Noxibel - instructions for use, dose, side effects, contraindications

Excipients: silicon dioxide colloidal anhydrous, starch pregelatinized, microcrystalline cellulose, hypromellose, magnesium stearate, lactose monohydrate;

sheath: coloring agent Opadrai (Opadry) II YS-30-18056 white (lactose, hydroxypropylmethylcellulose (hypromellose), titanium dioxide, triacetin), dye Opadry (Opadry) II YS-19-19054 Transparent (hydroxypropylmethylcellulose (hypromellose), maltodextrin, triacetin).

Description:Round, biconvex tablets, white, film-coated, with risk and engraving "NOB 30 "on one side and the company logo on the other.

Pharmacotherapeutic group:antidepressant

ATX: & nbsp

N.06.A.X.11 Mirtazapine

Pharmacodynamics:

Mirtazapine is a drug from the group of tetracyclic antidepressants, is an antagonist of presynaptic and postsynaptic a₂receptors in the central nervous system and enhances central noradrenergic and serotonergic (5-HT₁receptors) transmission of nerve impulses. Mirtazapine also blocks 5-HT₂ and 5-HT₃-receptors.

Sedative properties of mirtazapine are due to its antagonistic activity in relation to H₁-histamine receptors.

Mirtazapine is usually well tolerated. In therapeutic doses, it has almost no anticholinergic effect and practically no effect on the cardiovascular system.

In clinical conditions, anxiolytic and hypnotic properties also appear, so mirtazapine is most effective in anxiety depressions of different genesis. Antidepressant effect is manifested after 1-2 weeks of treatment.

Pharmacokinetics:

After oral administration of the drug mirtazapine quickly absorbed (bioavailability of about 50%), reaching a maximum concentration in the blood plasma after about 2 hours. About 85% mirtazapine binds to plasma proteins. The average half-life is between 20 and 40 hours (rarely up to 65 hours). A shorter half-life is observed in young people. The equilibrium concentration is established after 3-5 days. In the recommended dosage range, the pharmacokinetic parameters of mirtazapine are linearly dependent on the administered dose of the drug.

Eating does not affect the pharmacokinetics of the drug.

Mirtazapine is actively metabolized and excreted in urine and feces for several days. The main ways of its metabolism in the body are demethylation and oxidation followed by conjugation. Cytochrome P450-dependent enzymes CYP2D6 and CYP1A2 participate in the formation of 8-hydroxy metabolite mirtazapine, while CYP3A4 presumably determines education N-detylated and Noxidized metabolites.

The clearance of mirtazapine decreases with renal or hepatic insufficiency.

Indications:

Depressive states of various etiologies (including psychomotor retardation, sleep disorders, loss of interest in life, suicidal thoughts, etc.).

Contraindications:

Hypersensitivity to mirtazapine or other components of the drug.

Simultaneous reception with monoamine oxidase inhibitors (MAO).

Age to 18 years (effectiveness and safety not established).

Carefully:

- Epilepsy and organic lesions of the brain (against the background of mirtazapine therapy, in rare cases, the development of convulsive conditions);

- hepatic or renal insufficiency;

- heart disease (impaired cardiac muscle conduction, angina pectoris, or recent myocardial infarction).

- cerebrovascular diseases (including ischemic attacks in the anamnesis);

- arterial hypotension and conditions predisposing to hypotension (including dehydration and hypovolemia);

- in patients who abuse drugs, with drug dependence, manic disorders;

- violation of urination, including, with hyperplasia of the prostate;

- closed angle glaucoma and increased intraocular pressure;

- diabetes.

Pregnancy and lactation:

The safety of mirtazapine during pregnancy is not established, so it can be used during pregnancy only if the benefit to the mother exceeds the potential risk to the fetus and under the supervision of the doctor.

The use of the drug during lactation and breast-feeding is not recommended (there is no data on excretion of the drug with breast milk).

Dosing and Administration:

The drug Noxibel ® is taken orally, without chewing, with a small amount of water.

For adults: the initial dose is 15 mg per day, after 4 days it can be increased to 30 mg / day, after 10 days, in the absence of effect - up to 45 mg per day.

Elderly patients: the recommended dose of Noxibel® is the same as for adults.

To achieve a satisfactory effect and ensure safety, an increase in the dose of the drug should be carried out under close medical supervision.

In patients with renal or hepatic insufficiency clearance of mirtazapine may be reduced. This should be taken into account when prescribing the drug this category of patients.

The half-life of mirtazapine is 20-40 hours and therefore the drug is suitable for admission once a day. It is preferable to take the drug as a single dose before bedtime.The drug Noxibel ® can also be prescribed for admission twice a day, dividing the daily dose in half (once in the morning and once a night).

Treatment should be continued as far as possible until the patient has no symptoms in 4-6 months. After this treatment can be gradually canceled. Mirtazapine usually begins after 1-2 weeks of treatment. Treatment with an adequate dose should result in a positive response in 2-4 weeks. If the response to treatment is insufficient, the dose can be increased to the maximum dose. If there is no response to treatment after another 2-4 weeks, treatment should be discontinued.

Side effects:

From the nervous system: drowsiness, impaired concentration, is more common in the first weeks of treatment (lowering the dose usually does not lead to a decrease in sedation, but can reduce the antidepressant effect); in rare cases: psychomotor retardation, agitation, hallucinations, depersonalization, anxiety, emotional lability, hyperkinesis, myoclonus, hypokinesia, apathy, hyperesthesia, tremor, convulsive syndrome, fatigue, manic disorders, nightmares / bright dreams.

On the part of the organs of hematopoiesis: rarely - oppression hemopoiesis (granulocytopenia, neutropenia, eosinophilia, agranulocytosis, aplastic anemia and thrombocytopenia); increased activity of transaminases in blood plasma.

From the digestive system: nausea, vomiting, constipation, abdominal pain.

From the genitourinary system: dysmenorrhea, decreased potency.

From the side of the cardiovascular system: rarely orthostatic hypotension, lowering blood pressure.

Other: increased appetite and weight gain, dizziness, headache, edematous syndrome; rarely urticaria, back pain, arthralgia, myalgia, dysuria, withdrawal syndrome, dry mouth, thirst, flu-like syndrome, suffocation, drug dependence.

Overdose:

Inhibition of the central nervous system with impaired orientation, prolonged sedation, hallucinations, tachycardia, moderate increase or decrease in blood pressure.

Treatment: gastric lavage, Activated carbon, oxygenation and ventilation of the lungs, symptomatic therapy.

Interaction:

Mirtazapine can enhance the depressant effect of alcohol on the central nervous system.In this regard, patients during treatment are advised to refrain from drinking alcohol.

Mirtazapine should not be used concurrently with MAO inhibitors or within 2 weeks after discontinuation of their use.

Mirtazapine may enhance the sedative effects of benzodiazepines.

Caution is required in cases where strong inhibitors CYP3A4, such as HIV protease inhibitors, antifungal agents of the azole group, erythromycin and nefazodone, are administered concomitantly with mirtazapine.

The dose of mirtazapine may be reduced with the onset of concomitant treatment with cimetidine or increased when cimetidine treatment is completed.

Special instructions:

- In prescribing antidepressants to patients with schizophrenia or other psychotic disorders, psychotic disorders may be aggravated or potentiated; The depressive phase can be replaced by a manic one;

- since there is a risk of suicide, especially at the beginning of treatment, patients should be given only a small amount of tablets;

- despite the fact that antidepressants are not addictive, the abrupt withdrawal of therapy can cause nausea, headache and malaise;

- Older patients are often more sensitive, especially with regard to adverse effects of antidepressants;

- when there are signs of jaundice, the drug should be discontinued;

- oppression of bone marrow function, manifested in the form of granulocytopenia or agranulocytosis, is rare and usually occurs after 4-6 weeks of treatment and is restored after discontinuation of treatment. The doctor should inform the patient that if symptoms such as fever, sore throat, and other signs of flu-like syndrome occur; it is necessary to stop treatment, see a doctor, do a blood test;

- Women of reproductive age should be treated only if reliable contraception is used.

Effect on the ability to drive transp. cf. and fur:

During treatment with mirtazapine, avoidance of potentially hazardous activities requiring high rates of psychomotor reactions, such as driving a car or controlling machinery, should be avoided.

Form release / dosage:Tablets, film-coated, 30 mg.

Packaging:

For 15 tablets in a blister, for 1 or 2 blisters in a cardboard bundle along with instructions for use.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-007704/08

Date of registration:25.09.2008

Expiration Date:Unlimited

The owner of the registration certificate: Laboratorios Bago S.A. Laboratorios Bago S.A. Argentina

Manufacturer: & nbsp

Laboratorios BAGO, S.A. Argentina

Representation: & nbspBBC FARMA BV BBC FARMA BV Netherlands

Information update date: & nbsp06.09.2016

Illustrated instructions

Instructions

Noxibel® (Noxibel®)