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Indications

Valdoxan (agomelatine) is primarily indicated for the treatment of major depressive disorder (MDD) in adults. MDD is a condition characterized by persistent feelings of sadness, loss of interest or pleasure, changes in appetite or sleep patterns, and difficulty concentrating or making decisions.

Note that Valdoxan is not approved for other indications such as anxiety disorders or insomnia. Its use should be determined by a healthcare professional based on an individual’s specific condition and medical history.

Use and Dosage

The recommended dosage of Valdoxan is typically 25 mg once daily, taken orally before bedtime.

No dose adjustment is required based on age, including elderly patients aged 75 years and older.

The dosage may vary depending on the individual’s response to treatment and the severity of the condition. Follow the dosage instructions provided by your healthcare professional.

Please note that this information is not exhaustive, and it would be best to consult with a healthcare professional or refer to the package leaflet for comprehensive details about the use and dosage of Valdoxan.

Side Effects

Common side effects include:

• Valdoxan has been associated with weight gain as a potential side effect
• Fatigue or tiredness may occur in some individuals taking Valdoxan
• Valdoxan may rarely cause severe liver reactions.
• Nausea is a common side effect reported with Valdoxan
• Headaches may occur as a side effect of Valdoxan
• Some individuals may experience increased anxiety while taking Valdoxan
• Discontinuation of Valdoxan may lead to symptoms such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick, and shaking

Note that not all individuals will experience these side effects, and the severity and frequency of side effects may vary.

If you experience any side effects while taking Valdoxan, consult with your healthcare professional for further evaluation and guidance.

Cautions

• Valdoxan is contraindicated in patients with liver disease or known liver impairment. Caution should be exercised when prescribing Valdoxan to patients with hepatic impairment.
• Regular monitoring of liver function is recommended during treatment with Valdoxan, especially in patients with pre-existing liver conditions.
• Valdoxan may interact with certain medications, such as fluvoxamine (used in the treatment of depression) and ciprofloxacin (an antibiotic). Inform your healthcare professional about all the medications you are taking, including over-the-counter drugs and herbal supplements.
• Valdoxan should not be used in patients aged 75 years and older, as no effect of agomelatine is documented in this age group.
• Valdoxan should be used with caution in patients with a history of bipolar disorder, mania, or hypomania. It should be discontinued if a patient develops manic symptoms.
• Close supervision of patients, especially those at high risk, should accompany Valdoxan treatment. Patients and caregivers should be alerted to monitor for any clinical worsening, suicidal behavior or thoughts, and unusual changes in behavior.
• If you are pregnant, planning to become pregnant, or breastfeeding, discuss the use of Valdoxan with your healthcare professional for appropriate guidance and evaluation of potential risks and benefits.

Forms and Strengths

Valdoxan is available in the following forms and strengths:

• Valdoxan Tablet:
  • 25 mg

FAQ

How does Valdoxan work?

Valdoxan works by stimulating melatonin receptors (MT1 and MT2) and blocking serotonin 5-HT2C receptors.

Is Valdoxan effective in treating depression?

Valdoxan has demonstrated efficacy in reducing symptoms of depression, including anxiety symptoms, as early as the second week of treatment.

Are there any side effects associated with Valdoxan?

Common side effects of Valdoxan may include diarrhea, constipation, stomach pain, nausea, and vomiting. Consult with a healthcare professional for a complete list of potential side effects.

Can Valdoxan be used during pregnancy or while breastfeeding?

There is limited information available regarding the use of Valdoxan during pregnancy and breastfeeding. Discuss any plans for pregnancy or breastfeeding with a healthcare professional.

Resources:

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6614940/
2. https://www.news-medical.net/drugs/Valdoxan.aspx
3. https://apps.medicines.org.au/files/sepvaldx.pdf