Zylaxera pills 15 mg №28

Indications for use

• Treatment of schizophrenia.
• Treatment of manic episodes in bipolar disorder

Type I moderate and severe and the prevention of a new manic episode in adults who have predominantly manic episodes, which can be treated with aripiprazole.

• As an adjunct to antidepressant therapy for major depressive disorder.

Dosage and Administration

The drug should be taken orally, 1 time per day, regardless of the meal.

Schizophrenia

The initial dose of 10-15 mg 1 time per day.

Maintenance dose - 15 mg / day.

In clinical studies, the effectiveness of the drug in doses of 10 to 30 mg / day.

The maximum daily dose is 30 mg / day.

Manic Episodes in Type I Bipolar Disorder

The initial dose of 15-30 mg / day.

If necessary, dose adjustment is carried out with an interval of at least 24 hours.

In clinical studies demonstrated the effectiveness of the drug in doses of 15-30 mg / day with manic episodes when taken for 3-12 weeks.

The safety of the dose above 30 mg / day has not been evaluated in clinical studies.

When monitoring patients with type I bipolar disorder who underwent a manic or mixed episode, they had stabilized symptoms while taking aripiprazole (15 mg / day or 30 mg / day) for 6 weeks, then 6 months and beyond, for 17 months - the beneficial effect of such maintenance therapy has been established.

Patients should be examined periodically to determine the need for continued maintenance therapy.

Supplementary Therapy for Major Depressive Disorder

As an additional therapy for treatment with antidepressants, it is recommended to use the drug Zilaxer® in the initial dose of 5 mg / day. If necessary and good tolerance of therapy, the daily dose of the drug Zilaxer® can be weekly increased by 5 mg to the maximum - no more than 15 mg / day.

The duration of therapy with Zilaxer® for all the above indications has not been established, it is necessary to regularly examine the patient for possible cancellation of therapy.

Contraindications

• Hypersensitivity to aripiprazole or other components of the drug.
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome (as the composition contains lactose).
• Age up to 18 years (efficacy and safety have not been established).
• Breastfeeding period.

With care: cardiovascular diseases (coronary heart disease (CHD) or previous myocardial infarction, chronic heart failure (CHF) or conduction disturbances), cerebrovascular diseases, conditions predisposing to the development of arterial hypotension (dehydration, hypovolemia, use of antihypertensive drugs) in connection with the possibility of the development of orthostatic hypotension, convulsive seizures or diseases in which seizures are possible,increased risk of hyperthermia (eg, intense physical exertion, overheating, use of m-holinoblokatorov, dehydration, because neuroleptics can interfere with thermoregulation, patients with an increased risk of aspiration pneumonia because of the risk of development of motor function of the esophagus and aspiration, obesity or sugar diabetes in the family history; patients with a high risk of suicide (psychotic diseases, bipolar disorders, major depressive disorder), in people aged 18-24 years due to the risk of developing uicidal behavior.

Special patient groups

Dose adjustment in patients with renal insufficiency is not required.

In patients with mild and moderate hepatic insufficiency, dose adjustment is not required. In patients with severe hepatic insufficiency, dosing should be carried out with caution. However, in patients with severe hepatic insufficiency, the maximum daily dose of 30 mg should be used with caution.

Dose adjustment is not required.

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

The dosage regimen for smoking and non-smoking patients is the same.

With the simultaneous use of potent inhibitors of the CYP3A4 isoenzyme (ketoconazole, clarithromycin), the dose of Zilaxer® should be reduced by half. Accordingly, when canceling CYP3A4 isoenzyme inhibitors, the dose of Zilaxer® should be increased.

With the simultaneous use of potent inhibitors of the CYP2D6 isoenzyme (quinidine, Fluoxetine, paroxetine), the dose of Zilaxer® should be reduced by at least half. Accordingly, when canceling CYP2D6 isoenzyme inhibitors, the dose of Zilaxer® should be increased.

Zilaksera® drug should be used without changing the dosing regimen, if it is prescribed as an additional therapy in patients with major depressive disorder.

With the simultaneous use of potent inhibitors of CYP2D6 isoenzymes (quinidine, fluoxetine, paroxetine) and CYP3A4 (ketoconazole, clarithromycin), the dose of Zilaxer® should be reduced by ¾ (i.e. up to 25% of the usual dose). Accordingly, when canceling inhibitors of CYP2D6 and / or CYP3A4 isoenzymes, the dose of Zilaxer® should be increased.

With the simultaneous use of potent, moderate and mild inhibitors of CYP2D6 and / or CYP3A4 isoenzymes, the dose of Zilaxer® can be initially reduced by (that is, up to 25%) of the usual dose), and then increased to achieve an optimal clinical result.

For patients with low CYP2D6 isoenzyme activity, the dose of Zilaxer® should initially be reduced by half and then increased to achieve an optimal clinical outcome. With simultaneous use of a potent inhibitor of the CYP3A4 isoenzyme in patients with low activity of the CYP2D6 isoenzyme, the dose of Zilaxer® should be reduced by

3/4 (i.e. up to 25% of the usual dose).

With the simultaneous use of potential inducers of CYP3A4 isoenzyme (carbamazepine), the dose of the drug Zilaxer® should be increased in

2 times. Accordingly, when canceling CYP3A4 isoenzyme inductors, the dose of Zilaxer® should be reduced to 10-15 mg.

Use during pregnancy and lactation

Adequate and well-controlled studies in pregnant women have not been conducted. It is not known whether the use of aripiprazole in a pregnant woman can have a harmful effect on the fetus or cause a violation of the reproductive function. It is known that in newborns whose mothers took antipsychotics during the third trimester of pregnancy, in the postpartum period there is a risk of developing extrapyramidal disorders and / or "withdrawal" syndrome. They noted excitement, muscle hypertension or hypotension, tremor, drowsiness, respiratory distress syndrome, feeding disorders. These symptoms had varying degrees of severity, sometimes they passed without treatment, while in other cases newborns needed intensive care and prolonged hospitalization. With the use of aripiprazole, the development of new symptoms in newborns was very rare.

Patients should be warned that they should immediately inform the doctor about the occurrence of pregnancy during the treatment, they should also inform the doctor about the planned pregnancy.

Drug Zilaksera® can be accepted during pregnancy,only if the potential benefit to the mother outweighs the potential risk to the fetus.

Drug Zilaksera® gets into female breast milk. It is not recommended to breastfeed when using the drug.

Side effects

The classification of the incidence of side effects recommended by the World Health Organization (WHO):

very often ≥1 / 10

often from ≥1 / 100 to <1/10

infrequently from ≥1 / 1000 to <1/100

rarely from ≥1 / 10,000 to <1/1000

very rarely <1/10000

frequency unknown cannot be estimated based on available data.

infrequently: iron deficiency anemia;

very rarely: leukopenia, neutropenia, thrombocytopenia.

Immune system disorders:

very rarely: allergic reactions (anaphylaxis, angioedema, pruritus, urticaria), laryngospasm.

Endocrine Disorders:

infrequently: hypoglycemia, diabetes;

very rarely: hyperglycemia, diabetic ketoacidosis, diabetic hyperosmolar coma.

Metabolic and nutritional disorders:

often: weight loss;

infrequently: dehydration, edema, hypercholesterolemia, hypokalemia, hyperlipidemia, thirst, elevated levels of urea in the blood plasma, increased alkaline phosphatase activity, increased lactate dehydrogenase activity, obesity;

rarely: gout, hypernatremia, cyanosis, acidification of urine;

very rarely: hyponatremia, anorexia.

Mental Disorders:

very often: insomnia;

often: psychomotor agitation, depression, nervousness, hostility, suicidal thoughts, manic thoughts;

infrequently: panic reactions, hyperactivity, depersonalization;

seldom: obsessive thoughts.

Nervous system disorders:

very often: drowsiness, headache, akathisia;

often: dizziness, tremor, extrapyramidal syndrome, confusion, resistance to the performance of passive movements ("cogwheel" syndrome), lethargy, decreased concentration, sedation;

infrequently: dystonia, muscle twitching, paresthesia, limb tremor, impotence, bradykinesia, lowered / increased libido, apathy, memory loss, stupor, amnesia, stroke, dyskinesia, restless legs syndrome, myoclonus, depressed mood, increased reflexes, slow thinking, slowed thinking functions, hypersensitivity to stimuli, impaired oculomotor reaction;

seldom: delirium, euphoria, buccoglossal syndrome, akinesia, depression of consciousness up to loss of consciousness, reduced reflexes, neuroleptic malignant syndrome;

very rarely: speech disorder, convulsions.

Violations by the organ of vision:

often: blurred vision, photophobia;

infrequently: dry eyes, eye pain, blepharitis;

seldom: increased lacrimation, frequent blinking, amblyopia, diplopia, intraocular hemorrhages.

Disturbances from an organ of hearing and labyrinth disturbances:

often: ear pain;

infrequently: tinnitus, inflammation of the middle ear;

seldom: external otitis, deafness.

Heart disorders:

often: tachycardia;

infrequently: bradycardia, palpitations, myocardial infarction, prolongation of the QT interval, sudden cardiac arrest, atrial fibrillation, heart failure, atrioventricular block, myocardial ischemia, extrasystole;

seldom: expansion of borders of heart, an atrial flutter;

very rarely: fainting.