Caliksta tablets p / o 30mg, No. 30
Expiration Date: 05/2027
Russian Pharmacy name:
Каликста таблетки п/о 30мг, №30
Depressive states (including anhedonia, psychomotor retardation, insomnia, early awakening, weight loss, loss of interest in life, suicidal thoughts and mood lability).
The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.
When taken orally, the effective dose for adults is 15-45 mg / day, mainly 1 time / day at bedtime. The dose is gradually increased to 30-45 mg / day. The antidepressant effect develops gradually, usually after 2-3 weeks from the start of treatment, but the administration should be continued for another 4-6 months. If no therapeutic effect is observed within 6-8 weeks of treatment, treatment should be discontinued.
Cancellation of mirtazapine is carried out gradually.
Active substance:
mirtazapine - 30 mg
Excipients: lactose monohydrate - 88.8 mg, corn starch - 56 mg, hyprolose - 30 mg, microcrystalline cellulose - 30 mg, pregelatinized starch - 30 mg, talc - 2.8 mg, magnesium stearate - 1.4 mg, silicon dioxide - 1 mg.
The composition of the shell: hypromellose-5 CPS - 4.8 mg, macrogol 6000 - 0.4 mg, titanium dioxide - 0.5 mg, iron dye yellow oxide (E172) - 0.15 mg, iron dye red oxide (E172) - 0.05 mg, talc - 0.1 mg.
Renal and hepatic impairment,
pregnancy,
lactation,
hypersensitivity to mirtazapine,
childhood
Clinical and pharmacological group: Antidepressant
Pharmaco-therapeutic group: Antidepressant
pharmachologic effect
Antidepressant tetracyclic structure. Strengthens central adrenergic and serotonergic transmission. Blocks serotonin 5-HT2- and 5-HT3-receptors, in this regard, the enhancement of serotonergic transmission is realized only through serotonin 5-HT1 receptors. Both spatial enantiomers are involved in the manifestation of antidepressant activity: the S (+) - enantiomer blocks ?2-adrenergic receptors and serotonin 5-HT2 receptors. Moderately blocks histamine H1 receptors, has a sedative effect.
Has little effect on? 1-adrenergic receptors and cholinergic receptors; in therapeutic doses does not significantly affect the cardiovascular system.
In a clinical setting, anxiolytic and hypnotic effects are also manifested, therefore, mirtazapine is most effective for anxiety depressions of various origins. Due to its moderate sedative effect, it does not actualize suicidal thoughts during treatment.
Pharmacokinetics
After oral administration, mirtazapine is rapidly absorbed from the gastrointestinal tract. Bioavailability is 50%. Cmax in blood plasma is reached after 2 hours.
Css in blood plasma is established after 3-4 days of constant intake. Plasma protein binding is 85%.
It is actively metabolized in the liver by demethylation and oxidation, followed by conjugation. Dimethyl-mirtazapine is as pharmacologically active as the parent substance.
Mirtazapine is excreted by the kidneys and through the intestines. T1 / 2 is 20-40 hours.
In renal and hepatic insufficiency, a decrease in the clearance of mirtazapine is possible.
Indications
Depressive states (including anhedonia, psychomotor retardation, insomnia, early awakening, weight loss, loss of interest in life, suicidal thoughts and mood lability).
Dosage regimen
The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.
When taken orally, the effective dose for adults is 15-45 mg / day, mainly 1 time / day at bedtime. The dose is gradually increased to 30-45 mg / day. The antidepressant effect develops gradually, usually after 2-3 weeks from the start of treatment, but the administration should be continued for another 4-6 months. If no therapeutic effect is observed within 6-8 weeks of treatment, treatment should be discontinued.
Cancellation of mirtazapine is carried out gradually.
Side effect
From the side of the central nervous system and the peripheral nervous system: drowsiness, lethargy, emotional lability, changes in mentality, agitation, anxiety, apathy, hallucinations, depersonalization, hostility, mania, epileptic seizures, dizziness, vertigo, hyperesthesia, convulsions, hypoclonus, hyperkinesia, myocytosis ...
From the side of hematopoietic organs: oppression of hematopoiesis - granulocytopenia, agranulocytosis, neutropenia, eosinophilia, aplastic anemia, thrombocytopenia.
From the side of metabolism: a slight increase in appetite and an increase in body weight; in isolated cases - edema.
From the side of the cardiovascular system: rarely - orthostatic hypotension.
From the digestive system: nausea, vomiting, constipation, increased appetite, weight gain, dry mouth, thirst, abdominal pain; in isolated cases - an increase in the activity of liver transaminases.
From the reproductive system: decreased potency, dysmenorrhea.
Others: skin rashes, urticaria, flu-like syndrome, dyspnea, edema syndrome, myalgia, back pain, dysuria.
Contraindications for use
Renal and hepatic impairment,
pregnancy,
lactation,
hypersensitivity to mirtazapine,
childhood
Application during pregnancy and lactation
Contraindicated for use during pregnancy and lactation.
Application for violations of liver function
Use with caution in patients with impaired liver function.
Application for impaired renal function
Use with caution in patients with impaired renal function.
Application in children
Mirtazapine is not used in children due to the lack of data on the efficacy and safety of its use in pediatric practice.
special instructions
It is used with caution in patients with epilepsy and organic brain lesions, with impaired liver and / or kidney function, acute cardiovascular diseases, with arterial hypotension, with urinary disorders due to benign prostatic hyperplasia, with angle-closure glaucoma, and diabetes mellitus.
In patients with schizophrenia, mirtazapine can cause increased delusions and hallucinations. When treating the depressive phase of manic-depressive psychosis, this state can go into a manic phase.
Sudden discontinuation of mirtazapine after long-term treatment can cause nausea, headache, and deterioration of health.
It should be borne in mind that if symptoms such as fever, sore throat, stomatitis appear during the treatment period, treatment should be discontinued and a clinical blood test should be done.
If jaundice occurs, mirtazapine should be discontinued.
It should not be used concurrently with MAO inhibitors and within 2 weeks after their withdrawal.
The development of drug dependence, withdrawal syndrome is possible.
During the period of treatment, patients should refrain from drinking alcohol.
Mirtazapine is not used in children due to the lack of data on the efficacy and safety of its use in pediatric practice.
Influence on the ability to drive vehicles and use mechanisms
Use with caution in patients whose activities are associated with the need for a high concentration of attention and speed of psychomotor reactions.
Drug interactions
With the simultaneous use of mirtazapine enhances the sedative effect of benzodiazepine derivatives.
A case of the development of a hypertensive crisis with simultaneous use with clonidine is described.
With simultaneous use with levodopa, a case of severe psychosis has been described; with sertraline - a case of hypomania.
With simultaneous use with ethanol, it is possible to increase the inhibitory effect on the central nervous system of ethanol and ethanol-containing drugs.