Lenuxin - instructions for use, doses, side effects, contraindications, price, where to buy

Lenuxin®

- Escitalopram should not be prescribed concomitantly with MAO inhibitors due to the risk of developing serotonin syndrome. Escitalopram can be prescribed 14 days after stopping treatment with irreversible MAO inhibitors and at least 1 day after stopping treatment with a reversible MAO type A inhibitor (moclobemide). At least 7 days must pass after stopping escitalopram before treatment with non-selective MAO inhibitors can be started.

- In children, adolescents and young adults (under 24 years of age) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and behavior. Therefore, when prescribing Lenuxin® or any other antidepressants to children, adolescents and young adults (under 24 years of age), the risk of suicide should be weighed against the benefits of their use. If a decision is made to initiate antidepressant therapy, the patient should be closely monitored for early detection of disturbances or changes in behavior, as well as suicidality.

- When using drugs belonging to the therapeutic group of SSRIs, including escitalopram, the following should be considered: some patients with panic disorder may experience increased anxiety when starting treatment with SSRIs. This paradoxical reaction usually disappears within the first two weeks of treatment. To reduce the likelihood of an anxiogenic effect, it is recommended to use low initial doses. The drug should be discontinued if seizures develop. Use in patients with unstable epilepsy is not recommended; Controlled seizures require careful monitoring. If the frequency of seizures increases, SSRIs, including escitalopram, should be discontinued.

- SSRIs and SNRIs (selective norepinephrine reuptake inhibitors) have been associated with the development of akathisia, a condition characterized by unpleasant, debilitating restlessness and hyperactivity, often accompanied by an inability to sit or stand in one place. This condition most likely occurs during the first few weeks of therapy. Increasing the dose may be harmful to patients who experience these symptoms.

- Escitalopram should be used with caution in patients with a history of mania/hypomania. If a manic state develops, escitalopram should be discontinued.

- In patients with diabetes, treatment with escitalopram may change blood glucose levels. Therefore, dose adjustments of insulin and/or oral hypoglycemic drugs may be required.

— The risk of committing suicide is inherent in depression and can persist until a significant improvement in the condition occurs spontaneously or as a result of therapy. Careful monitoring of patients being treated with antidepressants is necessary, especially at the beginning of treatment, due to the possibility of clinical deterioration and/or the emergence of suicidal manifestations (thoughts and behavior). This precaution should also be observed when treating other mental disorders due to the possibility of concurrent depressive episodes.

- Hyponatremia, possibly associated with impaired secretion of antidiuretic hormone (ADH), occurs rarely when taking escitalopram and usually disappears when therapy is discontinued. Caution should be exercised when prescribing escitalopram and other SSRIs to persons at risk of developing hyponatremia: the elderly, patients with cirrhosis, and those taking drugs that can cause hyponatremia.

- When taking escitalopram, skin hemorrhages (ecchymosis and purpura) may develop. Escitalopram should be used with caution in patients with a tendency to bleed, as well as those taking oral anticoagulants and medications that affect blood clotting.

- Since clinical experience with the simultaneous use of escitalopram and ECT (electroconvulsive therapy) is limited, caution should be exercised in such cases.

- In rare cases, patients taking escitalopram and other SSRIs concomitantly with serotonergic drugs may develop serotonin syndrome. Escitalopram should be used with caution concomitantly with drugs that have serotonergic effects.

— Due to limited clinical experience, caution is recommended when using the drug in patients with coronary heart disease (CHD).

- After long-term use, abrupt cessation of escitalopram therapy in some patients may lead to a “withdrawal” reaction; gradual withdrawal of the drug over 1-2 weeks is recommended.

— Interaction with alcohol:

escitalopram does not interact pharmacodynamically or pharmacokinetically with alcohol. However, as with other antidepressants, you should avoid drinking alcohol during the entire period of treatment with the drug.

Lenuksin

Escitalopram should not be co-administered with MAO inhibitors due to the risk of developing serotonin syndrome. Escitalopram can be prescribed 14 days after stopping treatment with irreversible MAO inhibitors and at least 1 day after stopping treatment with a reversible MAO type A inhibitor (moclobemide). At least 7 days must pass after stopping escitalopram before treatment with non-selective MAO inhibitors can be started.

In children, adolescents and young adults (<24 years of age) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and behavior. Therefore, when prescribing Lenuxin or any other antidepressants to children, adolescents and young adults (under 24 years of age), the risk of suicide should be weighed against the benefits of their use. If a decision is made to initiate antidepressant therapy, the patient should be closely monitored for early detection of disturbances or changes in behavior, as well as suicidality.

When using drugs belonging to the SSRI therapeutic group, including Lenuxin, it should be taken into account that some patients with panic disorder may experience increased anxiety at the beginning of SSRI treatment. This paradoxical reaction usually disappears within the first two weeks of treatment. To reduce the likelihood of anxiogenic effects, low initial doses are recommended.

The drug should be discontinued if seizures develop. Use in patients with unstable epilepsy is not recommended; Controlled seizures require careful monitoring. If the frequency of seizures increases, SSRIs, including escitalopram, should be discontinued.

SSRIs and SNRIs (selective norepinephrine reuptake inhibitors) have been associated with the development of akathisia, a condition characterized by unpleasant, debilitating restlessness and hyperactivity, often accompanied by an inability to sit or stand in one place. This condition most likely occurs during the first few weeks of therapy. Increasing the dose may be harmful to patients who experience these symptoms.

The drug should be used with caution in patients with a history of mania/hypomania. If a manic state develops, the drug should be discontinued.

In patients with diabetes mellitus, treatment with escitalopram may change blood glucose levels. Therefore, dose adjustments of insulin and/or oral hypoglycemic drugs may be required.

The risk of committing suicide is inherent in depression and may persist until the condition significantly improves, either spontaneously or as a result of therapy. Careful monitoring of patients being treated with antidepressants is necessary, especially at the beginning of treatment, due to the possibility of clinical deterioration and/or the emergence of suicidal manifestations (thoughts and behavior). This precaution should also be observed when treating other mental disorders due to the possibility of concurrent depressive episodes.

Hyponatremia, possibly associated with impaired ADH secretion, occurs rarely with escitalopram and usually disappears when therapy is discontinued. Caution should be exercised when prescribing escitalopram and other SSRIs to persons at risk of developing hyponatremia: the elderly, patients with cirrhosis, and those taking drugs that can cause hyponatremia.

When taking the drug, it is possible to develop skin hemorrhages (ecchymosis and purpura). Escitalopram should be used with caution in patients with a tendency to bleed, as well as those taking oral anticoagulants and medications that affect blood clotting.

Since clinical experience with the simultaneous use of escitalopram and ECT (electroconvulsive therapy) is limited, caution should be exercised in such cases.

In rare cases, patients taking escitalopram and other SSRIs concomitantly with serotonergic drugs may develop serotonin syndrome. Escitalopram should be used with caution concomitantly with drugs that have serotonergic effects.

Due to limited clinical experience, caution is recommended when using the drug in patients with coronary heart disease.

After long-term use, abrupt cessation of drug therapy in some patients may lead to a withdrawal reaction. Undesirable reactions such as dizziness, headaches and nausea may occur. The severity of these reactions is usually mild and their duration is limited. To avoid withdrawal reactions, gradual withdrawal of the drug over 1-2 weeks is recommended.

Escitalopram does not interact pharmacodynamically or pharmacokinetically with ethanol. However, as with other antidepressants, you should avoid drinking alcohol during the entire period of treatment with the drug.

During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Lenuxin 10 mg 28 pcs. film-coated tablets

pharmachologic effect

Lenuxin is an antidepressant, selective serotonin reuptake inhibitor (SSRI);
increases the concentration of the neurotransmitter in the synaptic cleft, enhances and prolongs the effect of serotonin on postsynaptic receptors. Escitalopram practically does not bind to serotonin (5-HT), dopamine (D1 and D2), alpha-adrenergic, histamine, m-cholinergic receptors, as well as benzodiazepine and opioid receptors. The antidepressant effect usually develops 2-4 weeks after the start of use. The maximum therapeutic effect of treatment for panic disorders is achieved approximately 3 months after the start of treatment.

Composition and release form Lenuxin 10 mg 28 pcs. film-coated tablets

Escitalopram - 10 mg.

28 tablets per package.

Description of the dosage form

Film-coated tablets.

Directions for use and doses

Depression: The usual dose is 10 mg once daily. Depending on the individual response of the patient, the dose can be increased to a maximum of 20 mg per day.

After the symptoms of depression disappear, it is necessary to continue therapy to consolidate the effect for 6 months.

Panic states with or without agoraphobia: the recommended initial dose is 5 mg per day for the first week, then 10 - 20 mg per day. The maximum daily dose is 20 mg per day.

Maximum effectiveness is achieved after approximately 3 months. The duration of treatment is several months.

Social phobia: The usual dose is 10 mg once daily. It usually takes 2-4 weeks for symptoms to subside. The dose can be gradually, depending on the individual response of the patient, reduced to 5 mg or increased to 20 mg per day.

Generalized anxiety disorders.

The initial dose is 10 mg once daily. The maximum daily dose is 20 mg. The duration of treatment is at least 6 months.

Elderly patients: the recommended dose is 5 mg per day, the maximum daily dose is 10 mg.

Renal impairment: For mild to moderate renal impairment, no dose adjustment is required. Caution is recommended in patients with severe renal impairment (CLCR less than 30 ml/min).

Liver dysfunction: The recommended initial dose is 5 mg per day for reduced liver function during the first two weeks. Depending on the patient's individual response, the dose may be increased to 10 mg per day. Caution and extremely cautious dose increases are recommended in patients with severe hepatic impairment.

For patients with weak CYP2C19 isoenzyme activity, the recommended initial dose is 5 mg per day for the first two weeks of treatment. Depending on the patient's individual response, the dose may be increased to 10 mg per day.

When stopping treatment, the dose should be gradually reduced over 1 to 2 weeks in order to avoid withdrawal syndrome.

Indications for use Lenuxin 10 mg 28 pcs. film-coated tablets

Moderate to severe depression, panic disorder with or without agoraphobia, social anxiety disorder (social phobia), generalized anxiety disorder.

Contraindications

Children and adolescents (up to 18 years), concomitant use with MAO inhibitors, sucrase/isomaltase deficiency, fructose intolerance and glucose-galactose malabsorption, since the drug contains sucrose.

Hypersensitivity to the drug or its components.

With caution: renal failure (creatinine clearance below 30 ml/min), hypomania, mania, pharmacologically uncontrolled epilepsy, depression with suicidal attempts, diabetes mellitus, old age, liver cirrhosis, bleeding tendency; simultaneous use with drugs that reduce the seizure threshold and cause hyponatremia, with ethanol, as well as with drugs metabolized by the CYP2C19 isoenzyme.

Application Lenuxin 10 mg 28 pcs. film-coated tablets during pregnancy and breastfeeding

The use of the drug during pregnancy is not recommended due to insufficient data on efficacy and safety. While using the drug, breastfeeding should be discontinued.

The use of the drug is contraindicated in children under 18 years of age.

special instructions

When using drugs belonging to the therapeutic group of SSRIs, including escitalopram, the following should be considered: some patients with panic disorder may experience increased anxiety when starting treatment with SSRIs. This paradoxical reaction usually disappears within the first two weeks of treatment. To reduce the likelihood of an anxiogenic effect, it is recommended to use low initial doses.

Escitalopram should be used with caution in patients with a history of mania/hypomania. If a manic state develops, escitalopram should be discontinued.

In patients with diabetes mellitus, treatment with escitalopram may change blood glucose levels. Therefore, dose adjustments of insulin and/or oral hypoglycemic drugs may be required.

When taking escitalopram, skin hemorrhages (ecchymosis and purpura) may develop. Escitalopram should be used with caution in patients with a tendency to bleed, as well as those taking oral anticoagulants and medications that affect blood clotting.

Since clinical experience with the simultaneous use of escitalopram and ECT (electroconvulsive therapy) is limited, caution should be exercised in such cases.

Due to limited clinical experience, caution is recommended when using the drug in patients with coronary artery disease.

After long-term use, abrupt cessation of escitalopram therapy may lead to a withdrawal reaction in some patients. Undesirable reactions such as dizziness, headaches and nausea may occur. The severity of these reactions is usually mild and their duration is limited. To avoid withdrawal reactions, gradual withdrawal of the drug over 1-2 weeks is recommended.

Overdose

Symptoms: dizziness, tremor, agitation, drowsiness, unconsciousness, convulsions, tachycardia, ECG changes with ST-T changes, widening of the QRS complex, prolongation of the QT interval, arrhythmias, respiratory depression, vomiting, rhabdomyolysis, metabolic acidosis, hypokalemia.

Treatment: there is no specific antidote. Provide air supply pathways, sufficient oxygenation and respiratory function. Gastric lavage should be performed as soon as possible after oral administration. Activated carbon is used. It is recommended to monitor cardiac function and vital signs, as well as provide general symptomatic supportive therapy.

Side effects Lenuxin 10 mg 28 pcs. film-coated tablets

Side effects most often occur in the first or second week of treatment with the drug and then usually become less intense and occur less frequently as therapy is continued.

WHO classification of unwanted adverse reactions by frequency of development: very common - 1/10 prescriptions (> 10%), common - 1/100 prescriptions (> 1% and < 10%), uncommon - 1/1000 prescriptions (> 0.1% and < 1%), rare - 1/10,000 prescriptions (> 0.01% and <0.1%), very rare - 1/10,000 prescriptions (< 0.01%).

From the side of the central nervous system: often - headache, dizziness, weakness, insomnia or drowsiness, convulsions, tremor, movement disorders, serotonin syndrome (agitation, tremor, myoclonus, hyperthermia; less often - hallucinations, mania, confusion, agitation, anxiety, depersonalization, panic attacks, increased irritability, visual disturbances.

From the digestive system: very often - nausea, vomiting; often - diarrhea, dry mouth, taste disturbances, decreased appetite or, conversely, increased appetite, constipation.

From the skin: often - increased sweating, less often - skin rash, itching, ecchymosis, purpura, angioedema.

From the reproductive system: often - impaired ejaculation, impotence, possible menstrual irregularities.

From the urinary system: often - urinary retention.

On the part of the body as a whole: often - weakness, less often hyperthermia.

Metabolic disorders: rarely - insufficient secretion of antidiuretic hormone (ADH).

From the cardiovascular system: infrequently - orthostatic hypotension.

Laboratory indicators: often - changes in laboratory indicators of liver function, hyponatremia and changes in the electrocardiogram (prolongation of the QT interval, widening of the QRS complex, changes in the ST segment and T wave).

From the musculoskeletal system: infrequently - arthralgia, myalgia.

Allergic reactions: in some cases, anaphylactic reactions are possible.

The patient should be informed that if any of the side effects indicated in the instructions worsen or any other side effects not listed in the instructions occur, the doctor should be informed.

Drug interactions

Drugs acting on the central nervous system. Caution must be exercised when taken simultaneously with other centrally acting drugs.

Alcohol. Although escitalopram does not potentiate the effects of alcohol (data from clinical studies), as is the case with other psychotropic drugs, the simultaneous use of escitalopram and alcohol is not recommended.

MAO inhibitors. Incompatible with MAO inhibitors.

Drugs that affect blood clotting (NSAIDs, acetylsalicylic acid, warfarin, etc.). The release of serotonin from platelets plays an important role in hemostasis. Epidemiological studies (both case-control and cohort studies) have demonstrated an association between the use of psychotropic drugs that affect serotonin reuptake and the incidence of upper gastrointestinal bleeding. In two studies, the simultaneous use of NSAIDs, incl. acetylsalicylic acid, potentiated the risk of bleeding. Although these studies focused on bleeding from the lower gastrointestinal tract, there is reason to believe that bleeding from other sites is possible, so caution and monitoring of blood clotting parameters is necessary when taking escitalopram and drugs that affect blood clotting simultaneously.

Lithium. Lithium may potentiate the serotonergic effect of escitalopram, so caution should be used when coadministering.

Sumatriptan. There have been rare post-marketing reports of weakness, hyperreflexia and incoordination in patients when using SSRIs and sumatriptan. If the use of sumatriptan and SSRIs (such as fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, escitalopram) is clinically justified, appropriate patient monitoring is recommended.

Carbamazepine. Carbamazepine, by inducing microsomal liver enzymes, can increase the clearance of escitalopram, which should be kept in mind when prescribing these drugs simultaneously.

Ritonavir. Co-administration of a single dose of ritonavir (600 mg), which is both a substrate and a strong inhibitor of CYP3A4, and escitalopram (20 mg) was not accompanied by changes in the pharmacokinetics of either ritonavir or escitalopram.

In vitro studies did not reveal an inhibitory effect of escitalopram on CYP3A4, CYP1A2, CYP2C9, CYP2C19 and CYP2E1. Based on these data, little effect on metabolism mediated by this group of cytochrome P450 enzymes in vivo is expected.

CYP3A4 and CYP2C9 inhibitors. In vitro studies indicate that CYP3A4 and CYP2C9 are the main enzymes involved in the metabolism of escitalopram. However, co-administration of escitalopram (20 mg) and ritonavir (600 mg), a strong CYP3A4 inhibitor, did not have a significant effect on the pharmacokinetics of escitalopram. Because escitalopram is metabolized by multiple enzyme systems, inhibition of a single enzyme may not significantly reduce the clearance of escitalopram.

Drugs metabolized with the participation of the cytochrome P450 isoenzyme CYP2D6. In vitro studies did not reveal an inhibitory effect of escitalopram on CYP2D6. In addition, steady-state levels of citalopram racemate are not significantly different between weak and strong CYP2D6 metabolizers. This indicates a low likelihood of a clinically significant effect of CYP2D6 inhibitors on the metabolism of escitalopram. However, limited in vivo data indicate a moderate CYP2D6 inhibitory effect of escitalopram: coadministration of escitalopram (21 mg/day for 21 days) with the tricyclic antidepressant desipramine (50 mg single dose), a CYP2D6 substrate, resulted in a 40% increase in Cmax and a 100% increase in AUC of desipramine. The clinical significance of this observation is unknown. However, when co-administering escitalopram and drugs metabolized by CYP2D6, caution is indicated.

Metoprolol. Administration of escitalopram 20 mg/day to healthy volunteers for 21 days resulted in a 50% increase in Cmax and 82% increase in AUC of metoprolol (100 mg single dose). With increasing plasma levels of metoprolol, a decrease in cardioselectivity was observed. Co-administration of escitalopram and metoprolol did not have a clinically significant effect on blood pressure and heart rate.

Electroconvulsive therapy. There are no clinical studies on the combined use of electroconvulsive therapy and escitalopram.

Since escitalopram is the active isomer of citalopram racemate, these two drugs should not be used simultaneously.