Adult: Initially, 100 mg tid. Dose may be reduced to 100 mg once daily-bid in cases of diarrhoea or tremor.
Oral Niemann-Pick type C disease
Adult: Initially, 200 mg tid, reduce dose in case of diarrhoea. Child: ≤0.47 m2 BSA: 100 mg once daily; >0.47-0.73 m2 BSA: 100 mg bid; >0.73-0.88 m2 BSA: 100 mg tid; >0.88-1.25 m2 BSA: 200 mg bid; 12 years or >1.25 m2 BSA: Same as adult dose. Dose reduction may be necessary in case of diarrhoea.
Suy thận
Gaucher disease type 1
CrCl (mL/min)
Dosage
<30
Not recommended.
30-50
100 mg once daily.
50-70
100 mg bid.
Niemann-Pick type C disease
CrCl (mL/min)
Dosage
<30
Not recommended.
30-50
100
mg bid.
50-70
200 mg bid.
Cách dùng
May be taken with or without food.
Chống chỉ định
Pregnancy.
Thận trọng
Patient with history or significant gastrointestinal disease (e.g. inflammatory bowel diseases). Renal impairment. Children. Lactation.
Tác dụng không mong muốn
Significant: Peripheral neuropathy, tremor, diarrhoea, weight loss, reduced platelet count. Blood and lymphatic system disorders: Thrombocytopenia. Eye disorders: Visual disturbance. Gastrointestinal disorders: Abdominal pain/distention, flatulence, nausea, vomiting, constipation, xerostomia, dyspepsia, bloating, epigastric pain. General disorders and administration site conditions: Weakness, fatigue, malaise, asthenia, chills. Metabolism and nutrition disorders: Anorexia. Musculoskeletal and connective tissue disorders: Leg cramps, back pain, muscle spasm, heaviness in limbs. Nervous system disorders: Headache, dizziness, memory impairment, ataxia, paraesthesia, hypoaesthesia, migraine, unsteady gait. Psychiatric disorders: Depression, insomnia. Reproductive system and breast disorders: Menstrual disease, decreased libido.
PO: Z (Generally not recommended during pregnancy and is contraindicated in some product literature. Consult product literature for specific recommendations.)
Thông tin tư vấn bệnh nhân
This drug may cause dizziness, if affected, do not drive or operate machinery.
Chỉ số theo dõi
Assess neurological evaluation at baseline and every 6 months during therapy. Monitor renal function, weight, platelet count, nutritional status, frequency of bowel movement, and adverse events (e.g. tremor, peripheral neuropathy).
Tương tác với thức ăn
Food may decrease rate of absorption.
Tác dụng
Description: Mechanism of Action: Miglustat competitively and reversibly inhibits glucosylceramide synthase, an enzyme responsible for glycosylceramide and glycolipid synthesis, thereby reducing the rate of formation of these substrates which accumulate in Gaucher disease type 1 and Niemann-Pick type C disease respectively. Pharmacokinetics: Absorption: Rapidly absorbed. Bioavailability: 97%. Time to peak plasma concentration: 2-2.5 hours. Distribution: Volume of distribution: 83-105 L. Excretion: Mainly via urine (70-80%, as unchanged drug); faeces. Elimination half-life: 6-7 hours.
Đặc tính
Miglustat Source: National Center for Biotechnology Information. PubChem Database. Miglustat, CID=51634, https://pubchem.ncbi.nlm.nih.gov/compound/Miglustat (accessed on Jan. 22, 2020)
A16AX06 - miglustat ; Belongs to the class of various alimentary tract and metabolism products.
Tài liệu tham khảo
Anon. Miglustat. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 15/12/2017.Buckingham R (ed). Miglustat. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/12/2017.Joint Formulary Committee. Miglustat. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 15/12/2017.McEvoy GK, Snow EK, Miller J et al (eds). Miglustat. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 15/12/2017.Zavesca Capsule (Actelion Pharmaceuticals US, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 15/12/2017.
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