• Remeron ® tablets 30 mg №10

Remeron ® tablets 30 mg №10

Description for Remeron ® tablets 30 mg №10

Antidepressant. Strengthens the central adrenergic and serotonergic transmission. Blocks 5-HT2-and 5-HT3-serotonin receptors, and therefore the enhancement of serotonergic transmission occurs only in 5-HT1-receptors. In the manifestation of antidepressant activity involves both spatial enantiomers: S (+)-enantiomer blocks alpha 2-adrenergic and 5-HT2-serotonin receptors, R (-)-enantiomer - 5-HT3-serotonin receptors. Blocks H1-histamine receptors, has a sedative effect. At therapeutic doses, has practically no anticholinergic action and did not affect the function of CAS. Clinically manifest as anxiolytics and hypnotics properties, so that mirtazapine is more effective for anxiety depression different genesis. Thanks to the mild sedative action in the course of treatment is not updated by suicidal thoughts. Antidepressant effect appears after 1-2 weeks of treatment.

The active ingredient of Remeron mirtazapine is an antagonist of presynaptic alpha 2-adrenergic receptors in the CNS and enhances central noradrenergic and serotonergic transmission of nerve impulses. At the same time increasing serotonergic transmission is realized only through HT1 receptors because mirtazapine blocks HT2 and HT3 receptors. In the manifestation of antidepressant activity involves both spatial mirtazapine enantiomers, with S (+)-enantiomer blocks alpha 2 and HT2 receptors, and R (-)-enantiomer blocks HT3 receptors.

In addition, mirtazapine blocks H1 receptors, which accounts for its sedative effect.

At therapeutic doses, mirtazapine has practically no anticholinergic action and did not affect the function of the cardiovascular system, resulting in a drug is generally well tolerated.

Pharmacokinetics

Following oral administration, tablets Remeron its active ingredient mirtazapine is rapidly absorbed (bioavailability - about 50%), reaching a Cmax plasma levels after about 2 h. About 86% of mirtazapine is associated plasma proteins. The mean T1 / 2 is between 20-40 hours, sometimes marked and longer T1 / 2 - up to 65 h. Typically, T 1 / 2 in young men are shorter than in the elderly. Long T1 / 2 allows you to take the drug mirtazapine 1 per day. A stable concentration in plasma is reached after 3-4 days and will not change. The recommended dose range of pharmacokinetic parameters mirtazapine have a linear dependence of the administered dose.

Mirtazapine is actively metabolized and excreted in the urine and feces within a few days. The main routes of its metabolism in the body are demethylation and oxidation followed by conjugation. Demetilmirtazapin also pharmacologically active, and apparently has the same pharmacological effects as the starting material.

Cl mirtazapine may be decreased in renal or liver failure.

Statement

Depressive states.

Contraindications

Hypersensitivity to mirtazapine.

Pregnancy and breast feeding

Studies in animals have not revealed any Remeron teratogenic effects, but the safety of pregnancy in humans has not been investigated. Remeron should be used during pregnancy only if clearly needed. In the treatment of Remeron should use reliable methods of contraception.

Animal studies have shown that small amounts of mirtazapine is excreted in breast milk. Due to lack of data on the allocation of the breast milk of people did not recommend the use of Remeron in women during lactation.

Side effects

In patients with depression seen a number of symptoms caused by the disease itself. Therefore, it is sometimes difficult to distinguish symptoms associated with the disease and the symptoms caused by the use of Remeron.

In the treatment of Remeron usually are the following adverse effects: increased appetite and weight gain, drowsiness / lethargy, usually manifested in the first few weeks of treatment (dose reduction generally does not lead to a decrease in inhibition, but may weaken the antidepressant activity).

In rare cases: orthostatic hypotension, mania, seizures, tremor, myoclonus, fluid retention and associated weight gain, acute inhibition of blood (eosinophilia, granulocytopenia, agranulocytosis, aplastic anemia and thrombocytopenia), elevated transaminases, serum, skin reactions.

Interaction

Enhances the sedative effects of benzodiazepines (caution should be exercised when simultaneous appointment with Remeron), the inhibitory effect of alcohol on the central nervous system function (patients should abstain from alcohol during treatment). Incompatible with the simultaneous use with MAO inhibitors or within 2 weeks after the cessation of their use.

Overdose

Clinical safety of Remeron overdose has not been investigated. Toxicity studies showed no clinically significant cardiotoxic action with an overdose of Remeron. In clinical trials with an overdose of Remeron was not observed any clinically significant effects, except for the sedative action.

In case of overdose, the patient should be gastric lavage and appropriate treatment simptomatichsekoe to maintain the function of vital organs and systems.

Dosage and administration

Inward. The tablets should be swallowed without chewing, drinking a liquid, if necessary. The daily dose should preferably be taken at once, before going to bed. However, the method of fractional doses distributed during the day (1 times 1 times in the morning and evening), is also acceptable.

Adults should begin treatment with a daily dose of 15 mg. The dose should be gradually increased to achieve optimal clinical response. Typically, the effective daily dose is 15-45 mg.

The recommended dose for older adults to meet the dose. In order to achieve a satisfactory effect and safety, increasing the dose in elderly patients should be under close medical supervision.

Because the efficacy and safety of Remeron has not been studied in children, treatment of children with this drug is not recommended.

In the presence of renal or hepatic impairment decreases clearance of mirtazapine, which must be considered in these patients.

Treatment Remeron is desirable to continue for 4-6 months, until the complete disappearance of clinical symptoms. After this treatment can be gradually discontinued. In applying the correct doses of positive clinical effect appears after 2-4 weeks. In the absence of effective dose can be increased. If over the next 2-4 weeks the effect does not appear, then the treatment should be discontinued.

Precautionary measures

Violates the concentration and alertness. In the course of antidepressant treatment, patients should avoid performance of potentially hazardous activities requiring a high rate of psychomotor reactions, such as driving and control mechanisms.

The clinical application of most antidepressants is observed inhibition of blood, usually in the form of granulocytopenia or agranulocytosis. Most often it manifests itself in 4-6 weeks and usually disappears after discontinuation of treatment. Reversible agranulocytosis in rare cases, observed in clinical trials of Remeron. Physicians should pay attention to the emergence of such symptoms are like fever, sore throat, stomatitis or other signs of infection, should discontinue treatment and to CBC.

Careful selection of doses and regular medical monitoring is necessary in patients with epilepsy, organic brain disease (vozmozhnorazvitie seizures), with liver or kidney failure, heart disease, with conduction disturbances, angina pectoris and acute myocardial infarction, hypotension. Caution should be exercised when assigning patients with urinary disorders, including prostatic hypertrophy, acute narrow-angle glaucoma and increased intraocular pressure (however, these effects are unlikely, because the Remeron obsladaet weak anticholinergic activity), diabetes mellitus. When the treatment of jaundice Remeron should be discontinued.

During therapy, as in the case of taking other antidepressants should be considered:

- When using antidepressants in patients with schizophrenia or other mental disorders may increase psychotic symptoms,

- The treatment of the depressive phase of bipolar affective psychosis may occur with inversion affect the development of mania,

- Considering the possibility of suicidal ideation, the patient should give only a small number of tablets Remeron (especially early in treatment)

- Abrupt withdrawal after prolonged use Remeron may cause nausea, headache and a general deterioration of health,

- Elderly patients are often more sensitive to antidepressants, especially to their side effects. In a clinical study Remeron side effects in older patients were no more likely than other age groups, but the available information about this small.

Form of

Tablets of 30 mg for oral administration of 10 or 30 table. in the package.

Storage conditions

At a temperature of 2-30 ° C. In a dry, protected from light and out of reach of children.

Expiration date

3 years.

Pharmacy purchasing terms

By prescription.

Manufacturer

N. V. Organon, P.O 20, 5320 BH Oss, The Netherlands

Representation in the Russian Federation:

125445, Moscow, ul. Smolnaya 24 A, Meridian, Organon BV AGENCIES tel. (095) 960-28-97, fax (095) 960-28-96, e-mail - info@organon.ru

 

 

Structure and Composition

A coated tablet, contains mirtazapine 30 mg in blister pack 10 pcs., In box 1 or 3 blisters.

 

 

Pharmacological action

Blocks presynaptic alpha2-adrenergic receptors in the CNS and enhances noradrenergic transmission of nerve impulses. Strengthens and serotonergic transmission (in this case the effect is only realized through 5-HT1 receptors, since 5-HT2 and 5-HT 3 receptors are blocked.
Pharmacokinetics

After oral administration, is rapidly absorbed, bioavailability - about 50%, Cmax levels achieved in approximately 2 h. The binding to plasma proteins - about 86%. Equilibrium concentration in the blood is established after 3-4 days of continuous use. The recommended dose range of pharmacokinetic parameters have a linear dependence on the dose. Actively metabolized in the liver by demethylation and oxidation followed by conjugation. Demetilmirtazapin pharmacologically active as well as the starting material. Excreted in the urine and feces, T1 / 2 is 20-40 hours, sometimes - up to 65 hours (which allows one to take the drug once a day), T1 / 2 in young men are shorter than in the elderly. Clearance may decrease in renal or liver failure.
Pharmacodynamics

In the manifestation of antidepressant activity involves both spatial mirtazapine enantiomers, with S (+)-enantiomer blocks alpha 2-and 5-HT2 receptors, and R (-)-enantiomer blocks 5-HT3 receptors.

Blocks H1 receptors, has a sedative effect. At therapeutic doses, has practically no anticholinergic action and did not affect the function of the cardiovascular system.
Clinical Pharmacology

Attenuates the severity of symptoms such as anhedonia, psychomotor retardation, sleep disturbances (especially in the form of early awakenings), weight loss, loss of interest in life, suicidal tendencies and mood swings. Antidepressant effect appears after 1-2 weeks of treatment.

 

 

Statement

Depressive states.

 

 

Contraindications

Hypersensitivity.

 

 

Dosage and administration

Inside (tablets swallowed without chewing, drinking a liquid, if necessary), preferably at a time, before bed, let's say a reception in divided doses, distributed throughout the day (1 every morning and one time in the evening). Adults, the initial dose - 15 mg / day with a possible gradual increases to achieve optimal clinical response is usually an effective dose is 15-45 mg / day. The recommended dose for older people meet doses for adults. Desirable to continue treatment for 4-6 months to complete disappearance of clinical symptoms. If there is no improvement within 2-4 weeks of treatment the dose may be increased in the absence of clinical effect during the next 2-4 weeks, treatment should be discontinued.
Pregnancy and breast feeding

In pregnancy, the application is only possible 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).
Interaction

Enhances the sedative effects of benzodiazepines (caution should be exercised while receiving), the inhibitory effect of alcohol on the CNS. Incompatible with MAO inhibitors.
Overdose

Symptoms: marked sedative effect.

Treatment: gastric lavage, symptomatic treatment is to maintain the function of vital organs and systems.
Precautionary measures

It should not be given concurrently with MAO inhibitors and within two weeks after their withdrawal. It should be noted that the inhibition of blood (usually in the form of granulocytopenia or agranulocytosis) often appears after 4-6 weeks and usually disappears after discontinuation of treatment. If symptoms such as fever, sore throat, stomatitis and other signs of infection, treatment should be stopped and to CBC. When the treatment of jaundice and should be discontinued.

Used with caution in patients with epilepsy and organic brain disease (development of seizures), with liver or kidney f

Remeron ® tablets 30 mg №10

  • Product Code: 105
  • Availability: In Stock
  • $92.00

  • Ex Tax: $92.00

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