Cipralex, 10 mg 28 pcs

Cipralex is an antidepressant, a selective inhibitor of serotonin reuptake.

Inhibition of serotonin reuptake leads to increased concentration of this neurotransmitter in the synaptic cleft, increases 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-cholinoreceptors, benzodiazepine and opioid receptors.

Indications

Active ingredient

Composition

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

How to take, the dosage

Cipralex is prescribed once daily regardless of meals.

In depressive episodes, the drug is usually prescribed in a dose of 10 mg/day. Depending on the individual response of the patient, 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 symptoms of depression have disappeared, it is necessary to continue therapy for at least another 6 months to consolidate the effect obtained.

In panic disorder with/without agoraphobia, a dose of 5 mg/day is recommended for the first week of treatment with subsequent increases to 10 mg/day. Depending on the individual response of the patient, the dose may be increased to a maximum of 20 mg/day.

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

In elderly patients (over 65 years of age), half the normally recommended dose (i.e., only 5 mg/day) and a lower maximum dose (10 mg/day) are recommended.

In mild to moderate renal failure, no dose adjustment is required. In patients with severe renal insufficiency (CKD patients with impaired liver function, the recommended initial dose for the first 2 weeks of treatment is 5 mg/day. Depending on individual response to treatment, the dose may be increased up to 10 mg/day.

In case of reduced CYP2C19 isoenzyme activity, 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 treatment with Cipralex is discontinued, the dose should be reduced gradually over 1-2 weeks to avoid development of withdrawal syndrome.

Interaction

Pharmacodynamic interaction

The simultaneous use of Cipralex with MAO inhibitors, as well as the beginning of MAO inhibitor therapy in patients who have stopped taking Cipralex shortly before, may cause serious adverse reactions. Serotonin syndrome may develop in such cases.

The co-administration of Cipralex with serotonergic drugs (e.g. tramadol, sumatriptan and other triptans) may lead to the development of serotonin syndrome.
Cipralex may decrease the seizure threshold. Caution is required when prescribing Cipralex and other drugs that lower the seizure threshold at the same time.

With evidence of increased effects when Cipralex and lithium or tryptophan are co-administered, caution is advised when prescribing these drugs concomitantly.

The concomitant administration of Cipralex and preparations containing Hypericum perforatum may lead to increased side effects.

Concomitant administration of escitalopram with oral anticoagulants and drugs that affect blood clotting (e.g., atypical antipsychotics and phenothiazines, most tricyclic antidepressants, acetylsalicylic acid and NSAIDs, ticlopidine and dipyridamole) may lead to clotting disorders. In such cases, close monitoring of blood clotting is necessary at the beginning or at the end of therapy with escitalopram.

Escitalopram does not interact pharmacodynamically or pharmacokinetically with alcohol. 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 plasma concentration of escitalopram. Caution should be exercised when using escitalopram concomitantly with similar drugs (including omeprazole); reduction of the dose of escitalopram may be required.

Cypralex should be used with caution in high doses concomitantly with high-dose cimetidine, which is a strong inhibitor of the CYP2D6, CYP3A4 and CYP1A2 isoenzymes.

Escitalopram is an inhibitor of CYP2D6 isoenzyme. Caution should be exercised when concomitant administration of escitalopram and drugs that are metabolized with this isoenzyme and have a low therapeutic index, such as flecainide, propafenone and metoprolol (in cases of use in heart failure) or drugs mainly metabolized by CYP2D6 isoenzyme and acting on CNS, such as antidepressants desipramine, clomipramine, nortriptyline or antipsychotics risperidone, thioridazine, haloperidol. In these cases, dose adjustments may be necessary.

The simultaneous administration of escitalopram and desipramine or metoprolol leads to a twofold increase in concentrations of the latter two drugs.

Escitalopram may slightly inhibit the CYP2C19 isoenzyme. Therefore, caution is recommended when concomitant use of escitalopram and drugs metabolized with the participation of this isoenzyme.

Special Instructions

Escitalopram should not be prescribed concomitantly with MAO inhibitors. Excitalopram may be prescribed 14 days after stopping treatment with non-reversible MAO inhibitors and at least 1 day after stopping therapy with reversible type A MAO inhibitors (including moclobemide). At least 7 days should pass after stopping escitalopram before starting treatment with non-selective MAOI inhibitors.

In some patients with panic disorder, an increase in anxiety may be observed 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. The use of the drug is not recommended in patients with unstable epilepsy; in controlled seizures, close 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, blood glucose levels may change. Therefore, it may be necessary to adjust the doses of insulin and/or oral hypoglycemic drugs.

The clinical experience with escitalopram and other selective serotonin reuptake inhibitors indicates a possible increased risk of suicide during the first weeks of therapy. Close monitoring of patients during this period is important.

Hyponatremia, possibly associated with impaired ADH secretion, is rare with escitalopram and usually disappears with discontinuation of therapy. Caution should be exercised when prescribing escitalopram and other selective serotonin reuptake inhibitors in patients who are at risk for hyponatremia: the elderly, patients with cirrhosis of the liver, and patients taking medications that may cause hyponatremia.

The use of escitalopram may cause skin bleeding (ecchymoses and purpura).

Escitalopram should be used with caution in patients with a tendency to bleeding, as well as those taking oral anticoagulants and drugs that affect blood clotting.

The clinical experience with the use of escitalopram in combination with electroconvulsive therapy is limited, so caution should be exercised in this case.

The concomitant use of escitalopram and MAO type A inhibitors is not recommended because of the risk of serotonin syndrome.

Patients taking escitalopram and other selective serotonin reuptake inhibitors concomitantly with serotoninergic drugs may rarely develop serotonin syndrome.

Escitalopram should be used with caution concomitantly with drugs with serotonergic effects. 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 serotoninergic drugs should be discontinued immediately and symptomatic therapy administered.

The concomitant use of escitalopram and alcohol is not recommended.

Influence on driving and operating machinery

While escitalopram does not affect psychomotor activity, it is not recommended to drive or operate machinery during treatment.

Contraindications

Side effects

Digestive system disorders:

Most often – nausea, decreased appetite, diarrhea, constipation

Rarely – disorders of taste; possible – vomiting, dry mouth, changes in laboratory indicators of liver function.

CNS and peripheral nervous system:

Most often – insomnia or drowsiness, dizziness, weakness

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

Metabolic side:

Most often – increased sweating, hyperthermia

Possible – hyponatremia

From the sexual system: Most common – decreased libido, impotence, impaired ejaculation, anorgasmia (in women).

Cardiovascular system: Possible orthostatic hypotension.

From the endocrine system: Possible – insufficient secretion of ADH, galactorrhea.

Allergic reactions: possible – anaphylactic reactions, angioedema.

Dermatological reactions:possible – skin rash, itching, ecchymosis, purpura.

Others:

Most common – sinusitis

Possible – arthralgia, myalgia, urinary retention

When the drug is abruptly withdrawn after long-term use, withdrawal reactions – dizziness, headaches, and nausea – may occur. The severity of these reactions is mild and the duration is limited.

The side effects most commonly develop in 1 or 2 weeks of treatment and then usually become less intense and occur less frequently with continued therapy.

Overdose

Symptoms: dizziness, tremor, agitation, drowsiness, confusion, seizures, tachycardia, ECG changes (ST segment and T-wave changes, widening of QRS complex, prolongation of 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 of cardiovascular and respiratory function.

Pregnancy use

Cipralex is contraindicated in pregnancy and during lactation (breastfeeding).

Similarities