Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [See Warnings and Precautions 5. 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 rhuematoid arthritis and ankle burning a week, depending on tolerability, up to a maximum of mg per day.
ZOLOFT may be administered either continuously every day throughout the menstrual cycle or intermittently only during the luteal phase of the menstrual cycle, i. Intermittent dosing would be repeated with zoloft and triptans new cycle.
Prior to initiating treatment with ZOLOFT or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [See Warnings and Precautions 5.
Virgo and cancer romance the recommended starting dosage and therapeutic range in patients with mild hepatic impairment Child Pugh scores 5 or 6 are half the recommended daily dosage [See Dosage and Administration 2. Oral solution new name, same product as oral concentrate: It is supplied as a 60 mL bottle with an accompanying calibrated dropper that has 25 mg and 50 mg graduation marks.
In pooled analyses of placebo-controlled trials of antidepressant drugs SSRIs and other antidepressant classes that included approximately 77, adult patients and over 4, pediatric patients, the incidence of suicidal thoughts and zoloft and triptans in pediatric and young adult patients was greater in antidepressant-treated patients than in placebo-treated patients.
The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per patients treated are provided in Table 2. No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide. It is unknown whether the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use, i. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression.
Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes.
Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing ZOLOFT, in patients whose depression is persistently worse, zoloft and triptans, or who are experiencing emergent suicidal thoughts or behaviors. The risk is increased with concomitant use of other serotonergic drugs including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St.
Serotonin syndrome can also occur when these drugs are used alone. Serotonin syndrome signs and symptoms may include mental status changes e. No reports involved the administration of methylene blue by other routes such as oral tablets or local tissue injection. Discontinue treatment with ZOLOFT and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment.
If concomitant use of ZOLOFT with other serotonergic drugs is clinically warranted, inform patients of the increased risk for serotonin syndrome and viagra and dogs for symptoms. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs NSAIDsother antiplatelet drugs, warfarin, and other anticoagulants may add to this risk.
Case reports and epidemiological studies case-control and cohort design have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to drugs that interfere with serotonin reuptake have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages.
Inform patients of the increased risk of bleeding associated with the concomitant use of ZOLOFT and antiplatelet agents or anticoagulants.
For patients zoloft and triptans warfarin, zoloft and triptans, carefully monitor the international normalized ratio, zoloft and triptans. In controlled clinical trials, patients with bipolar disorder were generally zoloft and triptans however, symptoms renin inhibitors and cozaar combo mania or hypomania were reported in 0.
Prior to initiating treatment with ZOLOFT, screen patients for any personal or family history of bipolar disorder, mania, zoloft and triptans, or hypomania, zoloft and triptans. Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: A gradual reduction in dosage rather than abrupt cessation is recommended whenever possible [See Dosage and Administration 2, zoloft and triptans.
Patients with a history of seizures were excluded zoloft and triptans clinical studies. The pupillary dilation that occurs following use of many antidepressant drugs including ZOLOFT may trigger an angle closure attack in a patient with anatomically narrow angles who does not zoloft and triptans a patent iridectomy. Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to ultraviolet light and vitamin d. Signs and symptoms associated with more severe or acute cases have included hallucination, syncope, zoloft and triptans, seizure, coma, respiratory arrest, and death.
In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion SIADH.
This finding is due to lack of specificity of the screening tests. Most reports were confounded by zoloft and triptans risk factors. In a randomized, double-blind, placebo- and positive-controlled three-period crossover thorough QTc study in 54 healthy adult subjects, there was a positive relationship between the length of the rate-adjusted Zoloft and triptans interval and serum sertraline concentration.
The following adverse reactions are described in more detail in viagra and blindness sections of the prescribing information:.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to speed and blood pressure in the clinical trials of another drug and may not reflect the rates observed in practice, zoloft and triptans. In placebo-controlled studies, the following were the common adverse reactions leading to discontinuation in ZOLOFT-treated patients:.
Although changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of SSRI treatment. However, reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance and satisfaction are difficult to obtain, in part because patients and healthcare providers may be reluctant to discuss them.
Accordingly, estimates of the incidence of untoward sexual experience and performance cited in labeling may underestimate their actual incidence. In pediatric patients treated with ZOLOFT in placebo-controlled studies, the overall profile of adverse reactions was generally similar to that seen in adult studies, zoloft and triptans.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Based on pharmacokinetic studies, no dosage adjustment of ZOLOFT is necessary when used in combination with cimetidine. Overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in comparator populations.
Some studies have reported increases for specific major birth defects; however, zoloft and triptans, these study results are inconclusive [See Data ]. Although no teratogenicity was observed in zoloft and triptans reproduction studies, delayed fetal ossification was observed when sertraline was administered during the period of organogenesis at doses less than the maximum recommended human dose MRHD in rats and doses 3, zoloft and triptans.
When sertraline was administered to female rats during the last third of gestation, zoloft and triptans, there was an increase in the number of stillborn zoloft and triptans and pup deaths during the first four days after birth at the MRHD [See Data ].
The background risk of major birth defects and miscarriage for the indicated population are unknown. A prospective longitudinal study followed pregnant women with a history of major depression who were euthymic taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants.
Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. When treating a pregnant woman with ZOLOFT during the third trimester, carefully consider both the potential risks and benefits of treatment.
These findings are based on post-marketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, zoloft and triptans, irritability, and constant crying.
In some cases, the clinical picture was consistent with serotonin syndrome [See Warnings and Precautions 5. PPHN occurs in 1—2 per 1, live births in the general population and is associated with substantial neonatal morbidity and mortality. 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.
The weight of evidence from epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in pregnant women who were not exposed to sertraline.
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.
These doses correspond to approximately 3. There was no evidence of teratogenicity at any dose level. When female rats received sertraline during the last third of gestation and throughout lactation, there was an increase in stillborn pups and pup deaths during the first 4 days zoloft and triptans birth.
Pup body weights were also decreased during the first four days after birth. The decrease in pup survival was shown to be due to in utero exposure to sertraline, zoloft and triptans. The clinical significance of these effects is unknown. Available data from published literature demonstrate low levels of sertraline and its metabolites in human milk [See Data ]. There zoloft and triptans no data on the effects of sertraline on milk production.
No adverse reactions were observed in these infants. Safety and effectiveness in pediatric patients in patients with OCD below the age of 6 have not been established.
Safety and effectiveness have not been established in pediatric patients for indications other than OCD. Two placebo-controlled trials were conducted in pediatric patients with MDD, but the data were not sufficient to support an indication for use in pediatric patients.
Monitor all patients being zoloft and triptans with antidepressants for clinical worsening, suicidal thoughts, and unusual changes in behavior, especially during the initial few months of treatment, or at times of dose increases or decreases [See Boxed WarningWarnings and Precautions 5. Decreased appetite and weight loss have been observed with the use of SSRIs. However, there are no studies that directly evaluate the long-term effects of ZOLOFT on the growth, development, and maturation in pediatric patients.
A study conducted in juvenile rats at clinically relevant doses showed delay in sexual maturation, but there was no effect on fertility in either males or females. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be conservative, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy, zoloft and triptans.
The recommended dosage in patients with mild hepatic impairment Child-Pugh score 5 or 6 is half the recommended dosage due to increased exposure in this patient population. No dose adjustment is needed in patients with mild to severe renal impairment. Sertraline exposure does not appear to be affected by renal impairment [See Clinical Pharmacology In a placebo-controlled, double-blind, randomized study of the comparative abuse liability of ZOLOFT, zoloft and triptans, alprazolam, and d-amphetamine in humans, ZOLOFT did not produce the positive subjective effects indicative of abuse potential, such as euphoria or drug zoloft and triptans, that were observed with the other two drugs.
The most common signs and symptoms associated with non-fatal ZOLOFT overdosage were somnolence, zoloft and triptans, vomiting, tachycardia, nausea, dizziness, agitation and tremor. No cases of fatal overdosage with only sertraline have been reported. Other important adverse events reported with ZOLOFT overdose single or multiple drugs include bradycardia, bundle branch block, coma, convulsions, delirium, zoloft and triptans, hallucinations, hypertension, hypotension, manic reaction, pancreatitis, QTc-interval prolongation, Torsade de Pointes, serotonin syndrome, stupor, and syncope [See Clinical Pharmacology Contact Poison Control for latest recommendations.
Sertraline hydrochloride has a molecular weight of Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol.
Each mL of solution contains The solution contains the following inactive ingredients: The oral solution must be diluted prior to administration [See Dosage and Administration 2.