Abizol tablets 10 mg blister No. 28

Abizol tablets are intended for:

Composition

Active ingredient: aripiprazole;

1 tablet contains aripiprazole - 10 mg.

Excipients: mannitol (E 421), crospovidone, povidone, indigo carmine (E 132), magnesium stearate.

Contraindication

Hypersensitivity to aripiprazole or any other component of the drug. Phenylketonuria.

Method of application

Tablets are used internally by adults.

Schizophrenia. The recommended initial dose of the drug is 10 or 15 mg 1 time per day, regardless of meals. The maintenance dose is 15 mg per day. The effective dose is from 10 to 30 mg per day. Increased efficacy of the drug when using 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 starting dose is 15 mg once daily without regard to meals, either as monotherapy or in combination therapy. Some patients require a higher dose. The maximum daily dose should not exceed 30 mg.

Prevention of recurrent manic episodes in bipolar I disorder. For the prevention of manic episodes in patients receiving aripiprazole as monotherapy or in combination therapy, treatment should be continued at the same doses.

Application features

Pregnancy

There are no adequate and well-controlled studies of aripiprazole in pregnant women. Congenital anomalies have been reported, but a causal relationship has not been established. Patients taking aripiprazole should consult their doctor if they become pregnant or plan to become pregnant. Due to insufficient safety data during pregnancy, the drug should be prescribed only if the expected benefit to the woman outweighs the potential risk to the fetus. When taking neuroleptics, including aripiprazole, during the third trimester of pregnancy, there is a possible risk of adverse reactions in the newborn, including extrapyramidal symptoms and/or withdrawal symptoms of varying severity and duration. Agitation, hypertension or hypotension, tremor, drowsiness, respiratory distress, or breast-feeding disorders have been reported. Therefore, newborns should be closely monitored. Aripiprazole is excreted in breast milk. If necessary, breast-feeding should be discontinued.

Children

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

Overdose

There have been reports of accidental or intentional overdose of aripiprazole with a single dose of up to 1260 mg, which were not fatal.

Potentially medically significant symptoms included lethargy, increased blood pressure, drowsiness, tachycardia, nausea, vomiting, and diarrhea. In addition, cases of aripiprazole overdose in children (up to 195 mg) have been described, but none were fatal. Potentially dangerous symptoms of overdose include drowsiness, transient loss of consciousness, and extrapyramidal disorders.

Adverse reactions

The most common side effects are akathisia and nausea.

Storage conditions

Store at a temperature not exceeding 25 °C in the original packaging.

Keep out of reach of children.

Shelf life - 3 years.