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ZoloftAll links open a new browser window. Zoloft: Full Zoloft Description - Click here - Source: FDA Zoloft: Increased Risk of Neonatal Persistent Pulmonary Hypertension Click here - Source: FDA ALERT [7/2006] Zoloft: Patient Information Click here - Source: FDA Zoloft: How to discontinue Zoloft Click here Partial Zoloft description: FDA ALERT [07/2006] – Possible Life- Threatening
Serotonin Syndrome When Used With Triptan Medicines
Serotonin syndrome may be more likely to occur when starting or increasing the dose of an SSRI or a triptan. This information comes from reports sent to FDA and knowledge of how these medicines work. If you take migraine headache medicines, ask your healthcare professional if your medicine is a triptan. Before you take Zoloft and a triptan together, talk to
your healthcare professional. If you must take these medicines together, be
aware of the possibility of serotonin syndrome, and get medical care right away
if you think serotonin syndrome is happening to you. FDA ALERT [07/2006] – Infant Persistent Pulmonary Hypertension The results of a study that looked at the use of
antidepressant medicines during pregnancy in mothers of babies born with a
serious condition called persistent pulmonary hypertension of the newborn (PPHN)
were recently published in a medical journal.
The FDA plans to further look at the role of SSRIs in
babies with PPHN. This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available. What is Zoloft? Zoloft is in a class of medicines called selective serotonin reuptake inhibitors (SSRIs). Zoloft is used to treat:
Who Should Not Take Zoloft?
MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine sulfate), Marplan (isocarboxazid), and other brands.
What Are The Risks? The following are the major potential risks and side effects of Zoloft therapy. However, this list is not complete.
Tell your healthcare professional about all your medical conditions, especially if you have liver or heart disease. Tell your healthcare professional if you are breast-feeding or plan to breast-feed your baby. Are There Any Interactions With Drugs or Foods?
How Do I Take Zoloft?
The purpose of this communication is to inform healthcare professionals about a change in the prescribing information for Zoloft ® (sertraline hydrochloride) tablets and oral concentrate. This change, made at the request of the Food and Drug Administration, articulates a pimozide/sertraline interaction and arises from the results of the study entitled, “Phase 1 Open Study Designed to Determine the Potential Interaction of Sertraline With Cisapride or Pimozide in Healthy Male and Female Subjects.” Based upon these study results, the CONTRAINDICATIONS and PRECAUTIONS sections of the Zoloft prescribing information have been revised as follows (underlined text indicates new text): CONTRAINDICATIONS PRECAUTIONS—Drug Interactions—CNS Active Drugs In a placebo-controlled trial in normal volunteers, the administration of two doses of ZOLOFT did not significantly alter steady-state lithium levels or the renal clearance of lithium. Nonetheless, at this time, it is recommended that plasma lithium levels be monitored following initiation of ZOLOFT therapy with appropriate adjustments to the lithium dose. In a controlled study of a single dose (2 mg) of pimozide, 200 mg sertraline (q.d.) co-administration to steady state was associated with a mean increase in pimozide AUC and Cmax of about 40%, but was not associated with any changes in EKG. Since the highest recommended pimozide dose (10 mg) has not been evaluated in combination with sertraline, the effect on QT interval and PK parameters at doses higher than 2 mg at this time are not known. While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide and due to the interaction noted at a low dose of pimozide, concomitant administration of ZOLOFT and pimozide should be contraindicated (see CONTRAINDICATIONS). The risk of using ZOLOFT in combination with other CNS active drugs has not been systematically evaluated. Consequently, caution is advised if the concomitant administration of ZOLOFT and such drugs is required. There is limited controlled experience regarding the optimal timing of switching from other drugs effective in the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, and premenstrual dysphoric disorder to ZOLOFT. Care and prudent medical judgment should be exercised when switching, particularly from long-acting agents. The duration of an appropriate washout period which should intervene before switching from one selective serotonin reuptake inhibitor (SSRI) to another has not been established. Zoloft was launched in 1992 for the treatment of major depressive disorder. It is also approved for the treatment of panic disorder, obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD). It has been shown to be safe in the long-term treatment of pediatric OCD. Zoloft is the only SSRI approved for the long-term treatment of PTSD. Over the past decade, Zoloft has been used for more than 10.2 billion patient days of therapy worldwide.* We trust this information is useful in providing guidance on the appropriate use of sertraline concomitantly with pimozide. Sincerely, Cathryn M. Clary, MD
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