Selectra pills 10mg 56pcs

Composition

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of 1 tab. contains:

Active ingredients:

escitalopram oxalate – 12.78 mg, which corresponds to the content of escitalopram 10 mg;

Auxiliary substances:

prosolv SMCC90 / HD90 – 147.42 mg (microcrystalline cellulose-144.47 mg, silicon dioxide-2.95 mg),

croscarmellose sodium-9 mg,

talc-9 mg,

magnesium stearate-1.8 mg.

Composition of the film shell:

Opadry 03F28446 White ~ 5.4 mg:

hypromellose 6cP – 3.29 mg,

titanium dioxide-1.31 mg,

macrogol 6000-0

.8 mgPharmacological action

An antidepressant. Selectively inhibits the reuptake of serotonin; increases the concentration of the neurotransmitter in the synaptic cleft, enhances and prolongs the action of serotonin on postsynaptic receptors. Escitalopram practically does not bind to serotonin (5-HT), dopamine (D1 and D2) receptors, alpha-adreno-, m-holinoreceptors, as well as to benzodiazepine and opioid receptors. The antidepressant effect usually develops 2-4 weeks after the start of treatment. The maximum therapeutic effect of treatment of panic disorders is achieved approximately 3 months after the start of treatment.

Indications

• depressive disorders of any severity,
• panic disorder with / without agoraphobia,
• social anxiety disorder (social phobia),
• generalized anxiety disorder,
• obsessive-compulsive disorder.

Use during pregnancy and lactation

Escitalopram should be taken during pregnancy only when absolutely necessary and after careful assessment of the benefit / risk ratio. Breast-feeding during drug treatment is not recommended. The effect of escitalopram on fertility has not yet been observed, but there have been reports of reversible effects of other selective serotonin reuptake inhibitors (SSRIs) on sperm quality.

Contraindications

-simultaneous use with MAO inhibitors—

– simultaneous use of pimozide;

– children and adolescents (up to 18 years);

– pregnancy;

– lactation (breastfeeding);

– hypersensitivity to the drug or its components.

Side effects

Side effects most often occur at 1 or 2 weeks of treatment, then usually become less intense and occur less frequently with continued therapy.

From the central nervous system:  dizziness, weakness, insomnia or drowsiness, convulsions, tremors, motor disorders, serotonin syndrome (agitation, tremor, myoclonus, hyperthermia), hallucinations, manic disorders, confusion, agitation, anxiety, depersonalization, panic attacks, increased irritability, visual disturbances.

From the digestive system:  nausea, vomiting, dry mouth, taste disorders, decreased appetite, diarrhea, constipation.

From the cardiovascular system:  orthostatic hypotension.

From the endocrine system:  decreased ADH secretion, galactorrhea.

From the genitourinary system:  decreased libido, impotence, ejaculation disorders, anorgasmia (in women), urinary retention.

Dermatological reactions:  skin rash, pruritus, ecchymosis, purpura.

Allergic reactions: angioedema, anaphylactic reactions.

From the side of laboratory parameters:  hyponatremia, changes in laboratory parameters of liver function.

Other services:  increased sweating, hyperthermia, sinusitis, arthralgia, myalgia.

In addition, after prolonged use, abrupt discontinuation of Selectra therapy in some patients may lead to withdrawal symptoms. If escitalopram is abruptly discontinued, adverse reactions such as dizziness, headaches and nausea may occur, the severity of which is insignificant, and the duration is limited.

Interaction

Serious adverse reactions may occur when Selectra is administered concomitantly with MAO inhibitors, as well as when patients who have recently stopped taking the drug are taking MAO inhibitors. In such cases, serotonin syndrome may develop.

Escitalopram should not be administered concomitantly 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 MAO inhibitor type A-moclobemide. At least 7 days must elapse after the end of escitalopram before treatment with non-selective MAO inhibitors can be initiated.

Concomitant use with serotonergic drugs(such as tramadol, sumatriptan, and other triptans) may lead to the development of serotonin syndrome.

Selectra can lower the seizure alert threshold. Caution should be exercised when prescribing concomitantly with other medications that reduce the seizure threshold (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 drugs lithium.

Concomitant use of escitalopram and drugs containing St. John’s wort (Hypericum perforatum) may lead to an increase in the number of side effects.

Blood clotting disorders may occur when escitalopram is co-administered with oral anticoagulants and other medications that affect blood clotting (for example, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and NSAIDs, ticlopidine and dipyridamole). In such cases, monitoring of blood clotting parameters is necessary.

Escitalopram does not interact pharmacodynamically or pharmacokinetically with ethanol. However, as with other psychotropic medications, concomitant use of escitalopram and alcohol is not recommended.

Effect of other drugs on the pharmacokinetics of escitalopram

Concomitant use with drugs that inhibit CYP2C19 may increase the concentration of escitalopram in blood plasma. Caution should be exercised when using escitalopram concomitantly with similar medications, such as omeprazole. It may be necessary to reduce the dose of escitalopram.

Escitalopram should be administered with caution in high doses simultaneously with cimetidine, which is a strong inhibitor of the isoenzymes CYP2D6, CYP3A4 and CYP1A2, in high doses.

Effect of escitalopram on the pharmacokinetics of other drugs

Escitalopram is an inhibitor of the CYP2D6 isoenzyme. Caution should be exercised when prescribing escitalopram concomitantly with drugs that are metabolized by this isoenzyme and have a low therapeutic index, for example, flecainide, propafenone and metoprolol (in cases of use in heart failure) or drugs that are mainly metabolized by CYP2D6 and act on the central nervous system, for example, antidepressants – desipramine, clomipramine, nortriptyline or antipsychotics – risperidone, thioridazine, haloperidol. In these cases, it may be necessary to adjust the dose, because the concentration of escitalopram in the blood plasma increases.

Concomitant use of escitalopram and desipramine or metoprolol leads to a twofold increase in the concentration of the latter two drugs, which should be taken into account when choosing doses.

Escitalopram may slightly inhibit the CYP2C19 isoenzyme. Therefore, caution is recommended when using escitalopram concomitantly with medicinal products that are metabolized by CYP2C19.

How to take, course of use and dosage

The drug is prescribed for adults and children over 15 years of age 1 time/day inside, regardless of food intake.

For depressive disorders,10 mg is prescribed 1 time/day. Depending on the individual response of the patient, the dose can be increased to a maximum of 20 mg/day.

The antidepressant effect usually develops 2-4 weeks after the start of treatment. After the symptoms of depression disappear, at least for another 6 months, it is necessary to continue therapy to consolidate the effect obtained.

For panic disorders with / without agoraphobia, a dose of 5 mg/day is recommended during the first week of treatment, which is then increased to 10 mg / day. Depending on the individual response of the patient, the dose can be increased to a maximum of 20 mg/day.

The maximum therapeutic effect is achieved approximately 3 months after the start of treatment. The therapy lasts for several months.

Elderly patients (over 65 years of age) it is recommended to prescribe half of the usually recommended dose (i. e. only 5 mg/day) and a lower maximum dose (10 mg / day).

No dose adjustment is required for mild to moderate renal insufficiency. Patients with severe renal insufficiency (creatinine clearance below 30 ml / min) the drug should be prescribed with minimal therapeutic doses, gradually increasing them, taking into account the tolerability and effectiveness of the drug.

With impaired liver function The recommended starting dose for the first two weeks of treatment is 5 mg / day. Depending on the individual response of the patient, the dose can be increased to 10 mg/day.

For patients with low activity of the CYP 2C19 isoenzyme, the recommended initial dose for the first two weeks of treatment is 5 mg / day. Depending on the individual response of the patient, the dose can be increased to 10 mg/day.

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

Overdose

Symptoms: dizziness, tremor, agitation, drowsiness, confusion, convulsive seizures, tachycardia, ECG changes (ST segment changes, T wave changes, QRS complex expansion, QT interval prolongation), arrhythmias, respiratory depression, vomiting, rhabdomyolysis, metabolic acidosis, hypokalemia, very rarely – acute renal failure.

Treatment: symptomatic and supportive: gastric lavage, adequate oxygenation. Monitoring the function of the cardiovascular and respiratory systems. There is no specific antidote.

Description

White film-coated tablets, oval, biconvex, with the inscription “E” on one side, a risk on the other side and side risks.

Special instructions

Some patients with panic disorder may experience increased anxiety at the start of SSRI treatment. This paradoxical reaction usually disappears within two weeks of treatment. To reduce the likelihood of an anxiogenic effect, it is recommended to use the drug in a low initial dose.

The drug should be discontinued in case of convulsive seizures. It is not recommended for use in patients with uncontrolled epilepsy; for controlled seizures, careful monitoring is necessary. If the frequency of seizures increases, SSRIs, including escitalopram, should be discontinued.

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 alter blood glucose levels (both hypoglycemia and hyperglycemia are possible). Therefore, it may be necessary to adjust the dose of insulin and / or oral hypoglycemic drugs.

The risk of suicide is associated with depression and may persist until significant improvement occurs spontaneously or as a result of ongoing therapy. Patients treated with antidepressants should be carefully monitored, especially at the beginning of treatment, because of the possibility of clinical deterioration and / or the appearance of suicidal thoughts and behaviors. This precaution should also be taken in the treatment of other psychiatric disorders because of the possibility of simultaneous development of depression.

In some cases, treatment with SSRI antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults under 24 years of age, compared with placebo.

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 people at risk of developing hyponatremia: the elderly, patients with cirrhosis of the liver, and taking drugs that can cause hyponatremia.

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

Since clinical experience with concomitant use of escitalopram and electroconvulsive therapy is limited, caution should be exercised in such cases.

The combination of escitalopram and MAO type A inhibitors is not recommended due to the risk of serotonin syndrome.

Patients taking escitalopram and other SSRIs concomitantly with serotonergic medications may develop serotonin syndrome in rare cases. Escitalopram should be used with caution simultaneously with medications that have a serotonergic effect. A combination of symptoms such as agitation, tremor, myoclonus, and hyperthermia may indicate the development of serotonin syndrome. If this occurs, SSRIs and serotonergic medications should be discontinued immediately and symptomatic treatment should be prescribed.

Influence on the ability to drive motor vehicles and manage mechanisms

During treatment with the drug, patients should avoid performing potentially dangerous activities that require a high rate of psychomotor reactions, such as driving a car or operating mechanisms.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf life

1 year

Active ingredient

Escitalopram

Conditions of release from pharmacies

By prescription

Dosage form

Tablets