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Mirtazapine

N.V.Organon
780 Items
2019-09-19
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Clinical Pharmacology

Antidepressant. Remeron blocks the presynaptic alpha2-adrenoreceptors in the central nervous system and enhances the noradrenergic transmission of nerve impulses. It also enhances serotonergic transmission (the effect is realized only through 5-HT1 receptors, since the 5-HT2 and 5-HT3 receptors are blocked.

Indications

Depressive states.

Composition

1 coated tablet contains mirtazapine 30 mg

Mirtazapine is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Remeron® N.V.Organon Netherlands pills
Mirtazapine Canon Canonpharma Russia pills
Calixta Belupo Croatia pills

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Mirtazapine

Dosage and Administration

Remeron is taken orally (pills are swallowed without chewing, squeezed with liquid if necessary), preferably at one time, before bedtime; we also accept the use of fractional doses distributed during the day (1 time in the morning and 1 time in the evening). For adults, the initial dose is 15 mg / day, with a possible gradual increase until the optimum clinical effect is achieved, usually the effective dose is 15-45 mg / day. The recommended doses for older people are those for adults. Treatment is desirable to continue for 4-6 months until the complete disappearance of clinical symptoms. In the absence of improvement within 2-4 weeks of therapy, the dose can be increased, in the absence of a clinical effect over the next 2-4 weeks, treatment should be stopped.

Adverse reactions

On the part of the nervous system and sensory organs: drowsiness / lethargy (usually occur during the first weeks of treatment), rarely - mania, convulsions, tremor, myoclonus.

Since the cardiovascular system and blood (hematopoiesis, hemostasis): rarely - orthostatic hypotension, eosinophilia, granulocytopenia, agranulocytosis, aplastic anemia, thrombocytopenia.

Others: increased appetite and weight gain, rarely - fluid retention and concomitant weight gain, increased plasma transaminase activity, skin reactions.

Contraindications

Hypersensitivity.

Drug interactions

Pharmacokinetic interaction

- mirtazapine is extensively metabolized with the participation of CYP2D6 and CYP3A4 isoenzymes, and to a lesser extent with the participation of CYP1A2 isoenzyme. The study of the interaction in healthy volunteers showed that paroxetine, an inhibitor of the isoenzyme CYP2D6, does not affect the pharmacokinetics of mirtazapine in the equilibrium state. Administration 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 powerful inhibitors of the isoenzyme CYP3A4, HIV protease inhibitors, azole antifungal drugs, erythromycin or nefazodone.

- Carbamazepine and phenytoin, inducers of CYP3A4 isoenzyme, increased clearance of mirtazapine approximately two times, which led to a 45-60% decrease in plasma concentrations of mirtazapine. When adding carbamazepine or another inducer of hepatic metabolism (for example, rifampicin) to therapy with mirtazapine, the dose of mirtazapine should be increased if necessary. If you stop treatment with this drug, it may be necessary to reduce the dose of mirtazapine.

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

- in studies of in vivo interactions, mirtazapine did not affect 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 were observed in humans during treatment with mirtazapine in combination with lithium.

Pharmacodynamic interaction

- Mirtazapin should not be used in combination with MAO inhibitors or for two weeks after stopping treatment with an MAO inhibitor.

- Mirtazapin may enhance the sedative properties of benzodiazepines and other sedatives. Caution should be exercised when prescribing these medicines along with mirtazapine.

- Mirtazapin may enhance the depressive effect of alcohol on the central nervous system. Therefore, patients should be warned about the need to avoid alcohol.

- in case of using other serotonergic drugs (for example, selective serotonin and venlafaxine reuptake inhibitors) in combination with mirtazapine, there is a risk of interaction, which can lead to the development of serotonin syndrome. Based on the post-registration experience of using the drug, it turned out that serotonin syndrome occurs very rarely in patients receiving treatment with mirtazapnnom in combination with selective serotonin reuptake inhibitors or venlafaxine. If it is believed that such a combination is therapeutically necessary, then in this case the dose should be carefully changed and the signs of the onset of sustained serotonergic overstimulation should be directly monitored.

- Mirtazapin at a dose of 30 mg once a day 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 ruled out. It is recommended to control MHO in case of treatment with warfarin in combination with mirtazapine.

Pregnancy and Lactation

In pregnancy, Remeron is possible only in case of emergency (safety of use in pregnant women has not been studied). At the time of treatment should stop breastfeeding (no data on the penetration into breast milk).

Special instructions

When using the drug Remeron, it should be borne in mind that worsening of psychotic symptoms can occur when antidepressants are used to treat patients with schizophrenia or other psychotic disorders; paranoid ideas may increase; The depressive phase of a manic-depressive psychosis during treatment can be transformed into a manic phase.

In young people (under 24 years) with depression and other mental disorders, antidepressants, compared with placebo, increase the risk of suicidal thoughts and suicidal behavior. Therefore, when prescribing Remeron in young people (under 24 years old), the risk of suicide should be correlated with the benefit of using the drug. In short-term studies, the risk of suicide was not increased in people over 24 years old, and in people over 65 years old - somewhat decreased. Any depressive disorder itself increases the risk of suicide. Therefore, during treatment, the patient should be monitored to identify abnormalities or behavioral changes, as well as suicidal tendencies.

Although the drug Remeron is not addictive, based on post-registration experience, it turned out that abrupt cessation of treatment after prolonged use can sometimes cause withdrawal symptoms. Most undo reactions are weak and self-limiting. The most frequently reported withdrawal symptoms were dizziness, agitation, anxiety, headache, and nausea. Although they were reported as withdrawal symptoms, it should be understood that these symptoms may be associated with the underlying disease. It is recommended to stop treatment with mirtazapine gradually.

Elderly patients are usually more sensitive, especially with regard to side effects. In clinical studies of the drug Remeron, it was not noted that in elderly patients, side effects are more common than in other age groups, but they may be more pronounced; however, data is still limited.

If signs of jaundice appear, treatment should be interrupted.

Patients are advised to avoid the use of alcohol in the treatment of the drug Remeron.

Inhibition of bone marrow function, usually manifested in the form of granulocytopenia or agranulocytosis, is rarely observed when using the drug Remeron. Appears mostly after 4-6 weeks of treatment and is reversible after cessation of treatment.The physician should carefully consider (and inform the patient) symptoms such as fever, sore throat, stomatitis, and other signs of flu-like syndrome; If these symptoms appear, stop the treatment and have a blood test.

Based on the post-registration experience, it turned out that serotonin syndrome occurs very rarely in patients receiving treatment with Remeron only.

Influence on ability to drive and work with mechanisms. Remeron® may reduce concentration of attention. In the process of treatment with antidepressants, patients should avoid performing potentially hazardous activities that require high-speed psychomotor reactions, such as driving a car or controlling machinery.

Overdosage

Experience with an overdose of Remeron alone indicates that the symptoms are usually mild. Reported CNS depression, accompanied by disorientation and prolonged sedation combined with tachycardia and a weak increase or decrease in blood pressure. However, there is a possibility of more severe results (including death) at doses much higher than the therapeutic dose, especially when overdosing with several drugs taken at the same time. In the event of an overdose, symptomatic therapy should be carried out to support the vital functions of the body. Activate charcoal or flush the stomach.

  • Brand name: Remeron®
  • Active ingredient: Mirtazapine
  • Dosage form: pills
  • Manufacturer: N.V.Organon
  • Country of Origin: Netherlands

Studies and clinical trials of Mirtazapine (Click to expand)

  1. Pharmacokinetics of Mirtazapine from Orally Administered Tablets: Influence of Gender, Age and Treatment Regimen
  2. Mirtazapine oral single dose kinetics in patients with different degrees of renal failure
  3. Effects of nocturnal doses of mirtazapine and mianserin on sleep and on daytime psychomotor and driving performance in young, healthy volunteers
  4. Mirtazapine in seasonal affective disorder (SAD): a preliminary report
  5. Serotonin syndrome with mirtazapine–fluoxetine combination
  6. New antidepressants and the cytochrome P450 system: Focus on venlafaxine, nefazodone, and mirtazapine
  7. Efficacy of mirtazapine in clinically relevant subgroups of depressed patients
  8. Dysthymic disorder: Treatment with mirtazapine
  9. Sexual functioning in depressed outpatients taking mirtazapine
  10. Determination of the Absolute Configuration of (−)-Mirtazapine by Vibrational Circular Dichroism
  11. The MAOA T941G polymorphism and short-term treatment response to mirtazapine and paroxetine in major depression
  12. Evaluation of polysaccharide-based chiral stationary phases in quality control of (S)-mirtazapine
  13. Synthesis of Tetracyclic Pyrido[2,3-b]azepine Derivatives as Analogues of Mirtazapine via N-Acyliminium Ion Cyclization.
  14. Improved Synthesis of Mirtazapine (VI).
  15. Mania associated with mirtazapine augmentation of fluoxetine
  16. Effects of imipramine and mirtazapine on operant performance in rats
  17. Use of mirtazapine in an adult with refractory anorexia nervosa and comorbid depression: A case report
  18. Asymmetric Synthesis of (S)-Mirtazapine: Unexpected Racemization through an Aromatic ipso-Attack Mechanism
  19. Enantioselective separation of the novel antidepressant mirtazapine and its main metabolites by CEC
  20. Capillary electrophoretic chiral determination of mirtazapine and its main metabolites in human urine after enzymatic hydrolysis
  21. Mirtazapine orally disintegrating tablets in depressed nursing home residents 85 years of age and older
  22. Are there predictors of outcome in depressed elderly nursing home residents during treatment with mirtazapine orally disintegrating tablets?
  23. Mirtazapine add-on therapy in the treatment of schizophrenia with atypical antipsychotics: a double-blind, randomised, placebo-controlled clinical trial
  24. MAOA gene polymorphisms and response to mirtazapine in major depression

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