Calixta, 45 mg 30 pcs

Depression.

Active ingredient

Mirtazapine

Composition

1 film-coated tablet contains:

acting substance:

mirtazapine 45 mg,

excipients:

Lactose monohydrate, 133.2 mg;

Corn starch, 84 mg;

Hyprolose – 45 mg;

MCC – 45 mg;

Pregelatinized starch – 45 mg;

Talt – 4.2 mg;

Magnesium stearate – 2.1 mg;

silicon dioxide – 1.5 mg

coated film:

Hypromellose-5 CPS – 7.2 mg;

Macrogol 6000 – 0.6 mg;

Titanium dioxide – 1.05 mg.

How to take, the dosage

The tablets should be taken orally with liquids if necessary and swallowed without chewing.

Adults:

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

Elderly patients:

The recommended dose is the same as for adults. In elderly patients, dose increases should be done under direct medical supervision in order to achieve a satisfactory and safe response to treatment.

Hepatic and renal disorders:

In patients with renal or hepatic impairment, the clearance of mirtazapine may be reduced. This should be considered when prescribing Calixtav in this category of patients.

Calixta may be taken once daily, preferably at the same time, before bedtime. Calixta can also be given twice daily, dividing the daily dose in half (once in the morning and once at night; the higher dose should be taken at night).

The treatment should be continued for 4-6 months, if possible, until the patient’s symptoms completely disappear. After that, treatment may be gradually withdrawn. Mirtazapine usually begins to exert its effects after 1 to 2 weeks of treatment. Treatment with an adequate dose should lead to a positive result after 2-4 weeks. If necessary, the dose may 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.

Interaction

Pharmacokinetic interaction

Mirtazapine is extensively metabolized with CYP2D6 and CYP3A4 isoenzymes and, to a lesser extent, with CYP1A2 isoenzymes. Interaction studies in healthy volunteers have shown that paroxetine, a CYP2D6 isoenzyme inhibitor, has no effect on the pharmacokinetics of mirtazapine at equilibrium. Administration in combination with the potent CYP3A4 isoenzyme inhibitor, 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 CYP3A4 isoenzyme inhibitors, HIV protease inhibitors, azole antifungal drugs, erythromycin or nefazodone.

Carbamazepine and phenytoin, CYP3A4 isoenzyme inducers, increased mirtazapine clearance approximately twofold, resulting in 45-60% lower plasma concentrations of mirtazapine. When carbamazepine or another microsomal liver enzyme inducer (e.g., rifampicin) is added to mirtazapine therapy, the dose of mirtazapine should be increased if necessary. It may be necessary to reduce the dose of mirtazapine when discontinuing treatment with this medication.

When using mirtazapine in combination with cimetidine, the bioavailability of mirtazapine may be increased by more than 50%. The dose of mirtazapine should be decreased, if necessary, at the beginning of treatment in combination with cimetidine or increased when cimetidine treatment is stopped.

In in vivo interaction studies, mirtazapine had no effect on the pharmacokinetics of risperidone or paroxetine (CYP2D6 isoenzyme substrate), carbamazepine (CYP3A4 isoenzyme substrate), amitriptyline, cimetidine or phenytoin.
No important clinical effects or changes in pharmacokinetics have been observed in humans when treated with mirtazapine in combination with lithium.

Pharmacodynamic Interactions

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

Mirtazapine may increase the depressant effects of alcohol on the CNS. Therefore, patients should be warned to avoid alcoholic beverages.

If other serotonergic medications (e.g., selective serotonin takeover inhibitors and venlafaxine) are used in combination with mirtazapine, there is a risk of interaction that may lead to serotonin syndrome.

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

.

Special Instructions

When using Calixta, keep in mind:

• Worsening of psychotic symptoms may occur when using antidepressants to treat patients with schizophrenia or other psychotic disorders; paranoid ideas may increase.
• The depressive phase of manic-depressive psychosis may transform into a manic phase during treatment.
• In young adults (younger than 24 years) with depression and other psychiatric disorders, antidepressants, compared with placebo, increase the risk of suicidal ideation and suicidal behavior. Therefore, when prescribing Calixta in young adults (younger than 24 years of age), the risk of suicide and the benefits of the drug should be correlated. In short-term studies, people over 24 years of age did not increase their risk of suicide, and people over 65 years of age had a slightly decreased risk of suicide. Any depressive disorder itself increases the risk of suicide. Therefore, the patient should be monitored during treatment to detect abnormalities or behavioral changes as well as suicidal tendencies.
• Although Calixta is not addictive, based on post-registration experience it appears that abrupt discontinuation of treatment after prolonged use may sometimes cause withdrawal symptoms. Most withdrawal reactions are mild and self-limiting. The most commonly reported withdrawal symptoms were dizziness, agitation, anxiety, headache, and nausea. Although these have been reported as withdrawal symptoms, it should be understood that these symptoms may be related to the underlying disease. It is recommended that treatment with mirtazapine be discontinued gradually.
• Elderly patients tend to be more sensitive, especially with regard to side effects. In clinical trials of Calixta, side effects have not been observed to be more frequent in elderly patients than in other age groups, but they may be more severe, but data are still limited.
• In the event of signs of jaundice, treatment should be discontinued.
• Patients are advised to avoid alcohol during treatment with Calixta.
• Bone marrow suppression, which usually appears as granulocytopenia or agranulocytosis, is rarely seen with Calixta. It occurs mostly after 4-6 weeks of treatment and is reversible after discontinuation of treatment. The physician should be alert to symptoms such as fever, sore throat, stomatitis, and other flu-like symptoms and inform the patient; if these symptoms occur, treatment should be discontinued and blood tests performed.

Impact on driving and operating ability

Calixta may decrease concentration. During treatment with antidepressants, patients should avoid potentially hazardous activities requiring high psychomotor reaction rates, such as driving or operating machinery.

.

Contraindications

• high sensitivity to mirtazapine or any of the excipients;
• People with rare hereditary problems such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption should not be prescribed Calixta;
• Since the safety and efficacy of Calixta in children has not been established, it is not recommended to use Calixta in children under 18 years of age.

Cautions

Adjustment of the dosing regimen and regular medical monitoring are necessary for the following categories of patients:

• Patients with epilepsy and organic brain lesions (against the background of therapy with Calixta in rare cases, seizures may develop);
• Patients with hepatic or renal insufficiency;
• Patients with heart disease (conduction disorders, angina or recent myocardial infarction);
• Patients with cerebrovascular disease (including
• Patients with arterial hypotension and conditions predisposing to arterial hypotension (including with dehydration and hypovolemia;
• drug abusers, with dependence on drugs affecting the CNS, with mania, hypomania.

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

• disordered urination, including. in prostatic hyperplasia;
• acute closed-angle glaucoma and increased intraocular pressure;
• sugar diabetes;
• concomitant use of benzodiazepines with Calixta.

Side effects

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

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

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

Gastrointestinal tract: very often – dry mouth; often – nausea, diarrhea, vomiting; infrequently – decreased sensitivity of the oral mucosa; frequency is not determined – edema of the oral mucosa.

Skin and subcutaneous tissue: often – skin rash.

Skeletal-muscular system and connective tissue: often – arthralgia, myalgia, back pain.

Endocrine system disorders: frequency is not determined – disruption of antidiuretic hormone secretion.

Metabolism and nutrition: very often – increased appetite.

Cardiovascular system: frequent – orthostatic hypotension; infrequent – decreased BP.

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

Hepatic and biliary tract disorders: rarely – increased serum transaminase activity.

Mental disorders: often – unusual dreams, confusion, anxiety*, insomnia*, infrequent – nightmares, mania, agitation, hallucinations, psychomotor agitation (including agathasia and hyperkinesia); frequency is not established – suicidal ideas, 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 have very rarely been reported when treated with Calixta.

Overdose

Experience regarding overdose with Calixta alone indicates that symptoms are usually mild. CNS depression with disorientation and prolonged sedation, combined with tachycardia and a mild rise or fall in BP, have been reported.

But there is a possibility of more severe results (including death) at doses much higher than the therapeutic dose, especially in overdoses with multiple drugs taken simultaneously.

In case of overdose, symptomatic therapy should be given to support vital body functions. Activated charcoal or gastric lavage should be administered.

Similarities

Mirtazapine Canon, Mirtazapine