Duloxetine summary of product characteristics

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Duloxetine is a medication that is used to treat depression and anxiety disorders. It is also effective in managing chronic pain conditions such as fibromyalgia and neuropathic pain. Duloxetine works by increasing the levels of certain chemicals in the brain that are responsible for mood regulation.

Before taking duloxetine, it is important to consult with your healthcare provider to ensure that it is the right treatment for you. Some common side effects of duloxetine may include nausea, dizziness, and fatigue.

It is crucial to follow your doctor’s instructions carefully when taking duloxetine to maximize its benefits and minimize potential risks. If you have any concerns or questions about this medication, do not hesitate to discuss them with your healthcare provider.

Indications and Usage

Duloxetine is indicated for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), fibromyalgia, and chronic musculoskeletal pain. It is also used in the management of chronic lower back pain and chronic osteoarthritis pain.

Major Depressive Disorder (MDD)

  • Duloxetine is approved for the acute and maintenance treatment of MDD in adults.
  • It is recommended to start with an initial dose of 40 mg once daily, which can be increased to 60 mg once daily based on individual patient response.
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Generalized Anxiety Disorder (GAD)

  • Duloxetine is indicated for the treatment of GAD in adults.
  • The recommended starting dose for GAD is 60 mg once daily, with a maximum dose of 120 mg once daily for some patients.

In addition to these primary indications, duloxetine has demonstrated efficacy in managing various types of chronic pain conditions, making it a versatile medication for patients with coexisting depression, anxiety, and pain disorders.

Indications and Usage

Duloxetine is indicated for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), chronic musculoskeletal pain, and fibromyalgia.

Major Depressive Disorder (MDD)

Duloxetine is used to treat MDD in adults and adolescents aged 12 years and older. It helps improve mood, sleep, appetite, and energy levels, as well as reduce feelings of sadness and worthlessness.

Generalized Anxiety Disorder (GAD)

Duloxetine is indicated for the treatment of GAD in adults. It helps to decrease excessive anxiety and worry, improve concentration, and reduce physical symptoms of anxiety, such as muscle tension.

Note: The dosage and duration of therapy for each indication may vary. It is important to follow the healthcare provider’s instructions and not exceed the recommended doses.

Consult your healthcare provider for more information on the appropriate use of Duloxetine.

Dosage and Administration

Dosage and Administration

Dosage:

The recommended dose of Duloxetine for treating major depressive disorder is 60 mg once daily. For some patients, a dose of 30 mg once daily may be sufficient. For patients with comorbid depression and anxiety, a starting dose of 30 mg once daily is recommended. The dose may be increased to 60 mg once daily based on individual patient response.

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Administration:

Duloxetine should be taken orally with or without food. It is recommended to take the medication at the same time each day. The capsules should be swallowed whole and not chewed, crushed, or opened. If a dose is missed, it should be taken as soon as possible, unless it is almost time for the next dose. In such cases, the missed dose should be skipped, and the regular dosing schedule should be resumed.

Contraindications and Warnings

Before taking Duloxetine, it is important to be aware of the contraindications and warnings associated with this medication.

Contraindications:

Duloxetine should not be taken by individuals who are allergic to any of the active or inactive ingredients in the medication. It is also contraindicated in patients who are currently taking or have recently taken a monoamine oxidase inhibitor (MAOI) within the past 14 days.

Warnings:

Patients taking Duloxetine should be closely monitored for worsening depression, suicidal thoughts or behaviors, and changes in mood or behavior. This medication may increase the risk of bleeding, so caution should be exercised in patients taking anticoagulants or nonsteroidal anti-inflammatory drugs (NSAIDs).

It is important to inform your healthcare provider about any medications, supplements, or herbal products you are taking before starting Duloxetine to avoid potential drug interactions and adverse effects.

Adverse Reactions

Adverse reactions to duloxetine may include:

System Organ Class Adverse Reactions
Nervous System Disorders Dizziness, headache, somnolence
Gastrointestinal Disorders Nausea, dry mouth, constipation
Psychiatric Disorders Insomnia, anxiety, abnormal dreams
Cardiac Disorders Palpitations, tachycardia
Skin and Subcutaneous Tissue Disorders Sweating, rash, pruritus
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Patients should seek medical attention if they experience severe or persistent adverse reactions while taking duloxetine.

Drug Interactions

Drug Interactions

Duloxetine may interact with other medications, supplements, or substances. It is important to consult with your healthcare provider before starting duloxetine to ensure there are no potential interactions that could affect your health.

Some common drug interactions with duloxetine include:

  • MAO inhibitors: Concomitant use of MAO inhibitors with duloxetine can lead to serotonin syndrome, a potentially serious condition.
  • SSRIs and SNRIs: Combining duloxetine with other selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) may increase the risk of serotonin syndrome.
  • NSAIDs: Nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the risk of bleeding when used with duloxetine.

It is essential to inform your healthcare provider about all medications, supplements, and substances you are taking to avoid any potentially harmful interactions with duloxetine.

Additional Information

Before taking Duloxetine, inform your healthcare provider if you have a history of liver or kidney disease, seizures, bipolar disorder, glaucoma, or any other medical conditions.

It is important to follow your doctor’s instructions carefully when taking Duloxetine and not to stop the medication abruptly without consulting your healthcare provider.

Important Safety Information:

  • Duloxetine may cause dizziness or drowsiness. Avoid driving or operating machinery until you know how this medication affects you.
  • Avoid alcohol consumption while taking Duloxetine, as it can increase the risk of side effects.
  • Contact your healthcare provider immediately if you experience any unusual or severe side effects while taking Duloxetine.