Selectra pills 10 mg №28

Dosage form

Coated tablets

Composition

In 1 tablet, film-coated, contains: escitalopram oxalate 12.78 mg.

Excipients: brine SMCC 90 / HD90 (microcrystalline cellulose + silicon dioxide), sodium croscarmellose, talc, Magnesium stearate.

Shell composition: white opadry (Opadry 03F28446 White): bsR hypromellose, titanium dioxide, macrogol 6000.

Packing

In the package of 28 tablets.

Mechanism of action

Selectra is an antidepressant, selective serotonin reuptake inhibitor (SSRI).

Inhibition of serotonin reuptake leads to an increase in the concentration of this neurotransmitter in the synaptic cleft, enhances and prolongs its effect on postsynaptic receptor sites.

Escitalopram has no or very little ability to bind to a number of receptors, including: serotonin 5-HT 1A, 5-HT 2 receptors, dopamine D 1 and D 2 receptors, A 1 -, A 2 -, A-adrenergic receptors, histamine H 1, muscarinic cholinergic, benzodiazepine and opiate receptors.

Indications and usage

- Depressive disorders of any severity.
- Panic disorders with / without agoraphobia.

Contraindications

- Hypersensitivity to the drug or its components.
- Children's age (up to 15 years).
- Simultaneous intake with monoamine oxidase inhibitors (MAO).
- Pregnancy.
- The period of breastfeeding.

Renal failure (creatinine clearance (CC) below 30 ml / min).
- Hypomania.
- Manic disorders.
- Pharmacologically uncontrolled epilepsy.
- Depression with suicidal attempts.
- Diabetes.
- Elderly age.
- Cirrhosis of the liver.
- Tendency to bleed.
- Simultaneous administration with drugs: lowering the threshold of convulsive readiness, metabolized with the participation of the CYP2C19 system.

Dosage and administration

Inside Adults and children over 15 years: once a day, regardless of the meal.

Depressive disorders: 10 mg is usually prescribed once a day. Depending on the patient's individual response, the dose may be increased to a maximum of 20 mg / day. The antidepressant effect usually develops 2-4 weeks after the start of treatment. After the disappearance of the symptoms of depression, for at least a further 6 months, it is necessary to continue therapy to consolidate the effect obtained.

Panic disorders with / without agoraphobia: during the first week of treatment, a dose of 5 mg / day is recommended, which then increases to 10 mg / day. Depending on the patient's individual response, the dose may be increased to a maximum of 20 mg / day. The maximum therapeutic effect is achieved approximately 3 months after the start of treatment. Therapy lasts for several months.

Elderly patients (over 65): It is recommended to use half the usually recommended dose (i.e. only 5 mg / day) and a lower maximum dose (10 mg / day).

Reduced liver function: The recommended initial dose for the first two weeks of treatment is 5 mg / day. Depending on the patient's individual response, the dose may be increased to 10 mg / day.

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

When treatment is discontinued, the dose should be gradually reduced over a period of 1-2 weeks in order to avoid the onset of withdrawal syndrome.

Special notes

In some patients with panic disorder, increased anxiety may be observed at the beginning of an SSRI treatment. Such a paradoxical reaction usually disappears within two weeks of treatment. To reduce the likelihood of anxiogenic effect, it is recommended to use low initial doses.

The drug should be discontinued if seizures develop. Not recommended for use in patients with uncontrolled epilepsy; with controlled seizures, careful observation is necessary. When increasing the frequency of convulsive seizures SIOZS, including escitalopram, should be canceled.

Estsitalopram should be used with caution in patients with a history of mania / hypomania. With the development of a manic state, escitalopram should be abolished.

In patients with diabetes mellitus, escitalopram treatment may change the level of glucose in the blood (both hypoglycemia and hyperglycemia are possible). Therefore, it may be necessary to adjust the doses of insulin and / or oral hypoglycemic drugs.

The risk of committing suicide is peculiar to depression and may persist until a significant improvement in condition occurs spontaneously or as a result of therapy. Careful monitoring of patients under treatment with antidepressants especially at the beginning of treatment is necessary due to the possibility of clinical deterioration and / or the occurrence of suicidal manifestations (thoughts and behavior). This precaution must also be observed when treating other mental disorders due to the possibility of the simultaneous development of depression. In some cases, the treatment with antidepressants of the SSRI group has shown an increased risk of suicidal thoughts and behavior in children, adolescents and young people under 24 years of age compared with placebo.

Hyponatremia, possibly associated with impaired secretion of ADH, while receiving escitalopram, occurs rarely and usually disappears when therapy is canceled.

Caution should be exercised when prescribing escitalopram and other SSRIs to persons at risk of developing hyponatremia: the elderly, patients with cirrhosis of the liver and taking drugs that can cause hyponatremia. When receiving escitalopram may develop subcutaneous hemorrhage (ecchymosis and purpura).It is necessary with caution to use escitalopram in patients with a tendency to bleeding, as well as taking oral anticoagulants and other drugs that affect blood clotting.

Since clinical experience with simultaneous use of escitalopram and electroconvulsive therapy is limited, caution should be exercised in such cases. Combining escitalopram and MAO type A inhibitors is not recommended due to the risk of serotonin syndrome. In patients taking escitalopram and other SSRIs simultaneously with serotonergic drugs, in rare cases, serotonin syndrome may develop. It is necessary with caution to use escitalopram simultaneously with drugs that have a serotonergic effect. The combination of symptoms such as agitation, tremor, myoclonus, hyperthermia, may indicate the development of serotonin syndrome. If this happens, SSRIs and serotonergic drugs should be immediately discontinued and symptomatic treatment prescribed.

In the course of drug treatment, patients should avoid performing potentially hazardous activities that require high-speed psychomotor reactions, such as driving a car or controlling machinery.

Drug Interactions

You may experience serious adverse reactions while taking the drug Selectra and MAO inhibitors, as well as when taking MAO inhibitors by patients who have recently stopped taking the drug. In such cases, serotonin syndrome may develop.Escitalopram should not be administered simultaneously with MAO inhibitors. Escitalopram can be prescribed 14 days after discontinuation of treatment with irreversible MAO inhibitors and at least 1 day after discontinuation of therapy with a reversible inhibitor of MAO type A - moclobemide. At least 7 days must elapse after the end of the administration of escitalopram before you can begin treatment with non-selective MAO inhibitors.

Combined use with serotonergic drugs (for example, tramadol, Sumatriptan and other triptans) can lead to the development of serotonin syndrome.

Selectra can reduce the threshold of convulsive readiness. Caution must be exercised when administered concomitantly with other drugs that lower the threshold of convulsive readiness (tricyclic antidepressants, other SSRIs, neuroleptics (phenothiazines, thioxanthene and butyrophenone derivatives, mefloquine and tramadol).

Escitalopram enhances the pharmacological effects of tryptophan (increased serotonergic effect) and toxic effects of lithium preparations.

The simultaneous appointment of escitalopram and preparations containing St. John's wort (Hypericum perforatum), can lead to an increase in the number of side effects.

A bleeding disorder may occur with simultaneous administration of escitalopram with oral anticoagulants and other drugs that affect blood clotting (for example, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, Acetylsalicylic acid and nonsteroidal anti-inflammatory drugs, ticlopidine and Dipyridamole . In such cases, monitoring of blood coagulation parameters is necessary.

Escitalopram does not enter into pharmacodynamic or pharmacokinetic interaction with ethanol. However, as is the case with other psychotropic drugs, the simultaneous use of escitalopram and alcohol is not recommended.

Co-administration with drugs that inhibit cytochrome CYP2C19 may increase the concentration of escitalopram in the blood plasma. It is necessary to exercise caution when using escitalopram with similar drugs, such as Omeprazole . May require a reduction in escitalopram dose. With caution, it is necessary to prescribe high doses of escitalopram simultaneously with high doses of cimetidine, which is a strong inhibitor of cytochromes CYP2D6, CYP3A4 and CYP1A2.

Escitalopram is a CYP2D6 isoenzyme inhibitor. Care must be taken when prescribing escitalopram and drugs that are metabolized by this isoenzyme and have a low therapeutic index, such as flekainida, propafenone and Metoprolol (in cases of heart failure) ormainly metabolized by CYP2D6 and acting on the CNS, for example, antidepressants such as desipramine, clomipramine, nortriptyline, or the antipsychotic drugs Risperidone, thioridazine, Haloperidol . In these cases, dosage adjustment may be necessary as the concentration of escitalopram in the blood plasma increases. The simultaneous appointment of escitalopram and desipramine or metoprolol leads to a twofold increase in the concentration of the last two drugs, which should be considered when choosing doses. Escitalopram may slightly inhibit the CYP2C19 isoenzyme. Therefore, caution is advised when using escitalopram and medications that are metabolized by CYP2C19.

Symptoms: dizziness, tremor, agitation, drowsiness, stupefaction, convulsive seizures, tachycardia, ECG changes (change of ST segment, T wave, expansion of QRS complex, prolongation of QT interval), arrhythmias, inhibition of respiratory activity, vomiting, rhabdomyolysis, metabolic acidosis, hypokalemia, very rarely, acute renal failure .
Treatment: there is no specific antidote. Symptomatic and supportive treatment: gastric lavage, adequate oxygenation. Monitoring the function of the cardiovascular and respiratory systems.

Store at 25? С.

2 years.