Cipralex pills 10mg, 28pcs

Composition

1 tablet contains escitalopram (in the form of oxalate) 10 mg

Pharmacological action

Cipralex is an antidepressant, a selective serotonin reuptake inhibitor.

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 weak ability to bind to a number of receptors, including: serotonin 5-HT1A -,5-HT2-receptors, dopamine D1 – and D2-receptors, a1 -, a2 -, b-adrenergic receptors, histamine H1-receptors, m-cholinergic receptors, benzodiazepine and opioid receptors.

Indications

• Depressive episodes of any severity;
•  Panic disorders with / without agoraphobia.

Use during pregnancy and lactation

Cipralex is contraindicated for use during pregnancy and lactation (breastfeeding).

Contraindications

•  Concomitant use of MAO inhibitors;
• Pregnancy;
•  Lactation (breast-feeding);
• Children under 15 years of age;
•  Hypersensitivity to escitalopram and other components of the drug.

Side effects

From the digestive system:  

• Most often – nausea, loss of appetite, diarrhea, constipation

• Rarely-taste disorders; possible-vomiting, dry mouth, changes in laboratory parameters of liver function.

From the central nervous system and peripheral nervous system:  

• Most often – insomnia or drowsiness, dizziness, weakness

• Possible – visual disturbances, seizures, tremors, motor disorders, serotonin syndrome, hallucinations, mania, confusion, agitation, anxiety, depersonalization, panic attacks, increased irritability

From the side of metabolism:  

• Most often – increased sweating, hyperthermia

• Possibly hyponatremia

From the side of the reproductive system:  Most often – decreased libido, impotence, ejaculation disorders, anorgasmia (in women).

From the cardiovascular system:   Orthostatic hypotension is possible.

From the endocrine system:  possibly-insufficient ADH secretion, galactorrhea.

Allergic reactions:  possibly – anaphylactic reactions, angioedema.

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

Other services:  

• Most often – sinusitis

• Possible – arthralgia, myalgia, urinary retention

If the drug is abruptly discontinued after prolonged use, withdrawal reactions such as dizziness, headaches, and nausea may occur. The severity of these reactions is insignificant, and the duration is limited.

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

Interaction

Pharmacodynamic interaction

Serious adverse reactions may occur when Cipralex is co-administered with MAO inhibitors, as well as when patients who have recently stopped taking Cipralex start taking MAO inhibitors. In such cases, serotonin syndrome may develop.

The combined use of Cipralex with serotonergic drugs (for example, tramadol, sumatriptan and other triptans) can lead to the development of serotonin syndrome. Cipralex can lower the threshold of convulsive readiness. Caution is necessary when prescribing Cipralex and other drugs that reduce the threshold of convulsive readiness at the same time.

Since there have been reported cases of increased effects when co-prescribing Cipralex and lithium or tryptophan, it is recommended to exercise caution when prescribing these drugs simultaneously.

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

When escitalopram is co-administered with oral anticoagulants and drugs that affect blood clotting (for example, atypical antipsycholeptics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and NSAIDs, ticlopidine and dipyridamole), blood clotting disorders may occur. In such cases, careful monitoring of blood clotting is necessary at the beginning or end of escitalopram therapy.

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

Pharmacokinetic interaction

Concomitant use with drugs that inhibit the CYP2C19 isoenzyme may increase the concentration of escitalopram in blood plasma. Escitalopram should be used with caution concomitantly with similar medications (including omeprazole); it may be necessary to reduce the dose of escitalopram.

Caution should be exercised when prescribing high-dose Cipralex concomitantly with high-dose cimetidine, which is a strong inhibitor of the CYP2D6, CYP3A4, and CYP1A2 isoenzymes.

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 the CYP2D6 isoenzyme and act on the central nervous system, for example, the antidepressants desipramine, clomipramine, nortriptyline or risperidone antipsychotics. thioridazine, haloperidol. In these cases, a dose adjustment may be necessary.

Concomitant use of escitalopram and desipramine or metoprolol leads to a twofold increase in the concentration of the latter two drugs.

Escitalopram may slightly inhibit the CYP2C19 isoenzyme. Therefore, it is recommended to exercise caution when using escitalopram concomitantly with drugs that are metabolized with the participation of this isoenzyme.

How to take, course of use and dosage

of Cipralex is prescribed 1 time/day, regardless of food intake.

For depressive episodes, the drug is usually prescribed at a dose of 10 mg / 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 for at least 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, followed by an increase 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.

In elderly patients (over 65 years of age) It is recommended to use 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 in patients with mild to moderate renal insufficiency. In patients with severe renal insufficiency (CKD), the recommended initial dose for the first 2 weeks of treatment is 5 mg / day. Depending on the individual response to treatment, the dose may be increased to 10 mg / day.

If the activity of the CYP2C19 isoenzyme is reduced, the recommended initial dose for the first 2 weeks of treatment is 5 mg / day. Depending on the individual response to treatment, the dose may be increased to 10 mg / day.

When stopping treatment with Cipralex, the dose should be reduced gradually over 1-2 weeks to avoid the development of withdrawal syndrome.

Overdose

Symptoms:  dizziness, tremor, agitation, drowsiness, confusion, convulsive seizures, tachycardia, ECG changes (changes in the ST segment and T wave, expansion of the QRS complex, prolongation of the QT interval), arrhythmias, respiratory depression, vomiting, rhabdomyolysis, metabolic acidosis, hypokalemia.

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

Special instructions

Escitalopram should not be administered concomitantly with MAO inhibitors. Escitalopram may be prescribed 14 days after discontinuation of treatment with irreversible MAO inhibitors and at least 1 day after discontinuation of therapy with reversible MAO type A inhibitors (including moclobemide). At least 7 days should elapse after the end of escitalopram before treatment with non-selective MAO inhibitors can be initiated.

Some patients with panic disorders may experience increased anxiety at the beginning of treatment with selective serotonin reuptake inhibitors (including escitalopram). This paradoxical reaction usually disappears within 2 weeks of treatment. To reduce the likelihood of an anxiogenic effect, it is recommended to use the drug in low initial doses.

Escitalopram should be discontinued if seizures develop.It is not recommended to use the drug in patients with unstable epilepsy; for controlled seizures, careful monitoring is necessary. If the frequency of seizures increases, selective serotonin reuptake inhibitors, 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. When treating patients with diabetes mellitus with escitalopram, it is possible to change the level of glucose in the blood. Therefore, it may be necessary to adjust the dose of insulin and / or oral hypoglycemic drugs.

Clinical experience with escitalopram and other selective serotonin reuptake inhibitors indicates a possible increase in the risk of suicide in the first weeks of therapy. Careful monitoring of patients during this period is important.

Hyponatremia, possibly associated with impaired ADH secretion, occurs rarely with escitalopram and usually disappears when therapy is discontinued. Escitalopram and other selective serotonin reuptake inhibitors should be used with caution in patients at risk of developing hyponatremia: the elderly, patients with cirrhosis of the liver and 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 taking oral anticoagulants and medications that affect blood clotting.

Clinical experience with escitalopram in combination with electroconvulsive therapy is limited, so caution should be exercised in this case.

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

Patients taking escitalopram and other selective serotonin reuptake inhibitors simultaneously with serotonergic drugs 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, selective serotonin reuptake inhibitors and serotonergic drugs should be discontinued immediately and symptomatic therapy should be prescribed.

Concomitant use of escitalopram and alcohol is not recommended.

Influence on the ability to drive motor vehicles and manage mechanisms

Although escitalopram does not affect psychomotor activity, it is not recommended to drive a car or use machinery during treatment.

Form of production

Film-coated tablets

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Escitalopram

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Children over 15 years of age, Children as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Obsessive-compulsive disorder, Depression, Phobias and panic attacks