Symptoms may include headache; difficulty concentrating, memory changes or confusion; weakness and unsteadiness on your feet; and in severe or sudden cases hallucinations, fainting, seizures or coma. Each Trintellix tablet contains 6. Patients receiving other drugs that interfere with hemostasis should be carefully monitored when Trintellix is initiated or discontinued [see Warnings and Precautions 5.
Symptoms may include greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual. Mutagenicity Vortioxetine was not genotoxic in the in vitro bacterial reverse mutation assay Ames test , an in vitro chromosome aberration assay in cultured human lymphocytes, and an in vivo rat bone marrow micronucleus assay. 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. Geriatric Use No dose adjustment is recommended on the basis of age Figure 3.
Symptoms may include headache; difficulty concentrating, memory changes or confusion; weakness and unsteadiness on your feet; and in severe or sudden cases hallucinations, fainting, seizures or coma. Vortioxetine is present in rat milk [see Data ]. In case of overdose, call Poison Control Center at for latest recommendations.
Pay close attention to any changes, especially sudden changes in mood, behavior, thoughts or feelings. The oral dose of 40 mg is sufficient to assess the effect of metabolic inhibition.
Milk to plasma ratio in lactating rats was 1, 1. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Trintellix and any potential adverse effects on the breastfed child from Trintellix or from the underlying maternal condition.
The presence of hepatic mild, moderate or severe or renal impairment mild, moderate, severe and ESRD did not affect the apparent clearance of vortioxetine. Multiple doses of Trintellix did not affect the pharmacokinetics or pharmacodynamics composite cognitive score of diazepam.
Posted by: Gardabei | on October 2, 2012
Vortioxetine HBr is known chemically as 1-[2- 2,4-Dimethyl-phenylsulfanyl -phenyl]-piperazine, hydrobromide. In these studies, patients were randomized to Trintellix 5 mg, 10 mg, 15 mg or 20 mg or placebo once daily.
Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see Warnings and Precautions 5. In these studies, patients were randomized to Trintellix 5 mg, 10 mg, 15 mg or 20 mg or placebo once daily.
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Pharmacokinetics Vortioxetine pharmacological activity is due to the parent drug. Symptoms may include greatly increased energy; severe trouble sleeping; racing thoughts; reckless behavior; unusually grand ideas; excessive happiness or irritability; talking more or faster than usual.
Geriatric Use No dose adjustment is recommended on the basis of age Figure 3. Pediatric Use Clinical studies on the use of Trintellix in pediatric patients have not been conducted; therefore, the safety and effectiveness of Trintellix in the pediatric population have not been established.