Remeron: instructions for use, price, reviews from doctors and analogues

Pharmacodynamics and pharmacokinetics

Mirtazapine is an antagonist of presynaptic alpha-2 receptors , stimulates central norepinephrine and serotonergic transmission of nerve impulses. The substance blocks 5-HT2 and 5-HT3 receptors and the impulse can only pass through 5-HT1 . The drug has a sedative effect and does not affect cardiovascular activity.

After taking the tablets, the medicine is well and quickly absorbed and penetrates the systemic bloodstream, its bioavailability reaches 50%. The maximum concentration is observed after 2 hours. The active substance binds well to blood plasma . It is excreted from the body from 20 to 40 hours (up to 65). The drug reaches equilibrium concentration after 4 days, then mirtazapine no longer accumulates in the body. Food intake does not affect the pharmacokinetic parameters of the drug in any way.

The process of drug elimination occurs in feces and urine over several days. Metabolic reactions occur with the participation of cytochrome P450 enzymes CYP2D6 and CYP1A2 .

In cases of liver or kidney disease, the clearance of mirtazapine is reduced.

Pharmacokinetics

After oral administration, it is rapidly absorbed, bioavailability is about 50%, Cmax in the blood is reached in about 2 hours. Plasma protein binding is about 86%. Equilibrium concentration in the blood is established after 3–4 days of continuous use. In the recommended dose range, pharmacokinetic parameters have a linear relationship with dose. Actively metabolized in the liver by demethylation and oxidation followed by conjugation. Demethylmirtazapine is as pharmacologically active as the parent substance. It is excreted in urine and feces, T1/2 is 20–40 hours, sometimes up to 65 hours (which allows you to take the drug once a day), T1/2 is shorter in young people than in older people. Clearance may be reduced with renal or hepatic insufficiency.

Side effects

It is difficult to separate the symptoms of depression from the side effects resulting from drug treatment.

The most common symptoms observed during treatment with Remeron were: drowsiness , dry mouth, weight gain, increased appetite , headache , fatigue, sedation and dizziness . Less frequently identified were: insomnia , tremor , confusion, lethargy , myalgia , decreased blood pressure , nausea, vomiting, diarrhea , arthralgia , back pain, peripheral edema pseudo rubella .

Rarely and very rarely may occur:

nightmares, hallucinations and mania, hyponatremia , agranulocytosis ;
excessive psychomotor agitation , aplastic anemia , paresthesia , myoclonus ;
thrombocytopenia , suicidal tendencies, agitation , serotonin syndrome ;
swelling of the oral mucosa, increased activity of liver enzymes ;
bullous dermatitis , erythema , Stevens-Johnson syndrome ;
toxic epidermal necrolysis , hormonal ( antidiuretic hormone ).

Remeron and beer

You should not drink beer during treatment with Remeron. Such a ban is established not only by manufacturers, but also by doctors. The tandem of two substances can provoke depression of the central nervous system.

The body, while cleansing the body of ethanol, mistakes the drug molecules for toxins, so it tries to quickly remove it without processing it. Because of this, the therapeutic effect is lost and the therapy will have to be repeated again.

According to statistics, minor depression under the influence of beer and the drug can develop into manic thoughts and suicidal tendencies. If mixed, consult a doctor immediately.

Instructions for use of Remeron (Method and dosage)

Orally, with water. The tablets are not cut into pieces or separated.

The drug is taken once a day. It is advisable to take the medicine once a day, at night, before going to bed.

Also, if necessary, the dosage can be divided into two doses. And take most of it in the evening.

Upon completion of therapy, the dosage of the drug should be gradually reduced to avoid the development of withdrawal syndrome.

Dosage regimen

Adults are usually prescribed from 15 to 45 mg of the drug. The initial dosage is 15 or 30 mg. The effectiveness of the drug reaches its maximum 7-14 days after the start of therapy. If necessary, the dosage can be increased.

If positive changes have not occurred within a month, then the medicine must be replaced.

Elderly people do not require dosage adjustment. However, the process of increasing the dose should occur under the supervision of a physician.

In case of renal failure, it is recommended to regularly monitor QC .

In case of serious liver diseases, treatment with the drug should be carried out under the supervision of a specialist.

Indications for use of Remeron

Most often, the use of remeron is practiced for depression and the symptoms that accompany it. The drug acts quite gently. Positive dynamics in the patient’s condition are noted 1-2 weeks after the start of treatment. Tablet Remeron is quickly absorbed and reaches its maximum concentration in the body after 2 hours from the moment of use. Patients undergoing treatment with this drug are not recommended to drink alcohol or engage in activities that require high concentration, such as driving a car. Remeron, according to expert research, is not addictive, but abruptly stopping use can provoke withdrawal symptoms:

dizziness
headache
anxiety
nausea

To avoid the appearance of such symptoms, you need to stop taking Remeron slowly, gradually reducing the dosage. The attending physician, as a rule, when prescribing a drug treatment regimen, takes into account this feature of the drug.

Overdose

Typically, an overdose of Remedon causes symptoms of mild severity: disorientation , sedation , tachycardia , hypo- or hypertension , depression of the functions of the central nervous system. If an overdose occurs with several drugs at the same time, the symptoms can be much more serious, even fatal.

Therapy is symptomatic, supportive, taking activated charcoal , gastric lavage.

Compatibility of Remeron and alcohol

? During therapy with Remeron, drinking alcohol in any dosage is strictly prohibited. Symbiosis negatively affects the condition and depresses the central nervous system several times more.

By binding to ethanol molecules, the active substance of the drug is neutralized and removed from the body under the guise of toxins. As a result, the patient will not receive proper treatment and all therapy will be considered ineffective.

Tandem can provoke a transition from depression to mania; a person experiences paranoid thoughts and ideas, which, under the influence of ethanol, take on a different color. Under the influence of antidepressants. Suicidal thoughts leave a person, but alcohol can provoke them.

Interaction

The medicine enhances the CNS effect of benzodiazepines , sedatives , antipsychotics , antihistamines , and opioids .

Mirtazapine cannot be combined with MAO inhibitors . The break between courses of drugs should be at least 2 weeks. In addition, simultaneous use with selective serotonin reuptake inhibitors , Triptan , Tramadol , L-tryptophan , Venlafaxine , St. John's wort and lithium may increase the frequency and severity of side effects.

Caution should be used when combining the drug with Ketoconazole , Cimetidine , azole antifungals , Erythromycin , Nefazodone .

You should not drink alcohol while taking these drugs.

When treating with Warfarin and Remeron, it is recommended to monitor IPT , since this combination increases blood .

Phenytoin and carbamazepine , inducers of the CYP3A4 enzyme , increase the clearance of Mirtazapine . Therefore, its concentration is reduced by about half. When combining the drug with any liver enzyme inducers, it is necessary to adjust the dosage of the drug.

Precautionary measures

Should not be prescribed simultaneously with MAO inhibitors and within 2 weeks after their discontinuation. It should be borne in mind that suppression of hematopoiesis (usually in the form of granulocytopenia or agranulocytosis) often appears after 4-6 weeks and usually disappears after cessation of treatment. If symptoms such as fever, sore throat, stomatitis and other signs of the development of an infectious disease appear, treatment must be stopped and a clinical blood test performed. If jaundice appears, treatment should also be stopped.

Use with caution in patients with epilepsy and organic brain damage (possible development of convulsive seizures), with liver or kidney failure, heart disease with conduction disorders, angina pectoris and acute myocardial infarction, arterial hypotension, in patients with urination disorders, incl. with prostatic hypertrophy, in patients with acute angle-closure glaucoma, patients with diabetes mellitus.

special instructions

The risk of developing agranulocytosis increases significantly in people over 65 years of age. As a rule, granulocytopenia and agranulocytosis that occur during treatment are reversible, but cases of death have also been reported. In general, there was no dependence of the frequency of adverse reactions on the patient’s age.

The medicine contains lactose . galactose intolerance , lactase deficiency , and impaired absorption of glucose-galactose should not take this drug.

At the beginning of treatment, the risk of developing suicidal behavior may increase. Improvements in the patient's condition occur after several weeks of systematically taking the medicine. Patients who have previously attempted suicide and those with severe suicidal thoughts and tendencies should be monitored. Taking into account suicidal tendencies in the initial stages of treatment, the patient should take the minimum dosage of the drug for the first few weeks.

If the patient gets jaundice , then taking the pills should be stopped immediately and seek help from a doctor.

When combining the drug with serotonergic drugs, serotonin syndrome may develop . Its symptoms are: hyperthermia , myoclonus , muscle rigidity , fluctuations in vital signs, confusion, agitation, irritability. During monotherapy, the syndrome develops extremely rarely.

The medicine is prescribed with caution and in minimal dosage:

if the patient has arterial hypotension , prostatic hypertrophy , acute angle-closure glaucoma , increased intraocular pressure ;
with epilepsy or organic brain damage;
persons with liver and kidney failure ;
in case of cardiac muscle conduction disturbances, angina pectoris , recent myocardial infarction ;
Patients with diabetes insulin dosage adjustment .

Taking the medication may increase the psychotic symptoms of schizophrenia and paranoid thoughts .

With an abrupt cessation of drug therapy (especially in high doses), withdrawal syndrome was rarely observed: agitation , headache, dizziness, nausea . Over time, the symptoms go away on their own.

Special instructions for the use of the drug Remeron

Suicide/suicidal thoughts or worsening clinical symptoms. Depression is associated with an increased risk of suicidal ideation, self-harm, or suicide. The risk may last until significant remission occurs. Since improvement may not occur for the first few weeks of treatment or more, patients should be closely monitored until such improvement occurs. It is common clinical experience that the risk of suicide may increase in the early stages of recovery. It is known that patients with a history of suicidal events, or patients who exhibit a significant degree of suicidal ideation even before treatment, have a higher risk of suicidal ideation or suicide attempts, and should be closely monitored during treatment. A meta-analysis of placebo-controlled clinical trials of antidepressants used in adults with mental disorders showed an increased risk of suicidal behavior with antidepressants compared with patients under 25 years of age who received placebo. Careful monitoring of patients, especially those at high risk for suicidal behavior, should be accompanied by antidepressant therapy, especially during initial therapy and after dosage changes. Patients (and caregivers of patients) should be warned to be alert to any clinical signs, suicidal behavior or thoughts, and unusual changes in behavior, and to seek medical advice immediately if such symptoms are present. Taking into account the possibility of suicide, especially at the beginning of treatment, the patient should be given only the minimum required number of Remeron tablets. Suppression of bone marrow function. Bone marrow depression, usually manifested by granulocytopenia or agranulocytosis, has been reported during treatment with Remeron. Reversible agranulocytosis has been reported as a rare occurrence in clinical studies of Remeron. In the post-marketing period, very rare cases of agranulocytosis have been reported, most cases reversible, but in some cases fatal. Deaths occurred in patients over 65 years of age. Your doctor should watch for symptoms such as fever, sore throat, stomatitis, or other signs of infection. When such symptoms occur, treatment should be stopped and a clinical blood test performed. Jaundice Treatment should be stopped if jaundice occurs. Conditions that require medical supervision. Careful dosing and regular and close monitoring are necessary for patients with the following conditions:

epilepsy and organic brain lesions: although clinical experience shows that epileptic seizures occur rarely during treatment with mirtazapine, as with treatment with other antidepressants, Remeron should be used with particular caution in patients with a history of epileptic seizures. In patients who develop epileptic seizures, or when there is an increase in the frequency of epileptic seizures, treatment should be discontinued;
Hepatic Impairment: Following a 15 mg oral dose of mirtazapine, the clearance of mirtazapine is reduced by approximately 35% in patients with mild to moderate hepatic impairment compared with patients with normal hepatic function. The average plasma concentration of mirtazapine increases by approximately 55%. When prescribing 30 mg of mirtazapine, it is necessary to take into account the benefit/potential risk ratio for the patient;
Renal impairment: After a single 15 mg oral dose of mirtazapine in patients with moderate (creatinine clearance ≤40 mL/min - 10 mL/min) or severe (creatinine clearance ≤10 mL/min) renal impairment, mirtazapine clearance decreased by approximately 30 % and 50%, respectively, compared to healthy patients. The mean plasma concentrations of mirtazapine increased by 55% and 115%, respectively. There were no significant differences observed in patients with mild renal impairment (creatinine clearance ≤80 mL/min to 40 mL/min) compared with controls. When prescribing 30 mg of mirtazapine, it is necessary to consider the benefit/potential risk ratio for the patient and monitor creatinine clearance;
heart diseases such as conduction disorders, angina pectoris and recent myocardial infarction. Such cases require the usual precautions and concomitant therapy with caution;
arterial hypotension;
Diabetes mellitus: In patients with diabetes, antidepressants may affect blood glucose levels. Dosage adjustments of insulin and/or oral hypoglycemic agents may be necessary and close monitoring is recommended.

As with other antidepressants, the following must be taken into account:

when taking antidepressants in patients with schizophrenia or other mental disorders, psychotic symptoms may worsen; Paranoid thoughts may become more intense;
When treating the depressive phase of bipolar disorder, it can transform into a manic phase. Patients with a history of manic or hypomanic symptoms should be carefully monitored. Mirtazapine should be discontinued if the patient enters a manic phase;
Although Remeron is not addictive, post-marketing experience suggests that sudden cessation of treatment after prolonged use may sometimes lead to withdrawal symptoms. Most withdrawal reactions are clinically mild and resolve on their own. Among the variety of withdrawal symptoms reported, the most common were dizziness, agitation, restlessness, headache and nausea. Although these have been reported as withdrawal symptoms, it is important to understand that these symptoms may be related to the course of the underlying medical condition. It is recommended to gradually discontinue treatment with mirtazapine;
Caution is required when treating patients with urinary dysfunction, incl. with prostatic hypertrophy, patients with acute angle-closure glaucoma and increased intraocular pressure (however, the effect of Remeron is unlikely due to very weak anticholinergic activity);
akathisia/psychomotor agitation: the use of antidepressants is associated with the development of akathisia, which is characterized by subjectively unpleasant or anxious agitation with increased motor activity. It is most likely that these symptoms may occur during the first few weeks of treatment, so increasing the dose may be harmful to health.

Hyponatremia. Hyponatremia, which is associated with inappropriate antidiuretic hormone (ADH) secretion, has been very rarely reported with mirtazapine. Elderly patients or patients taking concomitant medications known to cause hyponatremia require the use of precautions. Serotonin syndrome. Interaction with serotonergic active substances: Serotonin syndrome may occur when selective serotonin reuptake inhibitors are used together with other serotonergic active substances. Symptoms of serotonin syndrome may include hyperthermia, rigidity, myoclonus, and autonomic instability with possible rapid fluctuations in vital signs. Mental status changes include confusion, irritability, and extreme agitation that progress to delirium and coma. It is known from post-marketing experience that serotonin syndrome occurs very rarely in patients who use only Remeron. Elderly patients When prescribing Remeron to elderly patients, it is necessary to take into account undesirable effects when using antidepressants. In clinical studies of the drug Remeron, the occurrence of adverse reactions in elderly patients was observed no more often than in patients of other age groups. Lactose The drug contains lactose. Patients with rare hereditary diseases of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption are contraindicated to take the drug. Use of the drug during pregnancy and lactation. Limited data from the use of mirtazapine in pregnant women do not indicate an increased risk of birth defects. Animal studies have not shown any teratogenic effects that manifest as clinical symptoms, but adverse effects on intrauterine development have been observed. Caution is necessary, taking into account the benefit/potential risk ratio for the fetus, when prescribing the drug to pregnant women. If Remeron is used before or immediately before birth, postnatal monitoring of the newborn is recommended to account for possible withdrawal effects. Animal studies and the limited available data from human studies have shown very low levels of mirtazapine excreting in breast milk. The decision whether to continue/discontinue breastfeeding or continue/discontinue therapy with Remeron should be made taking into account the benefits to the baby and the benefits of therapy with Remeron to the woman. Children. Remeron is not used to treat patients under 18 years of age. Behaviors related to suicide (suicide attempts and suicidal ideation) and aggression (primarily aggression, negativism, and anger) were most frequently observed in clinical studies among children and adolescents treated with antidepressants compared with children and adolescents treated with placebo. If a decision to treat is made based on clinical need, the patient should be closely monitored for the emergence of suicidal symptoms. In addition, long-term safety data in children and adolescents regarding growth, maturation, cognitive and behavioral development are lacking. Effect on the ability to drive a car and other mechanisms Remeron affects concentration. Patients taking antidepressants should not engage in potentially hazardous activities, including driving a car or using other machinery.

Remeron's analogues

Level 4 ATC code matches:
Pipofezin

Bethol

Incazan

Melitor

Azafen

Miaser

Velafax

Mirtazonal

Venlaxor

Venlafaxine

Lerivon

Mirtazapine

Cymbalta

Velaxin

Coaxil

Pyrazidol

Deprim

Gelarium Hypericum

Negrustin

Trittico

The closest analogues of the drug: Alventa, Velaxin, Venlaxor, Venlift, Gelarium Hypericum, Deprexor, Deprivit, Intriv, Coaxil, Medofaxin, Mianserin, Neuroplant, Pyrazidol, Trittico, Prefaxin, Negrustin, Valdoxan, Azafen, Normazidol, Venlafaxine, Cymbalta, Miaser, Melitor, Lerivon, Intriv, Deprim, Depresil, Wellbutrin, Brintellix .

During pregnancy and lactation

Experience with the use of the drug in pregnant women is limited. Animal studies have not shown any effects on the child's health. The question of prescribing the drug to pregnant women should be decided by the attending physician.

the mother took antidepressants during pregnancy , a postnatal examination of the newborn should be performed after birth to exclude the development of withdrawal syndrome.

The active ingredient of the drug passes into breast milk in small quantities. The decision to stop breastfeeding should be made after consultation with a specialist.

Reviews about Remeron

Judging by reviews from doctors, the drug is most often prescribed for panic attacks and vegetative-vascular dystonia . The medicine is well tolerated, brings patients back to life, improves sleep and appetite. Sometimes, to eliminate side effects from taking it, additional medications are prescribed. It should be remembered that Remeron is a fairly serious medicine and should not be taken without the consultation and recommendations of the attending physician.

Reviews of Remeron on forums

“The pills are good for relieving depression. Depression is endogenous, it is useless to look for reasons. I can only save myself with medicine. The disadvantage is increased appetite.”

“My attacks - breathing problems, migraines, dizziness - Remeron relieved me perfectly. But it also has its own “side effects”: it’s impossible to sit still and it’s impossible to stop eating! I was constantly running around and couldn’t sleep. And she began to gain weight by leaps and bounds, even while limiting herself in food.”

“Switched to it from another medicine. The difference is amazing! It's nice to feel like a real person again."