NSAIDs, acetylsalicylic acid and ticlopidine) or other medicines that might increase bleeding risk are concomitantly administered with SSRIs, including sertraline (see section 4.4). If used together, your doctor may change the dose or how often you use sertraline, or give you special instructions about the use of food, alcohol, or tobacco. In vitro studies indicate that sertraline has little or no potential to inhibit CYP 1A2.
Plasma levels of sertraline were about 50% higher in poor metabolizers of CYP2C19 versus extensive metabolizers. Some adverse drug reactions listed in Table 1 may decrease in intensity and frequency with continued treatment and do not generally lead to cessation of therapy.
Intake of three glasses of grapefruit juice daily increased the sertraline plasma levels by approximately 100% in a cross-over study in eight Japanese healthy subjects. 1. Sertraline had no effect on the beta-adrenergic blocking ability of atenolol. Children (6-12 years old) were initially started on a 25 mg dose. Food does not significantly change the bioavailability of sertraline tablets.
A juvenile toxicology study in rats has been conducted in which sertraline was administered orally to male and female rats on Postnatal Days 21 through 56 (at doses of 10, 40, or 80 mg/kg/day) with a nondosing recovery phase up to Postnatal Day 196.
In addition, on Postnatal Days 21 to 56, dehydration, chromorhinorrhea, and reduced average body weight gain was also observed. Never stop your treatment on your own. This risk persists until significant remission occurs. These undesirable effects are dose dependent and are often transient in nature with continued treatment. This makes side-effects more likely.
For CY-BOCs the mean baseline and change from baseline scores for the placebo group was 22.25 ± 6.15 and -3.4 ± 0.82, respectively, while for the sertraline group, the mean baseline and change from baseline scores were 23.36 ± 4.56 and -6.8 ± 0.87, respectively.
Dizziness, sensory disturbances (including paraesthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor and headache are the most commonly reported reactions. A placebo-controlled trial in normal volunteers suggests that chronic administration of sertraline 200 mg/day does not produce clinically important inhibition of phenytoin metabolism. Frequency of adverse reactions observed from placebo-controlled clinical trials in depression, OCD, panic disorder, PTSD and social anxiety disorder.
Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death. Due to the large volume of distribution of sertraline, forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit.Pharmacotherapeutic group: Selective serotonin reuptake inhibitors (SSRI), ATC code: N06 AB06 Sertraline is a potent and specific inhibitor of neuronal serotonin (5 HT) uptake in vitro, which results in the potentiation of the effects of 5-HT in animals. La sertraline appartient à un groupe de médicaments appelés Inhibiteurs Sélectifs de la Recapture de la Sérotonine (ISRS) ; ces médicaments sont utilisés pour traiter la dépression et/ou des troubles anxieux.
After a one week single blind placebo lead-in, patients were randomly assigned to twelve weeks of flexible dose treatment with either sertraline or placebo. Generally neglible to undetectable levels were found in infant serum, with one exception of an infant with serum levels about 50% of the maternal level (but without a noticeable health effect in this infant).
All of the aforementioned effects attributed to the administration of sertraline were reversed at some point during the nondosing recovery phase of the study. The use of sertraline in patients with hepatic disease must be approached with caution. If concomitant treatment with sertraline and triptans is clinically warranted, appropriate observation of the patient is advised (see section 4.4). Sertraline did not produce either the stimulation and anxiety associated with d-amphetamine or the sedation and psychomotor impairment associated with alprazolam. Long term safety and efficacy data are lacking for this paediatric population.
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