Zoloft: Instructions for use
- 1 tablet contains Sertraline (hydrochloride) 100 mg;
- Other ingredients: calcium phosphate, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate, hydroxypropylmethylcellulose, polyethylene glycol, polysorbates, titanium dioxide (E171).
Zoloft is an antidepressant, a powerful specific inhibitor of the reuptake of serotonin (5-HT) neurons. It has a very little effect on the reuptake of noradrenaline and dopamine. At therapeutic doses, blocks the uptake of serotonin in human platelets. It has no stimulating, sedative or anticholinergic action. Due to the selective inhibition of 5-HT capture, sertraline does not enhance adrenergic activity. Sertraline has no affinity for muscarinic, serotonin, dopamine, histamine, GABA-, benzodiazepine and adrenoceptors. Sertraline doesn’t cause drug dependence or an increase in body weight during chronic administration.
Indications for use
- Depression of different etiology (treatment and prevention);
- Obsessive-compulsive disorder (OCD);
- Panic disorder;
- Post-traumatic stress disorder (PTSD);
- Social phobia.
- Co-administration of MAO inhibitors and pimozidum;
- lactation period (breastfeeding);
- children under 6 years of age;
- hypersensitivity to the components of the drug.
Patients with organic brain diseases (including mental retardation), epilepsy, liver and/or kidney failure, marked by a reduction of body weight should take this preparation with caution.
Dosing and Administration
- The drug is prescribed 1 time per day in the morning or in the evening;
- The tablets can be taken without food;
- For the first signs of depression and OCD, treatment begins with a dosage of 50 mg per day;
- Treatment of panic disorder, PTSD, and social phobia begins with a dosage of 25 mg per day, which is increased after 1 week to 50 mg per day;
- Use of the drug according to such a scheme reduces the frequency of early treatment of adverse effects, typical for panic disorder;
- With a little effect of the application of sertraline by patients with a dosage of 50 mg/day, the daily dosage can be increased;
- The dose should be increased at intervals of not more than 1 time per week to a maximum recommended dose of 200 mg/day;
- The initial effect can be observed within 7 days after beginning treatment, but the overall effect is usually achieved after 2-4 weeks (or even after a long time in OCD);
- During the long-term maintenance therapy, the drug is administered in a minimum effective dose which subsequently can be changed depending on the clinical effect;
- Children and adolescents aged 13-17, suffering from OCD, should start treatment with a dose 50 mg per day;
- Children aged 6-12 years start OCD therapy with a dose of 25 mg per day, in 1 week it may be increased to 50 mg/day. Subsequently, in a case of a little effect, the dose can be increased gradually from 50 mg/day. to 200 mg / day. if needed;
- To avoid overdosing with increasing doses from 50 mg, take into account the smaller body weight of children as compared to adults;
- The dose should be changed at intervals of not less than 1 week;
- Elderly patients take the drug in the same dose as younger patients.
Zoloft and Pregnancy
There are no controlled results of sertraline appliance for pregnant women, so this drug may be prescribed during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.
Women of reproductive age should use effective methods of contraception during treatment with Sertraline. Sertraline is found in breast milk, therefore the use of Zoloft during lactation is not recommended. There is no reliable data on the safety of its use in this case. If the use of the drug is necessary, breastfeeding should be discontinued. In the case of sertraline use during pregnancy and lactation, some newborns whose mothers took antidepressants from the group of selective serotonin reuptake inhibitors, including serotonin, may experience symptoms similar to the reaction to the abolition of the drug.
Sertraline should not be administered together with MAO inhibitors and within 14 days after discontinuation of treatment with MAO inhibitors. Similarly, after the abolition of sertraline, you can not take MAOIs within 14 days.
With the use of selective serotonin reuptake inhibitors, there are described cases of serotonin syndrome and NMS, the risk of which is increased when combining SSRIs with other serotonergic drugs (including triptans), as well as drugs that affect the metabolism of serotonin (including MAO inhibitors), antipsychotics and other dopamine receptor antagonists.
Manifestations of serotonin syndrome may be the following:
- Mental status changes (eg, agitation, hallucinations, coma);
- autonomic lability (tachycardia, blood pressure fluctuations, hyperthermia);
- changes in neuromuscular transmission (hyperreflexia, incoordination) and/or disorders of the gastrointestinal tract (nausea, vomiting, and diarrhea).
Some symptoms of serotonin syndrome, including hyperthermia, muscle rigidity, autonomic lability with rapid fluctuations of vital signs parameters, and changes in mental status, may resemble symptoms developing at NSA. Monitoring of patients for the development of serotonin syndrome and NM is compulsory.
Severe symptoms are not observed with an overdose of sertraline, even when using the drug in high doses. However, Zoloft and alcohol combination may cause severe poisoning, even coma and lethal outcome. In case of overdose, a patient may experience the following overdose symptoms:
- increased sweating;
- myoclonus hyperreflexia.
Treatment: There are no specific antidotes. It requires intensive supportive care and constant monitoring of vital body functions. Vomiting induce is not recommended. Introduction of the activated carbon can be more effective than gastric lavage. It is necessary to maintain airway patency. In a large Vd sertraline, in this regard, increased diuresis, dialysis, hemoperfusion or blood transfusion may be ineffective.
The drug should be stored out of reach of children at or above 30° C.