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, triptans, and tramadol. Symptoms of serotonin syndrome include agitation, hallucinations, coma, and death, and immediate medical attention is required if these symptoms occur.

Additionally, duloxetine may increase blood pressure, so caution is advised in patients with preexisting hypertension or cardiovascular disease. Regular monitoring of blood pressure is recommended during treatment with duloxetine.

It is essential for healthcare providers to review the full prescribing information for duloxetine and discuss the contraindications and warnings with patients before initiating treatment to minimize the risk of adverse effects.

Contraindications and warnings

Contraindications and warnings

Duloxetine is contraindicated in patients with a known hypersensitivity to duloxetine.

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Patients taking monoamine oxidase inhibitors (MAOIs) or thioridazine should not take duloxetine due to the risk of serotonin syndrome.

Patients with uncontrolled narrow-angle glaucoma should not take duloxetine.

Caution should be exercised when prescribing duloxetine to patients with a history of mania or hypomania.

Patients should be monitored for the development of serotonin syndrome symptoms such as agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, excessive sweating, shivering or shaking, blurred vision, muscle spasm or stiffness, tremor, incoordination, stomach cramp, nausea, vomiting, and diarrhea.

Adverse Reactions

When taking duloxetine, some patients may experience adverse reactions. It is important to be aware of these possible side effects:

Common side effects include:

  • Nausea
  • Dry mouth
  • Headache
  • Dizziness

Serious side effects that require immediate medical attention:

  1. Severe allergic reactions
  2. Seizures
  3. Abnormal bleeding
  4. Black or bloody stools

If you experience any of these adverse reactions, contact your healthcare provider immediately. Do not discontinue the medication without consulting a medical professional.

Adverse Reactions

Adverse reactions to duloxetine may include:

System Organ Class Adverse Reactions
Nervous System Disorders Headache, dizziness, somnolence
Gastrointestinal Disorders Nausea, dry mouth, constipation
Psychiatric Disorders Insomnia, anxiety, abnormal dreams
Skin and Subcutaneous Tissue Disorders Skin rash, sweating increased

Patients should report any new or worsening symptoms to their healthcare provider.

Storage and Handling

Storage and Handling

Storage: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).

Handling: Handle with care. Keep out of reach of children. Do not store near heat sources or direct sunlight. Dispose of properly according to local regulations.

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