Quetiron 25mg 30 tablets — Made in Ukraine — Free Delivery

Product description

Quetiron® Asino tablets are prescribed for the following indications:

• Schizophrenia.
• Bipolar disorder, including manic episodes associated with bipolar disorders; major depressive episodes associated with bipolar disorder.
• Prevention of relapse in patients with bipolar disorder treated with quetiapine for manic attacks.

Composition

active substances: quetiapine;

excipients: lactose monohydrate, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate, povidone, magnesium stearate; shell: Opadry II White (Quetiron 25, Quetiron 200) (polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide (E 171)), Opadry II Yellow (Quetiron 100) (polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide (E 171), quinoline yellow (E 104), iron oxide red (E 172), iron oxide yellow (E 172)).

How to take the preparation

There are different dosages for each indication. The dose of the preparation and the duration of the treatment course are determined by the doctor individually for each patient, depending on the indications and severity of the disease.

For oral use.

Quetiapine can be taken regardless of food intake.

Adults

Course treatment of schizophrenia.

Quetiapine should be taken twice a day.

In the first 4 days of therapy, the daily dose is: 1st day – 50 mg, 2nd day – 100 mg, 3rd day – 200 mg, 4th day – 300 mg. Starting from the 4th day, increase the dose until the necessary clinical effect is achieved (in the range from 300 to 450 mg/day). Depending on the clinical effectiveness and tolerability of the preparation, the daily dose of Quetiron can range from 150 mg to 750 mg.

The maximum daily dose of the preparation Quetiron for the treatment of schizophrenia is 750 mg.

Course treatment of manic episodes associated with bipolar disorders.

Quetiapine should be taken twice a day.

The daily dose in the first 4 days of treatment is: 1st day – 100 mg, 2nd day – 200 mg, 3rd day – 300 mg, 4th day – 400 mg. In the subsequent dose increase (but not more than 200 mg daily) to 800 mg/day, starting from the 6th day of treatment. Depending on the clinical effectiveness and tolerability of the preparation, the dose may range from 200 to 800 mg/day. The usual effective dose is between 400 and 800 mg per day.

The maximum daily dose of Quetiron for the treatment of manic episodes is 800 mg.

Treatment of depressive episodes associated with bipolar disorder.

Quetiapine should be used once a day before going to bed.

The daily dose in the first 4 days of treatment is: 1st day – 50 mg, 2nd day – 100 mg, 3rd day – 200 mg, 4th day – 300 mg. The recommended daily dose is 300 mg. It is known that no additional benefit was observed in the 600 mg group compared to the 300 mg group in clinical trials. A dose of 600 mg may be effective for some patients. Clinical studies show that for some patients, in case of problems related to preparation intolerance, it is possible to consider reducing the dose to a minimum of 200 mg. Treatment for depressive episodes associated with bipolar disorder should be prescribed by a physician experienced in the treatment of bipolar disorder.

Prevention of relapses in patients with bipolar disorders.

To prevent subsequent manic, depressive, or mixed episodes in bipolar disorder, patients who have responded to quetiapine in the emergency treatment of bipolar disorder should continue treatment at the same dose. The dose can be adjusted depending on the clinical response and tolerability of each individual patient within the range of a daily dose from 300 mg to 800 mg, which is prescribed 2 times a day. It is important that the lowest effective doses are used for maintenance therapy.

Elderly patients.

In elderly patients, quetiapine, like other antipsychotics, should be prescribed with caution, especially at the beginning of treatment. A slower titration of the dose of quetiapine may be necessary, and the daily therapeutic dose should be lower than that used in young patients, depending on the clinical response and tolerability of treatment in each individual patient. The mean plasma clearance of quetiapine was reduced by 30-50% in elderly patients compared to younger patients.

Efficacy and safety have not been evaluated in patients over 65 years of age with depressive episodes in bipolar disorder.

Liver and kidney function disorders.

Dose adjustment is optional in patients with renal insufficiency.

Quetiapine is actively metabolized in the liver, so Quetiron should be used with caution in patients with liver failure, especially in the initial period of treatment.

Patients with impaired liver function should start with a dose of 25 mg/day. The dose is increased daily by 25-50 mg/day until the effective dose is reached, depending on the clinical response and the patient's tolerability of the preparation.

Children.

There are insufficient data on the safety and effectiveness of quetiapine to support its use in children, so quetiapine should not be used in pediatric practice.

Contraindication

Increased individual sensitivity to any of the components of the preparation.

Concomitant use of cytochrome P450 3A4 inhibitors, such as HIV protease inhibitors, azole antifungals, erythromycin, clarithromycin, and nefazodone (see section "Interaction with other preparations and other types of interactions").

Adverse reactions.

When taking quetiapine, the following can most often be observed: drowsiness, dizziness, dry mouth, headache, withdrawal syndrome, high level of triglycerides in the blood serum, an increase in the level of total cholesterol in the blood serum, an increase in body weight, a decrease in the level of hemoglobin and extrapyramidal symptoms.

Other possible side effects.

The frequency of adverse reactions is defined as follows: very often (≥ 1/10); often (≥1/100 to <1/10); infrequent (≥1/1000 to <1/100); rare (≥1/10,000 to <1/1,000); single (<1/10000); unknown (frequency cannot be determined based on existing data).

From the side of the blood and lymphatic system: very often - a decrease in hemoglobin22; often – leukopenia1,28, a decrease in the number of neutrophils, an increase in the level of eosinophils27; infrequently – neutropenia1, thrombocytopenia, anemia, decrease in the number of platelets13; rare - agranulocytosis26.

From the side of the immune system: infrequently - hypersensitivity (including allergic reactions of the skin); single - anaphylactic reaction5.

From the endocrine system: often – hyperprolactinemia15, decrease in total T424, decrease in free T424, decrease in total T324, increase in TSH24; infrequently – reduction of free T325, hypothyroidism; hypothyroidism21; isolated - violation of antidiuretic hormone secretion.

From the side of metabolism and metabolism: very often - increase in the level of triglycerides in blood serum10,30, increase in total cholesterol (especially LDL cholesterol)11,30, decrease in the level of high-density lipoproteins7,30, increase in body weight8,30; often – increase in appetite, increase in glucose level to values characteristic of hyperglycemia6,30; infrequently – hyponatremia19, diabetes mellitus1.5, exacerbation of diabetes; rare - metabolic syndrome29.

On the part of the psyche: often - abnormal dreams, nightmares, suicidal thoughts and behavior20; rare - somnambulism and related reactions such as sleep talking and sleep-related eating disorders.

From the side of the nervous system: very often - dizziness4,16, drowsiness2,16, headache, extrapyramidal symptoms1,21; often – dysarthria; infrequently – convulsions1, restless legs syndrome, tardive dyskinesia1,5, loss of consciousness4,16.

Cardiac disorders: often – tachycardia4, increased heartbeat23; infrequently – prolongation of the QT interval1,12,18, bradycardia32.

Vascular disorders: often – orthostatic hypotension4,16; rare – venous thromboembolism1; unknown - stroke.

On the part of the organs of vision: often - blurred vision.

From the side of the respiratory system: often – shortness of breath23; infrequent - rhinitis.

From the side of the digestive system: very frequent - dry mouth; frequent – constipation, dyspepsia, vomiting25; infrequently – dysphagia7; rare – pancreatitis1, intestinal obstruction.

From the side of the hepatobiliary system: often - an increase in the level of transaminases (alanine aminotransferase3, gamma-glutamyltransferase3); infrequently – an increase in the level of aspartate aminotransferase3; rare – jaundice5, hepatitis.

From the side of the skin and subcutaneous tissues: isolated angioneurotic edema5, Stevens-Johnson syndrome5; frequency unknown - toxic epidermal necrolysis, erythema multiforme, preparation reactions with eosinophilia and systemic symptoms.

From the musculoskeletal system: isolated - rhabdomyolysis.

From the side of the kidneys and urinary tract: infrequently - delayed urination.

Pregnancy, postpartum period and perinatal conditions: frequency unknown - preparation withdrawal syndrome in newborns31

From the reproductive system and mammary glands: infrequently – sexual dysfunction; rare - priapism, galactorrhea, swelling of the mammary glands, menstrual cycle disorders.

General disorders: very often – withdrawal symptoms1,9; often - mild asthenia, peripheral edema, irritability, hyperthermia; rare – malignant neuroleptic syndrome1, hypothermia.