Zoloft - Instructions For The Use Of Tablets, Analogs, Reviews, Price

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Zoloft

Zoloft: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. For violations of liver function
12. 12. In case of impaired renal function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Zoloft

ATX code: N06AB06

Active ingredient: sertraline (sertraline)

Manufacturer: Haupt Pharma Latina (Italy), Pfizer Inc. (USA)

Description and photo update: 2019-13-08

Prices in pharmacies: from 420 rubles.

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Zoloft is a drug with an antidepressant effect.

Release form and composition

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

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).

Pharmacological properties

Pharmacodynamics

The antidepressant sertraline is a potent selective serotonin (5-HT) reuptake inhibitor and, at the same time, only slightly affects the reuptake of dopamine and norepinephrine.

When used in therapeutic doses, sertraline is able to block the reuptake of serotonin in human platelets. Controlled clinical studies indicate the absence of anticholinergic, sedative or stimulating effects, as well as cases of impaired psychomotor functions in volunteers. With prolonged use of sertraline, the development of drug dependence is not observed, and long-term treatment with this substance does not lead to an increase in body weight.

Animal studies have shown that, due to the selective inhibition of 5-HT uptake, sertraline has no affinity for muscarinic (cholinergic), dopaminergic, adrenergic, serotonergic, histaminergic, benzodiazepine or GABA receptors, and also does not enhance catecholamine activity and does not have a cardiotoxic effect.

Taking sertraline does not lead to drug abuse. A placebo-controlled, double-blind, comparative study examining the abuse potential of sertraline, dextroamphetamine, and alprazolam did not reveal this ability in sertraline. At the same time, patients treated with dextroamphetamine and alprazolam were more likely to develop drug abuse compared with placebo. To assess the degree of propensity to abuse, indicators were measured such as the ability of the drug to cause abuse, euphoria and positive emotions. Sertraline was not a positive stimulus for those accustomed to self-administration of cocaine rhesus monkeys (in contrast to the use of dextroamphetamine and phenobarbital).

Pharmacokinetics

When using sertraline at a dose of 50-200 mg, the increase in C _max and AUC is dose-proportional and linear. In the case of taking sertraline at a dose of 50-200 mg once a day for 14 days, C _max was observed 4.5-8.4 hours after administration. Absorption is high and slow. When taken simultaneously with food, the bioavailability of the drug changes slightly (by 25%).

Sertraline binds well to blood plasma proteins (approximately 98%).

During the first passage through the liver, active biotransformation of sertraline occurs. The main metabolic pathway is N-demethylation. The main metabolite, N-desmethylsertraline, is found in plasma, the activity of which is approximately 20 times less than that of sertraline in vitro. In addition, this metabolite is virtually inactive in in vivo models of depression. The half-life of N-desmethylsertraline is from 62 to 104 hours.

Sertraline and N-desmethylsertraline undergo oxidative deamination and subsequent reduction, hydroxylation and glucuronidation. When labeled sertraline is administered to healthy volunteers, less than 5% of radioactive sertraline is found in blood plasma. After 9 days, approximately 40–45% of the administered dose was found in urine, another 40–45% - in feces (including 12–14% of unchanged sertraline). Unchanged sertraline in a small amount (<0.2%) is excreted by the kidneys.

AUC (0-24 hours), _{Cm ax} and _{Cm in} N-desmethylsertraline increases depending on time and dose from 1 to 14 days approximately 5-9 times.

The average elimination half-life of sertraline in both young and elderly patients is 22 to 36 hours. When Zoloft is taken 1 time per day for 1 week, approximately two-fold cumulation of the drug is observed until the onset of equilibrium concentrations. The half-life of N-desmethylsertraline is 62-104 hours. Sertraline and N-desmethylsertraline are actively biotransformed, the resulting metabolites are excreted through the intestine and by the kidneys in equal amounts. The pharmacokinetic profile in patients aged 18–65 years does not differ from those in adolescents and the elderly.

The pharmacokinetics of sertraline in children with OCD (obsessive-compulsive disorder) are similar to those in adults, although the metabolism of sertraline in children is slightly more active. At the same time, the body weight in children (especially between the ages of 6 and 12 years) is lower, therefore, during therapy, it is necessary to use smaller doses of the drug.

Repeated reception of sertraline patients with liver cirrhosis, lung flow leads to an increase in half-life and Zoloft almost tripling C _{m ax} and AUC (compared to healthy people). In these two groups, no significant differences were observed in the binding of sertraline to blood plasma proteins. When treating patients with impaired liver function with the drug, it is necessary to assess the feasibility of reducing the dose or lengthening the interval between doses of the drug.

With repeated administration of sertraline in patients with mild to moderate renal impairment (CC from 30 to 60 ml / min) and patients with moderate or severe renal impairment (CC from 10 to 29 ml / min) C _max and AUC of the drug did not differ significantly from the group control. The half-life of sertraline was the same in all groups. Also, no differences were observed in binding to blood plasma proteins. Excretion of sertraline by the kidneys is negligible, therefore, dose adjustment of Zoloft is not required in renal failure.

Indications for use

• Sociophobia (social anxiety disorder);
• OCD (obsessive compulsive disorder);
• PTSD (post-traumatic stress disorder);
• Episodic paroxysmal anxiety (panic disorder);
• Depressive states of various etiologies (prevention and therapy).

Contraindications

Absolute:

• Simultaneous use of sertraline with monoamine oxidase inhibitors (MAO) and pimozide;
• Age up to 6 years;
• Hypersensitivity to drug components.

With caution (due to the increased likelihood of complications):

• Epilepsy;
• Severe weight loss;
• Organic brain damage (including mental retardation);
• Renal and / or hepatic impairment.

Controlled studies on the use of sertraline during pregnancy have not been carried out, therefore, prescribing the drug to pregnant women is allowed only if the expected benefit to the mother significantly exceeds the potential risk of developing fetal pathologies. Women of reproductive age who are expected to prescribe Zoloft for therapy should use effective contraceptives.

Sertraline passes into breast milk. Taking Zoloft during breastfeeding is not recommended, since the safety of use in this case has not been reliably confirmed. If treatment is necessary, then temporarily stop breastfeeding.

As a result of the use of sertraline during pregnancy and during breastfeeding in combination with antidepressants from the SSRI group (selective serotonin reuptake inhibitors), including serotonin, some newborns may experience withdrawal-like symptoms.

Instructions for the use of Zoloft: method and dosage

Zoloft is taken orally, regardless of food intake, once a day, in the morning or in the evening:

• OCD and depressive states of various etiologies: initial dose - 50 mg per day;
• PTSD, social phobia, panic disorder: the initial dose is 25 mg per day, after 1 week the dose is increased to 50 mg per day (such a scheme reduces the frequency of early undesirable effects from therapy, characteristic of panic disorder).

If the use of sertraline at a dose of 50 mg per day is not effective enough, the dose can be increased. It is recommended to increase the dose at intervals of no more than 1 time per week, not exceeding the maximum recommended dose of 200 mg per day.

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

For a course of long-term maintenance treatment, Zoloft is prescribed in the minimum effective dose, which can be changed depending on the clinical result achieved.

Recommended dosing regimen for the treatment of OCD in children and adolescents, depending on age:

• 6-12 years: the initial dose is 25 mg per day, after 1 week it is increased to 50 mg per day; in the future, if the effect is insufficient, the dose can be increased in steps of 50 mg to 200 mg per day;
• 13-17 years old: initial dose - 50 mg per day.

Clinical studies of the pharmacokinetic profile of sertraline in patients with depression and OCD aged 6 to 17 years showed that it was similar to that in adults. In order to avoid an overdose, increasing the dose of Zoloft more than 50 mg, it should be borne in mind that children have less body weight than adults.

The half-life of sertraline is about a day, so the dose should be changed at intervals of at least a week.

In old age, dose adjustment of Zoloft is not required.

Side effects

• Cardiovascular system (CVS): tachycardia, heart palpitations, arterial hypertension;
• Digestive system: abdominal pain, dry mouth, pancreatitis, dyspeptic disorders (nausea, vomiting, flatulence, diarrhea, constipation);
• Musculoskeletal system: muscle cramps, arthralgia;
• Respiratory system: yawning, bronchospasm;
• Central and peripheral nervous system: paresthesias, fainting, migraine, headache, dizziness, tremors, drowsiness, insomnia, anxiety, hypomania, mania, agitation, hallucinations, euphoria, psychosis, decreased libido, nightmares, suicide, coma, extrapyramidal disorders (akathisia, bruxism, dyskinesia, gait disturbance);
• Urinary system: enuresis, urinary retention or incontinence;
• Reproductive system and mammary gland: galactorrhea, gynecomastia, impaired sexual function (decreased potency, delayed ejaculation), menstrual irregularities, priapism;
• Organs of vision: mydriasis, visual impairment;
• Endocrine system: hypothyroidism, hyperprolactinemia, syndrome of inappropriate antidiuretic hormone (ADH) secretion;
• Hepatobiliary system: jaundice, hepatitis, liver failure;
• Allergic reactions: itching, urticaria, anaphylactoid reaction;
• Others: weakness, ringing in the ears, "flushing" of blood to the face or redness of the skin, alopecia, facial edema, angioedema, periorbital edema, photosensitivity reaction, increased sweating, purpura, decreased appetite, up to anorexia (rarely - increase), increase or weight loss, bleeding (including gastrointestinal, nasal, or hematuria), peripheral edema, rarely Steven-Johnson syndrome, and epidermal necrolysis;
• Laboratory data: in the case of prolonged use, an asymptomatic increase in serum transaminase activity rarely occurs (when the drug is canceled, the enzyme activity is normalized); development of thrombocytopenia and leukopenia, increased serum cholesterol levels are possible; cessation of sertraline therapy in rare cases can cause a withdrawal syndrome, accompanied by paresthesias, hypesthesia, symptoms of depression, hallucinations, aggressive reactions, psychomotor agitation, anxiety or psychosis symptoms that cannot be distinguished from signs of the underlying disease.

With an overdose of sertraline, no significant side effects have been identified, even in the case of high doses. Using Zoloft with other substances / preparations or alcohol can cause severe poisoning, up to coma and death.

Signs of an overdose - serotonin syndrome, accompanied by psychomotor agitation, nausea, vomiting, tachycardia, agitation, drowsiness, dizziness, diarrhea, increased sweating, hyperreflexia and myoclonus. There are no specific antidotes, intensive supportive therapy with constant monitoring of vital functions is required. It is not effective to provoke vomiting, the intake of activated charcoal may be more effective than gastric lavage. It is important to maintain a clear airway. Due to the large volume of distribution of sertraline, and the increase in diuresis as a result, dialysis or hemoperfusion, as well as blood transfusion, may be ineffective.

Overdose

In case of an overdose of Zoloft, the following adverse effects may develop:

• pirouette-type ventricular arrhythmia;
• serotonin syndrome with prolonged QT interval;
• tachycardia;
• nausea, vomiting, diarrhea;
• agitation, psychomotor agitation;
• tremor;
• drowsiness;
• dizziness;
• increased sweating;
• myoclonus;
• hyperreflexia;
• coma (in some cases).

Also, in case of an overdose of the drug, the onset of severe poisoning, up to coma and death (with monotherapy or simultaneous use with other drugs and / or alcohol), is possible, therefore, any overdose of Zoloft should be accompanied by intensive therapy.

There are no specific antidotes, therefore, it is recommended to conduct intensive supportive therapy and ensure constant monitoring of vital body functions (for example, ECG monitoring due to the possibility of prolonging the QT interval when using sertraline). Induction of vomiting is not recommended, and gastric lavage is advisable to replace the administration of a laxative together with activated carbon. Measures must be taken to maintain an airway. Due to the large volume of distribution of sertraline, forced diuresis, blood transfusion, hemoperfusion, or dialysis may be ineffective.

special instructions

Sertraline is not used in conjunction with MAO inhibitors; a break of at least 2 weeks should be observed between courses of taking these substances.

When using SSRIs, cases of the development of serotonin syndrome and NMS (neuroleptic malignant syndrome) have been described, the likelihood of which increases with the combined use of third-generation antidepressants with other serotonergic substances (including triptans), as well as drugs that affect the metabolism of serotonin (including MAO inhibitors), antipsychotics and other dopamine receptor antagonists. Signs of serotonin syndrome can be: changes in mental status (hallucinations, agitation, coma), autonomic lability (fluctuations in blood pressure, tachycardia, hyperthermia), changes in neuromuscular transmission (impaired coordination of movements, hyperreflexia) and / or disorders of the gastrointestinal tract (diarrhea, nausea, vomiting). Some symptoms of serotonin syndromeincluding hyperthermia, muscle rigidity, autonomic lability with the possibility of frequent fluctuations in the parameters of vital functions, and changes in mental status, are similar to the symptoms that develop with NNS. It is necessary to monitor the development of clinical effects of serotonin syndrome and NNS in patients in order to provide timely medical care.

Sertraline should be used concurrently with other drugs that enhance serotonergic neurotransmission (for example, fenfluramine, tryptophan, or 5-HT agonists) with caution, since there is a possibility of their pharmacodynamic interaction.

In patients undergoing electroshock therapy, there is insufficient experience with the simultaneous use of sertraline. There is no data on both positive results and undesirable effects of such combinations. There is also no experience of using Zoloft for the treatment of convulsive syndrome, therefore, the drug should not be used for unstable epilepsy, and in the case of controlled epilepsy, careful monitoring of patients is required (if seizures appear, the drug should be canceled).

When switching to Zoloft from other SSRIs, antiobsessive drugs or antidepressants, caution should be exercised, especially in the case of previously used drugs with prolonged action, for example, fluoxetine. There is no data on the size of the required interval that must be observed between the cancellation of one of the SSRI drugs and the start of taking another similar drug.

Constant monitoring from the beginning of the course to the period of stable remission is necessary when treating patients with depression with Zoloft, due to the increased risk of suicide.

There is an insignificant likelihood of activation of mania / hypomania in patients receiving sertraline, and in patients with manic-depressive psychosis who have used other antiobsessive or antidepressant drugs.

Given the active biotransformation of sertraline in the liver and the data of a pharmacokinetic study, it should be used with caution in case of impaired liver function: it is recommended to reduce the dose or increase the interval between doses of the drug.

According to the results of studies of the use of Zoloft in patients with renal insufficiency, it was found that, given the insignificant renal excretion of sertraline, dose adjustment depending on the severity of renal failure is not required.

Pathological hemorrhages / bleeding are possible when prescribing selective serotonin reuptake inhibitors with drugs that have an established ability to change platelet functions, as well as in patients with a history of hemorrhagic pathologies.

Transient hyponatremia develops more often in patients in old age, as well as when taking sertraline with diuretics or a number of other drugs. A similar side reaction is associated with the syndrome of inappropriate secretion of ADH. In this case, Zoloft should be canceled and appropriate therapy should be prescribed to correct the sodium level in the blood. Symptoms and signs of hyponatremia: headache, memory impairment, impaired concentration, weakness and impairment of the vestibular apparatus, which can lead to falls; in more complex episodes, fainting, convulsions, hallucinations, coma, respiratory arrest and death are possible.

Sertraline therapy is usually not accompanied by impaired concentration and a decrease in the speed of psychomotor reactions, but its use with other substances / drugs can lead to impaired coordination and attention. Therefore, when taking Zoloft, it is not recommended to drive special equipment, vehicles or engage in activities associated with an increased risk.

Application during pregnancy and lactation

Pregnancy

There are no data from controlled studies of the use of sertraline during pregnancy, therefore, the use of Zoloft during this period is possible only after a thorough analysis of the possible risk to the child and the expected benefit to the mother.

Analysis of a significant amount of data did not allow to conclude that the use of sertraline induces congenital defects. In animal studies, information has been obtained about the possible effect of sertraline on reproductive function. It is likely that this effect is associated with maternal toxicity, which is caused by the pharmacodynamic effects of sertraline on the fetus.

Some infants whose mothers took sertraline during pregnancy have experienced withdrawal-like symptoms.

Women of reproductive age who take sertraline must use reliable contraceptives.

Lactation

Sertraline and N-desmethylsertraline are found in small amounts in breast milk. In most cases, insignificant concentrations of sertraline were found in the blood plasma of newborns. An exception is one case when 50% of the concentration of sertraline in the mother's blood plasma was found in the blood plasma of the newborn (there was no noticeable effect on the health of the newborn). When prescribing Zoloft during lactation, it is recommended to stop breastfeeding.

In newborns whose mothers received treatment with Zoloft and other SSRIs or SSRIs during pregnancy, complications were observed that required additional hospitalization, tube feeding, and support of the respiratory system. Newborns whose mothers received sertraline in the late stages of pregnancy need careful monitoring: such children may develop respiratory distress, cyanosis, seizures, apnea, instability of body temperature, vomiting, difficulty feeding, hypoglycemia, hypo- or hypertonia, hyperreflexia, twitching muscles, tremors, as well as prolonged crying, irritability, drowsiness, lethargy, difficulty falling asleep. The described symptoms may indicate the development of a withdrawal syndrome or may be associated with direct serotonergic effects. These complications often begin immediately after birth or soon (less than 24 hours) after birth. It should be borne in mind that in some cases, the clinical picture may resemble the symptoms of serotonergic syndrome.

In newborns whose mothers took SSRIs during pregnancy, the risk of developing persistent pulmonary hypertension of the newborn (PPHN) is also possible, which is 5 cases per 1000 pregnancies and is one of the causes of morbidity and mortality in newborns. Several recent epidemiological studies have found a possible link between the development of PLHN and the use of SSRIs (including Zoloft).

Fertility

One of two studies in mice showed a decrease in fertility with sertraline at a dose of 80 mg per kg of body weight (4 times the maximum recommended dose for humans when calculated in mg / m ²).

The reported clinical cases indicate that some SSRIs may have a reversible effect on sperm quality.

Pediatric use

According to the instructions, Zoloft is forbidden to be used to treat children under 6 years old.

In children aged 13 to 17 years with OCD, the starting daily dose of the drug should be 50 mg. When treating OCD in children aged 6 to 12 years, the starting daily dose of Zoloft should be 25 mg. After 1 week, the daily dose can be increased to 50 mg, and in the absence of a sufficient effect, up to 200 mg (it is allowed to add no more than 50 mg per day). In order to avoid an overdose with an increase in the dose of more than 50 mg, it is necessary to take into account the fact that the body weight in children is less than that in adults. The minimum interval between dose changes is 1 week.

For violations of liver function

Patients with impaired liver function and hepatic insufficiency should be prescribed Zoloft with caution. When treating patients with hepatic insufficiency, it is necessary to use smaller doses or increase the interval between doses of the drug.

With impaired renal function

In patients with renal insufficiency, the drug should be administered with caution. Due to the insignificant renal excretion of sertraline, dose adjustment of Zoloft for patients in this category is not required.

Use in the elderly

No dose adjustment is required for elderly patients.

Drug interactions

• Class IC antiarrhythmic drugs (flecainide, propafenone), tricyclic antidepressants: long-term administration of sertraline at a dose of 50 mg per day increases their plasma concentration, since the isoenzyme CYP2D6 is involved in metabolism;
• Indirect anticoagulants (warfarin): there is a slight, but statistically significant increase in prothrombin time, in these cases prothrombin time should be monitored at the beginning of treatment with sertraline and after its cancellation;
• Antipyrine: when coadministered with sertraline (200 mg dose per day) results in a slight (5%) but significant decrease in T ¹ / ₂ antipyrine;
• Atenolol: Sertraline has no effect on its β-adrenergic blocking effect;
• Digoxin and glibenclamide: drug interactions with sertraline (at a dose of 200 mg per day) have not been identified;
• Selective inhibitors of the neuronal reuptake of serotonin (including lithium preparations): increased caution is required when used together with sertraline (the pharmacokinetics of lithium does not change, but tremors are more often observed in patients);
• MAOIs, including those with a reversible type of action (linezolid, moclobemide) and selectively acting (selegilin): severe complications are possible (development of serotonin syndrome with rigidity, myoclonus, hyperthermia, lability of the autonomic nervous system (rapid fluctuations in the parameters of the cardiovascular and respiratory activity)), changes in mental status (including pronounced agitation, increased irritability, confusion, which in some episodes can turn into delirium or coma). Similar complications, sometimes fatal, arise when MAOIs are prescribed during treatment with antidepressants that inhibit the neuronal uptake of monoamines, or immediately after their withdrawal;
• Medicinal substances metabolized by isoenzymes CYP3A3 / 4, CYP2C9, CYP2C19, CYP1A2: sertraline minimally inhibits or practically does not affect these isoenzymes;
• Pimozide: an increase in its level is possible with a single administration in a low dose (2 mg). Since the mechanism of this interaction has not been determined, and pimozide has a target therapeutic index, the simultaneous administration of pimozide with sertraline is contraindicated;
• Drugs that bind to blood proteins (diazepam, tolbutamide): sertraline affects their concentration in the blood plasma, reducing clearance (it is required to control the glucose content in the blood);
• Sumatriptan: In extremely rare episodes, weakness, increased tendon reflexes, confusion, anxiety and agitation are noted; in the case of simultaneous use with sertraline, observation of patients is recommended;
• Tryptophan, fenfluramine: simultaneous use with sertraline should be avoided;
• Phenytoin: sertraline (at a dose of 200 mg per day) does not suppress metabolism, does not have a clinically significant effect on phenytoin, but despite this, from the beginning of their simultaneous use, it is necessary to carefully monitor the content of phenytoin in blood plasma in order to adjust the dose;
• Cimetidine: significantly reduces sertraline clearance;
• Ethanol and substances / drugs that depress the central nervous system: there was no potentiation of the effect of carbamazepine, phenytoin, haloperidol or ethanol on psychomotor and cognitive functions in healthy people, but the combined use of Zoloft and alcohol is not recommended.

Analogs

Zoloft's analogues are: Serenata, Solotik, Asentra, Aleval, Sertralux, Sertraloft, Stimuloton, Deprefolt, Depralin, Seralin, Sertraline hydrochloride, Zalox, Torin, A-depresin, Adjuvin, Sertralin, Serlift.

Terms and conditions of storage

Keep out of the reach of children at a temperature not exceeding 30 ° C.

The shelf life is 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Zoloft

Reviews of Zoloft indicate that this drug is often used in the treatment of various phobias, depression and other disorders of the nervous system.

In most reviews, users note the effectiveness of Zoloft (normalization of sleep and psychological state), but its effect can manifest itself rather slowly.

There is also information about the development of side effects during therapy in the form of insomnia or severe drowsiness. In addition, some users report the development of diseases that affect the functioning of the liver and kidneys.

According to doctors, Zoloft is a highly effective drug that improves the state of the nervous system. At the same time, it should be borne in mind that treatment with this drug should be carried out under strict dosage control and only under the supervision of a specialist.

The price of Zoloft in pharmacies

The price of Zoloft 100 mg (28 tablets per pack) is approximately 1219 rubles.

The price of Zoloft 50 mg (28 tablets per pack) is approximately 944 rubles.

The price of Zoloft 50 mg (14 tablets per pack) is approximately 497 rubles.

Zoloft: prices in online pharmacies

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Zoloft 100 mg film-coated tablets 28 pcs. 1061 RUB Buy

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Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!