There are no adequate studies in pregnant women. However, a substantial amount of available data has not revealed that sertraline induces congenital malformations.
Effects on ability to drive and use machines
Clinical pharmacology studies have shown that sertraline does not affect psychomotor skills. However, is 25mg of zoloft enough for anxiety because psychotropic drugs can alter the mental or physical faculties required to deal with potentially dangerous tasks, such as driving a car or operating machinery, patients should be appropriately warned.
Side effects
Nausea is the most common side effect. In the treatment of social anxiety disorder, sexual dysfunction (ejaculation failure) occurred in men in 14% of subjects being treated with sertraline.
Overdose
Toxicity
Sertraline has a safety margin that depends on the patient population and / or the use of concomitant medications . Deaths have been reported due to overdoses of sertraline, taken alone or in combination with other medicines and / or alcohol. Therefore, any case of overdose should be managed with aggressive clinical treatment.
Symptoms
Symptoms of overdose include serotonin-mediated undesirable effects such as somnolence, gastrointestinal disturbances (eg nausea and vomiting), tachycardia, tremor, agitation and dizziness. Coma episodes have been reported although less frequently.
Cases of QTc interval prolongation / Torsade de Pointes have been reported following overdose of sertraline; ECG monitoring is therefore recommended in all cases of ingestion of excessive doses of sertraline (see sections 4.4, 4.5 and 5.1).
Management
There are no specific antidotes to sertraline. It is recommended to establish and maintain a clear airway and, if necessary, to ensure adequate oxygenation and ventilation. Activated charcoal, which can be used with a cathartic, can be as effective or more effective than gastric lavage and should be considered when treating overdose. Induction of emesis is not recommended. Along with general symptomatic and supportive measures, cardiac (eg ECG) and vital signs monitoring is also recommended. Due to the large volume of distribution of sertraline, forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit.
Pharmacodynamic properties
Pharmacotherapeutic group: Selective serotonin reuptake inhibitors (SSRIs). ATC code: N06AB06.
Mechanism of action
Sertraline is a potent specific inhibitor of neuronal uptake of serotonin (5-HT) in vitro, with a …
Pharmacokinetic properties
Absorption
In humans, following a daily oral dose of 50 mg-200 mg for 14 days, peak plasma concentrations of sertraline are reached between 4.5 and 8.4 …
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. Reproductive toxicity studies …
List of excipients
Film-coated tablets Tablet
core:
calcium hydrogen phosphate dihydrate (E341)
microcrystalline cellulose (E460)
hydroxypropyl cellulose (E463)
sodium starch glycolate (type A)
magnesium stearate (E572)
Tablet coating:
Opadry
