Nystatin


Thông tin thuốc gốc
Chỉ định và Liều dùng
Oral
Oral candidiasis
Adult: As oral susp: 100,000 units 4 times daily, higher doses of 400,000-600,000 units 4 times daily may also be given as necessary; swish and retain in the mouth, and keep in contact with the affected areas for as long as possible before swallowing. Treatment duration: 7-14 days; continue treatment for at least 48 hours after clinical cure is achieved to prevent relapse. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
Child: As oral susp: Infants 100,000 units 4 times daily. Alternatively, 200,000 units 4 times daily, administer 1/2 of the dose in each side of the mouth and avoid feeding for 5-10 minutes; Children and adolescents Same as adult dose. Swish and retain in the mouth, and keep in contact with the affected areas for as long as possible before swallowing. Treatment duration: 7-14 days; continue treatment for at least 48 hours after clinical cure is achieved to prevent relapse. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
Neonate: As oral susp: Preterm neonates 100,000 units 4 times daily; Term neonates 200,000 units 4 times daily. Administer 1/2 of the dose in each side of the mouth and avoid feeding for 5-10 minutes. Treatment duration: 7-14 days; continue treatment for at least 48 hours after clinical cure is achieved to prevent relapse. Dosage recommendations may vary among countries and individual products (refer to specific local or product guidelines).

Oral
Prophylaxis of invasive candidiasis in low birth weight neonates
Neonate: As an alternative therapy in neonates with <1,500 g birth weight when fluconazole is unavailable or if resistance precludes the use of fluconazole in the neonatal ICU (with >10% rate of invasive candidiasis): As oral susp: 100,000 units tid for 6 weeks.

Oral
Intestinal candidiasis
Adult: As tab or cap: Usual dose: 500,000-1,000,000 units 3 or 4 times daily. As oral susp: 500,000 units 4 times daily. Continue treatment for at least 48 hours after clinical cure is achieved to prevent relapse.
Child: Infants and children As oral susp: 100,000 units 4 times daily. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

Oral
Prophylaxis of candidiasis
Neonate: For prophylaxis of oral infection in neonates born to mothers with vaginal candidiasis: As oral susp: 100,000 units once daily. Treatment recommendations may vary among countries and individual products (refer to specific local or product guidelines).

Topical/Cutaneous
Cutaneous or mucocutaneous mycotic infections
Adult: For fungal infections caused by susceptible Candida species: As 100,000 units/g cream or ointment: Apply to the affected areas bid or as clinically indicated until healing is complete. As 100,000 units/g topical powder: Apply to the affected areas 2-3 times daily until healing is complete. For fungal infection of the feet, dust the powder on the feet and in all footwear (e.g. shoes, socks).
Child: Infants and children Same as adult dose. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).
Neonate: For fungal infections caused by susceptible Candida species: As 100,000 units/g cream or ointment: Apply to the affected areas bid or as clinically indicated until healing is complete. As 100,000 units/g topical powder: Apply to the affected areas 2-3 times daily until healing is complete.

Vaginal
Vulvovaginal candidiasis
Adult: As pessary: 100,000-200,000 units daily preferably at bedtime for 14 consecutive days or longer. As vaginal cream: Apply 100,000 units (1 applicatorful) intravaginally 1 or 2 times daily for 14 days or longer.
Cách dùng
May be taken with or without food.
Chống chỉ định
Hypersensitivity.
Thận trọng
Immunocompromised patients. Oral preparations are not indicated for the treatment of systemic mycoses. Vaginal preparations may decrease the effectiveness of latex contraceptive agents (e.g. condoms, diaphragms), concurrent use is not recommended. Topical preparations are not intended for the treatment of systemic, oral, intravaginal, or ophthalmic infections. Neonates and children. Pregnancy and lactation.
Tác dụng không mong muốn
Significant: Hypersensitivity, irritation.
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, gastrointestinal distress.
General disorders and administration site conditions: Application site reactions (e.g. pruritus, pain, burning, dermatitis).
Skin and subcutaneous tissue disorders: Rarely, rash, urticaria. Very rarely, Stevens-Johnson syndrome.
Mouth/Throat/PO/Topical: C
Tác dụng
Description:
Mechanism of Action: Nystatin interferes with the fungal cell wall permeability by binding to sterols in the fungal cell membrane, thereby allowing the leakage of intracellular components.
Onset: Symptomatic relief of candidiasis: 24-72 hours.
Pharmacokinetics:
Absorption: Poorly absorbed from the gastrointestinal tract (oral); not absorbed through mucous membranes or intact skin (topical).
Excretion: Oral: Via faeces (as unchanged drug).
Đặc tính

Chemical Structure Image
Nystatin

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 6433272, Nystatin. https://pubchem.ncbi.nlm.nih.gov/compound/Nystatin. Accessed Oct. 26, 2022.

Bảo quản
Store below 25°C. Protect from light. Storage recommendations may vary among individual products (refer to specific product guidelines).
Phân loại MIMS
Thuốc kháng nấm / Thuốc tác dụng lên âm đạo
Phân loại ATC
D01AA01 - nystatin ; Belongs to the class of antibiotics. Used in the topical treatment of fungal infection.
A07AA02 - nystatin ; Belongs to the class of antibiotics. Used in the treatment of intestinal infections.
G01AA01 - nystatin ; Belongs to the class of antibiotics. Used in the treatment of gynecological infections.
Tài liệu tham khảo
Pappas PG, Kauffman CA, Andes DR et al. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases. 2016 Feb;62(4):e1-50. doi: 10.1093/cid/civ933. Accessed 01/06/2023

Anon. Nystatin (Oral) (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/06/2023.

Anon. Nystatin (Oral). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/10/2022.

Anon. Nystatin (Topical) (Pediatric and Neonatal Lexi-Drugs). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 01/06/2023.

Anon. Nystatin (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/10/2022.

Anon. Nystatin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 01/06/2023.

Buckingham R (ed). Nystatin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/06/2023.

Candistatin Cream 100,000 U/g (Idaman Pharma Manufacturing Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/06/2023.

Devatis Limited. Nystatin Devatis 100,000 IU/mL Oral Drops data sheet August 2021. Medsafe. http://www.medsafe.govt.nz. Accessed 05/10/2022.

Joint Formulary Committee. Nystatin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/10/2022.

Nyspes Pessaries 100,000 Units (Chelonia Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 05/10/2022.

Nystabs Tablets 500,000 Units (Chelonia Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 05/10/2022.

Nystan 100,000 units/mL Oral Suspension (Ready-Mixed) (Vygoris Limited). MHRA. https://products.mhra.gov.uk. Accessed 01/06/2023.

Nystatin Cream (Torrent Pharmaceuticals Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/06/2023.

Nystatin Ointment (Torrent Pharmaceuticals Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/10/2022.

Nystatin Ointment (Viona Pharmaceuticals Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/06/2023.

Nystatin Oral Suspension BP (Sandoz Limited). MHRA. https://products.mhra.gov.uk. Accessed 05/10/2022.

Nystatin Pessary 100,000 IU Vaginal Tablets (SM Pharmaceuticals Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/10/2022.

Nystatin Powder (Leading Pharma, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/06/2023.

Nystatin Suspension (McKesson Corporation dba as SKY Packaging). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/06/2023.

Nystatin Tablet 500,000 IU (SM Pharmaceuticals Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/10/2022.

Nystatin Tablet, Coated (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/10/2022.

Nystatin. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 01/06/2023.

Paediatric Formulary Committee. Nystatin. BNF for Children [online]. London. BMJ Group, Pharmaceutical Press, and RCPCH Publications. https://www.medicinescomplete.com. Accessed 01/06/2023.

Pharmacy Retailing (NZ) Limited. Nilstat 500,000 IU Tablets, 20,000 IU/g Vaginal Cream, 100,000 IU/mL Oral Drops, 500,000 IU Capsules data sheet May 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 001/06/2023.

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics. Mycostatin 100,000 Units/mL Topical Cream data sheet May 2019. Medsafe. http://www.medsafe.govt.nz. Accessed 05/10/2022.

Tystatin Oral Suspension (IMEKS Pharma Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 23/06/2023.

YSP Nystatin Capsule 500,000 Units (Y.S.P Industries [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/10/2022.

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