Calixta, pills 45mg, 30pcs

Composition

1 film-coated tablet contains:

Active ingredient:

mirtazapine 45 mg,

excipients:

lactose monohydrate-133.2 mg;

corn starch-84 mg;

giprolose-45 mg;

MCC-45 mg;

pregelatinized starch-45 mg;

talc — 4.2 mg;

magnesium stearate-2.1 mg;

silicon dioxide-1.5 mg

 film shell:

hypromellose-5 CPS-7.2 mg;

macrogol 6000-0.6 mg;

titanium dioxide-1.05 mg.

Indications

Depression.

Contraindications

• hypersensitivity to mirtazapine or to any of the excipients;
• patients with such a rare hereditary problems such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption, drug Calixtus should not be assigned;
• as the safety and efficacy of the drug Calixtus for the child’s age is not set, then use the drug Calixtus for the treatment of children up to 18 years is not recommended.

With caution

The correction mode and regular medical monitoring is required for the following categories of patients:

• patients with epilepsy and organic brain lesions (on the background of drug therapy Calixtus in rare cases may develop convulsions);
• patients with hepatic or renal insufficiency;
• patients with diseases of the heart (conduction disorder, angina or recent myocardial infarction);
• patients with cerebrovascular disease (including ischemic stroke in anamnesis);
• patients with hypotension and with conditions predisposing to hypotension (including dehydration and hypovolemia);
• patients who abuse drugs with addiction to drugs affecting the Central nervous system, with delusions, hypomania.

Like other antidepressants, Calixta should be used with caution in the following cases: :

• violation of urination, including with prostatic hyperplasia;
• acute angle-closure glaucoma and increased intraocular pressure;
• diabetes mellitus;
• with simultaneous use of benzodiazepines with the drug Calixta.

Side effects

Patients with depression have a number of symptoms associated with the disease, so it can sometimes be difficult to distinguish between symptoms associated with the disease and those caused by the use of the drug.

Blood and lymphatic system disorders:  the frequency is not established-bone marrow depression (granulocytopenia, agranulocytosis, aplastic anemia and thrombocytopenia), eosinophilia.

Nervous system disorders:  very often – drowsiness (which can lead to impaired concentration), usually occurs during the first weeks of treatment. (N. B. dose reduction usually does not lead to less sedation, but may reduce the effectiveness of an antidepressant), sedation, headache; often – lethargy, dizziness, tremor; infrequently – paresthesia, restless legs syndrome, fainting; rarely – myoclonus, very rarely – convulsions (stroke), serotonin syndrome, paresthesia of the oral mucosa.

From the gastrointestinal tract:  very often-dry mouth; often-nausea, diarrhea, vomiting; infrequently-decreased sensitivity of the oral mucosa; frequency is not established-swelling of the oral mucosa.

Skin and subcutaneous tissue disorders:  often – a skin rash.

Musculoskeletal and connective tissue disorders:  often-arthralgia, myalgia, back pain.

From the endocrine system:  frequency not established – violation of antidiuretic hormone secretion.

From the side of metabolism and nutrition:  very often-increased appetite.

From the cardiovascular system:  often-orthostatic hypotension; infrequently-a decrease in blood pressure.

General disorders and disorders at the injection site:  often-local edema; infrequently-fatigue.

Liver and biliary tract disorders:  rarely-increased activity of serum transaminases.

Mental disorders:  often-unusual dreams, confusion, anxiety*, insomnia*, infrequently-nightmares, mania, agitation, hallucinations, psychomotor agitation (including akatasia and hyperkinesia); frequency not established – suicidal ideation, suicidal behavior.

* usually, when treated with antidepressants, anxiety and insomnia, which may be symptoms of depression, may develop or worsen. The development or worsening of anxiety and insomnia has been reported very rarely during treatment with Calixta.

Interaction

Pharmacokinetic interaction Mirtazapine is extensively metabolized with the participation of the isoenzymes CYP2D6 and CYP3A4, and to a lesser extent with the participation of the isoenzyme CYP1A2. Interaction studies in healthy volunteers showed that paroxetine, an inhibitor of the CYP2D6 isoenzyme, does not affect the pharmacokinetics of mirtazapine at steady state. use in combination with a potent inhibitor of the CYP3A4 isoenzyme, ketoconazole, increased the maximum plasma concentration and AUC of mirtazapine by approximately 40% and 50%, respectively. Caution should be exercised when using mirtazapine in combination with potent inhibitors of the CYP3A4 isoenzyme, HIV protease inhibitors, azole antifungal drugs, erythromycin or nefazodone.

Carbamazepine and phenytoin, inducers of the CYP3A4 isoenzyme, increased the clearance of mirtazapine approximately twice, which led to a 45-60% decrease in plasma concentrations of mirtazapine. When carbamazepine or another inducer of microsomal liver enzymes (for example, rifampicin) is added to mirtazapine therapy, the dose of mirtazapine should be increased if necessary. When stopping treatment with such a drug, it may be necessary to reduce the dose of mirtazapine.

When mirtazapine is used in combination with cimetidine, the bioavailability of mirtazapine may increase by more than 50%. If necessary, the dose of mirtazapine should be reduced at the beginning of treatment in combination with cimetidine or increased at the end of treatment with cimetidine.

In in vivo interaction studies, mirtazapine did not affect the pharmacokinetics of risperidone or paroxetine (a substrate of the CYP2D6 isoenzyme), carbamazepine (a substrate of the CYP3A4 isoenzyme), amitriptyline, cimetidine, or phenytoin. No significant clinical effects or pharmacokinetic changes were observed in humans when treated with mirtazapine in combination with lithium.

Pharmacodynamic interaction

Mirtazapine should not be used in combination with MAO inhibitors or for two weeks after discontinuation of treatment with an MAO inhibitor. Mirtazapine may enhance the sedative properties of benzodiazepines and other sedatives. Caution should be exercised when prescribing these medications together with mirtazapine.

Mirtazapine may increase the depressive effect of alcohol on the central nervous system. Therefore, patients should be warned to avoid drinking alcoholic beverages.

If other serotonergic drugs (such as selective serotonin reuptake inhibitors and venlafaxine) are used in combination with mirtazapine, there is a risk of interaction that may lead to the development of serotonin syndrome.

Mirtazapine at a dose of 30 mg 1 time / day caused a small but statistically significant increase in MHO (international normalized ratio) in subjects treated with warfarin. A more pronounced effect cannot be excluded with a higher dose of mirtazapine. It is recommended to monitor MHO in the case of treatment with warfarin in combination with mirtazapine.

How to take, course of use and dosage

Tablets should be taken orally, washed down with liquid if necessary, and swallowed without chewing.

Adults:

The effective daily dose is usually between 15 mg and 45 mg; the initial dose is 15 mg or 30 mg.

Elderly patients:

The recommended dose is the same as for adults. In elderly patients, in order to achieve a satisfactory and safe response to treatment, an increase in the dose should be made under the direct supervision of a doctor.

Impaired liver and kidney function:

In patients with renal or hepatic insufficiency, mirtazapine clearance may be reduced. This should be taken into account when prescribing Calixtav to this category of patients.

The drug Calixta can be taken 1 time / day, preferably at the same time, before bedtime. The drug Calixta can also be prescribed for taking 2 times/day, dividing the daily dose in half (once in the morning and once at night, a higher dose should be taken at night).

If possible, treatment should be continued for 4-6 months until the patient’s symptoms completely disappear. After that, the treatment can be gradually canceled. Mirtazapine usually begins to exert its effect after 1-2 weeks of treatment. Treatment with an adequate dose should lead to a positive result in 2-4 weeks. If necessary, the dose can be increased to the maximum dose (up to 45 mg). If there is no positive dynamics of treatment after another 2-4 weeks, treatment should be discontinued.

Overdose

Experience with overdose with Calixta alone indicates that symptoms are usually mild. CNS depression has been reported, accompanied by disorientation and prolonged sedation in combination with tachycardia and a slight increase or decrease in blood pressure.

However, there is a potential for more severe outcomes (including death) at doses much higher than the therapeutic dose, especially with overdoses of several drugs taken simultaneously.

In case of overdose, symptomatic therapy should be performed to maintain vital body functions. You should inject activated charcoal or flush your stomach.

Special instructions

When using the drug Calixta, you should keep in mind:

• Psychotic symptoms may worsen with the use of antidepressants for the treatment of patients with schizophrenia or other psychotic disorders; paranoid ideas may increase.
• The depressive phase of manic-depressive psychosis can be transformed into a manic phase during treatment.
• In young adults (under 24 years of age) with depression and other psychiatric disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when prescribing the drug Calixta in young people (under 24 years of age), the risk of suicide and the benefits of using the drug should be correlated. In short-term studies, the risk of suicide did not increase in people over 24 years of age, and in people over 65 years of age – slightly decreased. Any depressive disorder itself increases the risk of suicide. Therefore, during treatment, the patient should be monitored for violations or changes in behavior, as well as suicidal tendencies.
• Despite the fact that the drug Calixta is not addictive, based on their post-marketing experience, it turned out that abrupt discontinuation of treatment after prolonged use can sometimes cause withdrawal symptoms. Most withdrawal reactions are mild and self-limiting. The most frequently reported withdrawal symptoms were dizziness, restlessness, anxiety, headache, and nausea. Although they have been reported as withdrawal symptoms, it should be understood that these symptoms may be related to the underlying medical condition. It is recommended to stop mirtazapine treatment gradually.
• Older patients are usually more sensitive, especially with regard to side effects. In clinical studies of the drug Calixta, it was not noted that in elderly patients, side effects are more common than in other age groups, but they may be more pronounced, but data are still limited.
• If signs of jaundice appear, treatment should be discontinued.
• Patients are advised to avoid the use of alcohol during treatment with Calixta.
• Inhibition of bone marrow function, usually appearing in the form of granulocytopenia or agranulocytosis, is rarely observed with the use of Calixta. It appears mostly after 4-6 weeks of treatment and is reversible after discontinuation of treatment. The doctor should pay close attention to symptoms such as fever, sore throat, stomatitis, and other signs of flu-like syndrome and inform the patient about this; if such symptoms occur, stop treatment and perform a blood test.

Influence on the ability to drive vehicles and mechanisms

The drug Calixta may reduce the concentration of attention. During treatment with antidepressants, patients should avoid performing potentially dangerous activities that require a high rate of psychomotor reactions, such as driving a car or operating machinery.

Composition

Tablet Form of production

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Mirtazapine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets