Nystatin Oral Susp 100000unit/ml
It is used to treat fungal infections in the mouth.
Drug Class
Antifungal
Pharmacologic Class
Polyene antifungal
Pregnancy Category
Category B
FDA Approved
Jan 1957
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nystatin oral suspension is an antifungal medicine used to treat yeast infections in the mouth and throat, commonly known as oral thrush. It works by stopping the growth of the yeast.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food. Before using, shake the bottle well to mix the contents. When taking a liquid dose, measure it carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one to ensure accurate dosing. Swish the medication around your mouth for as long as possible before swallowing.
It's essential to continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better. This will help ensure that you receive the full benefits of the treatment.
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. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who can provide guidance on the best method. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss 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 continue with 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 get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food. Before using, shake the bottle well to mix the contents. When taking a liquid dose, measure it carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one to ensure accurate dosing. Swish the medication around your mouth for as long as possible before swallowing.
It's essential to continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better. This will help ensure that you receive the full benefits of the treatment.
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. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who can provide guidance on the best method. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss 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 continue with 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, including regular brushing and flossing.
- Clean dentures thoroughly if applicable, as they can harbor yeast.
- Avoid sugary foods and drinks, which can promote yeast growth.
- For infants, clean pacifiers and bottle nipples regularly.
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:
400,000 to 600,000 units (4-6 mL of 100,000 units/mL suspension) four times daily
Dose Range:
400000 - 600000 mg
Condition-Specific Dosing:
oralCandidiasis:
400,000 to 600,000 units (4-6 mL) four times daily, swish and retain in mouth for as long as possible before swallowing. Continue for at least 48 hours after symptoms have disappeared.
Pediatric Dosing
Neonatal:
100,000 units (1 mL of 100,000 units/mL suspension) four times daily, applied to each side of the mouth.
Infant:
200,000 units (2 mL of 100,000 units/mL suspension) four times daily, applied to each side of the mouth.
Child:
400,000 to 600,000 units (4-6 mL of 100,000 units/mL suspension) four times daily, swish and retain in mouth for as long as possible before swallowing.
Adolescent:
400,000 to 600,000 units (4-6 mL of 100,000 units/mL suspension) four times daily, swish and retain in mouth for as long as possible before swallowing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; Nystatin is 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. This binding creates pores or channels in the membrane, leading to increased permeability and leakage of intracellular components (e.g., potassium, amino acids), ultimately causing fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible (less than 1%)
Tmax:
Not clinically relevant due to minimal systemic absorption
FoodEffect:
Not significant, as absorption is minimal
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Excreted almost entirely unchanged in the feces following oral administration
Unchanged:
Nearly 100% of oral dose
Pharmacodynamics
OnsetOfAction:
Local effect, typically within 24-72 hours for symptomatic relief
PeakEffect:
Local effect, typically within several days of consistent use
DurationOfAction:
Dependent on dosing frequency (e.g., 6 hours for QID dosing)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 symptoms that bother you or do not go away, contact your doctor:
Diarrhea
Stomach pain
Upset stomach
* Vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 symptoms that bother you or do not go away, contact your doctor:
Diarrhea
Stomach pain
Upset stomach
* Vomiting
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. 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 oral thrush symptoms (e.g., more white patches, increased pain)
- Development of new symptoms (e.g., rash, difficulty breathing, swelling of face/lips/tongue/throat) which could indicate an allergic reaction (rare)
- Nausea, vomiting, or diarrhea that becomes severe or persistent
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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current 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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current 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 currently breast-feeding, be sure to discuss this with your doctor. This conversation will help you understand the potential benefits and risks of this medication for both you and your baby, allowing you to make an informed decision.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Abdominal discomfort
What to Do:
Due to minimal systemic absorption, overdose with Nystatin oral suspension is unlikely to cause serious systemic toxicity. Treatment is generally supportive. If a large amount is ingested, contact a poison control center (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of oral mucosa
Rationale: To establish baseline severity and extent of oral candidiasis.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical assessment of oral mucosa (resolution of white patches, erythema, soreness)
Frequency: Daily or every few days during treatment
Target: Resolution of symptoms and visible lesions
Action Threshold: Lack of improvement or worsening symptoms may indicate non-compliance, resistant infection, or need for alternative therapy.
Symptom Monitoring
- Resolution of white patches in the mouth or throat
- Decrease in oral soreness or pain
- Improved ability to eat and swallow
Special Patient Groups
Pregnancy
Nystatin is considered safe for use during pregnancy (Pregnancy Category B) due to its minimal systemic absorption. It is not expected to cause fetal harm.
Trimester-Specific Risks:
First Trimester:
Low risk
Second Trimester:
Low risk
Third Trimester:
Low risk
Lactation
Nystatin is considered safe for use during breastfeeding (Lactation Risk L1) because it is not absorbed systemically by the mother and therefore not excreted into breast milk. It poses no known risk to the nursing infant.
Infant Risk:
Low risk
Pediatric Use
Nystatin oral suspension is commonly used and well-tolerated in pediatric patients, including neonates and infants, for the treatment of oral candidiasis. Dosing is adjusted based on age and weight.
Geriatric Use
No specific dose adjustments are required for geriatric patients. Nystatin is generally well-tolerated in this population due to its local action and minimal systemic absorption.
Clinical Information
Clinical Pearls
- Instruct patients to swish the suspension around in their mouth for as long as possible (several minutes) before swallowing, to maximize contact time with the oral lesions.
- For infants and young children, the suspension can be applied directly to the affected areas with a clean finger or cotton swab.
- Continue treatment for at least 48 hours after symptoms have disappeared to prevent relapse.
- If using for denture stomatitis, advise patients to remove dentures before swishing and to clean dentures thoroughly.
- Nystatin is fungistatic and fungicidal against a variety of yeasts and yeast-like fungi, including Candida species.
Alternative Therapies
- Clotrimazole troches (for oral candidiasis, dissolved slowly in the mouth)
- Fluconazole (for more severe, refractory, or systemic candidiasis, or in immunocompromised patients)
Cost & Coverage
Average Cost:
$15 - $40 per 60 mL bottle (100,000 units/mL)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. It is also important to note that some medications may have additional patient information leaflets available; you can inquire about this with your pharmacist. If you have any questions or concerns about your medication, do not 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 detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.