Vintelix Tablet

Vintelix Tablet is used for: Major Depressive Disorder

Oral Major depressive disorder Adult: Initially, 10 mg once daily, may be increased up to 20 mg once daily as tolerated or decreased to 5 mg once daily according to patient response. Elderly: Initially, 5 mg once daily, increased to 10 mg once daily if tolerated. Efficacy and safety of doses >20 mg/day have not been evaluated. Hepatic impairment No dosage adjustment is necessary Dosing Considerations Before initiating treatment Screen for personal or family history of bipolar disorder, mania, or hypomania Discontinuing treatment Maybe abruptly discontinued; patients may experience transient adverse reactions (eg, headache, muscle tension) following abrupt discontinuation if dose is 15-20 mg/day To avoid these adverse reactions, decrease to 10 mg/day for 1 week before full discontinuation of 15-20 mg/day doses

No dosage adjustment is necessary

May be taken with or without food.

Hypersensitivity to vortioxetine or any component of formulation MAOI Use of MAOIs (intended to treat psychiatric disorders) or within 21 days of discontinuing with vortioxetine Use of vortioxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders Currently being treated with another MAOI (eg, linezolid, IV methylene blue)

Suicidal thoughts and behaviors Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies Closely monitor all antidepressant-treated patients for clinical worsening and for the emergence of suicidal thoughts and behaviors Not approved for use in pediatric patients Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (SSRIs, SNRIs, and triptans), but also when taken alone. If it occurs, discontinue Vortioxetine and initiate supportive measures. • Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, other antiplatelet drugs, warfarin, or other drugs that affect coagulation may increase risk. • Activation of Mania/Hypomania: Screen patients for bipolar disorder. • Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. • Hyponatremia: Can occur in association with the syndrome of inappropriate antidiuretic hormone secretion (SIADH). • Sexual Dysfunction: Vortioxetine may cause symptoms of sexual dysfunction.

Pregnancy Limited human data available on use during pregnancy to inform any drug-associated risks. Exposure to SSRIs, particularly in month before delivery, associated with <2-fold increase in risk of postpartum hemorrhage; bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages. Use in the month before delivery may be associated with an increased risk of postpartum hemorrhage. Animal data Administered to pregnant rats and rabbits during organogenesis at doses ?15 times and 10x the maximum recommended human dose (MRHD), respectively, resulted in decreased fetal body weight and delayed ossification. No malformations were seen at doses up to 77x and 58x the MRHD, respectively. Orally administered to pregnant rats during gestation and lactation at doses >20x the MRHD resulted in a decrease in the number of live-born pups and an increase in early postnatal pup mortality. Decreased pup weight at birth to weaning occurred at 58x the MRHD and delayed physical development occurred at ?20 times the MRHD. Advise pregnant females of the potential risk to a fetus. Clinical consideration Disease-associated maternal and/or embryo/fetal risk Women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants; consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Fetal/Neonatal adverse reactions Exposure to serotonergic antidepressants, including vortioxetine, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN); monitor neonates who were exposed to drug in the third trimester of pregnancy for PPHN and drug discontinuation syndrome. Human Data Third Trimester Exposure Neonates exposed to SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support and tube feeding. These findings are based on postmarketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or possibly, a drug discontinuation syndrome. In some cases, the clinical picture was consistent with serotonin syndrome. Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in one to two per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. Lactation There is no information regarding presence of vortioxetine in human milk, effects on the breastfed infant, or effects on milk production. Present in rat milk. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for therapy and any potential adverse effects on the breastfed child from therapy or from the underlying maternal condition.

Increased serum concentration with strong CYP2D6 inhibitors (e.g. bupropion, quinidine, fluoxetine, paroxetine). May increase risk of bleeding with anticoagulants (e.g. warfarin), antiplatelet drugs (e.g. aspirin) or NSAIDs. Concomitant use of drugs with potential of lowering seizure threshold e.g. antidepressants (tricyclics, SNRI), neuroleptics (phenothiazines, thioxanthenes, butyrophenones), mefloquine, bupropion, and tramadol may increase risk of seizure. Potentially Fatal: Increased risk of serotonin syndrome with serotonergic agents (e.g. triptans, TCAs, fentanyl, lithium, tramadol, buspirone, tryptophan) or agents that impair the metabolism of serotonin (e.g. MAO inhibitors including linezolid and IV methylene blue).

Side effects of Vortioxetine : >10% Nausea (21-32%) 1-10% Diarrhea (7-10%) Dizziness (6-9%) Dry mouth (6-8%) Constipation (3-6%) Vomiting (3-6%) Flatulence (1-3%) Pruritus (1-3%) Abnormal dreams (<1-3%)

The mechanism of the antidepressant effect is not fully understood but is thought to be related to its enhancement of serotonergic activity in the CNS through inhibition of the reuptake of serotonin (5-HT). It also has several other activities including 5-HT3 receptor antagonism and 5-HT1A receptor agonism; the contribution of these activities to the antidepressant effect has not been established.

Vintelix 5 mg Tablet manufactured by Beximco Pharmaceuticals Ltd.. Its generic name is Vortioxetine. Vintelix is availble in Bangladesh. Farmaco BD drug index information on Vintelix Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.