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vortioxetine hydrobromide
Commercial name
TIOXY
Category
NEUROLOGICAL DRUGS
Chemical composition

Each film coated tablet contains 5 mg vortioxetine hydrobromide.

Each film coated tablet contains 10 mg vortioxetine hydrobromide.

Each film coated tablet contains 15 mg vortioxetine hydrobromide.

Each film coated tablet contains 20 mg vortioxetine hydrobromide

Dosage Form
film - coated tablets
Pharmaceutical group
PSYCHOTROPIC DRUGS / ANTIDEPRESSANTS
Contraindications

- Hypersensitivity to the active substance or to any of the excipients.

- Concomitant use with non-selective monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors

Drug interactions

- Permanent non-selective MAOIs: Due to the risk of developing serotonin syndrome, vortioxetine is contraindicated in any combination with non-selective, irreversible MAOIs. Treatment with vortioxetine should not be started for at least 14 days after stopping treatment with a non-selective MAOI.

- A selective reversible MAO-A inhibitor (moclobemide): concomitant use with tioxy is contraindicated.

- Linezolid: It is contraindicated when used with Tioxy. Clinical monitoring and administration of the lowest possible dose should be given if necessary.

- Slegiline and rasagiline: they are non-reversible selective MAO-B inhibitors: the risk of developing serotonin syndrome is reduced, but caution should be exercised in balanced use with Tioxy, clinical monitoring and dose reduction if necessary.

- St. John's wort: concomitant use may increase side effects, including serotonin syndrome.

- CYP2D6 Inhibitors (Bupropion, Quinidine, Fluoxetine, Paroxetine): The dose used should be reduced.

- Cytochrome P450 inducers: The dose should be adjusted when (rifampicin, carbamazepine, phenytoin) with vortioxetine.

Dosage and usage

 

- It is mainly used to treat major depressive episodes in adults.

- The recommended starting dose of TioxY is 10 mg vortioxetine once daily in adults under 65 years of age.

- Depending on the individual patient's response, the dose may be increased to a maximum of 20 mg vortioxetine once daily or reduced to 5 mg vortioxetine at least once daily.

- After depressive symptoms have been treated, treatment for at least 6 months is recommended to enhance the antidepressant response.

- Elderly: Caution should be exercised when treating patients over 65 years of age with doses greater than 10 mg vortioxetine once daily.

Side Effect

 nausea, vomiting, constipation, allergic reactions, hyponatremia, insomnia, dizziness, hostility, serotonin syndrome, mydriasis, angioedema

Marketing authorization number(s)

TIOXY  5 mg f.c.tablets.....................(218\2021).

TIOXY  10 mg f.c.tablets....................(219\2021).

TIOXY  15 mg f.c.tablets....................(220\2021).

TIOXY  20 mg f.c.tablets.....................(221\2021).

The nature and content of the packaging

a carton box containing 3 blisters,each one contains 10 f.c.tablets.