Ariprizol tablets 10mg, No. 30

schizophrenia (acute attacks and supportive care);

bipolar I disorder (manic episodes and supportive therapy to prevent relapse in patients with bipolar I disorder who have recently had a manic or mixed episode);

adjunct to therapy with lithium or valproic acid for the treatment of manic or mixed episodes within bipolar I disorder with or without psychotic symptoms and supportive therapy to prevent relapse in patients with bipolar I disorder;

addition to antidepressant therapy for major depressive disorder.

Inside, regardless of the meal.

Schizophrenia. The recommended starting dose is 10 to 15 mg once a day. The maintenance dose is 15 mg / day. Clinical studies have shown the effectiveness of the drug in doses from 10 to 30 mg / day. The maximum daily dose should not exceed 30 mg.

Manic episodes in bipolar disorder. As monotherapy, the recommended starting dose is 15 mg once a day, regardless of food intake. If necessary, the dose should be changed at intervals of at least 24 hours. Clinical studies have shown the effectiveness of the drug in doses of 15 to 30 mg / day for 3Ц12 weeks. The safety of the drug in doses over 30 mg / day has not been evaluated in clinical trials.

When observing patients with bipolar I disorder who underwent a manic or mixed episode, who showed stabilization of symptoms while taking aripiprazole for 6 weeks at a dose of 15 or 30 mg / day with an initial dose of 30 mg / day, then 6 months, and then - within 17 months, a favorable effect of such supportive therapy was established. Patients should be examined periodically to determine the need for continued maintenance therapy.

Adjunct to therapy with lithium or valproic acid for bipolar I disorder. The recommended starting dose is 10 to 15 mg once a day, regardless of food intake. The maintenance dose is 15 mg / day. The dose can be increased up to 30 mg / day depending on clinical indications.

When observing patients with bipolar I disorder, a beneficial effect of maintenance therapy with aripiprazole at a dose of 10 to 30 mg / day was established as an adjunct to therapy with lithium or valproic acid preparations. Patients should be periodically evaluated to determine the need for continued maintenance therapy.

Adjunctive therapy for major depressive disorder. The recommended starting dose is 5 mg / day, regardless of food intake. If necessary and well tolerated, the daily dose can be increased weekly by 5 mg to the maximum - no more than 15 mg / day.

The duration of therapy for all of the above indications has not been established. It is necessary to regularly examine the patient for the possibility of canceling therapy.

Special patient groups

Impaired renal function. No dose adjustment is required.

Liver dysfunction. No dose adjustment is required. For patients with severely impaired liver function, a dose of 30 mg is prescribed with caution.

Patients over 65 years of age. No dose adjustment is required.

Floor. The dosage regimen of the drug for patients of both sexes is the same.

Smoking. The dosage regimen of the drug for smokers and non-smokers is the same.

Dosage regimen with concomitant therapy

With the simultaneous use of aripiprazole and powerful inhibitors of the isoenzyme CYP3A4 (ketoconazole, clarithromycin), the dose of drugs should be reduced by 2 times; when canceling inhibitors of the isoenzyme CYP3A4, the dose of the drug should be increased.

With the simultaneous use of aripiprazole and powerful inhibitors of the isoenzyme CYP2D6 (quinidine, fluoxetine, paroxetine), the dose of the drug should be reduced by 2 times; when canceling inhibitors of the isoenzyme CYP2D6, the dose of the drug should be increased.

If the drug is prescribed as adjunctive therapy for major depressive disorder, drugs should be used without changing the dosage regimen.

With the simultaneous use of the drug and powerful inhibitors of isoenzymes CYP2D6 (quinidine, fluoxetine, paroxetine) and CYP3A4 (ketoconazole, clarithromycin), the drug dose should be reduced to 25% of the usual dose. When canceling inhibitors of isoenzymes CYP3A4 and / or CYP2D6, the dose of the drug should be increased.

With the simultaneous use of the drug and powerful, moderate or weak inhibitors of isoenzymes CYP3A4 and CYP2D6, its dose can be initially reduced to 25% of the usual dose, and then increased to achieve an optimal clinical result.

When prescribing the drug to patients with low activity of the isoenzyme CYP2D6, its dose should initially be reduced by half, and then increased to achieve an optimal clinical result. With the simultaneous use of the drug and a powerful inhibitor of the CYP3A4 isoenzyme in patients with low activity of the CYP2D6 isoenzyme, its dose should be reduced to 25% of the usual dose. With the simultaneous use of the drug and potential inducers of the isoenzyme CYP3A4 (carbamazepine), the dose of the drug should be doubled. After stopping the intake of inducers of the CYP3A4 isoenzyme, the dose of the drug should be reduced to the recommended dose.

hypersensitivity to aripiprazole or any component of the drug;

lactase deficiency, rare hereditary galactosemia, glucose-galactose malabsorption;

age up to 18 years.

With caution: patients with cardiovascular diseases (coronary artery disease or myocardial infarction, heart failure and conduction disturbances), cerebrovascular diseases and conditions predisposing to arterial hypotension (dehydration, hypovolemia and taking antihypertensive drugs) due to the possibility of orthostatic hypotension; patients with convulsive seizures or suffering from diseases in which convulsions are possible; patients with an increased risk of hyperthermia (for example, with intense physical exertion, overheating, taking m-anticholinergics, dehydration due to the ability of antipsychotics to disrupt thermoregulation); patients with an increased risk of aspiration pneumonia due to the risk of impaired esophageal motor function and aspiration; obese patientsand in the presence of diabetes mellitus in a family history; patients at high risk of suicide (psychotic illness, bipolar disorder, major depressive disorder); persons aged 18Ц24 years due to the risk of developing suicidal behavior.