Arpizol pills 10mg №30

Indications

Treatment of acute attacks of schizophrenia, supportive therapy of schizophrenia.

Treatment of acute manic episodes of bipolar I disorder and for maintenance therapy in patients with bipolar I disorder who have recently had a manic or mixed episode.

Dosage and administration

Individual, depending on the indications, the course of the disease, tolerability of therapy. The dose is 10-30 mg 1 time / day.

Side effect

Cardiovascular: often - orthostatic hypotension, tachycardia; possible - bradycardia, palpitations, myocardial infarction, prolonged QT interval, cardiac arrest, hemorrhage, atrial fibrillation, heart failure, AV-blockade, myocardial ischemia, deep vein thrombosis, phlebitis, extrasystole; rarely - vasovagal syndrome, heart enlargement, atrial flutter, thrombophlebitis, intracranial bleeding, cerebral ischemia; very rarely - fainting.

Gastrointestinal: very often - nausea, loss of appetite; often - dyspepsia, vomiting; constipation; possible - increased appetite, gastroenteritis, difficulty swallowing, flatulence, gastritis, dental caries, gingivitis, hemorrhoids, gastro-esophageal reflux, gastrointestinal hemorrhages, periodontal abscess, tongue swelling, fecal incontinence, colitis,rectal hemorrhages, stomatitis, ulcerations in the mouth, cholecystitis, fecalom, candidiasis of the oral mucosa, gallstone disease, belching, stomach ulcers; rarely - esophagitis, bleeding gums, inflammation of the tongue, hematemesis, intestinal bleeding, duodenal ulcer, cheilitis, hepatitis, liver enlargement, pancreatitis, intestinal perforation; very rarely - an increase in the activity of ALT, AST, ALP.

Allergic reactions: very rarely, anaphylaxis, angioedema, pruritus and urticaria.

Musculoskeletal system: often - myalgia, convulsions; possibly - pain in the joints and bones, myasthenia, arthritis, arthrosis, muscle weakness, spasms, bursitis; very rarely - an increase in CPK activity, rhabdomyolysis, tendenitis, tenobursitis, rheumatoid arthritis, myopathy.

From the side of the central nervous system and peripheral nervous system: very often - insomnia, drowsiness, akathisia; often - dizziness, tremor, extrapyramidal syndrome, psychomotor agitation, depression, nervousness, increased salivation, hostility, suicidal thoughts, manic thoughts, unsteady gait, confusion, resistance to the performance of passive movements (cogwheel syndrome); possibly - dystonia, muscle twitching, weakening of concentration, paresthesia, tremor of extremities, impotence, bradykinesia, decreased / increased libido, panic reactions, apathy, weakening of memory, stupor, amnesia, stroke, hyperactivity, depersonalization, dyskinesia,“restless legs” syndrome (akathisia), myoclonus, depressed mood, increased reflexes, slowed mental function, increased sensitivity to stimuli, hypotension, impaired oculomotor response; rarely - delirium, euphoria, buccoglossal syndrome, akinesia, depression of consciousness up to loss of consciousness, diminished reflexes, obsessive thoughts, ZNS.

Respiratory: often - shortness of breath, pneumonia; possible - asthma, nosebleeds, hiccups, laryngitis; rarely - hemoptysis, aspiration pneumonia, increased sputum production, dry nasal mucosa, pulmonary edema, pulmonary embolism, hypoxia, respiratory failure, apnea.

Dermatologic: often - dry skin, itching, excessive sweating, skin ulceration; possibly - acne, vesicular (blistering) rash, eczema, alopecia, psoriasis, seborrhea; rarely - maculo-papular rash, exfoliative dermatitis, urticaria.

From the senses: often - conjunctivitis, pain in the ears; possible - dry eyes, eye pain, tinnitus, inflammation of the middle ear, cataracts, loss of taste, blepharitis; seldom - increased tearing, frequent flashing, external otitis, amblyopia, deafness, diplopia, eye hemorrhages, photophobia.

From the urinary system: often - urinary incontinence; possible - cystitis, frequent urination, leukorrhea, urinary retention, hematuria, dysuria, amenorrhea, premature ejaculation, vaginal bleeding,vaginal candidiasis, renal failure, uterine bleeding, menorrhagia, albuminuria, kidney stones, nocturia, polyuria, urge to urinate; rarely - pain in the mammary gland, cervicitis, galactorrhea, anorgasmia, burning sensation in the urogenital system, glycosuria, gynecomastia (an increase in the mammary glands in men), urolithiasis, painful erection.

On the part of the body as a whole: often - flu-like syndrome, peripheral edema, pain in the chest, neck; possible - pelvic pain, swelling of the face, malaise, photosensitivity, jaw pain, chills, jaw stiffness, abdominal distension, chest tension; rarely - sore throat, stiffness in the back, heaviness in the head, candidiasis, stiffness in the throat, Mendelssohn's syndrome, heat stroke.

Metabolism: often - weight loss, increased levels of CPK; possible - dehydration, edema, hypercholesterolemia, hyperglycemia, hypokalemia, diabetes mellitus, hyperlipidemia, hypoglycemia, thirst, increased blood levels of urea, hyponatremia, iron deficiency anemia, elevated creatinine, bilirubinemia, elevated LDH, obesity; rarely - hyperkalemia, gout, hypernatraemia, cyanosis, acidification of urine, hypoglycemic reaction.

Contraindications

Senile dementia, lactation, childhood and adolescence to 18 years, hypersensitivity to aripiprazole.

Use during pregnancy and lactation

Adequate and strictly controlled clinical studies of the safety of use during pregnancy have not been conducted. Aripirazole can be used during pregnancy in cases where the potential benefit of therapy for the mother outweighs the possible risk to the fetus.

It is not known whether aripirazole is excreted in human breast milk. The use of aripiprazole during lactation (breastfeeding) is contraindicated.

AT experimental studies Aripiprazole has been shown to be excreted in milk in lactating rats.

Use in children

Contraindications: children and adolescents up to 18 years.

Special notes

Use with caution in patients with cardiovascular diseases (coronary artery disease, including myocardial infarction, chronic heart failure, conduction disturbance), conditions predisposing to arterial hypotension (dehydration, hypovolemia and taking antihypertensive drugs) due to the possibility of development orthostatic hypotension; in patients with cerebrovascular diseases, with convulsive seizures or suffering from diseases in which seizures are possible; in patients with an increased risk of hyperthermia (for example, with intense physical exertion, overheating, taking anticholinergic drugs, with dehydration due to the ability of neuroleptics to violate thermoregulation); in patients with an increased risk of aspiration pneumonia due to the risk of impaired motor function of the esophagus and aspiration; in patients with obesity, with a history of diabetes mellitus; receiving funds with m-anticholinergic activity.

Tendency to suicidal thoughts and attempts is characteristic of psychosis, therefore, when conducting drug therapy requires careful medical supervision.

The risk of tardive dyskinesia increases as the duration of neuroleptic therapy increases, therefore, when symptoms of tardive dyskinesia appear on the background of aripiprazole intake, reduce its dose or cancel it. After discontinuation of therapy, these symptoms may temporarily worsen or even appear for the first time.

When treating neuroleptics, incl. aripiprazole may develop ZNS, which is manifested by hyperpyrexia, muscle rigidity, mental disorders and instability of the autonomic nervous system (irregular pulse and blood pressure, tachycardia, sweating, and cardiac arrhythmias). In addition, sometimes there is an increase in the activity of CPK, myoglobinuria (rhabdomyolysis) and acute renal failure. In the event of symptoms of ZNS or unexplained fever, all neuroleptics, including Aripirazole, you must cancel.

Hyperglycemia, in some cases severe and associated with ketoacidosis, which can lead to hyperosmolar coma and, even death, was noted in patients taking atypical antipsychotics. Although the relationship between taking atypical antipsychotics and hyperglycemic type disorders remains unclear, patients diagnosed with diabetes should regularly determine blood glucose levels when taking atypical antipsychotics.Patients who have risk factors for diabetes (obesity, the presence of diabetes in the family) while taking atypical neuroleptics should determine the level of glucose in the blood at the beginning of the course and periodically in the process of taking the drug. In all patients taking atypical antipsychotics, constant monitoring of the symptoms of hyperglycemia, including increased thirst, frequent urination, polyphagy, weakness, is necessary.

Influence on ability to drive motor transport and control mechanisms

As with the appointment of other neuroleptics, when prescribing aripiprazole, the patient must be warned about the dangers of working with moving machinery and driving.

Drug interaction

There are various metabolic pathways of aripiprazole, incl. with the participation of CYP2D6 and CYP3A4 enzymes. In studies in healthy people, potent inhibitors of CYP2D6 (quinidine) and CYP3A4 (ketoconazole) reduced the clearance of aripiprazole when taken orally by 52% and 38%, respectively (a dose of aripiprazole should be reduced while used with CYP3A4 and CYP2D6 inhibitors).

Reception of aripiprazole in a dose of 30 mg simultaneously with Carbamazepine, a powerful inducer of CYP3A4, was accompanied by a decrease in C_max and AUC of aripiprazole by 68% and 73%, respectively, and a decrease in C_max and AUC of its active metabolite dehydroaripiprazole by 69% and 71%, respectively. You can expect a similar effect and other powerful inducers CYP3A4 and CYP2D6.