Zoloft pills coated 50mg №14

Coated tablets

Composition

1 coated pill contains: Sertralin (in the form of hydrochloride) 50 mg

Excipients: Calcium phosphate, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycolate, Magnesium stearate, hydroxypropylmethylcellulose, polyethylene glycol, polysorbates, titanium dioxide (E171)

Mechanism of action

Zoloft is an antidepressant, a specific serotonin reuptake inhibitor (5-HT) in neurons.

It has a very weak effect on the reuptake of norepinephrine and dopamine. At therapeutic doses, it blocks serotonin uptake in human platelets. It does not have a stimulating, sedative or anticholinergic effect. Due to the selective inhibition of the capture of 5-HT, sertraline does not enhance adrenergic activity. Sertralin has no affinity for muscarinic cholinergic receptors, serotonin, dopamine, histamine, GABA-, benzodiazepine and adrenergic receptors.

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

Indications and usage

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

Contraindications

- The simultaneous appointment of MAO inhibitors and pimozide.
- Pregnancy.
- Lactation period (breastfeeding).
- Children's age up to 6 years.
- Hypersensitivity to sertraline.

With caution, the drug should be used in the following cases:

- With organic brain diseases (including mental retardation).
- Epilepsy.
- Hepatic and / or renal failure.
- Pronounced weight loss.

Pregnancy and Breastfeeding

Pregnant women do not have controlled results of sertraline, therefore, it is possible to prescribe Zoloft during pregnancy only if the expected benefits to the mother outweigh the potential risk to the fetus.

Women of reproductive age should use effective methods of contraception during sertraline treatment.

Sertralin is found in breast milk, and 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 appointment of the drug is necessary, then breastfeeding should be stopped.

Dosage and administration

Zoloft is prescribed 1 time per day in the morning or in the evening. pills can be taken regardless of the meal.

With 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 not more than 1 time per week to the maximum recommended dose of 200 mg / day.

The initial effect can be observed 7 days after the start of treatment, however, the full effect is usually achieved in 2-4 weeks (or even for a longer time with OCD).

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

- For depression and OCD. Treatment begins with a dose of 50 mg / day.

- With panic disorders, PTSD and social phobias. Treatment 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 allows to reduce the frequency of early undesirable effects of treatment characteristic of panic disorder.

- Use in children and adolescents
- In children and adolescents aged 13-17 years suffering from 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, with insufficient effect, the dose can be increased in steps of 50 mg / day to 200 mg / day as needed. To avoid overdose, increasing the dose to more than 50 mg should take into account the lower body weight in children compared with adults. Change the dose should be at intervals of at least 1 week.

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

- Use in violation of liver function. In patients with impaired liver function, use smaller doses or increase the interval between doses of the drug.

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

Adverse reactions

- 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 disturbances, extrapyramidal disorders (dyskinesias, akathisia), paresthesias, seizures. Movement disorders were more frequently observed in patients with indications of their presence in history or with concomitant use of antipsychotics. When discontinuing treatment with sertraline, rare cases of withdrawal syndrome have been described. Paresthesias, hypoesthesia, symptoms of depression, hallucinations, aggressive reactions, agitation, anxiety, or symptoms of psychosis, which cannot be distinguished from the symptoms of the underlying disease, may appear.

- On the part of the body as a whole: Excessive sweating, weight loss or increase in body weight, weakness.

- On the part of the digestive system: Reduced appetite (rarely - increased), up to anorexia, dry mouth, dyspepsia (flatulence, nausea, vomiting, diarrhea), abdominal pain.

- On the part of the reproductive system: Disruption of sexual function (delayed ejaculation, decreased libido, reduced potency, anorgasmia).

- Since the cardiovascular system: Redness of the skin or flushing of the face, bleeding (including nasal), heartbeat.

- Allergic reactions: Urticaria, pruritus.

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

- From the side: endocrine system Disorders of the menstrual cycle, galactorrhea, hyperprolactinemia.

- On the part of laboratory parameters, Transient hyponatremia (often develops in elderly patients, as well as when taking diuretics or a number of other drugs. Such a side effect is associated with the syndrome of inappropriate secretion of ADH); rarely (with long-term use) - asymptomatic increase in the activity of transaminases in the serum (the abolition of the drug leads to the normalization of enzyme activity).

Special notes

Zoloft can be administered no earlier than 14 days after discontinuation of MAO inhibitors. MAO inhibitors can also be administered no earlier than 14 days after Zoloft is discontinued.

Care must be taken when 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.

Caution should be taken Zoloft with drugs that depress the central nervous system. Drinking alcohol and drugs containing ethanol during sertraline treatment is prohibited.

The experience of clinical studies, the purpose of which was to determine the optimal time required for the transfer of patients from taking other anti-depressive and anti-obsessive 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 cancellation of one selective serotonin reuptake inhibitor and the start of taking another similar drug has not been established.

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

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

Depressed patients are at risk of suicidal attempts. This danger persists until the development of remission. Therefore, from the start of treatment and until the optimum clinical effect is achieved, patients should be provided with constant medical supervision.

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

- Use in violation of liver function Zoloft should be used with caution in patients with liver diseases; it is necessary to correct the dosing regimen. In patients with impaired liver function, use smaller doses or increase the interval between doses of the drug. With caution in liver failure.

- Application for impaired renal function In patients with impaired renal function, dose adjustment based on the severity of renal failure is not required. With caution in renal failure.

- Use in pediatrics The safety and efficacy of sertraline are established in children with OCD (aged 6 to 17 years).

- Impact on the ability to drive vehicles and control mechanisms The purpose 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 increased risk during treatment with sertraline.

With the joint use of sertraline and pimozide, there was an increase in the levels of pimozide with its single appointment in a low dose (2 mg). An increase in pimozide levels was not associated with any changes on the ECG. 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 simultaneous use of sertraline and MAO inhibitors, including selectively acting (selegiline) and with a reversible type of action (moclobemide). Perhaps the development of serotonin syndrome: 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 irritability, marked excitement, confusion, which in some cases can turn into a delirious state or to whom.

When co-prescribing Warfarin with sertraline, a slight but statistically significant increase in prothrombin time is noted - in these cases it is recommended to monitor the prothrombin time at the beginning of treatment with sertraline and after its withdrawal.

- Pharmacokinetic interaction Sertralin binds to plasma proteins. Therefore, it is necessary to consider the possibility of its interaction with other drugs that bind to proteins (for example, diazepam and tolbutamide). Simultaneous use with cimetidine significantly reduces the clearance of sertraline. Long-term treatment with sertraline at a dose of 50 mg / day increases the plasma concentration of concurrently used drugs, the metabolism of which involves the CYP2D6 isoenzyme (tricyclic antidepressants, antiarrhythmic drugs of class IC - propafenone, flecainide).Experiments to study the interaction in vitro showed that the beta-hydroxylation of endogenous cortisol carried out by CYP3A3 / 4 isoenzymes, as well as the metabolism of Carbamazepine and terfenadine with a long-term administration of sertraline at a dose of 200 mg / day do not change. The concentration in plasma of tolbutamide, phenytoin and warfarin with the prolonged administration of sertraline in the same dose also does not change. Thus, it can be concluded that sertraline does not inhibit the CYP2C9 isoenzyme. However, while taking sertraline reduces the clearance of tolbutamide - requires control of blood glucose levels. Sertralin does not affect the concentration of diazepam in the serum, which indicates the absence of inhibition of the CYP2C19 isoenzyme. According to in vitro studies, sertraline has virtually no effect or is minimally inhibited by the CYP1A2 isoenzyme. The pharmacokinetics of lithium do not change with the concomitant administration of sertraline. However, tremor occurs more often with their combined use. The combined use of sertraline with drugs that affect serotonergic transmission (for example, with lithium), requires increased caution. When replacing one inhibitor of neuronal seizure of serotonin with another, there is no need for a “laundering period”. However, care is required when changing the course of treatment. Co-administration of tryptophan or fenfluramine with sertraline should be avoided. Sertralin causes minimal induction of liver enzymes.The simultaneous administration of sertraline 200 mg and antipyrine leads to a small (5%) but significant decrease in the half-life of antipyrine. With the joint introduction of sertraline does not alter the beta-adrenoceptor blocking effect of Atenolol. With the introduction of sertraline in a daily dose of 200 mg of drug interaction with glibenclamide and Digoxin was not detected. Prolonged use of sertraline at a dose of 200 mg / day has no clinically significant effect and does not inhibit the metabolism of phenytoin. Despite this, careful monitoring of the plasma phenytoin level is recommended from the moment of administration of sertraline with appropriate adjustment of the dose of phenytoin. There are extremely rare cases of weakness, increased tendon reflexes, confusion, anxiety and arousal in patients simultaneously taking sertraline and Sumatriptan. It is recommended that patients be monitored for appropriate clinical reasons for simultaneous administration of sertraline and sumatriptan.

Severe symptoms of sertraline overdose were not detected even with the use of the drug in high doses. However, when administered simultaneously with other drugs or alcohol, severe poisoning can occur.

- Symptoms: manifestations of serotonin syndrome: nausea, vomiting, drowsiness, tachycardia, agitation, dizziness, psychomotor agitation, diarrhea, increased sweating, myoclonus and hyperreflexia.
- Treatment: no specific antidotes. Requires intensive supportive care and constant monitoring of vital body functions. Vomiting is not recommended. The introduction of Activated carbon may be more effective than gastric lavage. It is necessary to maintain airway patency. Sertraline has a large volume of distribution, therefore, increased diuresis, dialysis, hemoperfusion, or blood transfusion may be unsuccessful.

The drug should be stored at a temperature not higher than 30 ° C.
Keep out of reach of children.

5 years.