Cipralex pills coated 10 mg N14
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Active ingredients
Escitalopram
Release form
Pills
Composition
Active ingredient: Escitalopram Concentration of active ingredient (mg): 10 mg
Pharmacological effect
Antidepressant. selectively inhibits serotonin reuptake; increases the concentration of neurotransmitter in the synaptic cleft, strengthens and prolongs the action of serotonin on postsynaptic receptors. escitalopram practically does not bind to serotonin (5-ht), dopamine (d1 and d2) receptors, α-adreno-, m-cholinergic receptors, and also to benzodiazepine and opioid receptors. The antidepressant effect usually develops after 2-4 weeks. after starting treatment. The maximum therapeutic effect of treating panic disorders is reached approximately 3 months after the start of treatment.
Pharmacokinetics
Suction does not depend on food intake. Bioavailability - 80%. The time to reach Cmax in plasma is 4 h. The kinetics of escitalopram is linear. Css is reached after 1 week. The average Css is 50 nmol / l (from 20 to 125 nmol / l) and is achieved at a dose of 10 mg / day. Seeming Vd - from 12 to 26 l / kg. Plasma protein binding - 80%. Metabolized in the liver to active demethylated and dimethylated metabolites. After repeated use, the average concentration of demethyl and dimethylmetabolites is 28–31% and less than 5%, respectively, of the concentration of escitalopram. The metabolism of escitalopram with the formation of a demethylated metabolite occurs mainly with the participation of the isoenzymes CYP2C19, CYP3A4 and CYP2D6. In persons with a weak activity of the CYP2C19 isoenzyme, the concentration of escitalopram can be 2 times higher than in individuals with a high activity of this isoenzyme. Significant changes in the concentration of the drug with a weak activity of the isoenzyme CYP2D6 is not observed. T1 / 2 after repeated use - 30 h. The major metabolites of escitalopram T1 / 2 are longer. Clearance - 0.6 l / min. Escitalopram and its major metabolites are excreted by the liver and most of it by the kidneys, partially excreted in the form of glucuronides. T1 / 2 and AUC increases in elderly patients.
Indications
Depressive episodes of any severity. Panic disorders with and without agoraphobia.
Contraindications
Hypersensitivity, simultaneous use of MAO inhibitors, age up to 15 years, pregnancy, lactation. With caution.Renal failure (QC below 30 ml / min), hypomania, mania, pharmacologically uncontrolled epilepsy, depression with suicidal attempts, diabetes mellitus, advanced age, liver cirrhosis, bleeding tendency; simultaneous administration with drugs that reduce the threshold of convulsive readiness, causing hyponatremia, ethanol, drugs metabolized with the participation of the CYP2C19 system.
Precautionary measures
Keep out of the reach of children.
Use during pregnancy and lactation
Contraindicated use during pregnancy and lactation (breastfeeding).
Dosage and administration
Cipralex is prescribed 1 time per sui regardless of food intake. In depressive episodes, the drug is usually prescribed at a dose of 10 mg per day. Depending on the patient's individual response, the dose may be increased to the maximum (20 mg per 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 another 6 months, it is necessary to continue therapy to consolidate the effect obtained. For panic disorders with and without agoraphobia during the first week of treatment, a dose of 5 mg per day is recommended, followed by an increase to 10 mg per day. Depending on the patient's individual response, the dose may be increased to a maximum of 20 mg per day. The maximum therapeutic effect is achieved approximately 3 months after the start of treatment. Therapy lasts for several months. In elderly patients (over 65), it is recommended to use half the usually recommended dose (that is, only 5 mg per day) and a lower maximum dose (10 mg per day). In renal insufficiency, mild and moderate severity of dose adjustment is not required. Patients with severe renal insufficiency should be prescribed with caution. For patients with impaired liver function, the recommended initial dose for the first 2 weeks of treatment is 5 mg per day. Depending on the individual response to treatment, the dose may be increased to 10 mg per day. With a reduced activity of the isoenzyme CYP2C19, the recommended initial dose for the first 2 weeks of treatment is 5 mg per day. Depending on the individual response to treatment, the dose may be increased to 10 mg per day.When discontinuing treatment with Cipralex, the dose should be reduced gradually over a period of 1-2 weeks in order to avoid the development of withdrawal syndrome.
Side effects
On the part of the digestive system: most often - nausea, loss of appetite, diarrhea, constipation; rarely, taste disturbances; possible - vomiting, dry mouth, changes in laboratory parameters of liver function. On the part of the central nervous system and peripheral nervous system: most often - insomnia or drowsiness, dizziness, weakness; possible - visual disturbances, seizures, tremor, movement disorders, serotonin syndrome, hallucinations, mania, confusion, agitation, anxiety, depersonalization, panic attacks, irritability. On the part of metabolism: most often - excessive sweating, hyperthermia; possibly - hyponatremia. On the part of the reproductive system: most often - decreased libido, impotence, impaired ejaculation, anorgasmia (in women). Since the cardiovascular system: possible orthostatic hypotension. On the part of the endocrine system: perhaps - insufficient secretion of ADH, galactorrhea. Allergic reactions: perhaps - anaphylactic reactions, angioedema. Dermatological reactions: possible - skin rash, itching, ecchymosis, purpura. Other: most often - sinusitis; possibly - arthralgia, myalgia, urinary retention. With the abrupt cancellation of the drug after prolonged use of possible reactions cancel - dizziness, headaches and nausea. 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.
Overdose
Data on escitalopram overdose is limited, in many such cases there was an overdose of other drugs. In most cases, the symptoms of overdose do not manifest or are mild. Cases of overdose of escitalopram (without taking other drugs) with a fatal outcome are rare, in most cases there is also an overdose of other drugs. Symptoms: mainly from the central nervous system (from dizziness, tremor and agitation to rare cases of serotonin syndrome, convulsive disorders, coma ), from the gastrointestinal tract (nausea / vomiting), cardiovascular disease (hypotension, tachycardia, prolongation of the QT interval and arrhythmia) and electrolyte imbalance (hypokalemia, hyponatremia). Treatment: the specific antidote of the drug does not exist.It is necessary to ensure normal airway, oxygenation and ventilation of the lungs. It should hold a gastric lavage and assign activated charcoal. Gastric lavage should be carried out as soon as possible after taking the drug. It is recommended to monitor the performance of the heart and other vital organs and to carry out symptomatic and supportive therapy.
Interaction with other drugs
With simultaneous use with MAO inhibitors increases the risk of serotonin syndrome and serious adverse reactions. Combined use with serotonergic drugs (including tramadol, triptanami) can lead to the development of serotonin syndrome. When used simultaneously with drugs that reduce the threshold of convulsive readiness, increases the risk of seizures. Estsitalopram enhances the effects of tryptophan and lithium preparations, increases the toxicity of Hypericum drugs, the effects of drugs that affect clotting blood count (control of blood coagulation indices is necessary). Preparations metabolized with the participation of CYP2C19 isoenzyme (including omeprazole), as well as being strong inhibitors of CYPZA4 and CYP2D6 (including flekainid, propafenone, metoprolol, desipramine, clomipramine, nortriptilin, risperidone, thioridazine, haloperidol), increase the concentration of escitalopram in the blood plasma. Escitalopram increases the plasma concentration of desipramine and metoprolol by 2 times.
special instructions
Caution should be used in patients with renal insufficiency (CC less than 30 ml / min), hypomania, mania, with pharmacologically uncontrolled epilepsy, with depression with suicidal attempts, diabetes mellitus, in elderly patients, with cirrhosis of the liver, with a tendency to bleed, simultaneously with taking medications that reduce the threshold of convulsive readiness, causing hyponatremia, with ethanol, with drugs that are metabolized with the participation of isoenzymes of the CYP2C19 system. Escitalopram should be prescribed only es 2 weeks. after discontinuation of irreversible MAO inhibitors and 24 hours after cessation of therapy with a reversible MAO inhibitor. Non-selective MAO inhibitors can be prescribed no earlier than 7 days after withdrawal of escitalopram. In some patients with panic disorder, at the beginning of treatment with escitalopram, an increased anxiety may occur, which usually disappears within the next 2 weeks. treatment.To reduce the likelihood of anxiety, it is recommended to use low initial doses. Escitalopram should be canceled if epileptic seizures develop or their frequency increases with pharmacologically uncontrolled epilepsy. Escitalopram should be discontinued when a manic state develops. correction of doses of hypoglycemic drugs. Clinical experience of using escitalopram indicates a possible increased and the risk of suicidal attempts in the first weeks of therapy, and therefore it is very important to carefully monitor patients during this period. Hyponatremia associated with a decrease in the secretion of ADH, while receiving escitalopram, occurs rarely and usually disappears when it is canceled. With the development of serotonin syndrome escitalopram should be immediately canceled and symptomatic treatment prescribed. Impact on the ability to drive vehicles and control mechanisms. During the period of treatment, patients should avoid driving vehicles. ort and other activities that require high concentration and speed of psychomotor reactions.