Quest for the right Drug
סרוקואל 25 מ"ג SEROQUEL 25 MG (QUETIAPINE AS FUMARATE)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
פומי : PER OS
צורת מינון:
טבליות מצופות פילם : FILM COATED TABLETS
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Adverse reactions : תופעות לוואי
4.8 Undesirable effects The most commonly reported Adverse Drug Reactions (ADRs) with quetiapine (≥10%) are somnolence, dizziness, headache, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms. The incidences of ADRs associated with quetiapine therapy, are tabulated below (Table 1) according to the format recommended by the Council for International Organizations of Medical Sciences (CIOMS III Working Group; 1995). Table 1 ADRs associated with quetiapine therapy The frequencies of adverse events are ranked according to the following: Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000) and not known (cannot be estimated from the available data). SOC Very Common Uncommon Rare Very Rare Not known Common Blood and Decreased Leucopenia 1, 28, Neutropenia1, Agranulocytosi lymphatic haemoglobin22 decreased s26 Thrombocytope system neutrophil nia, Anaemia, disorders count, platelet count eosinophils decreased13 increased27 Immune system Hypersensitivity Anaphylactic disorders (including reaction5 allergic skin reactions) Endocrine Hyperprolactina Decreases in Inappropriat disorders emia15, free T3 24, e decreases in Hypothyroidism antidiuretic 21 total T4 24, hormone decreases in secretion free T4 24, decreases in total T3 24, increases in TSH 24 Metabolism and Elevations in Increased Hyponatraemia19, Metabolic nutritional serum appetite, blood Diabetes syndrome29 1,5 disorders triglyceride glucose Mellitus levels 10,30 increased to Exacerbation of Elevations in hyperglycaemic pre-existing total cholesterol levels 6, 30 diabetes (predominantly LDL cholesterol) 11,30 Decreases in HDL cholesterol 17,30, Weight gain 8,30 Psychiatric Abnormal Somnambulis disorders dreams and m and related nightmares, reactions such as Suicidal ideation sleep talking and and sleep related Suicidal eating disorder behaviour20 Nervous system Dizziness 4, 16, Dysarthria Seizure 1, disorders somnolence 2,16, Restless legs headache, syndrome, Extrapyramidal Tardive symptoms1, 21 dyskinesia 1, 5, Syncope 4,16 Confusional state 4 cardiomyopathy Cardiac Tachycardia , QT and myocarditis disorders Palpitations23 prolongation 1,12, 18 Bradycardia32 Eye disorders Vision blurred Vascular Orthostatic Venous Stroke33 disorders hypotension 4,16 thromboembolis m 1 23 Respiratory, Dyspnoea Rhinitis thoracic and mediastinal disorder Gastrointestinal Dry mouth Constipation, Dysphagia7 Pancreatitis1, disorders dyspepsia, Intestinal vomiting25 obstruction/Ileus Hepato-biliary Elevations in Elevations in Jaundice5, disorders serum alanine serum aspartate Hepatitis aminotransferas aminotransferas e (ALT)3, e (AST) 3 Elevations in gamma-GT levels3 Skin and Angioedema5, Toxic subcutaneous Stevens- Epidermal tissue disorders Johnson Necrolysis syndrome5 Erythema Multiforme, Acute Generalized Exanthematous Pustulosis (AGEP), Drug Rash with Eosinophilia and Systemic Symptoms SOC Very Common Uncommon Rare Very Rare Not Common known (DRESS) Cutaneous vasculitis Musculoskeletal Rhabdomyoly and connective sis tissue disorders Renal and Urinary urinary retention disorders Pregnancy, Drug puerperium and withdrawal perinatal syndrome conditions neonatal31 Reproductive Sexual Priapism, system and dysfunction galactorrhoea, breast disorders breast swelling, menstrual disorder General Withdrawal (dis Mild asthenia, Neuroleptic disorders and continuation) peripheral malignant administration symptoms 1,9 oedema, syndrome 1, site conditions irritability, hypothermia pyrexia Investigations Elevations in blood creatine phosphokinase14 1. See section 4.4. 2. Somnolence may occur, usually during the first two weeks of treatment and generally resolves with the continued administration of quetiapine. 3. Asymptomatic elevations (shift from normal to >3 x ULN at any time) in serum transaminase (ALT, AST) or gamma-GT levels have been observed in some patients administered quetiapine. These elevations were usually reversible on continued quetiapine treatment. 4. As with other antipsychotics with alpha1 adrenergic blocking activity, quetiapine may commonly induce orthostatic hypotension, associated with dizziness, tachycardia and, in some patients, syncope, especially during the initial dose-titration period. (see section 4.4). 5. Calculation of Frequency for these ADR’s have been taken from post-marketing data only. 6. Fasting blood glucose ≥126 mg/dL (≥7.0 mmol/L) or a non-fasting blood glucose ≥200 mg/dL (≥11.1 mmol/L) on at least one occasion. 7. An increase in the rate of dysphagia with quetiapine vs. placebo was only observed in the clinical trials in bipolar depression. 8. Based on >7% increase in body weight from baseline. Occurs predominantly during the early weeks of treatment in adults. 9. The following withdrawal symptoms have been observed most frequently in acute placebo-controlled, monotherapy clinical trials, which evaluated discontinuation symptoms: insomnia, nausea, headache, diarrhoea, vomiting, dizziness, and irritability. The incidence of these reactions had decreased significantly after 1 week post-discontinuation. 10. Triglycerides ≥200 mg/dL (≥2.258 mmol/L) (patients ≥18 years of age) or ≥150 mg/dL (≥1.694 mmol/L) (patients <18 years of age) on at least one occasion. 11. Cholesterol ≥240 mg/dL (≥6.2064 mmol/L) (patients ≥18 years of age) or ≥200 mg/dL (≥5.172 mmol/L) (patients <18 years of age) on at least one occasion. An increase in LDL cholesterol of ≥30 mg/dL (≥0.769 mmol/L) has been very commonly observed. Mean change among patients who had this increase was 41.7 mg/dL (≥1.07 mmol/L). 12. See text below. 13. Platelets ≤100 x 109/L on at least one occasion. 14. Based on clinical trial adverse event reports of blood creatine phosphokinase increase not associated with neuroleptic malignant syndrome. 15. Prolactin levels (patients >18 years of age): >20 μg/L (>869.56 pmol/L) males; >30 μg/L (>1304.34 pmol/L) females at any time. 16. May lead to falls. 17. HDL cholesterol: 40 mg/dL (1.025 mmol/L) males; 50 mg/dL (1.282 mmol/L) females at any time. 18. Incidence of patients who have a QTc shift from <450 msec to ≥450 msec with a ≥30 msec increase. In placebo-controlled trials with quetiapine the mean change and the incidence of patients who have a shift to a clinically significant level is similar between quetiapine and placebo. 19. Shift from >132 mmol/L to ≤132 mmol/L on at least one occasion. 20. Cases of suicidal ideation and suicidal behaviours have been reported during quetiapine therapy or early after treatment discontinuation (see sections 4.4 and 5.1). 21. See section 5.1. 22. Decreased haemoglobin to ≤13 g/dL (8.07 mmol/L) males, ≤12 g/dL (7.45 mmol/L) females on at least one occasion occurred in 11% of quetiapine patients in all trials including open label extensions. For these patients, the mean maximum decrease in haemoglobin at any time was –1.50 g/dL. 23. These reports often occurred in the setting of tachycardia, dizziness, orthostatic hypotension and/or underlying cardiac/respiratory disease. 24. Based on shifts from normal baseline to potentially clinically important value at any time post-baseline in all trials. Shifts in total T4, free T4, total T3 and free T3 are defined as <0.8 x LLN (pmol/L) and shift in TSH is > 5 mIU/L at any time. 25. Based upon the increased rate of vomiting in elderly patients ( ≥65 years of age). 26. Based on shift in neutrophils from > =1.5 x 10 9L at baseline to <0.5 x 109/L at any time during treatment and based on patients with severe neutropenia (<0.5 x 109/L) and infection during all quetiapine clinical trials (see section 4.4). 27. Based on shifts from normal baseline to potentially clinically important value at any time post-baseline in all trials. Shifts in eosinophils are defined as >1 x 10 9 cells/L at any time. 28. Based on shifts from normal baseline to potentially clinically important value at any time post-baseline in all trials. Shifts in WBCs are defined as ≤3 x 109 cells/L at any time. 29. Based on adverse event reports of metabolic syndrome from all clinical trials with quetiapine. 30. In some patients, a worsening of more than one of the metabolic factors of weight, blood glucose and lipids was observed in clinical studies (see section 4.4). 31. See section 4.6 32. May occur at or near initiation of treatment and be associated with hypotension and/or syncope. Frequency based on adverse event reports of bradycardia and related events in all clinical trials with quetiapine. 33. Based on one retrospective non-randomised epidemiological study. Cases of QT prolongation, ventricular arrhythmia, sudden unexplained death, cardiac arrest and torsades de pointes have been reported with the use of neuroleptics and are considered class effects. Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with quetiapine treatment. Paediatric population The same ADRs described above for adults should be considered for children and adolescents. The following table summarises ADRs that occur in a higher frequency category in children and adolescent patients (10-17 years of age) than in the adult population or ADRs that have not been identified in the adult population. Table 2 ADRs in children and adolescents associated with quetiapine therapy that occur in a higher frequency than adults, or not identified in the adult population The frequencies of adverse events are ranked according to the following: Very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10,000, <1/1000) and very rare (<1/10,000). SOC Very Common Common Endocrine disorders Elevations in prolactin1 Metabolism and nutritional Increased appetite disorders Nervous system disorders Extrapyramidal symptoms3, 4 Syncope Vascular disorders Increases in blood pressure2 Respiratory, thoracic and Rhinitis mediastinal disorders Gastrointestinal disorders Vomiting General disorders and Irritability3 administration site conditions 1. Prolactin levels (patients < 18 years of age): >20 μg/L (>869.56 pmol/L) males; >26 μg/L (>1130.428 pmol/L) females at any time. Less than 1% of patients had an increase to a prolactin level >100 μg/L. 2. Based on shifts above clinically significant thresholds (adapted from the National Institutes of Health criteria) or increases >20 mmHg for systolic or >10 mmHg for diastolic blood pressure at any time in two acute (3-6 weeks) placebo-controlled trials in children and adolescents. 3. Note: The frequency is consistent to that observed in adults, but might be associated with different clinical implications in children and adolescents as compared to adults. 4. See section 5.1. Reporting of suspected adverse events Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il
פרטי מסגרת הכללה בסל
א. הטיפול בתרופה יינתן : 1. למבוטח בגיר שהוא חולה סכיזופרניה;2. למבוטח קטין הסובל מסכיזופרניה או מפסיכוזה אחרת; 3. בהפרעה ביפולרית כקו טיפולי שני. ב. התחלת הטיפול בתרופה תהיה על פי הוראתו של רופא מומחה בפסיכיאטריה או בפסיכיאטריה של הילד והמתבגר, לפי העניין. ג. לא יינתנו לחולה בו בזמן שתי תרופות או יותר ממשפחת התרופות האנטיפסיכוטיות האטיפיות.
מסגרת הכללה בסל
התוויות הכלולות במסגרת הסל
התוויה | תאריך הכללה | תחום קליני | Class Effect | מצב מחלה |
---|---|---|---|---|
בהפרעה ביפולרית כקו טיפולי שני. | ARIPIPRAZOLE, OLANZAPINE, QUETIAPINE | |||
למבוטח קטין הסובל מסכיזופרניה או מפסיכוזה אחרת; | ||||
למבוטח בגיר שהוא חולה סכיזופרניה; | OLANZAPINE, ARIPIPRAZOLE, AMISULPRIDE, ILOPERIDONE, QUETIAPINE, PALIPERIDONE, SERTINDOLE, ZIPRASIDONE |
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
15/05/2006
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