Duloxetine product insert

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Duloxetine: Discover the benefits of this powerful medication.

Important safety information: Before taking Duloxetine, consult your healthcare provider.

Overview and Usage

Duloxetine is a medication used to treat depression, anxiety, and certain types of chronic pain conditions. It belongs to a class of drugs known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs), which work by increasing the levels of certain chemicals in the brain that help regulate mood and pain sensation.

This medication is typically taken orally, with or without food, once or twice a day as prescribed by a healthcare provider. It is important to follow the dosage instructions provided by your doctor and not to exceed the recommended amount.

Duloxetine should be taken regularly to maximize its effectiveness. It may take several weeks before you notice an improvement in your symptoms, so it is important to continue taking the medication as directed even if you do not feel immediate relief.

It is essential to inform your doctor about any other medications, supplements, or herbal products you are taking, as they may interact with duloxetine and cause unwanted side effects. Additionally, do not stop taking duloxetine suddenly without consulting your doctor, as this can lead to withdrawal symptoms.

If you experience any severe or persistent side effects while taking duloxetine, such as suicidal thoughts, extreme mood changes, or allergic reactions, seek medical help immediately. It is important to follow up with your healthcare provider regularly to monitor your progress and adjust your treatment plan as needed.

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Indications and Dosage

Indications:

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

Dosage:

The recommended starting dose for MDD is 40 mg once daily. For GAD, the recommended dose is 60 mg once daily. For DPNP and FM, the recommended dose is 60 mg once daily. The dosage may be adjusted based on individual patient response and tolerability, but should not exceed 120 mg per day. For chronic musculoskeletal pain, the initial dose is 30 mg once daily, with a gradual increase to 60 mg once daily or 60 mg twice daily based on patient response. Dosage adjustments should be made with caution in patients with renal or hepatic impairment.

Indications and Dosage

Duloxetine is indicated for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), and chronic musculoskeletal pain. The dosage of duloxetine varies depending on the condition being treated.

Major Depressive Disorder (MDD)

The recommended starting dose for MDD is 20 mg once daily, with or without food. Based on individual patient response, the dosage may be increased to 60 mg per day.

Generalized Anxiety Disorder (GAD)

For GAD, the initial dose is 30 mg once daily, with or without food. The dosage may be increased to 60 mg per day based on response and tolerability.

  • The capsules should be swallowed whole and not chewed or crushed.
  • The dosage should be adjusted based on individual patient response.
  • It is important to follow the prescribing healthcare provider’s instructions.

It is essential to adhere to the prescribed dosage and not exceed the recommended daily amount to minimize the risk of adverse effects.

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Warnings and Precautions

Before taking duloxetine, it is important to be aware of the following warnings and precautions:

1. Suicidal thoughts: Duloxetine may increase the risk of suicidal thoughts or behavior, especially in young adults under 24 years old. Patients should be closely monitored for any changes in mood or behavior.

2. Serotonin syndrome: Taking duloxetine with other medications that affect serotonin levels, such as SSRIs or SNRIs, can increase the risk of developing serotonin syndrome. Symptoms include agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

3. Liver function: Patients with liver problems should use duloxetine with caution, as the medication is metabolized in the liver. Liver function tests should be monitored regularly.

4. Glaucoma: Duloxetine can increase intraocular pressure, which may worsen the condition in patients with glaucoma. Regular eye exams are recommended for patients taking this medication.

5. Bleeding risk: Duloxetine may increase the risk of bleeding, especially when taken with other medications that affect blood clotting. Patients on blood thinners or with a history of bleeding disorders should use duloxetine with caution.

6. Withdrawal symptoms: Abruptly stopping duloxetine can lead to withdrawal symptoms such as dizziness, nausea, headache, fatigue, irritability, insomnia, and electric shock sensations. It is important to gradually taper off the medication under medical supervision.

Possible Side Effects

  • Common side effects of duloxetine may include nausea, dry mouth, constipation, dizziness, drowsiness, and fatigue.
  • Less common side effects may include sweating, blurred vision, increased heart rate, and changes in appetite or weight.
  • Serious side effects such as liver problems, allergic reactions, and serotonin syndrome may occur but are rare. Seek medical attention if you experience these.
  • It is important to report any unusual or severe side effects to your healthcare provider promptly.
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Drug Interactions

Interactions with Other Drugs:

Before taking Duloxetine, inform your healthcare provider about all the medications you are currently taking. Certain drugs can interact with Duloxetine and may increase the risk of side effects or decrease the effectiveness of either medication. Some examples of drugs that may interact with Duloxetine include:

  • Monoamine oxidase inhibitors (MAOIs): Taking Duloxetine with MAOIs can lead to serious, sometimes fatal reactions such as serotonin syndrome.
  • Antidepressants: Combining Duloxetine with other antidepressants may increase the risk of serotonin syndrome.
  • Thioridazine: Concurrent use of Duloxetine and Thioridazine can cause an irregular heart rhythm known as QT prolongation.
  • NSAIDs or aspirin: Using NSAIDs or aspirin with Duloxetine may increase the risk of bleeding.

Interactions with Herbal Supplements:

It’s also essential to disclose your use of herbal supplements to your healthcare provider before starting Duloxetine. Certain herbal supplements can interact with Duloxetine and impact its effectiveness. Examples of herbal supplements that may interact with Duloxetine include St. John’s Wort, which can reduce the effectiveness of Duloxetine.

Storage and Handling

Storage and Handling

Storage:

Store duloxetine at room temperature between 68°F to 77°F (20°C to 25°C).

Keep the medication out of reach of children and pets.

Handling:

Handle duloxetine tablets with clean, dry hands to avoid contamination.

Do not crush, chew, or break the tablets unless directed by your healthcare provider.

Keep the medication in its original packaging to protect it from light and moisture.

Do not share duloxetine with others, even if they have similar symptoms.

If you have any unused or expired medication, dispose of it properly according to local guidelines.