Approved on.
Date of revision.
Quetiapine Fumarate Tablets Instructions
Please read the instructions carefully and use under the guidance of your physician
Warning statements
Elderly patients with dementia-related psychosis are at increased risk of mortality when treated with antipsychotics. In 17 placebo-controlled trials completed in such patients (with a plural duration of approximately 10 weeks), atypical antipsychotics caused 1.6-1.7 times the risk of death compared with placebo. In a typical 10-week controlled clinical study, the mortality rate was 4.5% in the medication group and 2.6% in the placebo control group. Although the causes of death varied, most deaths were due to cardiovascular disease (e.g., heart failure, sudden death) or infection (e.g., pneumonia). Observational studies suggest that, similar to atypical antipsychotics, conventional antipsychotics may increase mortality. The extent to which the increase in mortality in these observational studies was due to the antipsychotic or to certain characteristics of the patients is unclear. Quetiapine fumarate tablets are not approved for the treatment of dementia-related psychosis.
[Drug Name].
Generic name: Quetiapine Fumarate Tablets
Hanyu Pinyin: Fumasuan Kuiliuping Pian
Trade Name: Shu Si
English name: Quetiapine Fumarate Tablets
[Ingredients
Main component: Quetiapine Fumarate.
Chemical name: 11-[4-[2-(2-hydroxyethoxy)ethyl-1-piperazinyl]]dibenzo[b,f][1,4]thiazepine fumarate (2:1)
Chemical structure formula.
Molecular formula: (C21H25N3O2S)2.
Molecular weight: 883.08
[Properties
This product is a film-coated tablet, which appears white or off-white after removing the coating.
[Indications
This product is used to treat schizophrenia and to treat manic episodes of bipolar disorder.
[Specifications
According to C21H25N3O2S 0.1g
[Dosage].
Orally. Take 2 times a day, before or after meals.
Adults.
1. For the treatment of schizophrenia
The total daily dose at the beginning of treatment is 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4.
After day 4, the dose is gradually increased to the effective dose range, typically 300-450 mg daily, and may be adjusted to 150-750 mg daily depending on the patient’s clinical response and tolerability.
2. For the treatment of manic episodes in bipolar disorder
When used as monotherapy or as an adjunct to a mood stabilizer, the total daily dose is 100 mg on day 1, 200 mg on day 2, 300 mg on day 3, and 400 mg on day 4. The dose may be further increased to 800 mg daily by day 6, but the daily dose should not be increased by more than 200 mg.
The dose may be adjusted to 200-800 mg daily depending on the patient’s clinical response and tolerability, with a commonly used effective dose range of 400-800 mg daily.
Elderly patients.
As with other antipsychotics, this product should be used with caution in elderly patients, especially at the time of dosing initiation. The starting dose for elderly patients should be 25 mg daily, followed by an increase to an effective dose in the range of 25-50 mg daily, but the effective dose may be lower than in younger patients in general.
Patients with renal and hepatic impairment.
Clearance after oral quetiapine is decreased by approximately 25% in patients with renal and hepatic impairment. Quetiapine is extensively metabolized in the liver and should therefore be used with caution in patients with hepatic impairment.
In patients with renal or hepatic impairment, the starting dose should be 25 mg daily, followed by an increase in the effective dose in the range of 25-50 mg daily.
Or as directed by your doctor.
[Adverse Reactions
The most common adverse drug reactions (ADRs) in quetiapine therapy (≥ 10%) include drowsiness, dizziness, headache, dry mouth, withdrawal (discontinuation) symptoms, elevated serum triglyceride levels, elevated total cholesterol levels (primarily LDL cholesterol), decreased HDL cholesterol levels, weight gain, decreased hemoglobin, and extrapyramidal symptoms.
The following table (Table 1) shows the incidence of ADRs with quetiapine therapy and is based on the format recommended by the Council of International Organizations of Medical Sciences (CIOMS III Working Group, 1995).
Table 1 ADRs associated with quetiapine therapy
The incidence of adverse events was categorized according to the following rules: very common (≥ 1/10), common (≥ 1/100, < 1/10), occasional (≥ 1/1000, < 1/100), rare (≥ 1/10,000, < 1/1000), very rare (< 1/10,000), not yet determined ( The frequency of events cannot be assessed based on currently available data).
Full body classificationVery commonCommonEventuallyRareVery rareunknownDiseases of the blood and lymphatic systemHemoglobinopenia 22Leukopenia1, 28, neutrophil count decreased, eosinophils increased27Neutropenia 1, thrombocytopenia, anemia, reduced platelet count 13Granulocyte deficiency26 Immune System Disorders hypersensitivity reactions (including skin sensitization reactions) Allergic reactions5 Endocrine Disorders hyperprolactinemia 15, decreased total T4 levels 24 and decreased free T4 levels24, decreased total T3 levels24, and elevated TSH levels24decreased free T3 levels 24. Hypothyroidism21 Anti-diuretic hormone dysregulation Metabolic disease and malnutritionElevated serum triglyceride levels 10,30
Elevated total cholesterol (mainly LDL cholesterol)11,30
HDL, decreased cholesterol levels 17,30, weight gain 8,30Increased appetite and elevated blood glucose to hyperglycemic levels6,30Hyponatremia 19,diabetes1,5, worsening of previous diabetesMetabolic syndrome29 Mental illness Dreaming abnormalities and nightmares, suicidal thoughts and suicidal behaviors20 Sleepwalking and related reactions such as sleep talking and sleep-induced eating disorders Neurological disordersDizziness 4,16, drowsiness 2,16, headache, extrapyramidal symptoms 1,21Constructive disorderseizures1, restless legs syndrome, delayed movement disorder1, 5, syncope4,16 Heart disease Tachycardia4, palpitations23QT prolongation1,12, 18 bradycardia32 Eye Disease Blurred vision Vascular disease Upright hypotension 4,16 “border-top: none; border-left: none; border-bottom: solid black 0.5pt; border-right: solid black 0.5pt”>Venous thromboembolism1 Respiratory, thoracic, and mediastinal disorders Hard to breathe23Rhinitis Gastrointestinal DisordersDry mouthConstipation, indigestion, vomiting25 difficulty swallowing7Pancreatitis1, intestinal obstruction Hepatobiliary disease Elevated serum alanine aminotransferase (ALT) 3, elevated γ-GT levels 3Elevated aspartate aminotransferase (AST) 3Jaundice5, hepatitis Dermatologic and subcutaneous tissue disorders Angioedema5, Stevens-Johns syndrome5Toxic epidermal necrolysis relaxans, erythema multiforme Musculoskeletal and connective tissue disorders