Nystatin Oral Susp 100000u/ml 60ml
It is used to treat fungal infections in the mouth.
Drug Class
Antifungal
Pharmacologic Class
Polyene Antifungal
Pregnancy Category
Category B
FDA Approved
Jan 1954
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 thrush. It works by stopping the growth of the yeast.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. Take your medication with or without food, as directed. Before using the liquid form, shake the bottle well to ensure the ingredients are mixed properly. Measure the liquid dose carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.
When taking the medication, swish it around your mouth for as long as possible before swallowing. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, 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 by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who may be aware of 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 is 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 a missed dose.
To use this medication safely and effectively, follow your doctor's instructions and the information provided with your prescription. Take your medication with or without food, as directed. Before using the liquid form, shake the bottle well to ensure the ingredients are mixed properly. Measure the liquid dose carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.
When taking the medication, swish it around your mouth for as long as possible before swallowing. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, 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 by your pharmacist. If you have questions about disposing of your medication, consult with your pharmacist, who may be aware of 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 is 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 a missed dose.
Lifestyle & Tips
- Maintain good oral hygiene, including regular brushing and flossing.
- Clean dentures thoroughly if worn, as they can harbor yeast.
- Rinse mouth with water after using inhaled corticosteroids to prevent thrush.
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) four times daily
Dose Range:
400000 - 600000 mg
Condition-Specific Dosing:
oralCandidiasis:
Swish in mouth for as long as possible (at least several minutes) and then swallow. Continue for at least 48 hours after symptoms have disappeared.
Pediatric Dosing
Neonatal:
100,000 units (1 mL) four times daily, applied to each side of the mouth.
Infant:
100,000 to 200,000 units (1-2 mL) four times daily, applied to each side of the mouth.
Child:
400,000 to 600,000 units (4-6 mL) four times daily, swish and swallow.
Adolescent:
400,000 to 600,000 units (4-6 mL) four times daily, swish and swallow.
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 (e.g., potassium, amino acids) and ultimately causes cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible (<1%)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not clinically significant due to negligible absorption
Distribution:
Vd:
Not applicable (not systemically distributed)
ProteinBinding:
Not applicable (not systemically absorbed)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (not systemically absorbed)
Clearance:
Not applicable
ExcretionRoute:
Excreted almost entirely unchanged in the feces
Unchanged:
Nearly 100% (of the unabsorbed portion)
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically within 24-72 hours
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 Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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), such as:
+ 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. Although 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 or seek medical help:
Diarrhea
Stomach pain
Upset stomach
* Throwing up
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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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), such as:
+ 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. Although 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 or seek medical help:
Diarrhea
Stomach pain
Upset stomach
* Throwing up
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:
- Rash, itching, or hives (signs of allergic reaction)
- Difficulty breathing or swelling of face/throat (severe allergic reaction)
- Worsening of mouth/throat symptoms despite treatment
- New or severe nausea, vomiting, or diarrhea
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or change 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or change 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 this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Diarrhea
- Abdominal discomfort
What to Do:
Due to negligible systemic absorption, overdose is unlikely to cause serious systemic toxicity. Treatment is generally supportive. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Monitoring
Routine Monitoring
Clinical symptoms of oral candidiasis (e.g., white patches, pain, difficulty swallowing)
Frequency: Daily
Target: Resolution of symptoms
Action Threshold: Lack of improvement or worsening symptoms after 7-14 days of therapy may indicate resistant infection or need for alternative treatment.
Symptom Monitoring
- Resolution of white patches in mouth/throat
- Decrease in oral pain or discomfort
- Improved ability to swallow
- Absence of fever (if associated with infection)
Special Patient Groups
Pregnancy
Nystatin is considered safe for use during pregnancy 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. It is not absorbed systemically by the mother, so it is not excreted in breast milk and poses no risk to the nursing infant.
Infant Risk:
Very low risk (L1)
Pediatric Use
Nystatin oral suspension is commonly used and well-tolerated in infants and children for the treatment of oral candidiasis. Dosing is adjusted by age/weight.
Geriatric Use
No specific dose adjustments are necessary for elderly patients. Due to minimal systemic absorption, age-related changes in renal or hepatic function do not significantly impact its use.
Clinical Information
Clinical Pearls
- Instruct patients to swish the suspension in their mouth for as long as possible (e.g., several minutes) before swallowing to maximize contact time with the oral mucosa.
- For infants and young children, the suspension can be applied directly to the affected areas of the mouth with a clean finger or cotton swab.
- Advise patients to continue treatment for at least 48 hours after symptoms have disappeared to prevent relapse.
- If dentures are worn, they should be removed and cleaned thoroughly during treatment to prevent reinfection.
- Nystatin is effective only against fungal infections; it is not effective against bacterial or viral infections.
Alternative Therapies
- Clotrimazole troches (for oral candidiasis)
- Miconazole buccal tablets (for oral candidiasis)
- Fluconazole (systemic antifungal, for more severe or refractory oral candidiasis)
Cost & Coverage
Average Cost:
$10 - $30 per 60 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.