Arip MT (aripiprazole) tablets 10 mg. №30

Description

Ingredients:

active substance: aripiprazole;

1 tablet contains aripiprazole 10 mg or 15 mg;

excipients: mannitol (E 421), colloidal anhydrous silicon dioxide, magnesium stearate, crospovidone, hydroxypropyl cellulose, microcrystalline cellulose, tartaric acid, vanillin, acesulfame potassium.

Medicinal form . Tablets.

The main physical and chemical properties:

10 mg tablets: round, white to off-white tablets debossed with “10” on one side and smooth on the other side;

15 mg tablets: round, white to off-white tablets debossed with “15” on one side and plain on the other side.

Pharmacotherapeutic group. Antipsychotics (neuroleptics).

ATX code N05A X12.

Pharmacodynamics.

The therapeutic effect of aripiprazole in schizophrenia is due to a combination of partial agonist activity against D2-dopamine and 5HT1a-serotonin receptors and antagonistic activity against 5HT2 serotonin receptors.

Aripiprazole has a high in vitro affinity for D2- and D3-dopamine receptors, 5HT1a- and 5HT2a-serotonin receptors, and a moderate affinity for D4-dopamine, 5HT2c- and 5HT7-serotonin receptors, a1-adrenoceptors and 1-adrenoceptors. Aripiprazole is also characterized by a moderate affinity for the serotonin reuptake sites and a lack of affinity for muscarinic receptors. Aripiprazole in animal experiments showed antagonism against dopaminergic hyperactivity and agonism against dopaminergic hypoactivity. Not only dopamine and serotonin receptors can interact with some of the clinical effects of aripiprazole.

Pharmacokinetics.

The activity of the drug is due to the active substance – aripiprazole. The average half-life of aripiprazole is approximately 75 hours. The equilibrium concentration is reached after 14 days. Cumulation of the drug with repeated administration is predictable. Pharmacokinetics of aripiprazole at steady state are dose proportional. No daily fluctuations in the distribution of aripiprazole and its metabolite of dehydroaripiprazole were noted. It has been established that the major metabolite in human blood plasma, dehydroaripiprazole, has the same affinity for D2-dopamine receptors as aripiprazole.

Indications.

Adults

Treatment of schizophrenia.

Treatment of moderate and severe manic episodes of bipolar I disorder.

Prevention of new manic episodes in patients who have already experienced these episodes and who have been treated with aripiprazole.

Treatment of moderate to severe manic episodes of bipolar I disorder lasting 12 weeks.

Contraindications.

Hypersensitivity to aripiprazole or any other component of Arip MT (aripiprazole). Phenylketonuria.

Dosage and Administration.

Arip MT (aripiprazole) tablets are used orally by adults.

Schizophrenia. The recommended initial dose of Arip MT (aripiprazole) is 10 or 15 mg once a day, regardless of food intake. The maintenance dose is 15 mg per day. The effective dose of the drug is from 10 to 30 mg per day. An increase in the effectiveness of the drug at a dose of more than 15 mg has not been demonstrated, although some patients may require a higher dose. The maximum daily dose should not exceed 30 mg.

Manic episodes in bipolar I disorder. The recommended initial dose is 15 mg 1 time per day, regardless of food intake, both in monotherapy and in combination therapy. Some patients need a higher dose. The maximum daily dose should not exceed 30 mg.

Prevention of repeated manic episodes in bipolar I disorder. To prevent manic episodes in patients receiving Arip MT (aripiprazole) as monotherapy or in combination therapy, treatment should be continued at the same doses.

Adjusting the daily dose or reducing the dose is determined by the doctor, taking into account the clinical condition of the patient.

Patients with impaired liver function

No dosage adjustment is required for patients with moderate to moderate hepatic impairment. Available data are insufficient to make recommendations for patients with severe hepatic impairment. For such patients, the dose should be selected very carefully. However, the maximum daily dose of 30 mg should be used with caution in patients with severe hepatic impairment.

Patients with impaired kidney function

Dose adjustment is not required.

Elderly patients

The effectiveness of aripiprazole in the treatment of schizophrenia with bipolar I disorder in patients aged 65 years and older has not been studied.

Dose adjustment during interaction

In case of simultaneous use of strong inhibitors of CYP3A4 or CYP2D6 with aripiprazole, the dose of the latter is reduced. When using CYP3A4 or CYP2D6 inhibitors in combination therapy, the dose of aripiprazole should be increased.

In case of simultaneous use of a strong CYP3A4 inducer with aripiprazole, the dose of the drug should be increased. When using a CYP3A4 inducer in combination therapy, the dose of aripiprazole should be reduced to the recommended dose.

Children.

The safety and efficacy of aripiprazole in children under 18 years of age have not been studied.