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 the number of stillborn pups and in the number of pups dying during the first 4 days after 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. The clinical significance of these effects is unknown. There are no adequate and well-controlled studies in pregnant women. Sertraline hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy-Nonteratogenic Effects Neonates exposed to sertraline and other SSRIs or SNRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding.
These findings are based on postmarketing 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, irritability, and constant crying.
PPHN occurs in 1 to 2 per 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 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy.
There is currently no corroborative evidence regarding the risk for PPHN following exposure to SSRIs in pregnancy; this is the first study that has investigated the potential risk. Physicians should note that in a prospective longitudinal study of women with a history of major depression who were euthymic in the context of antidepressant therapy at the beginning of pregnancy, women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication.
Labor and Delivery The effect of sertraline on labor and delivery in humans is unknown. Nursing Mothers It is not known whether, and if so in what amount, sertraline or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sertraline is administered to a nursing woman. Clinical Worsening and Suicide Risk. Anyone considering the use of sertraline hydrochloride tablets in a child or adolescent must balance the potential risks with the clinical need.
Approximately patients between 6 and 17 years of age have received sertraline in clinical trials, both controlled and uncontrolled. As with other SSRIs, decreased appetite and weight loss have been observed in association with the use of sertraline. At baseline the mean weight for children was 39 kg for sertraline and At baseline the mean weight for adolescents was There was a bigger difference between sertraline and placebo in the proportion of outliers for clinically important weight loss in children than in adolescents.
A mean weight loss of approximately 0. The subjects continuing in the open label study began gaining weight compared to baseline by week 12 of sertraline treatment. Regular monitoring of weight and growth is recommended if treatment of a pediatric patient with an SSRI is to be continued long term. Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely. Your doctor will check your progress and the effects of this medicine at regular visits.
Keep all medicine out of the reach of children. Never share your medicine with anyone. Possible side effects Summary More details Call your doctor right away if you notice any of these side effects: Itching or hives , swelling in your face or hands , swelling or tingling in your mouth or throat , chest tightness, trouble breathing Blistering , peeling, or red skin rash Confusion, weakness, and muscle twitching Eye pain, vision changes, seeing halos around lights Feeling more excited or energetic than usual Thoughts of hurting yourself or others, unusual behavior Unusual bleeding or bruising.
A serotonin balance is reached between attachment to the nearby nerves and reuptake. Selective serotonin inhibitors block the reuptake of serotonin, therefore changing the level of serotonin in the brain. It is believed that some illnesses such as depression are caused by disturbances in the balance between serotonin and other neurotransmitters. The leading theory is that drugs such as sertraline restore the chemical balance among neurotransmitters in the brain.
Review of hepatotoxicity of antidepressants mentions that clinically apparent liver injury from the SSRIs is rare and serratine has been implicated in only a few cases of severe hepatic injury. Pharmacotherapy of depression and anxiety disorders. Textbook of pharmacology and therapeutics. Toleration and safety of sertraline: Int Clin Psychopharmacol ; 6 Suppl 2: Menon RR, Howard R.
Sertraline and liver toxicity in the elderly. Int J Geriatr Psychiatry ; 9: Symptomatic liver injury probably related to sertraline. Gastroenterol Clin Biol ; If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered.
Subsequently, the physician may continue decreasing the dose, but at a more gradual rate. Concomitant treatment with irreversible monoamine oxidase inhibitors MAOIs is contraindicated due to the risk of serotonin syndrome with symptoms such as agitation, tremor and hyperthermia. Sertraline should not be used in combination with a MAOI.
Concomitant use in patients taking pimozide is contra-indicated see section 4. A multiple dose pharmacokinetic study in subjects with mild, stable cirrhosis demonstrated a prolonged elimination half-life and approximately three-fold greater AUC and Cmax in comparison to normal subjects. There were no significant differences in plasma protein binding observed between the two groups.
The use of sertraline in patients with hepatic disease must be approached with caution. If sertraline is administered to patients with hepatic impairment, a lower or less frequent dose should be considered. Sertraline should not be used in patients with severe hepatic impairment see section 4. Paradoxical anxiety Some patients with panic disorder may experience increased anxiety symptoms at the beginning of treatment with antidepressants.
This paradoxical reaction usually subsides within two weeks during continued treatment. A low starting dose is advised to reduce the likelihood of an anxiogenic effect see section 4. Seizures Seizures may occur with sertraline therapy: The medicinal product should be discontinued in any patient who develops seizures. SSRIs should be avoided in patients with unstable epilepsy and patients with controlled epilepsy should be carefully monitored.
SSRIs should be discontinued if there is an increase in seizure frequency. Close surveillance by the physician is required. SSRIs should be discontinued in any patient entering a manic phase. Diabetes In patients with diabetes, treatment with an SSRI may alter glycaemic control, possibly due to improvement depressive symptoms. This risk persists until significant remission occurs.
As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs. It is general clinical experience that the risk of suicide may increase in the early stages of recovery.
Other psychiatric conditions for which Sertraline is prescribed can also be associated with an increased risk of suicide-related events. In addition, these conditions may be co-morbid with major depressive disorder.
The same precautions observed when treating patients with major depressive disorder should therefore be observed when treating patients with other psychiatric disorders. Patients with a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
A meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo in patients less than 25 years old. Close supervision of patients and in particular those at high risk should accompany drug therapy especially in early treatment and following dose changes.
Patients and caregivers of patients should be alerted about the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
This has been reported rarely with the use of SSRIs and generally resolves on discontinuation of therapy. Also patients taking diuretics or who are otherwise volume-depleted may be at greater risk see Use in elderly.
Discontinuation of sertraline should be considered in patients with symptomatic hyponatraemia and appropriate medical intervention should be instituted.
50mg data is available for children under 6 zoloft of age see also section 4. Drugs Metabolized by P 2D6 — Many drugs effective in the treatment of major depressive disorder, e. Rev Esp Enferm Dig. Warfarin Co-administration of sertraline mg daily with warfarin resulted in a small but statistically significant increase in prothrombin time, the clinical significance of which is unknown which may in some rare cases unbalance the INR value. The undesirable effects profile commonly observed in double-blind, placebo controlled studies in patients with OCD, panic disorder, PTSD and social anxiety disorder was similar to that observed in clinical trials in patients tablet depression. Care and prudent zoloft judgment should be exercised when switching, particularly from long-acting agents such as fluoxetine. Seizure Sertraline has not been evaluated in patients with a seizure disorder. When female rats received sertraline during the last third of gestation and throughout lactation, there was an increase in the number of stillborn pups and in the number of pups dying during 50mg first 4 days after birth. Patients should be told that although Sertraline hydrochloride 50mg not been shown to impair the ability of normal subjects to perform tasks requiring complex motor and mental skills in laboratory experiments, drugs that act upon the central nervous tablet may affect some tablets adversely. Care and prudent medical judgment should be exercised when switching, particularly from long-acting agents such as fluoxetine. Weight Loss Significant weight loss may be an undesirable result of treatment with sertraline for some zoloft, but on average, patients in controlled trials had minimal, 1 to 2 pound weight loss, zoloft 50mg tablets, versus smaller changes on placebo. There were subjects in placebo-controlled geriatric clinical studies of Sertraline hydrochloride in major depressive disorder. Patients with depression should be treated for a sufficient period of time of at least 6 months to ensure they are free from symptoms. J Pediatr Gastroenterol Nutr ; If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Name of the medicinal product Sertraline 50 mg Tablets, zoloft 50mg tablets.
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