Zoloft (Sertraline): side effects. Zoloft: instructions for use, analogues and reviews, prices in pharmacies in Russia Zoloft tachycardia

Zoloft is an antidepressant.

Release form and composition

The dosage form of Zoloft is film-coated tablets.

The active ingredient of the drug is sertraline (in the form of hydrochloride), 1 tablet may contain 50 or 100 mg.

Excipients: microcrystalline cellulose, calcium phosphate, hydroxypropyl methylcellulose, hydroxypropyl cellulose, polysorbates, magnesium stearate, sodium starch glycolate, polyethylene glycol, titanium dioxide (E171).

14 tablets are sold. in blisters, 1 or 2 blisters per pack.

Indications for use

Zoloft is used to treat:

Panic disorder;
Social phobia;
Depression of various etiologies (as well as for its prevention);
Post-traumatic stress disorder (PTSD);
Obsessive-compulsive disorder (OCD).

Contraindications

The use of Zoloft is contraindicated:

Children under 6 years old;
During pregnancy;
Breastfeeding women;
Patients taking pimozide;
Simultaneously with MAO inhibitors and within 2 weeks after their cancellation;
In case of hypersensitivity to sertraline or auxiliary components.

It is possible to use the drug, but under close medical supervision when:

Epilepsy;
Organic brain diseases, including mental retardation;
Pronounced decrease in body weight;
Renal / hepatic impairment;
The need to use other drugs that bind to blood plasma proteins (for example, with tolbutamide or diazepam);
Prescribing to the patient agents that affect serotonergic transmission (for example, lithium preparations).

Method of administration and dosage

Zoloft should be taken once a day (morning or evening), regardless of food intake.

The initial daily dose for panic disorder, social phobia and PTSD is 25 mg, after 7 days it is increased to 50 mg. This dosing regimen is preferable because reduces the incidence of side effects associated with the treatment of panic disorder.

Treatment for depression and OCD begins with a daily dose of 50 mg.

If 50 mg / day is not enough to achieve the desired therapeutic effect, the dose is gradually increased, no more than 1 time per week. The maximum allowable daily dosage is 200 mg. It is important to take into account that the first positive dynamics can be observed already a week after the start of taking Zoloft, however, a pronounced effect is achieved by the end of 2-4 weeks, and sometimes even later (for example, with ORK).

When carrying out maintenance therapy, the drug is prescribed in the minimum effective dose. If necessary, it is corrected depending on the clinical effect.

With ORC in children aged 6-12 years, the drug is prescribed at a starting dose of 25 mg / day and only after 7 days is increased to 50 mg. As necessary (in case of insufficient effect), the dosage is gradually increased to the maximum permissible level of 200 mg. To avoid an overdose, when prescribing a dose of more than 50 mg, the child's body weight should be taken into account less than that of an adult.

Treatment of ARC in adolescents over 13 years old is immediately started with a daily dose of 50 mg.

Side effects

When using Zoloft, side effects may occur:

On the part of the digestive system, nausea and / or vomiting, constipation or diarrhea, flatulence, dry mouth, pancreatitis, hepatitis, abdominal pain, jaundice, loss of appetite up to anorexia, liver failure occur relatively often. Rarely, an increase in appetite is possible, in rare cases of prolonged use - a reversible asymptomatic increase in the activity of transaminases in the blood serum;
Reactions from the cardiovascular system, manifested by arterial hypertension, tachycardia, palpitations;
Disturbances from the central and peripheral nervous systems, expressed by extrapyramidal disorders (gait disorder, gnashing of teeth, akathisia, dyskinesia), involuntary muscle contractions, fainting, paresthesia, drowsiness or insomnia, headache, migraine, tremor, dizziness, mania, hypomania , euphoria, hallucinations, psychosis, nightmares, decreased libido, suicide attempts, coma;
Musculoskeletal reactions such as muscle cramps and arthralgia;
Pathologies of the respiratory system, manifested by yawning and bronchospasm;
On the part of the urinary system, urinary retention or incontinence, enuresis are possible;
Disorders of the senses: ringing in the ears, mydriasis, visual impairment;
Disorders of the endocrine system, expressed by hypothyroidism, hyperprolactinemia, inadequate secretion of ADH;
Reactions from the reproductive system: gynecomastia, galactorrhea, decreased potency, delayed ejaculation, priapism, menstrual irregularities;
Reactions from the hematopoietic system (there is a risk of developing leukopenia, thrombocytopenia);
Other side effects: increase or decrease in body weight, increase in serum cholesterol levels, weakness, peripheral edema, bleeding (including gastrointestinal, nasal, hematuria);
Dermatological reactions: alopecia, increased sweating, purpura, flushing or redness of the skin, photosensitivity;
Allergic reactions, manifested by itching, urticaria, periorbital edema, angioedema, facial edema, anaphylactoid reactions. There are isolated cases of epidermal necrolysis and Stevens-Johnson syndrome.

With a sharp cessation of taking Zoloft, there is a risk of developing a withdrawal syndrome, expressed by hallucinations, symptoms of psychosis and depression, hypesthesia, paresthesias, aggressive reactions, anxiety - signs that cannot be distinguished from the symptoms of the underlying disease.

Sertraline overdose is usually not accompanied by the development of severe symptoms. However, with the simultaneous use of Zoloft with other drugs and alcoholic beverages, severe poisoning may occur, in some cases leading to coma and death. In some cases, an overdose of the drug is fraught with the development of serotonin syndrome, manifested by nausea, vomiting, agitation, tachycardia, drowsiness, diarrhea, psychomotor agitation, increased sweating, hyperreflexia, myoclonus. There is no specific antidote to sertraline. Patients who have taken a high dose of Zoloft require intensive therapy aimed at maintaining vital systems and functions. Inducing vomiting is not recommended. Taking activated charcoal is considered preferable to gastric lavage. It is important to maintain a clear airway.

special instructions

By itself, sertraline, as a rule, does not have a negative effect on psychomotor functions. However, its use in combination with other drugs can cause impaired attention and / or coordination of movements. For this reason, during the period of treatment with Zoloft, it is not recommended to drive a car and perform potentially dangerous types of work.

Close attention is necessary for patients who are prescribed Zoloft in combination with drugs that depress the central nervous system.

During the period of treatment, it is forbidden to consume alcohol and medicines containing ethanol.

Patients who take indirect anticoagulants (for example, warfarin) need to control the prothrombin time at the beginning of treatment with Zoloft and after its cancellation.

Cimetidine significantly reduces sertraline clearance.

With prolonged use of Zoloft in a daily dose of 50 mg, there is an increase in the plasma concentration of class IС drugs (propafenone, flecainide), antiarrhythmic drugs, tricyclic antidepressants.

With the combined use of sertraline and lithium preparations, tremor may appear.

When taking sertraline at a dose of 200 mg in combination with antipyrine, there is a decrease in the half-life of the latter.

Special observation is required for patients who are prescribed Zoloft during the period of taking sumatriptan, since such a combination can lead to confusion, increased tendon reflexes, severe weakness, agitation and anxiety.

Analogs

With the same active ingredient, Aleval, Asentra, Deprefolt, Seralin, Serenata, Serlift, Stimuloton, Torin preparations are produced.

Zoloft is a synthetic drug that is used in the treatment of depressive conditions and some other disorders of the nervous system. The active component of Zoloft - sertraline, is characterized by an antidepressant effect, without exerting a stimulating, sedative or anticholinergic effect.

According to numerous reviews about Zoloft, its advantage over other antidepressants is that, with prolonged use, it does not provoke an increase in body weight and drug dependence.

In this article, we will consider why doctors prescribe Zoloft, including instructions for use, analogues and prices for this drug in pharmacies. If you have already used Zoloft, leave your feedback in the comments.

Composition and form of release

Clinical and pharmacological group: antidepressant. Composition of 1 tablet:

Active ingredient: sertraline - 50 or 100 mg (in the form of sertraline hydrochloride);
Auxiliary components: microcrystalline cellulose, calcium phosphate, hydroxypropyl cellulose, magnesium stearate, sodium starch glycolate, hydroxypropyl methylcellulose, polysorbates, polyethylene glycol, titanium dioxide (E171).

Zoloft is produced in the form of coated tablets: oblong, white, on one side is embossed with the inscription "Pfizer", on the other side for a dose of 50 mg - "ZLT | 50", for a dose of 100 mg - "ZLT | 100" (by 14 pcs. In blisters of aluminum foil and opaque polypropylene, 1 or 2 blisters in a cardboard box).

What is Zoloft used for?

Indications for Zoloft:

Depression of various etiologies (treatment and prevention);
Obsessive-compulsive disorder;
Panic disorder;
Post-traumatic stress disorder (PTSD);
Social phobia.

Pharmacodynamics

Antidepressant, a potent specific inhibitor of serotonin (5-HT) reuptake in neurons. Has a very weak effect on the reuptake of norepinephrine and dopamine. In therapeutic doses, it blocks the uptake of serotonin in human platelets. It has no stimulating, sedative or anticholinergic effect.

Due to the selective inhibition of 5-HT uptake, sertraline does not increase adrenergic activity. Sertraline has no affinity for muscarinic cholinergic receptors, serotonin, dopamine, histamine, GABA-, benzodiazepine and adrenergic receptors.
Sertraline does not cause drug dependence, does not cause an increase in body weight with prolonged use.

Instructions for use

According to the instructions for use, Zoloft is used orally, 1 time / day in the morning or in the evening. The tablets can be taken with or without food. When carrying out long-term maintenance therapy, the drug is prescribed in the minimum effective dose, which is subsequently changed depending on the clinical effect.

Initial results may be observed 7 days after starting the drug, but the maximum effect is usually achieved after 2-4 weeks (in the case of OCD, this usually takes a longer time).

For depression and OCD, treatment begins with a dose of 50 mg / day.
Treatment of panic disorder, PTSD and social phobia begins with a dose of 25 mg / day, which is increased after 1 week to 50 mg / day. The use of the drug according to this scheme can reduce the frequency of early adverse effects of treatment, characteristic of panic disorder.
With an insufficient effect of sertraline in patients at a dose of 50 mg / day, the daily dose can be increased. The dose should be increased at intervals of no more than 1 time per week to the maximum recommended dose of 200 mg / day.

The initial effect can be seen as early as 7 days after starting treatment, but the full effect is usually achieved after 2–4 weeks (or even longer for OCD).

In children and adolescents aged 13-17 years with OCD, treatment with Zoloft should be started with a dose of 50 mg / day. In children aged 6-12 years, OCD therapy begins with a dose of 25 mg / day, after 1 week it is increased to 50 mg / day. Subsequently, if the effect is insufficient, the dose can be increased in steps of 50 mg / day to 200 mg / day as needed. In clinical trials in patients with depression and OCD aged 6 to 17 years, it was shown that the pharmacokinetic profile of sertraline was similar to that in adults. To avoid overdose, when the dose is increased over 50 mg, it is necessary to take into account the lower body weight in children compared to adults.

In elderly patients, the drug is used in the same doses as in younger patients. The drug should be used with caution in patients with liver disease. In patients with hepatic impairment, lower doses should be used or the interval between doses should be increased.

Contraindications

Contraindications for Zoloft:

Known hypersensitivity to sertraline;
Simultaneous use of MAO inhibitors and pimozide;
Pregnancy;
Breastfeeding period;
Children under 6 years of age.

With care: organic brain diseases (including mental retardation); epilepsy; hepatic and / or renal failure; marked decrease in body weight.

Side effects

From the peripheral and central nervous systems Zoloft can cause the following side effects:

Gait disorder;
Grinding of teeth;
Drowsiness or insomnia;
Euphoria;
Decreased libido;
Mania and hypomania;
Hallucinations;
Akathisia;
Involuntary muscle contractions;
Dyskinesias;
Paresthesia;
Migraine and headaches;
Nightmares;
Dizziness;
Fainting;
Tremor;
Psychosis;
Coma.

The use of Zoloft can lead to the following side effects from the digestive system:

Constipation or diarrhea;
Pancreatitis;
Liver failure;
Hepatitis;
Flatulence;
Nausea and vomiting;
Stomach ache;
Dry mouth;
Jaundice;
Decreased appetite, up to the development of anorexia.

The use of Zoloft can become the cause of the development of the following allergic and dermatological reactions:

Periorbital edema;
Epidermal necrolysis;
Photosensitivity reaction;
Redness of the skin;
Alopecia;
Purpura;
Angioedema;
Steven Johnson Syndrome;
Anaphylactoid reaction;
Swelling of the face;
Hives;
Itchy skin;
Increased sweating.

On the part of the cardiovascular system against the background of the use of Zoloft, side effects can be observed in the form of tachycardia, palpitations and arterial hypertension, and on the part of the musculoskeletal system, muscle cramps and arthralgia. The use of the drug can cause sexual dysfunction, prypiasm, galactorrhea, menstrual irregularities and gynecomastia.

Overdose

Sertraline overdose did not show severe symptoms even when the drug was prescribed in high doses. However, when administered simultaneously with other drugs or alcohol, severe poisoning can occur, up to coma and death.

Overdose can cause serotonin syndrome with nausea, vomiting, drowsiness, tachycardia, agitation, dizziness, psychomotor agitation, diarrhea, increased sweating, myoclonus and hyperreflexia.

Treatment: no specific antidotes. Requires intensive supportive therapy and constant monitoring of vital body functions. Inducing vomiting is not recommended. The administration of activated charcoal may be more effective than gastric lavage. The airway must be kept clear. Sertraline has a large volume of distribution, in this regard, increased diuresis, dialysis, hemoperfusion or blood transfusion may be ineffective.

Application during pregnancy and lactation

There are no controlled results of the use of sertraline in pregnant women, therefore, it is possible to prescribe Zoloft during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.

Women of reproductive age should use effective contraception during treatment with sertraline.
Sertraline is found in breast milk, and therefore the use of Zoloft during lactation is not recommended. In this case, there is no reliable data on the safety of its use. If the appointment of the drug is necessary, then breastfeeding should be discontinued.

In the case of the use of sertraline during pregnancy and during breastfeeding, some newborns whose mothers took antidepressants from the group of selective serotonin reuptake inhibitors, including serotonin, may experience symptoms similar to the reaction to drug withdrawal.

Additionally

For liver diseases, Zoloft is prescribed in reduced dosages compared to usual. No effects of Zoloft on psychomotor functions have been noted, but the risk of side effects with a weakening of attention and concentration, deterioration of vision, when deciding whether to drive a car, should be taken into account. When working with dangerous machinery while taking Zoloft, you must be extremely careful.

Two weeks is a necessary break between taking Zoloft and MAO inhibitors to prevent possible lethal complications.

Analogs

With the same active ingredient, Aleval, Asentra, Deprefolt, Seralin, Serenata, Serlift, Stimuloton, Torin preparations are produced.

Prices

The average price in pharmacies (Moscow) is 433 rubles.

Storage conditions and periods

List B. The drug should be stored out of the reach of children at a temperature not exceeding 30 ° C. The shelf life is 5 years.

Conditions of dispensing from pharmacies

The drug is available with a prescription.

faith
She took Zoloft for a long time. The drug helped to cope with the terrible PA. However, after withdrawal, an increase in body weight is observed. I have been doing sports seriously and for a very long time. Nowadays, neither grueling exercise nor food control is helping. If someone had such a problem, tell me, there is a chance that over time the weight will return to its previous readings.
Jeanne
I am 22 years old, my condition was very serious, I was in the hospital for 3 weeks and treated me with the wrong one, I pay very dearly to a good qualified psychotherapist for classes, she prescribed me this drug, the side effects were not significant for 2 weeks, now everything is super, I am sure that it’s not repeat, because the condition is excellent. I was terribly afraid to drink them 17 doctors went through in half a year (neurologists, therapists, enderinologists), no one could help then, I was terribly thought that it would not end, but alas, everything passed and I remember with a smile thanks to zoloft and psychotherapy.
Gulya
suffered for almost a year, was diagnosed with cholecystitis, gastritis, liver cyst, etc. in the fall there was an exacerbation of cholecystitis, as I thought, shortness of breath, lost appetite, weakness, underwent MRI, EGD for the second time, ultrasound for the third time, passed a lot of tests: biochemistry, immunoassays, oncotests, I don’t even remember what complex tests were, couldn’t deliver the diagnosis, because the temperature was not knocked down 37.4 was all day, by the evening it returned to normal, whether early menopause was suspected, because it was fever, then chills, fever because the temperature, everything burns, and everything hurts, especially the stomach and abdominal cavity ... I spent the entire course of antibiotics, expensive medicines for the stomach and for cholecystitis. It did not help, for the 7th month there is a subfebrile temperature. I began to say goodbye to family and friends, I thought that my end at 44 years old. I have lost interest in life, I sit and cry…. And finally, the doctors recommended to undergo psychotherapy, she was treated for 20 days in the department of neuroses. So I think the fool did not obey early, quickly missed the time on useless treatments, they said, "This is your neurosis, do not go to the doctors already on the second round ...." The doctor prescribed "ZOLOFT" - the hormones of happiness, as I think .. everything returned to normal over time, the pains disappeared, it took some time, of course, to start smiling, joy came. I have been taking it for the second month already, of course there are side effects, drowsiness and that's it. But there is no other option yet. It helped me!
Alexandra
After an unsuccessful, I would even say, a useless 8-month treatment with other drugs (Paxil, Aleval, etc.), which was prescribed by a local doctor, a private doctor discharged her teenage daughter Zoloft. And almost immediately the improvement of the state of health began, the therapy will be prolonged, tk. we are at the beginning of the road. The effect of treatment for six months is very good and the side effects are not as terrible as in the above-described analogues.

An antidepressant, a specific inhibitor of serotonin (5-HT) reuptake in neurons.
Preparation: ZOLOFT ™

The active substance of the drug: sertraline
ATX coding: N06AB06
KFG: Antidepressant
Reg. number: P No. 013622 / 01-2002
Date of registration: 18.07.08
Owner reg. ID: PFIZER (Italy)

Zoloft release form, drug packaging and composition.

The tablets are white coated, oblong, with an embossed "Pfizer" inscription on one side, with a line and an embossed inscription "ZLT50" on the other side of the tablet.
1 tab.

50 mg

Coated tablets, white, oblong, with the words “Pfizer” pressed on one side and “ZLT100” on the other side of the tablet.
1 tab.
sertraline (as hydrochloride)
100 mg

Excipients: calcium phosphate, microcrystalline cellulose, hydroxypropyl cellulose, sodium starch glycolate, magnesium stearate, hydroxypropyl methyl cellulose, polyethylene glycol, polysorbates, titanium dioxide (E171).

14 pcs. - blisters (1) - cardboard packs.
14 pcs. - blisters (2) - cardboard packs.

The description of the product is based on the officially approved instructions for use.

Pharmacological action Zoloft

An antidepressant, a specific inhibitor of serotonin (5-HT) reuptake in neurons. Has a very weak effect on the reuptake of norepinephrine and dopamine. In therapeutic doses, it blocks the uptake of serotonin in human platelets. It has no stimulating, sedative or anticholinergic effect. Due to the selective inhibition of 5-HT uptake, sertraline does not increase adrenergic activity. Sertraline has no affinity for muscarinic cholinergic receptors, serotonin, dopamine, histamine, GABA-, benzodiazepine and adrenergic receptors.

Sertraline does not cause drug dependence, does not cause an increase in body weight with prolonged use.

Pharmacokinetics of the drug.

Suction

Absorbed completely, but at a slow rate. When the drug is taken simultaneously with food, bioavailability increases by 25%, Cmax increases by 25% and Tmax decreases.

In humans, when taking sertraline at a dose of 50 to 200 mg 1 time / day for 14 days, Cmax was reached 4.5-8.4 hours after administration. Cmax and AUC are proportional to the dose within the range of 50-200 mg of sertraline 1 time / day for 14 days, while the linear nature of the pharmacokinetic dependence is revealed.

Distribution

Plasma protein binding is about 98%.

Before the onset of an equilibrium state, after 1 week of treatment (taking a dose 1 time / day), approximately two-fold cumulation of the drug is observed.

Metabolism

Sertraline undergoes active biotransformation during the "first pass" through the liver. The main metabolite found in plasma, N-desmethylsertraline, is significantly inferior (about 20 times) to sertraline in in vitro activity and is actually inactive in in vivo depression models.

Sertraline and N-desmethylsertraline are actively biotransformed.

Withdrawal

The average T1 / 2 of sertraline in young and elderly men and women is 22-36 hours. T1 / 2 of N-desmethylsertraline varies within 62-104 hours. Metabolites are excreted in the feces and urine in equal amounts. Only a small part of the drug (less than 0.2%) is excreted in the urine unchanged.

Pharmacokinetics of the drug.

in special clinical cases

The pharmacokinetic profile in adolescents and the elderly does not differ significantly from that in patients aged 18 to 65 years.

Shown, that

Pharmacokinetics of the drug.

sertraline in children with OCD is similar to that in adults (although sertraline is slightly more metabolized in children). However, given the lower body weight in children (especially aged 6-12 years), the drug is recommended to be used at a lower dose to avoid excessive plasma levels.

In patients with liver cirrhosis, the T1 / 2 of the drug and the AUC increase in comparison with those in healthy people.

According to a pharmacokinetic study, with repeated administration of sertraline in patients with stable mild liver cirrhosis, an increase in the T1 / 2 of the drug and an almost threefold increase in the AUC (area under the concentration / time curve) and Cmax of the drug were observed in comparison with those in healthy people. There were no significant differences in binding to plasma proteins in the 2 groups.

In patients with mild to moderate renal failure (CC 30-60 ml / min) and in patients with moderate or severe renal failure (CC 10-29 ml / min) pharmacokinetic parameters (AUC0-24 and Cmax) of sertraline after repeated administration did not differ significantly from control. In all groups, the T1 / 2 of the drug was the same, as well as there were no differences in binding to plasma proteins.

Indications for use:

Depression of various etiologies (treatment and prevention);

Obsessive-compulsive disorder (OCD);

Panic disorder;

Post-traumatic stress disorder (PTSD);

Social phobia.

Dosage and method of administration of the drug.

Zoloft is prescribed 1 time / day in the morning or in the evening. The tablets can be taken with or without food.

For depression and OCD, treatment begins with a dose of 50 mg / day.

Treatment of panic disorder, PTSD and social phobia begins with a dose of 25 mg / day, which is increased after 1 week to 50 mg / day. The use of the drug according to this scheme can reduce the frequency of early adverse effects of treatment, characteristic of panic disorder.

With an insufficient effect of sertraline in patients at a dose of 50 mg / day, the daily dose can be increased. The dose should be increased at intervals of no more than 1 time per week to the maximum recommended dose of 200 mg / day.

The initial effect can be seen as early as 7 days after starting treatment, but the full effect is usually achieved after 2–4 weeks (or even longer for OCD).

When carrying out long-term maintenance therapy, the drug is prescribed in the minimum effective dose, which is subsequently changed depending on the clinical effect.

In children and adolescents aged 13-17 years with OCD, treatment with Zoloft should be started with a dose of 50 mg / day. In children aged 6-12 years, OCD therapy begins with a dose of 25 mg / day, after 1 week it is increased to 50 mg / day. Subsequently, if the effect is insufficient, the dose can be increased in steps of 50 mg / day to 200 mg / day as needed. To avoid overdose, when the dose is increased over 50 mg, it is necessary to take into account the lower body weight in children compared to adults. The dose should be changed at intervals of at least 1 week.

In old age, the drug is used in the same doses as in younger patients.

In patients with impaired liver function, lower doses should be used or the interval between doses of the drug should be increased.

In patients with impaired renal function, dose adjustment based on the severity of renal failure is not required.

Side effects of Zoloft:

From the side of the central nervous system and peripheral nervous system: headache, dizziness, tremor, insomnia (rarely - drowsiness), anxiety, agitation, hypomania, mania, gait disturbances, visual impairment, extrapyramidal disorders (dyskinesia, akathisia), paresthesia, convulsions. Movement disorders were more often observed in patients with indications of their presence in the anamnesis or with concomitant use of antipsychotics.

With the termination of treatment with sertraline, rare cases of withdrawal syndrome have been described. Paresthesias, hypesthesia, symptoms of depression, hallucinations, aggressive reactions, agitation, anxiety, or psychosis symptoms that cannot be distinguished from the symptoms of the underlying disease may appear.

On the part of the body as a whole: increased sweating, decrease or increase in body weight, weakness.

From the digestive system: decreased appetite (rarely - increased), up to anorexia, dry mouth, dyspeptic disorders (flatulence, nausea, vomiting, diarrhea), abdominal pain.

From the reproductive system: sexual dysfunction (delayed ejaculation, decreased libido, decreased potency, anorgasmia).

From the side of the cardiovascular system: skin redness or flushing of the face, bleeding (including nosebleeds), palpitations.

Allergic reactions: urticaria, itching.

Dermatological reactions: skin rash; rarely - Stevens-Johnson syndrome, epidermal necrolysis.

From the endocrine system: menstrual irregularities, galactorrhea, hyperprolactinemia.

On the part of laboratory indicators: transient hyponatremia (often develops in elderly patients, as well as when taking diuretics or a number of other drugs. A similar side effect is associated with the syndrome of inadequate secretion of ADH); rarely (with prolonged use) - an asymptomatic increase in the activity of transaminases in the blood serum (withdrawal of the drug leads to the normalization of enzyme activity).

Contraindications to the drug:

Simultaneous administration of MAO inhibitors and pimozide;

Pregnancy;

Lactation period (breastfeeding);

Children under 6 years of age;

Hypersensitivity to sertraline.

With caution - with organic diseases of the brain (including mental retardation), epilepsy, hepatic and / or renal failure, severe weight loss.

Application during pregnancy and lactation.

There are no controlled results of the use of sertraline in pregnant women, therefore, Zoloft can 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 contraception during treatment with sertraline.

Sertraline is found in breast milk, and therefore the use of Zoloft during lactation is not recommended. In this case, there is no reliable data on the safety of its use. If the appointment of the drug is necessary, then breastfeeding should be discontinued.

Special instructions for the use of Zoloft.

Zoloft can be prescribed no earlier than 14 days after the withdrawal of MAO inhibitors. MAO inhibitors can also be prescribed no earlier than 14 days after Zoloft is discontinued.

Care must be taken when concomitantly administering Zoloft with other drugs that enhance serotonergic neurotransmission, such as tryptophan, fenfluramine, or 5-HT agonists. If possible, such a joint appointment should be excluded, given the likelihood of pharmacodynamic interaction.

Zoloft should be used with caution with drugs that depress the central nervous system. The use of alcoholic beverages and preparations containing ethanol during treatment with sertraline is prohibited.

Experience in clinical trials aimed at determining the optimal time required for transferring patients from other antidepressant and antiobsessive drugs to sertraline is limited. Care must be taken with this transition, especially with long-acting drugs such as fluoxetine. The required interval between the withdrawal of one selective serotonin reuptake inhibitor and the start of another similar drug has not been established.

It should be noted that in patients undergoing electroconvulsive therapy, there is no sufficient experience with the use of sertraline. The possible success or risk of such combination therapy has not been studied.

There is no experience with the use of sertraline in patients with convulsive syndrome, therefore, its use in patients with unstable epilepsy should be avoided, and patients with controlled epilepsy should be carefully monitored during treatment. If seizures appear, the drug should be discontinued.

Patients suffering from depression are at risk of suicide attempts. This danger persists until remission develops. Therefore, from the beginning of treatment until the optimal clinical effect is achieved, constant medical supervision should be established for patients.

During clinical studies, hypomania and mania were observed in approximately 0.4% of patients receiving sertraline. Cases of activation of mania / hypomania have also been described in a small proportion of patients with manic-depressive psychosis who received other antidepressant or antiobsessive drugs.

Zoloft should be used with caution in patients with liver disease; it is necessary to correct the dosage regimen.

Use in pediatrics

The safety and effectiveness of sertraline has been established in children with OCD (ages 6 to 17).

Influence on the ability to drive vehicles and use mechanisms

The appointment of sertraline, as a rule, is not accompanied by a violation of psychomotor functions. However, its use simultaneously with other drugs can lead to impaired attention and coordination of movements. Therefore, it is not recommended to drive vehicles, special equipment or engage in activities associated with an increased risk during treatment with sertraline.

Drug overdose:

Sertraline overdose did not show severe symptoms even with high doses of the drug. However, when administered simultaneously with other drugs or alcohol, severe poisoning may occur.

Symptoms: manifestations of serotonin syndrome: nausea, vomiting, drowsiness, tachycardia, agitation, dizziness, psychomotor agitation, diarrhea, increased sweating, myoclonus and hyperreflexia.

Interaction of Zoloft with other drugs.

With the combined use of sertraline and pimozide, there has been an increase in pimozide levels with its single administration in a low dose (2 mg). Increases in pimozide levels were not associated with any ECG changes. Since the mechanism of this interaction is not known, and pimozide has a narrow therapeutic index, the simultaneous administration of pimozide and sertraline is contraindicated.

There are severe complications with the simultaneous use of sertraline and MAO inhibitors, including selectively acting (selegiline) and with a reversible type of action (moclobemide). The development of serotonin syndrome is possible: hyperthermia, rigidity, myoclonus, lability of the autonomic nervous system (rapid fluctuations in the parameters of the respiratory and cardiovascular systems), changes in mental status, including increased irritability, pronounced agitation, confusion, which in some cases can turn into a delirious state or to whom.

With the joint appointment of warfarin with sertraline, there is a slight, but statistically significant increase in prothrombin time - in these cases, it is recommended to control the prothrombin time at the beginning of treatment with sertraline and after its cancellation.

Pharmacokinetic interaction

Sertraline binds to plasma proteins. Therefore, it is necessary to take into account the possibility of its interaction with other drugs that bind to proteins (for example, diazepam and tolbutamide).

Concomitant use with cimetidine significantly reduces sertraline clearance.

Long-term treatment with sertraline at a dose of 50 mg / day increases the plasma concentration of simultaneously used drugs, in the metabolism of which the CYP2D6 isoenzyme takes part (tricyclic antidepressants, antiarrhythmic drugs of the IC class - propafenone, flecainide).

Experiments to study the interaction in vitro have shown that the beta-hydroxylation of endogenous cortisol carried out by the isoenzymes CYP3A3 / 4, as well as the metabolism of carbamazepine and terfenadine, do not change with long-term administration of sertraline at a dose of 200 mg / day.

The plasma concentration of tolbutamide, phenytoin and warfarin also does not change with long-term administration of sertraline at the same dose. Thus, it can be concluded that sertraline does not inhibit the CYP2C9 isoenzyme.

However, with the simultaneous administration of sertraline, the clearance of tolbutamide decreases - control of blood glucose levels is necessary.

Sertraline does not affect the serum diazepam concentration, which indicates the absence of inhibition of the CYP2C19 isoenzyme. According to in vitro studies, sertraline practically does not affect or minimally inhibits the CYP1A2 isoenzyme.

Pharmacokinetics of the drug.

lithium does not change with the concomitant administration of sertraline. However, tremors are more common when they are used together. The combined use of sertraline with drugs that affect serotonergic transmission (for example, with lithium) requires increased caution.

When replacing one inhibitor of neuronal serotonin seizure with another, there is no need for a "washout period". However, care must be taken when changing the course of treatment. Avoid co-administration of tryptophan or fenfluramine with sertraline.

Sertraline causes minimal induction of liver enzymes. The simultaneous administration of sertraline at a dose of 200 mg and antipyrine leads to a small (5%) but significant decrease in the half-life of antipyrine.

When administered together, sertraline does not alter the beta-blocking action of atenolol.

With the introduction of sertraline in a daily dose of 200 mg, drug interactions with glibenclamide and digoxin were not detected.

Long-term use of sertraline at a dose of 200 mg / day does not have a clinically significant effect and does not suppress phenytoin metabolism. Despite this, it is recommended to carefully monitor the level of phenytoin in the blood plasma from the moment of administration of sertraline with a corresponding adjustment of doses of phenytoin.

There have been extremely rare cases of weakness, increased tendon reflexes, confusion, anxiety and agitation in patients who were simultaneously taking sertraline and sumatriptan. It is recommended to monitor patients who have an appropriate clinical reason for the simultaneous administration of sertraline and sumatriptan.

Conditions of sale in pharmacies.

The drug is available with a prescription.

Terms of storage conditions of the drug Zoloft.

List B. The drug should be stored out of the reach of children at a temperature not exceeding 30 ° C. The shelf life is 5 years.

Film-coated tablets - 1 tab .:

sertraline (as hydrochloride) - 50/100 mg;
excipients: calcium phosphate; MCC; hydroxypropyl cellulose; sodium starch glycolate; magnesium stearate; hydroxypropyl methylcellulose; polyethylene glycol; polysorbates; titanium dioxide (E 171)

The blister contains 14 pcs.; in a box 1 or 2 blisters.

pharmachologic effect

Specifically inhibits serotonin reuptake.

Indications for use of Zoloft

Depression of various origins.

Contraindications to the use of Zoloft

severe renal dysfunction;
glaucoma;
prostate adenoma;
epilepsy;
hypersensitivity to the drug.

Zoloft Use during pregnancy and children

Contraindicated in pregnancy and lactation.

Zoloft Side effects

headache, sleep disturbances, increased anxiety;
dizziness, increased fatigue;
decreased libido, weakening or disappearance of orgasm;
nausea, diarrhea, dry mouth, decreased appetite;
allergic reactions.

Drug interactions

Competes with other drugs for the connection with plasma proteins (diazepam, tolbutamide, warfarin, cimetidine). Concomitant use with lithium leads to an increase in the frequency of side effects. Incompatible with serotonergic drugs (such as tryptophan or fenfluramine).

Zoloft dosage

Assign 1 tablet once a day in the morning or in the evening, you can take it regardless of food intake. The maximum daily dose is 200 mg.

Overdose

Unlikely (has wide safety margins). Fatal cases have been reported with an overdose of sertraline in combination with other drugs or alcohol. Treatment is symptomatic, there are no specific antidotes.

Precautionary measures

At least 2 weeks should elapse between discontinuation of the drug and the appointment of an MAO inhibitor and vice versa. Patients with impaired liver function should be treated with lower doses. Use with caution in combination with diazepam, tolbutamide, warfarin, cimetidine, as well as in patients with impaired renal function. When combined with lithium preparations, it is recommended to control the level of the latter in plasma.