Thông tin thuốc của Racecadotril

Thông tin này không áp dụng cho tất cả các quốc gia. Vui lòng tham khảo thông tin kê toa lưu hành tại Việt Nam.

Thông tin thuốc gốc

Chỉ định và Liều dùng

Oral
Acute diarrhoea

Adult: As cap: Initially, 100 mg to be taken regardless of the time of the day, then 100 mg tid. Continue treatment until 2 normal stools are recorded. Max duration of treatment: 7 days. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
Child: In combination with oral rehydration: As granules/powder for oral susp: Recommended dose: 1.5 mg/kg tid. Max: Approx 6 mg/kg daily. Usual doses: Infants (>3 months) <9 kg: 10 mg; 9-<13 kg: 20 mg; Children 13-27 kg: 30 mg; >27 kg: 60 mg. All doses to be taken tid. Continue treatment until 2 normal stools are recorded. Max duration of treatment: 7 days. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

Cách dùng

cap: May be taken with or without food. Swallow whole, do not open/break/chew. Administer initial cap at any time of the day. Subsequent cap, preferably taken prior to meals.
granules/powder for oral susp: May be taken with or without food. May be added to food or dispersed in a glass of water or in the feeding bottle. Mix well & take immediately after prep. Powder may be administered directly into mouth.

Chống chỉ định

Diarrhoea associated with fever and/or bloody or purulent stools; antibiotic-associated diarrhoea. Patients who have experienced angioedema with ACE inhibitors.

Thận trọng

Patient with history of angioedema of any other aetiology. Administer racecadotril in combination with rehydration therapy. Avoid use in case of prolonged vomiting. Concomitant use with ACE inhibitors. Renal and hepatic impairment; avoid use in children with hepatic or renal impairment. Infants and children.

Tác dụng không mong muốn

Significant: Hypersensitivity or angioedema.
Nervous system disorders: Headache.
Respiratory, thoracic and mediastinal disorders: Tonsillitis (particularly in infants or children).
Skin and subcutaneous tissue disorders: Rash, erythema nodosum, erythema multiforme, urticaria, papular rash, prurigo, pruritus.
Potentially Fatal: Rarely, severe skin reactions.

Tương tác

May increase the risk of angioedema with ACE inhibitors (e.g. captopril, enalapril).

Tương tác với thức ăn

Delayed peak activity by 1-1.5 hours when given with food.

Tác dụng

Description:
Mechanism of Action: Racecadotril is a prodrug of thiorphan, which is an inhibitor of enkephalinase, a cell membrane peptidase enzyme that aids in the hydrolysis of exogenous peptides and the breakdown of endogenous peptides (e.g. enkephalins). Inhibition of enkephalinase enzymatic degradation prolongs peptide action at enkephalinergic synapses in the small intestine and decreases hypersecretion without affecting basal secretion.
Duration: Enkephalinase inhibition: Approx 8 hours.
Pharmacokinetics:
Absorption: Rapidly absorbed. Delayed time to peak activity by 1-1.5 hours with food.
Distribution: Plasma protein binding: 90%, mainly to albumin (thiorphan).
Metabolism: Rapidly hydrolysed to thiorphan glycine (active metabolite), which is further metabolised to inactive metabolites.
Excretion: Mainly via urine (81.4%); faeces (approx 8%); as active and inactive metabolites. Elimination half-life: Approx 3 hours (racecadotril).

Đặc tính

Chemical Structure Image — **Racecadotril**

Bảo quản

Store below 30°C.

Phân loại MIMS

Thuốc trị tiêu chảy

Phân loại ATC

A07XA04 - racecadotril ; Belongs to the class of other antidiarrheals.

Tài liệu tham khảo

Anon. Racecadotril. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 06/04/2022.

Buckingham R (ed). Racecadotril. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 06/04/2022.

Hidrasec 100 mg Hard Capsules (Abbot Laboratories [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/04/2022.

Hidrasec 100 mg Hard Capsules (Bioprojet Europe Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 06/04/2022.

Hidrasec Infants 10 mg Granules for Oral Suspension; Hidrasec Children 30 mg Granules for Oral Suspension (Abbot Laboratories [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 06/04/2022.

Hidrasec Infants 10 mg, Granules for Oral Suspension (Bioprojet Europe Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 06/04/2022.

Hidrasec Paediatric 10 mg; Hidrasec Paediatric 30 mg (Abbott Laboratories Ltd.). MIMS Thailand. http://www.mims.com/thailand. Accessed 06/04/2022.

Rasec 30 mg/Sachet Powder for Oral Suspension (The Cathay Drug Co., Inc.). MIMS Philippines. http://www.mims.com/philippines. Accessed 06/04/2022.

Vaprino 100 mg Capsules, Hard (Opella Healthcare UK Limited, trading as Sanofi). MHRA. https://products.mhra.gov.uk. Accessed 06/04/2022.

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