Nystatin 500,000 Units Oral Tablets
It is used to treat fungal infections in the mouth.
Drug Class
Antifungal
Pharmacologic Class
Polyene Antifungal
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nystatin is an antifungal medicine used to treat yeast infections in your mouth (thrush) or intestines. It works by stopping the growth of the yeast. For mouth infections, you usually swish the tablet in your mouth before swallowing.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking the medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking the medication as prescribed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Maintain good oral hygiene (brushing teeth, cleaning dentures) to prevent recurrence of oral candidiasis.
- Follow directions carefully, especially for swishing and swallowing for oral thrush.
- Complete the full course of medication, even if symptoms improve, to prevent recurrence.
Available Forms & Alternatives
Available Strengths:
- Nystatin Cream 15gm
- Nystatin Oral Susp 100000unit/ml
- Nystatin Oral Susp 100000u/ml 60ml
- Nystatin Cream 30gm
- Nystatin 500,000 Units Oral Tablets
- Nystatin Top Pwdr 100,000 15gm
- Nystatin 500,000 Units Oral Tablets
- Nystatin Top Pwdr 100,000 60gm
- Nystatin Top Pwdr 100,000 30gm
- Nystatin Cream 30gm
- Nystatin Cream 15gm
- Nystatin Ointment 15gm
- Nystatin Ointment 30gm
- Nystatin Oral Susp 100000unit/ml
- Nystatin Oral Susp 100000u/ml 60ml
- Nystatin Top Pwdr 100,000 15gm
- Nystatin Top Pwdr 100,000 30gm
- Nystatin Top Pwdr 100,000 60gm
- Nystatin Oral Susp 100000u/ml 60ml
Dosing & Administration
Adult Dosing
Standard Dose:
500,000 to 1,000,000 units (1 to 2 tablets) three times daily
Dose Range:
500000 - 1000000 mg
Condition-Specific Dosing:
Oral Candidiasis (Thrush):
500,000 units (1 tablet) 3 to 5 times daily, swish and swallow
Intestinal Candidiasis:
500,000 to 1,000,000 units (1 to 2 tablets) three times daily
Pediatric Dosing
Neonatal:
Not established (oral suspension preferred for infants)
Infant:
Not established (oral suspension preferred)
Child:
For older children who can swallow tablets: 500,000 units (1 tablet) 3 to 4 times daily, swish and swallow for oral candidiasis.
Adolescent:
500,000 to 1,000,000 units (1 to 2 tablets) three times daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; not significantly absorbed systemically.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Nystatin is a polyene antifungal antibiotic that binds to sterols (primarily ergosterol) in the fungal cell membrane, leading to a change in membrane permeability. This allows for leakage of intracellular components, ultimately causing cell death.
Pharmacokinetics
Absorption:
Bioavailability:
< 5% (negligible systemic absorption)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Minimal to no clinically significant effect due to poor systemic absorption
Distribution:
Vd:
Not applicable (not distributed systemically)
ProteinBinding:
Not applicable (not distributed systemically)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (not absorbed systemically)
Clearance:
Not applicable (not absorbed systemically)
ExcretionRoute:
Excreted unchanged in feces
Unchanged:
Nearly 100% (oral dose)
Pharmacodynamics
OnsetOfAction:
Local effect within days
PeakEffect:
Not applicable (local action)
DurationOfAction:
Dependent on dosing frequency and continued presence of drug at site of action
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a severe skin reaction (Stevens-Johnson syndrome), including:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Mouth irritation
Fast heartbeat
Muscle pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor or seek medical help:
Diarrhea
Stomach pain
Upset stomach
* Vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a severe skin reaction (Stevens-Johnson syndrome), including:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Mouth irritation
Fast heartbeat
Muscle pain
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor or seek medical help:
Diarrhea
Stomach pain
Upset stomach
* Vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Worsening of symptoms despite treatment
- Development of new or severe side effects (e.g., severe nausea, vomiting, diarrhea, rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
- Signs of allergic reaction
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
What to Do:
Due to minimal systemic absorption, systemic toxicity from oral overdose is unlikely. Treatment is generally supportive. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical diagnosis of candidiasis
Rationale: To confirm the fungal infection requiring treatment
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (e.g., white patches, oral discomfort, GI upset)
Frequency: Daily to weekly, based on clinical assessment
Target: Complete resolution or significant improvement
Action Threshold: Lack of improvement or worsening symptoms may indicate need for alternative therapy or re-evaluation of diagnosis
Symptom Monitoring
- Oral discomfort or pain
- White patches or lesions in the mouth or throat
- Difficulty swallowing
- Abdominal pain or cramping (for intestinal candidiasis)
- Diarrhea (for intestinal candidiasis)
- Nausea or vomiting
Special Patient Groups
Pregnancy
Nystatin is considered safe for use during pregnancy (Pregnancy Category B) as it is minimally absorbed systemically.
Trimester-Specific Risks:
First Trimester:
Low risk
Second Trimester:
Low risk
Third Trimester:
Low risk
Lactation
Nystatin is considered safe for use during lactation (Lactation Risk L2) as it is not absorbed systemically by the mother and therefore not excreted in breast milk.
Infant Risk:
Low risk
Pediatric Use
Nystatin is commonly used in pediatric patients for oral candidiasis. Oral suspension is generally preferred for infants and young children who cannot swallow tablets. Dosing should be adjusted based on age and weight for older children.
Geriatric Use
No specific dose adjustments are required for geriatric patients. Nystatin is generally well-tolerated in this population due to its lack of systemic absorption.
Clinical Information
Clinical Pearls
- For oral candidiasis, instruct patients to allow the tablet to dissolve slowly in the mouth, or to chew it, and then swish the dissolved medication around the mouth for as long as possible before swallowing. This maximizes local contact time.
- Emphasize the importance of completing the full prescribed course of therapy, even if symptoms improve, to prevent relapse.
- Nystatin is effective only against fungal infections; it is not effective against bacterial or viral infections.
- Due to its poor systemic absorption, Nystatin is generally very safe and has minimal drug interactions.
Alternative Therapies
- Clotrimazole troches (for oral candidiasis)
- Fluconazole (for more severe or refractory oral/esophageal candidiasis, or systemic infections)
- Miconazole buccal tablets (for oral candidiasis)
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.