Metronidazole + Nystatin


Concise Prescribing Info
Indications/Uses
Mixed vaginal infections caused by Trichomonas vaginalis and Candida albicans.
Dosage/Direction for Use
Adult : Vaginal Insert 1 vaginal tablet/ovule or 1 applicatorful of vaginal cream daily at bedtime for 10 days. May repeat for 10 more days.
Dosage Details
Vaginal
Vaginal infections
Adult: For mixed infections caused by Trichomonas vaginalis and Candida albicans: Insert 1 vaginal tablet/ovule or 1 applicatorful of vaginal cream daily, preferably at bedtime, for 10 days. May repeat for 10 more days if infection is still not completely eliminated, oral metronidazole may be concomitantly given.
Contraindications
Hypersensitivity to metronidazole and other imidazoles and to nystatin. Lactation.
Special Precautions
Patient with Cockayne syndrome, peripheral and central nervous system diseases, hepatic encephalopathy. Severe hepatic impairment. Pregnancy.
Adverse Reactions
Significant: Central or peripheral neuropathy, dark urine discolouration; superinfection such as Clostridium difficile-associated diarrhoea and pseudomembranous colitis (prolonged use).
Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, xerostomia, metallic taste.
Nervous system disorders: Headache, dizziness.
Reproductive system and breast disorders: Vaginal pruritus, burning and granular sensation and discharge; vaginitis UTI.
Patient Counseling Information
This drug may cause dizziness, if affected, do not drive or operate machinery. This drug decreases effectivity of condoms and diaphragms, if needed, use other forms of contraception. May cause dark urine discolouration. Avoid use of menstrual tampons and of soaps with an acidic pH.
MonitoringParameters
Monitor LFT before, during and after treatment (until normal); total and differential leukocyte count before and after treatment; for signs and symptoms of peripheral or central neuropathy.
Drug Interactions
Metronidazole: Psychotic reactions with disulfiram. May cause toxicity of busulfan, 5-fluorouracil. May cause increased exposure to ciclosporin, lithium. Increased anticoagulant effect of warfarin. Decreased effectivity with phenobarbital, phenytoin. May diminished therapeutic effect of progesterone. May cause a disulfiram-like reaction with lopinavir.
Food Interaction
Disulfiram-like reaction with alcohol.
Action
Description: Metronidazole is a 5-nitroimidazole antiprotozoal agent. It binds to the deoxyribonucleic acid (DNA) of the causative organism causing disruption in its structure and thereby, inhibiting protein synthesis and causing apoptosis.
Nystatin is a polyene antifungal agent. It binds to the sterols of the fungal cell membrane thereby changing its permeability and causing leakage of cellular contents.
Pharmacokinetics:
Absorption: Metronidazole: Poorly absorbed after vaginal administration. Bioavailability: Approx 20-25%.
Distribution: Metronidazole: Widely distributed in most body tissues and fluids e.g. bile, bone, cerebral abscess CSF, liver, saliva, seminal fluid, and vaginal secretions. Crosses the placenta and enters breast milk. Plasma protein binding: <20%.
Metabolism: Metronidazole: Metabolised in the liver via oxidation and glucuronidation into metabolites including 1-(2-hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole and 2-methyl-5-nitroimidazole-1-acetic acid.
Excretion: Metronidazole: Mainly via urine (60-80% as unchanged drug and metabolites; approx 20% of total as unchanged drug); faeces (6-15%). Elimination half-life: Approx 8 hours.
Chemical Structure

Chemical Structure Image
Metronidazole

Source: National Center for Biotechnology Information. PubChem Database. Metronidazole, CID=4173, https://pubchem.ncbi.nlm.nih.gov/compound/Metronidazole (accessed on Jan. 22, 2020)


Chemical Structure Image
Nystatin

Source: National Center for Biotechnology Information. PubChem Database. Nilstat, CID=6433272, https://pubchem.ncbi.nlm.nih.gov/compound/Nilstat (accessed on Jan. 22, 2020)

Storage
Store between 15-25°C. Protect from light.
MIMS Class
ATC Classification
P01AB51 - metronidazole, combinations ; Belongs to the class of nitroimidazole derivatives antiprotozoals. Used in the treatment amoebiasis and other protozoal diseases.
References
Anon. Metronidazole (Systemic). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/06/2018.

Anon. Metronidazole (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/06/2018.

Anon. Metronidazole and Nystatin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/06/2018.

Anon. Nystatin (Topical). Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/06/2018.

Buckingham R (ed). Metronidazole. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/06/2018.

Buckingham R (ed). Nystatin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/06/2018.

Disclaimer: This information is independently developed by MIMS based on Metronidazole + 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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