Zoloft patient package insert

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The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per patients treated are provided in Table 2. Sertraline potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin 5-HT. These doses correspond to approximately 3. No adverse reactions were observed in these infants. When treating a pregnant woman with ZOLOFT during the third trimester, carefully consider both the potential risks and benefits of treatment.

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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. In a retrospective case-control study of women whose infants were born with PPHN and women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20 th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy.

ZOLOFT and some medicines may interact with each other, may not work as well, or may cause serious side effects. If you prefer, you may contact the U.

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The clinical significance of this apparent gender effect is unknown at this time. Other important adverse events reported with ZOLOFT overdose single or multiple drugs include bradycardia, bundle branch block, coma, convulsions, delirium, hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QT-interval prolongation, Torsade de Pointes, serotonin syndrome, stupor, and syncope.

This small change in antipyrine half-life reflects a clinically insignificant change in hepatic metabolism. Relapse during the double-blind phase was defined as the following conditions being met on two consecutive visits: Elderly people may be at greater risk for this.

There were no significant differences in plasma protein binding observed between the two groups. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [See Warnings and Precautions 5. In controlled clinical trials, patients with bipolar disorder were generally excluded; however, symptoms of mania or hypomania were reported in 0.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

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Skin and subcutaneous tissue disorders. There is variability among the drugs effective in the treatment of MDD in the extent of clinically important 2D6 inhibition, and in fact ZOLOFT at lower doses has a less prominent inhibitory effect on 2D6 than some others in the class.

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Women who are pregnant, plan to become pregnant, or who are breastfeeding should not take ZOLOFT without consulting their physician. Sertraline undergoes extensive first pass metabolism. Consistent with the terminal elimination half-life, there is an approximately two-fold accumulation up to steady-state concentrations, which are achieved after one week of once-daily dosing.

Call your healthcare provider if you have eye pain, changes in your vision, or swelling or redness in or around the eye. Insufficient clinical response during the double-blind phase indicated a worsening of the patient's condition that resulted in study discontinuation, as assessed by the investigator.

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Concomitant use is contraindicated due the alcohol content of the oral concentrate and oral solution [See Contraindication 4 ].


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