The mean duration of PTSD for these patients was 12 years (Studies PSTD-1 and PSTD-2 combined) and 44% of patients (169 of the 385 patients treated) had secondary depressive disorder.Studies PSTD-1 and PSTD-2 were 12-week flexible dose studies. False-positive test results may be expected for several days following discontinuation of ZOLOFT. A dosage of 25 mg or 50 mg per day is the initial therapeutic dosage.For adults and pediatric patients, subsequent dosages may be increased in case of an inadequate response in 25 to 50 mg per day increments once a week, depending on tolerability, up to a maximum of 200 mg per day. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia with SSRIs and SNRIs False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking ZOLOFT. Excretion of unchanged drug in urine is a minor route of elimination. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in Table 2.No suicides occurred in any of the pediatric studies. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence.Table 4 below displays the incidence of sexual adverse reactions reported by at least 2% of ZOLOFT-treated patients and twice placebo from pooled placebo-controlled trials. Advise a pregnant woman of possible risks to the fetus when prescribing ZOLOFT.ZOLOFT oral solution contains 12% alcohol and is not recommended during pregnancy because there is no known safe level of alcohol exposure during pregnancy.A prospective longitudinal study followed 201 pregnant women with a history of major depression who were euthymic taking antidepressants at the beginning of pregnancy. Contact Poison Control (1-800-222-1222) for latest recommendations.ZOLOFT contains sertraline hydrochloride, an SSRI. Steady-state, therefore, was achieved after 2 to 3 weeks in older patients. 0000005778 00000 n
An increased risk of congenital cardiac defects, specifically septal defects, the most common type of congenital heart defect, was observed in some published epidemiologic studies with first trimester sertraline exposure; however, most of these studies were limited by the use of comparison populations that did not allow for the control of confounders such as the underlying depression and associated conditions and behaviors, which may be factors associated with increased risk of these malformations.Reproduction studies have been performed in rats and rabbits at doses up to 80 mg/kg/day and 40 mg/kg/day, respectively. Adverse reactions that do not appear in Table 3 (most common adverse reactions in adults) yet were reported in at least 2% of pediatric patients and at a rate of at least twice the placebo rate include fever, hyperkinesia, urinary incontinence, aggression, epistaxis, purpura, arthralgia, decreased weight, muscle twitching, and anxiety.Other infrequent adverse reactions, not described elsewhere in the prescribing information, occurring at an incidence of < 2% in patients treated with ZOLOFT were:The following adverse reactions have been identified during postapproval use of ZOLOFT. The exposure to desmethylsertraline was approximately 2-fold greater in patients with mild hepatic impairment compared to age-matched volunteers with normal hepatic function. Adverse reactions can occur when ZOLOFT is discontinued Advise patients to notify their healthcare provider if they develop an allergic reaction such as rash, hives, swelling, or difficulty breathing Inform pregnant women that ZOLOFT may cause withdrawal symptoms in the newborn or persistent pulmonary hypertension of the newborn (PPHN) This product's label may have been updated. See full prescribing information for sertraline hydrochloride tablets. This diminishes the possibility of administration errors by … For patients taking warfarin, carefully monitor the international normalized ratio.In patients with bipolar disorder, treating a depressive episode with ZOLOFT or another antidepressant may precipitate a mixed/manic episode. A few times I forgot to take it 2 days in a row and I went to the hospital for severe … 0000004184 00000 n
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