Nytenso(Vortioxetine Hydrobromide)
Therapeutic Group: Antidepressants
Presentation
NytensoTM 5: Each tablet contains Vortioxetine Hydrobromide INN equivalent to Vortioxetine 5 mg.
NytensoTM 10: Each tablet contains Vortioxetine Hydrobromide INN equivalent to Vortioxetine 10 mg.
NytensoTM 20: Each tablet contains Vortioxetine Hydrobromide INN equivalent to Vortioxetine 20 mg.
Description
Vortioxetine is a serotonin modulator and stimulator. The precise mechanism of action of Vortioxetine is unknown, but is thought to be related to increase the level of serotonin (5-HT).
Indications
Vortioxetine is indicated for treatment of major depressive disorder (MDD) in adults.
Dosage & Administration
The recommended starting dose is 10 mg administered orally once daily without regard to meals.
Then, the dose can be increased to 20 mg/day, as tolerated. Consider 5 mg/day for patients who do not tolerate higher doses.
Vortioxetine can be discontinued abruptly. However, it is recommended that doses of 15 mg/day or 20 mg/day be reduced to 10 mg/day for one week prior to full discontinuation if possible.
Side Effects
The most common adverse reactions of Vortioxetine are nausea, constipation and vomiting.
Precautions
Caution should be exercised when Vortioxetine is prescribed in patients with:
• SSRIs, SNRIs, and triptans- increase risk of serotonin syndrome
• Concomitant use of aspirin, nonsteroidal anti inflammatory drugs and other antiplatelet drugs, angle closure glaucoma, hyponatremia and sexual dysfunction can occur when a patient is treated with an antidepressant.
Use in Pregnancy & Lactation
Pregnancy & Lactation: Third trimester use may increase risk for persistent pulmonary hypertension and withdrawal in the newborn. There is no information regarding the presence of vortioxetine in human milk, the effects on the breastfed infant, or the effects on milk production.
Pediatric use: The safety and effectiveness of Vortioxetine have not been established in pediatric patients for the treatment of MDD.Geriatric use: No dose adjustment is recommended on the basis of age.
Drug Interaction
Vortioxetine should be used with caution in combination with:
• Strong inhibitors of CYP2D6- Vortioxetine dose should be by half when coadministered.
• Strong CYP Inducers: Vortioxetine dose should be increased when coadministered for more than 14 days. The maximum recommended dose should not exceed 3 times the original dose .
Over Dose
The most frequently reported symptoms with overdoses up to 80 mg (four times the maximum recommended daily dose) were nausea and vomiting.
Storage
Do not store above 30 ºC. Keep away from light and out of the reach of children.
Commercial Pack
NytensoTM 5: Each box contains 3 blister strips of 10 tablets. NytensoTM 10: Each box contains 3 blister strips of 10 tablets. NytensoTM 20: Each box contains 3 blister strips of 10 tablets.
