Vortiox
Generic Name
Vortioxetine
Manufacturer
Hypothetical Pharma Co.
Country
Global (Developed by Lundbeck)
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| vortiox 20 mg tablet | ৳ 45.00 | ৳ 450.00 |
Description
Overview of the medicine
Vortioxetine is an antidepressant used to treat major depressive disorder (MDD). It works by affecting multiple serotonin receptors in the brain, as well as inhibiting the serotonin transporter.
Uses & Indications
Dosage
Adults
The starting dose is 10 mg once daily. Depending on individual patient response and tolerability, the dose may be increased to a maximum of 20 mg once daily or decreased to a minimum of 5 mg once daily.
Elderly
No specific dose adjustment is recommended based on age alone. However, caution should be exercised in elderly patients, and a lower starting dose (e.g., 5 mg) may be considered.
Renal_impairment
No dose adjustment is required in patients with renal impairment (mild, moderate, or severe). No studies have been conducted in patients with end-stage renal disease.
How to Take
Vortioxetine tablets should be taken orally once daily, with or without food. Swallow the tablet whole with water.
Mechanism of Action
Vortioxetine's antidepressant activity is thought to be related to its direct modulation of serotonin receptor activity and inhibition of the serotonin transporter (SERT). It acts as a serotonin reuptake inhibitor, a 5-HT3 and 5-HT7 receptor antagonist, and a 5-HT1A receptor agonist.
Pharmacokinetics
Onset
Antidepressant effects typically begin within 1-2 weeks, with full effect potentially taking several weeks.
Excretion
Approximately 59% of the dose is excreted in the urine and 26% in the feces over a 10-day period. Primarily as metabolites, with negligible excretion of unchanged drug.
Half life
Approximately 66 hours (range 57-73 hours), allowing once-daily dosing.
Absorption
Well absorbed after oral administration, peak plasma concentration reached within 7 to 11 hours. Bioavailability is approximately 75%.
Metabolism
Extensively metabolized in the liver, primarily by cytochrome P450 enzymes (CYP2D6, CYP3A4/5, CYP2C9, CYP2C8, CYP2C19) through oxidation and subsequent glucuronic acid conjugation.
Side Effects
Contraindications
- Hypersensitivity to vortioxetine or any excipients.
- Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOIs.
Drug Interactions
MAOIs
Risk of serotonin syndrome (hyperthermia, rigidity, myoclonus, autonomic instability).
SSRIs/SNRIs, Triptans, Tramadol, St. John's Wort
Increased risk of serotonin syndrome.
CYP inducers (e.g., rifampicin, carbamazepine, phenytoin)
May decrease vortioxetine plasma levels, requiring dose adjustment.
CYP2D6 inhibitors (e.g., bupropion, quinidine, paroxetine)
May increase vortioxetine plasma levels, requiring dose adjustment.
Storage
Store at room temperature (20°C to 25°C), away from moisture and light. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, dizziness, abdominal discomfort, diarrhea, pruritus, somnolence, and flushing. Management is symptomatic and supportive, including monitoring vital signs, cardiac rhythm, and general supportive measures. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C (older classification): Limited human data; use only if potential benefit justifies potential risk to the fetus. Not recommended during lactation due to unknown excretion into breast milk and potential for adverse effects in the infant.
Side Effects
Contraindications
- Hypersensitivity to vortioxetine or any excipients.
- Concomitant use with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuing MAOIs.
Drug Interactions
MAOIs
Risk of serotonin syndrome (hyperthermia, rigidity, myoclonus, autonomic instability).
SSRIs/SNRIs, Triptans, Tramadol, St. John's Wort
Increased risk of serotonin syndrome.
CYP inducers (e.g., rifampicin, carbamazepine, phenytoin)
May decrease vortioxetine plasma levels, requiring dose adjustment.
CYP2D6 inhibitors (e.g., bupropion, quinidine, paroxetine)
May increase vortioxetine plasma levels, requiring dose adjustment.
Storage
Store at room temperature (20°C to 25°C), away from moisture and light. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, dizziness, abdominal discomfort, diarrhea, pruritus, somnolence, and flushing. Management is symptomatic and supportive, including monitoring vital signs, cardiac rhythm, and general supportive measures. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C (older classification): Limited human data; use only if potential benefit justifies potential risk to the fetus. Not recommended during lactation due to unknown excretion into breast milk and potential for adverse effects in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Usually 24 to 36 months from the date of manufacture, specific to manufacturer.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved
Patent Status
Patent expired in some regions, active in others
Clinical Trials
Vortioxetine has been evaluated in multiple short-term (6-8 weeks) and long-term (up to 6 months) placebo-controlled clinical trials for the treatment of MDD, demonstrating efficacy in improving depressive symptoms.
Lab Monitoring
- Monitor for changes in mood and behavior, especially suicidality.
- Consider monitoring serum sodium levels, especially in patients at risk for hyponatremia.
Doctor Notes
- Monitor patients for emergent suicidality, especially at treatment initiation or dose changes.
- Educate patients on proper discontinuation protocol to minimize withdrawal symptoms.
- Consider CYP2D6 metabolizer status if dose adjustments are challenging or side effects are prominent.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Do not stop taking vortioxetine abruptly without consulting your doctor, as this may lead to withdrawal symptoms.
- Report any worsening of depression, suicidal thoughts, or unusual changes in behavior to your doctor immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Vortioxetine may cause dizziness, somnolence, or blurred vision. Patients should be cautious when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Avoid alcohol consumption while taking vortioxetine, as it may worsen central nervous system depression.
- Maintain a regular sleep schedule and healthy diet to support overall mental well-being.
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