Side effects of nystatin

Generic Name: nystatin (oral) (nye STAT in)
Brand Name: Bio-Statin

Medically reviewed by Drugs.com on Feb 28, 2019 – Written by Cerner Multum

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Contents

What is nystatin?

Nystatin is an antifungal medication that fights infections caused by fungus.

Nystatin when taken by mouth is used to treat yeast infections in the mouth or stomach.

Oral nystatin is not absorbed into your bloodstream and will not treat fungal infections in other parts of the body or on the skin.

Nystatin may also be used for purposes other than those listed in this medication guide.

Important Information

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use nystatin if you are allergic to it.

It is not known whether nystatin will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether nystatin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give nystatin to a child without medical advice.

How should I take nystatin?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water.

Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

When taking liquid nystatin to treat a yeast infection of the mouth, you may need to hold the medicine in your mouth for as long as possible. This allows the medicine to stay in contact with the infected area. Follow your doctor’s instructions.

Do not share this medicine with another person, even if they have the same symptoms you have.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medicine. Nystatin will not treat a viral infection such as the flu or a common cold.

Nystatin is usually given for up to 48 hours after lab tests show that the infection has cleared.

Store the Bio-Statin brand of nystatin in the refrigerator. Do not freeze.

Other brands or forms of this medicine may be stored at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking nystatin?

Do not use nystatin to treat any condition that has not been checked by your doctor.

Nystatin side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fast heart rate;

  • trouble breathing; or

  • severe skin reaction–fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • mouth irritation;

  • upset stomach, nausea, vomiting, diarrhea; or

  • skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Nystatin dosing information

Usual Adult Dose for Oral Thrush:

Recommended dose: 400,000 to 600,000 units of the oral suspension orally 4 times a day
Duration of therapy: At least 48 hours after symptoms have disappeared and cultures demonstrate eradication
Comment:
-For the treatment of oral candidiasis, the suspension should be retained in the mouth for as long as possible before swallowing.
Use: Treatment of oral candidiasis in the oral cavity

Usual Adult Dose for Intestinal Candidiasis:

Recommended dose: 500,000 to 1,000,000 units of the tablet formulation orally 3 times a day
Duration of therapy: At least 48 hours after clinical cure
Use: Treatment of non-esophageal mucus membrane gastrointestinal candidiasis

Usual Pediatric Dose for Oral Thrush:

1 month to 12 months:
-Recommended dose: 200,000 units of the oral suspension orally 4 times a day
1 year to 18 years:
-Recommended dose: 400,000 to 600,000 units of the oral suspension orally 4 times a day
-Duration of therapy: At least 48 hours after symptoms have disappeared and cultures demonstrate eradication

-Limited data in premature and low birth weight infants indicated efficacy with 100,000 units orally 4 times a day.
-Infants should avoid feeding for 5 to 10 minutes after administration.
-For the treatment of oral candidiasis, the suspension should be retained in the mouth for as long as possible before swallowing.
Use: Treatment of oral candidiasis in the oral cavity

What other drugs will affect nystatin?

Other drugs may interact with nystatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 4.02.

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Consumer resources

  • Nystatin Tablets and Capsules
  • Nystatin Oral Suspension
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  • Nystatin (Advanced Reading)

Other brands: Mycostatin, Bio-Statin, Nilstat

Professional resources

  • Nystatin (Oral) (Wolters Kluwer)
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Related treatment guides

  • Oral Thrush
  • Gastrointestinal Candidiasis

About nystatin suspension

Type of medicine An antifungal medicine
Used for Treatment of thrush in the mouth or throat
Also called Nystan®
Available as Oral suspension (drops)

Thrush is an infection caused by the Candida yeast fungus. The mouth is a common site where Candida causes infection. Candidal infection in the mouth is called oral thrush. The infection causes the mouth to become sore and red, and white spots sometimes develop.

Small numbers of Candida commonly live in a healthy mouth and are usually harmless. However, certain situations or conditions can cause an overgrowth of Candida and this can lead to a bout of oral thrush. These include wearing dentures, after a course of antibiotics, using corticosteroid inhalers, having diabetes or anaemia, being in poor health, and smoking. It is also quite common for young babies to have oral thrush.

Nystatin suspension (drops) are an option for the treatment of oral thrush. Nystatin works by killing the Candida fungus which is causing the mouth infection.

Before using nystatin suspension

To make sure this is the right treatment for you, before you start using nystatin it is important that your doctor knows:

  • If you are taking or using any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
  • If you have ever had an allergic reaction to a medicine.
  • If you are pregnant or breastfeeding. Nystatin is not known to be harmful during pregnancy or breastfeeding, but it is still important that you tell your doctor.

How to use nystatin suspension

  • Before you start the treatment, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about how to use nystatin drops. If you have been given any additional information by your doctor, please read this also.
  • Use the suspension exactly as your doctor tells you to. It is to be used four times daily. Space the doses evenly throughout the day. Your doctor will tell you how many droppersful (ml) to use for each dose.
  • Shake the bottle well before you use the drops. Use the dropper to drop the liquid inside your mouth near to the affected areas but try not to touch your mouth with the dropper as you do this. Swish the suspension around your mouth a little and then keep it on the affected areas for as long as possible before you swallow. The longer the medicine is in contact with the site of infection the better.
  • It is recommended that you use the drops after mealtimes. This is to prevent the medicine from being washed out of your mouth too soon by anything you eat or drink.
  • If you forget to use the drops, have a dose as soon as you remember. Try to take the correct number of doses each day but do not take two doses at the same time to make up for a missed dose.
  • Most doctors recommend that you continue to use the drops for two days after your symptoms have gone – a typical course of treatment will last around seven days.

Getting the most from your treatment

  • If your symptoms have not improved after seven days of using the drops, make another appointment to speak with your doctor for further advice.
  • There are some things that you may be able to do to prevent further bouts of oral thrush. Please see the section ‘Can oral thrush be prevented?’ in the separate condition leaflets called Oral Thrush and Oral Thrush in Babies.

Can nystatin suspension cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the ones associated with nystatin, although these occur only occasionally. You will find a full list in the manufacturer’s information leaflet supplied with your medicine. Speak with your doctor or pharmacist if any of the following continue or become troublesome.

Occasional nystatin side-effects What can I do if I experience this?
Mouth irritation or sensitivity Stop using the drops and speak with your doctor again
Feeling sick (nausea) or being sick (vomiting), diarrhoea Drink some water to replace any lost fluids. If it continues, speak with your doctor

If you experience any other symptoms which you think may be due to the medicine, please speak with your doctor or pharmacist for further advice.

How to store nystatin

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.

Important information about all medicines

Never take more than the prescribed dose. If you suspect that you or someone else might have taken an overdose of this medicine, go to the accident and emergency department of your local hospital. Take the container with you, even if it is empty.

This medicine is for you. Do not give it to other people even if their condition appears to be the same as yours.

If you are due to have an operation or dental treatment, please tell the person carrying out the treatment which medicines you are taking.

If you buy any medicines, check with a pharmacist that they are suitable to take with your other medicines.

Do not keep out-of-date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.

If you have any questions about this medicine ask your pharmacist.

ratio-Nystatin

How does this medication work? What will it do for me?

Nystatin belongs to the group of medications known as antifungals. Nystatin oral medications in liquid form are most often used to treat fungal infections in the mouth.

The liquid and tablets are used to treat a fungal infection of the intestine known as candidiasis. This occurs when the fungus known as Candida albicans overgrows in the intestine as a result of antibiotic or corticosteroid use. The medication may also be used to prevent fungal infections.

The powder can be used to make an oral liquid or added to creams or ointments. The skin cream and ointment are used to treat fungal skin infections. The vaginal cream and vaginal tablets are used to treat vaginal infections caused by Candida albicans.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Oral Suspension

Each mL of light yellow suspension with cherry-like odour contains nystatin 100,000 units. Nonmedicinal ingredients: artificial flavouring, calcium disodium EDTA, D&C Yellow No. 10, magnesium aluminum silicate, methylparaben, polysorbate 80, propylparaben, purified water, and sucrose.

Topical Cream

Each g of light yellow cream with a characteristic odour contains nystatin 100,000 units. Nonmedicinal ingredients: emulsifying wax, glycerin, isopropyl myristate, lactic acid, purified water, and sorbic acid.

Topical Ointment

Each g of yellow, smooth, homogenous ointment contains nystatin 100,000 units. Nonmedicinal ingredients: mineral oil and polyethylene.

Vaginal Cream

Each g of light yellow cream with a characteristic odour contains nystatin 100,000 units. Nonmedicinal ingredients: emulsifying wax, glycerin, isopropyl myristate, purified water, and sorbic acid.

How should I use this medication?

Oral suspension (ready-made liquid or powder mixed with liquid): The recommended dose of nystatin oral suspension for prevention or treatment of candida infections in infants and children with mouth or intestinal infections is 100,000 units (1 mL of suspension) 3 or 4 times daily, dropped onto the tongue and then swallowed. In some cases the solution should be held in the mouth for some time and gargled before swallowing.

For young infants and children, the solution may be mixed with milk, lukewarm formula, jam, or peanut butter. For adults, the usual dose is 400,000 to 600,000 units 4 times daily. Shake the bottle before use. Use an oral syringe to measure each dose of the liquid, as it gives a more accurate measurement than household teaspoons.

Oral tablets: The usual dose is one tablet (500,000 units) 3 times daily. In adults, this dosage can be increased to 2 tablets 3 times daily if necessary.

Skin cream or ointment: Apply cream or ointment liberally to affected areas twice daily or as prescribed by your doctor. Severe fungal infections may require the use of both oral and topical nystatin.

Vaginal cream: The usual dose is one full applicator (5 grams) inserted into the vagina daily. In severe infections, a dose of one applicator every 12 hours may be given. Usually, treatment is given for 2 weeks. Treatment should be continued during menstruation.

Vaginal tablets: The usual dose is one tablet inserted high into the vagina using the applicator, once or twice daily. Usually, treatment is given for 2 weeks. Treatment should be continued during menstruation.

To prevent a relapse, treatment should be continued for at least 48 hours after the symptoms go away, regardless of dosage form.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication as directed by your doctor or pharmacist and keep it out of the reach of children.

This medication is available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms listed here. The forms available for the specific brand you have searched are listed under “What form(s) does this medication come in?”

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you are allergic to nystatin or any ingredients of the medication.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • diarrhea
  • nausea or vomiting
  • rash
  • stomach pain
  • vaginal or skin irritation

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • difficulty breathing
  • hives
  • muscle pain
  • rapid heart rate
  • Stevens-Johnson syndrome (severe skin rash with blistering and sloughing off of the skin)
  • swelling of the face

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Diabetes: Nystatin suspension contains significant amounts of sucrose. If you have diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: The safety of nystatin for use during pregnancy has not been established. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using this medication, contact your doctor immediately.

Breast-feeding: It is not known if nystatin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

What other drugs could interact with this medication?

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/ratio-Nystatin

What is Nystatin oral suspension?

Nystatin oral suspension contains the antifungal medicine nystatin.

Nystatin oral suspension is used to treat infections of the mouth, throat and intestines with Candida species of fungi, in particular Candida albicans. These fungi are found naturally in the mouth and gut but can sometimes increase in numbers if the conditions in these areas change, and this can cause infection.

Nystan is a well-known brand name of nystatin oral suspension.

Nystatin oral suspension is only available on prescription in the UK.

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What is Nystatin oral suspension used for?

Preventing and treating Candida infections of the mouth (oral thrush), throat and intestines (candidosis).

Preventing oral thrush in babies born to mothers with vaginal thrush.

How does Nystatin oral suspension work?

Nystatin kills fungi and yeasts by interfering with their cell membranes. It works by binding to a substance called ergosterol, which is an essential component of fungal cell membranes. This disrupts the cell membrane, causing holes to appear in it.

The cell membranes of fungi are vital for their survival. They keep unwanted substances from entering the cells and stop the contents of the cells from leaking out. As nystatin causes holes to appear in the cell membranes, essential constituents of the fungal cells can leak out. This kills the fungi and treats the infection.

Nystatin is not absorbed into the bloodstream, which allows it to act directly in the area of infection.

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Key info to know about Nystatin oral suspension

▪️ Nystatin oral suspension should not be diluted.

▪️ For the treatment of mouth and throat infections the suspension should be held in the mouth for as long as possible before swallowing, as this will keep it in contact with the fungi for longer.

▪️ Nystatin oral suspension is not absorbed into the bloodstream and so will not be effective for treating fungal infections or disease involving other areas of the body.

▪️ Nystatin oral suspension may not be suitable for people with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

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Dosage instructions for Nystatin oral suspension

  • The usual dose for adults and children is 1ml of the suspension dropped into the mouth four times a day after food. Space the doses evenly throughout the day.
  • The recommended dose for new-born babies is 1ml dropped into the mouth once a day.
  • Each dose should be measured using the dropper/spoon provided with the bottle of medicine.
  • If you are treating an infection in the mouth or throat you should hold each dose of the medicine in your mouth for as long as possible before swallowing it.
  • Missed dose: If you forget to take a dose take it as soon as you remember, unless it is nearly time for your next dose. In this case just leave out the missed dose and take the next dose as usual when it is due. Do not take a double dose to make up for a missed dose.
  • Treatment is usually needed for seven days, however, follow the instructions given by your doctor. The treatment should usually be continued for two days after the symptoms of the infection have cleared up.

Is it safe to use nystatin oral suspension if pregnant or breastfeeding?

Nystatin oral suspension is not absorbed into the bloodstream in significant amounts from the mouth or gut, so can be used during pregnancy or breastfeeding.

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Possible side effects of nystatin oral suspension

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

  • Nausea.
  • Mouth irritation. If you experience this, you should stop using this medicine and consult your doctor.
  • Diarrhoea.
  • Vomiting.
  • Rash.
  • Allergic reactions such as severe skin reactions or swelling of the face, throat or tongue. Stop using this medicine and get medical advice if you experience this.

Read the leaflet that comes with the medicine or talk to your doctor or pharmacist if you want any more information about the possible side effects of Nystatin oral suspension. You can find a copy of this here

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If you think you have experienced a side effect, you can report this using the yellow card website?

Can I take other medicines with nystatin oral suspension?

Nystatin oral suspension does not affect any other medicines, as it is not absorbed into the bloodstream.

It is fine to give children liquid paracetamol or ibuprofen while having treatment with nystatin oral suspension.

Last updated 19.11.2019

Rita Ghelani (BPharm, MRPharmS) Pharmacist A UK registered practising pharmacist with over 20 years’ experience, Rita is a member of the medical journalists’ association (MJA) and has a wealth of experience in community pharmacy.

Nystatin Tablets

Dosage Form: film coated

Medically reviewed by Drugs.com. Last updated on Dec 1, 2019.

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Rx only

Nystatin Tablets Description

Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:

Nystatin Tablets are provided for oral administration as coated tablets containing 500,000 units nystatin.

Inactive ingredients: anhydrous lactose, carnauba wax, corn starch, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, and titanium dioxide.

Nystatin Tablets – Clinical Pharmacology

Pharmacokinetics

Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.

Microbiology

Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Indications and Usage for Nystatin Tablets

Nystatin Tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

Contraindications

Nystatin Tablets are contraindicated in patients with a history of hypersensitivity to any of their components.

Precautions

General

This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.

Pregnancy

Teratogenic Effects

Category C

Animal reproduction studies have not been conducted with nystatin. It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.

Adverse Reactions

Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported. (See PRECAUTIONS: General.)

Gastrointestinal

Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.

Dermatologic

Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.

Other

Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been rarely reported.

Overdosage

Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

Nystatin Tablets Dosage and Administration

The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

How is Nystatin Tablets Supplied

Nystatin Tablets, USP 500,000 units, are round, brown, film coated, debossed MP 83. Available as follows:

Bottles of 50

NDC 53489-400-02

Bottles of 100

NDC 53489-400-01

Bottles of 250

NDC 53489-400-03

Bottles of 500

NDC 53489-400-05

Bottles of 1000

NDC 53489-400-10

Store at 20° to 25°C (68° to 77°F).

DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Distributed by:
Sun Pharmaceutical Industries, Inc.
Cranbury, NJ 08512

Rev 02, November 2014

PRINCIPAL DISPLAY PANEL – 100 Tablet Bottle Label

NystatinTablets USP (oral)- 100 tablets

NYSTATIN
nystatin tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53489-400
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nystatin (nystatin) nystatin 500000
Inactive Ingredients
Ingredient Name Strength
anhydrous lactose
carnauba wax
starch, corn
FD&C BLUE NO. 2
FD&C RED NO. 40
HYDROXYPROPYL CELLULOSE (90000 WAMW)
HYPROMELLOSE, UNSPECIFIED
magnesium stearate
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
starch, potato
stearic acid
titanium dioxide
D&C yellow no. 10
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code MP;83
Contains
Packaging
# Item Code Package Description
1 NDC:53489-400-02 50 TABLET, FILM COATED in 1 BOTTLE
2 NDC:53489-400-01 100 TABLET, FILM COATED in 1 BOTTLE
3 NDC:53489-400-03 250 TABLET, FILM COATED in 1 BOTTLE
4 NDC:53489-400-05 500 TABLET, FILM COATED in 1 BOTTLE
5 NDC:53489-400-10 1000 TABLET, FILM COATED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062838 12/22/1988

Labeler – Sun Pharmaceutical Industries, Inc. (146974886)

Sun Pharmaceutical Industries, Inc.

  • Can triamcinolone acetonide B be used to treat severe diaper rash on a little girl?

Medical Disclaimer

  • Side Effects
  • During Pregnancy or Breastfeeding
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  • Drug Images
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  • Support Group
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  • Drug class: mouth and throat products
  • Nystatin
  • … +4 more
  • Nystatin (Oral) (Wolters Kluwer)
  • Nystatin Oral Suspension (FDA)
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  • Oral Thrush
  • Gastrointestinal Candidiasis

Nystatin for Candida infection

This leaflet is about the use of nystatin for Candida infection, which is a type of fungal infection (caused by a yeast-like fungus). Candida is also commonly known as thrush. Nystatin is used to prevent or treat Candida infection in the mouth, throat and intestine.

This leaflet has been written for parents and carers about how to use this medicine in children. Our information sometimes differs from that provided by the manufacturers, because their information is usually aimed at adult patients. Please read this leaflet carefully. Keep it somewhere safe so that you can read it again.

Name of drug

Nystatin
Brand name: Nystan®

Why is it important for my child to take this medicine?

Candida (thrush) is an infection caused by a yeast-like fungus. Nystatin kills the fungus and so gets rid of the infection, or stops an infection from developing.

Some of the fungus may remain after the symptoms of the infection have gone. It is therefore important that you continue to give the medicine as your doctor has prescribed, to make sure that all the fungi are killed, otherwise the infection may come back. Please do not stop early.

What is nystatin available as?

Liquid medicine (suspension): 100,000 units in 1 mL; contains sucrose and may contain alcohol. If you have any concerns or questions, speak with your child’s doctor or pharmacist.

When should I give nystatin?

For treatment of an infection: When used to treat an infection, nystatin is usually given four times each day after food. This should be after breakfast, after lunch, after tea and at bedtime. These times should be at least 3 hours apart.

For prevention of infection: When used to prevent infection, nystatin is given once a day, after a meal. This should be at about the same time each day.

Give the medicine at about the same time(s) each day so that this becomes part of your child’s daily routine, which will help you to remember.

How much should I give?

Your doctor will work out the amount of nystatin (the dose) that is right for your child. The dose will be shown on the medicine label.

It is important that you follow your doctor’s instructions about how much to give.

How should I give nyastin?

Nystatin should always be given after a meal or some food, not before it.

  • Shake the medicine well. Measure out the right amount using an oral syringe or medicine spoon. You can get these from your pharmacist. Do not use a kitchen teaspoon as it will not give the right amount.
  • Put the medicine into your child’s mouth. They should keep it in their mouth for as long as possible – the longer it is in contact with the infected area, the better it will work.
  • Your child should then swallow or spit out the medicine, depending on what your doctor has told you to do.

Do not dilute the medicine or mix it with food or drink.

When should the medicine start working?

Your child should start to get better after taking the medicine for 2 days. They should continue to take the medicine even after they start to feel better, as it takes a while to kill all the fungus.

What if my child is sick (vomits)?

  • If your child is sick less than 30 minutes after having a dose of nystatin, give them the same dose again.
  • If your child is sick more than 30 minutes after having a dose of nystatin, you do not need to give them another dose. Wait until the next normal dose.

What if I forget to give it?

If you are giving it four times a day to treat an infection: If you miss a dose, wait until the next normal dose. Do not give the missed dose.

If you are giving it once a day to prevent infection: Give the missed dose as soon as you remember, as long as this is at least 12 hours before the next normal dose. You do not need to wake your child up to give a missed dose.

What if I give too much?

Nystatin is normally a safe drug and it is unlikely to cause any problems if you give an extra dose by mistake.

If you are worried that you may have given your child too much nystatin, contact your doctor or local NHS services (111 in England and Scotland; 0845 4647 in Wales). Have the medicine container or packet with you if you telephone for advice.

Are there any possible side-effects?

We use medicines to make our children better, but sometimes they have other effects that we don’t want (side-effects).

Nystatin may cause some minor side-effects when your child first starts taking it. These should wear off after a few days. If they are still a problem after a week, contact your doctor for advice.

  • Your child may get a skin rash or itching, although this is unlikely. You can apply an aqueous cream or cream for itching.
  • Your child may feel sick.
  • Your child’s mouth and throat may feel sore or feel irritated.

There may, sometimes, be other side-effects that are not listed above. If you notice anything unusual and are concerned, contact your doctor. You can report any suspected side-effects to a UK safety scheme at http://www.mhra.gov.uk/yellowcard.

Can other medicines be given at the same time as nystatin?

  • You can give your child medicines that contain paracetamol or ibuprofen, unless your doctor has told you not to.
  • Check with your doctor or pharmacist before giving any other medicines to your child. This includes herbal and complementary medicines.

Is there anything else I need to know about nystatin?

  • If your child is taking nystatin to treat an infection, it is important that they take the whole course of treatment. The Candida fungi may remain after your child starts to feel well; however, it is important to kill all the fungi to make sure that the infection doesn’t come back.
  • If your child has a dental brace or dentures, ask your doctor or pharmacist about how to clean them.
  • Never save medicine for future illnesses. Throw away any unused medicine or return it to the pharmacy.

General information about medicines

  • Try to give medicines at about the same times each day, to help you remember.
  • Only give nystatin to your child. Never give it to anyone else, even if their condition appears to be the same, as this could do harm.
  • If you think someone else may have taken the medicine by accident, contact your doctor for advice.

Where should I keep this medicine?

  • Keep the medicine in a cupboard, away from heat and direct sunlight.
  • Make sure that children cannot see or reach the medicine.
  • Keep the medicine in the container it came in.

Who to contact for more information

Your child’s doctor, pharmacist or nurse will be able to give you more information about nystatin and about other medicines used to treat Candida.

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