Sulpiride


Thông tin thuốc gốc
Chỉ định và Liều dùng
Oral
Schizophrenia
Adult: Dosage is individualised according to patient response and the predominant symptoms manifested. In patients with mainly positive symptoms: Initially, 400 mg bid, increased as necessary. Max: 1,200 mg bid. In patients with mainly negative symptoms: 200-400 mg bid. Max: 800 mg daily. In patients with mixed positive and negative symptoms (neither predominating): 400-600 mg bid.
Child: ≥14 years Same as adult dose.
Suy thận
Dosage adjustment may be necessary. Severe: Contraindicated.
Suy gan
Severe: Contraindicated.
Cách dùng
May be taken with or without food.
Chống chỉ định
Known or suspected phaeochromocytoma, acute porphyria, severe haematologic disorders including bone marrow suppression, CNS depression, prolactin-dependent tumours (e.g. pituitary gland prolactinomas, breast cancer), alcohol intoxication. Severe renal and hepatic impairment. Concomitant use with levodopa or antiparkinsonian drugs.
Thận trọng
Patient with hypomania, risk factors for blood dyscrasias (e.g. pre-existing low WBC, history of drug induced leucopenia or neutropenia); pre-existing abnormal lipid profile; predisposition to aspiration pneumonia (e.g. Alzheimer disease); risk factors for tardive dyskinesia (e.g. pseudoparkinsonism symptoms, major depressive disorder, previous brain damage, postmenopausal women, alcoholism); history of impulse control disorder; CV disease, risk factors for Qt prolongation (e.g. family history, congenital prolongation of QT interval, bradycardia, hypokalaemia); Lewy body dementia, Parkinson’s disease; current or risk factors for diabetes mellitus, hypertension, history of jaundice, ileac or pyloric stenosis, current or family history of angle-closure glaucoma, myasthenia gravis; prostatic hyperplasia or urinary retention; severe respiratory disorder; unstable epilepsy or history of seizures. Avoid abrupt withdrawal. Renal and hepatic impairment. Elderly particularly in those with dementia-related psychosis. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: Blood dyscrasias (e.g. leucopenia, neutropenia, agranulocytosis), dyslipidaemia, oesophaegeal dysmotility/aspiration, extrapyramidal symptoms (e.g. akathisia, tardive dyskinesia, pseudoparkinsonism, acute dystonic reactions), hyperglycaemia, hyperprolactinaemia, impulse control disorders (e.g. pathological gambling, uncontrolled sexual urges, uncontrolled spending, binge eating), photosensitivity, weight gain, lowered seizure threshold, hypertensive crisis; somnolence, orthostatic hypotension, motor or sensory instability leading to an increased risk of falls. Rarely, agitation/mania, venous thromboembolism.
Gastrointestinal disorders: Constipation.
Investigations: Increased liver enzymes.
Musculoskeletal and connective tissue disorders: Tremor.
Nervous system disorders: Sedation, drowsiness.
Psychiatric disorders: Insomnia.
Reproductive system and breast disorders: Galactorrhoea, mastalgia
Skin and subcutaneous tissue disorders: Maculopapular rash.
Potentially Fatal: Significant hyperglycaemia associated with ketoacidosis or hyperosmolar coma; QT prolongation and ventricular arrhythmias (e.g. torsades de pointes). Rarely, neuroleptic malignant syndrome.
Thông tin tư vấn bệnh nhân
This drug may cause drowsiness, dizziness, or slowing of reaction time, if affected, do not drive or operate machinery. Avoid or minimise exposure to sunlight (including sunlamps), if exposure cannot be avoided, use sunscreens or protective clothing.
Chỉ số theo dõi
Monitor mental status; vital sign as clinically indicated; blood pressure (at baseline and after 3 months of therapy, then annually); weight, height, BMI, waist circumference (at baseline, then at 4, 8, 12 weeks after initiating or changing therapy, then quarterly); CBC as clinically indicated; electrolytes and LFT (annually or as needed); fasting glucose, HBA1C, lipid profile (at baseline, then after 3 months from initiation, and as necessary). Monitor changes in menstruation, reproductive function. Monitor for signs and symptoms of Parkinson's and tardive dyskinesia.
Quá liều
Symptoms: Restlessness, clouding of consciousness, extrapyramidal symptoms, agitation, confusion, low blood pressure, coma. Management: Symptomatic and supportive treatment. Sulpiride may be partially removed by haemodialysis or treated with alkaline osmotic diuresis. May administer anti-parkinsonian drugs, if necessary.
Tương tác
Increased risk of torsades de pointes with β-blockers, some Ca channel blockers (e.g. diltiazem, verapamil, clonidine); diuretics, stimulant laxatives, amphotericin B; Class Ia antiarrhythmic drugs (e.g. quinidine, disopyramide); Class III antiarrhythmic drugs (e.g. amiodarone, sotalol); pimozide, haloperidol, imipramine, antidepressants. Enhanced postural hypotension with other antihypertensive drugs. Decreased bioavailability with antacids or sucralfate. Increased risk of extrapyramidal side effects with lithium. May reduce effectiveness of ropinirole. Antagonism of effects of dopaminergic agents (e.g. bromocriptine, amantadine, cabergoline, lisuride). Potentiated sedative and hypotensive effects with opioid analgesics.
Potentially Fatal: Reciprocal antagonism of effects between levodopa and neuroleptics.
Tương tác với thức ăn
Enhanced sedative effects with alcohol.
Tác dụng
Description: Sulpiride is a substituted benzamide antipsychotic. It is a selective antagonist of central dopamine (D2, D3, D4) receptors.
Onset: Schizophrenia: Within 1-2 weeks.
Pharmacokinetics:
Absorption: Moderately well absorbed from the gastrointestinal tract. Time to peak plasma concentration: 3-6 hours. Bioavailability: 25-40%
Distribution: Rapidly distributed to the tissues; poorly distributed to the blood-brain barrier; crosses the placenta, enters breast milk (low concentration). Plasma protein binding: Approx 40%.
Metabolism: Not significantly metabolised (5% as the inactive metabolite 5-oxypyrrolidinyl sulpiride).
Excretion: Via urine and faeces (95%, as unchanged drug). Elimination half-life: Approx 3-10 hours.
Đặc tính

Chemical Structure Image
Sulpiride

Source: National Center for Biotechnology Information. PubChem Database. Sulpiride, CID=5355, https://pubchem.ncbi.nlm.nih.gov/compound/Sulpiride (accessed on Jan. 23, 2020)

Bảo quản
Store below 25°C.
Phân loại MIMS
Thuốc chống loạn thần
Phân loại ATC
N05AL01 - sulpiride ; Belongs to the class of benzamides antipsychotics.
Tài liệu tham khảo
Anon. Sulpiride. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/06/2021.

Buckingham R (ed). Sulpiride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/06/2021.

Joint Formulary Committee. Sulpiride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/06/2021.

Sulpin F.C. Tablet (Averroes Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/06/2021.

Sulpiride Rosemont 200 mg/5 mL Oral Solution (Rosemont Pharmaceuticals Ltd). MHRA. https://products.mhra.gov.uk. Accessed 01/06/2021.

Sulpiride Tablets 400 mg (Generics [UK] Ltd). MHRA. https://products.mhra.gov.uk. Accessed 01/06/2021.

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