Nystatin


Generic Medicine Info
Indications and Dosage
Oral
Oral candidiasis
Adult: As 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. 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 susp: Infants: 100,000-200,000 units 4 times daily; 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. Continue treatment for at least 48 hours after clinical cure is achieved to prevent relapse. For prophylaxis of oral candidiasis in infants born of mothers with vaginal candidiasis: 100,000 units once daily. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

Oral
Intestinal candidiasis
Adult: As tab or cap: Usual dose: 500,000-1,000,000 units 3 or 4 times daily. As 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 susp: 100,000 units 4 times daily. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

Topical/Cutaneous
Cutaneous or mucocutaneous mycotic infections
Adult: As cream or ointment: Apply to the affected areas bid or as clinically indicated until healing is complete. As powder: Apply to the affected areas 2-3 times daily until healing is complete.
Child: Infants and children: Same as adult dose. Dosage recommendations may vary among countries and individual products (refer to specific product guidelines).

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.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity.
Special Precautions
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. Children. Pregnancy and lactation.
Adverse Reactions
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
Action
Description: 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).
Chemical Structure

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.

Storage
Store below 25°C. Protect from light. Storage recommendations may vary among individual products (refer to specific product guidelines).
MIMS Class
Antifungals / Preparations for Vaginal Conditions
ATC Classification
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.
References
Anon. Nystatin (Oral). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/10/2022.

Anon. Nystatin (Topical). AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 05/10/2022.

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 05/10/2022.

Buckingham R (ed). Nystatin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/10/2022.

Candistatin Cream 100,000 Units/g (Idaman Pharma Manufacturing Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/10/2022.

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 05/10/2022.

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

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

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 05/10/2022.

Nystatin Suspension (McKesson Corporation dba as SKY Packaging). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/10/2022.

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.

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 05/10/2022.

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 05/10/2022.

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.

Disclaimer: This information is independently developed by MIMS based on Nystatin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 MIMS. All rights reserved. Powered by MIMS.com
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