Mycelex 10mg Troche
It is used to treat or prevent fungal infections in the mouth.
Drug Class
Antifungal
Pharmacologic Class
Imidazole Antifungal
Pregnancy Category
Category B
FDA Approved
Aug 1982
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clotrimazole troches are lozenges that dissolve slowly in your mouth to treat fungal infections, like thrush (white patches in the mouth and throat). It works by stopping the growth of the fungus.
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 the medication as directed, dissolving it slowly in your mouth. Do not swallow the medication whole, and avoid chewing, breaking, or crushing it. Continue taking the medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing temperatures. Keep it in a dry place, away from bathrooms. Ensure that all medications are stored in a safe location, out of the reach of children and pets.
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 the medication as directed, dissolving it slowly in your mouth. Do not swallow the medication whole, and avoid chewing, breaking, or crushing it. Continue taking the medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing temperatures. Keep it in a dry place, away from bathrooms. Ensure that all medications are stored in a safe location, out of the reach of children and pets.
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
- Do not chew or swallow the troche whole; allow it to dissolve slowly in your mouth, preferably near the affected area.
- Do not eat or drink immediately after the troche has dissolved to allow the medication to work effectively.
- Maintain good oral hygiene.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg troche, dissolved slowly in the mouth, 5 times daily for 14 consecutive days.
Condition-Specific Dosing:
oropharyngealCandidiasis:
10 mg troche, dissolved slowly in the mouth, 5 times daily for 14 consecutive days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Children >3 years: 10 mg troche, dissolved slowly in the mouth, 5 times daily for 14 consecutive days.
Adolescent:
10 mg troche, dissolved slowly in the mouth, 5 times daily for 14 consecutive days.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific considerations due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Pharmacology
Mechanism of Action
Clotrimazole is an imidazole antifungal that inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This leads to structural and functional impairment of the fungal cytoplasmic membrane, resulting in leakage of cellular contents and ultimately cell death.
Pharmacokinetics
Absorption:
Bioavailability:
<10% (systemic, due to first-pass metabolism and low oral absorption from troche)
Tmax:
Not clinically relevant for local action; systemic Tmax is variable and low.
FoodEffect:
Troche is designed to dissolve slowly in the mouth, not swallowed whole. Food does not significantly impact local action.
Distribution:
Vd:
Not well-defined for local action; low systemic distribution.
ProteinBinding:
Not clinically significant for local action; ~90% for systemically absorbed drug.
CnssPenetration:
Limited/Negligible
Elimination:
HalfLife:
Not well-defined for local action; systemic half-life is short (approx. 3-5 hours).
Clearance:
Rapid systemic clearance if absorbed.
ExcretionRoute:
Primarily biliary/fecal for systemically absorbed drug.
Unchanged:
<1% (systemically)
Pharmacodynamics
OnsetOfAction:
Symptomatic relief typically within 2-3 days; mycological cure may take longer.
PeakEffect:
Continuous local antifungal activity as long as the troche is dissolving.
DurationOfAction:
Local effect persists for several hours after dissolution.
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 liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
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:
Itching
Upset stomach or vomiting
* Numbness or tingling in the mouth
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 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 liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
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:
Itching
Upset stomach or vomiting
* Numbness or tingling in the mouth
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 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:
- Severe stomach upset, nausea, or vomiting (rare)
- Unusual tiredness or weakness (rare)
- Yellowing of the skin or eyes (jaundice, rare, indicative of liver problems)
- Dark urine or pale stools (rare, indicative of liver problems)
- Rash or allergic reaction (rare)
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.
The patient's age, particularly if they are under 3 years old. This medication is not suitable for children younger than 3 years of age.
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.
Any existing health problems, as this medication may interact with them.
To ensure safe treatment, always check with your doctor before:
Starting any new medication
Stopping any medication
* Changing the dosage of any medication
Your doctor and pharmacist need to be aware of all your medications and health issues to confirm that it is safe for you to take this medication.
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.
The patient's age, particularly if they are under 3 years old. This medication is not suitable for children younger than 3 years of age.
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.
Any existing health problems, as this medication may interact with them.
To ensure safe treatment, always check with your doctor before:
Starting any new medication
Stopping any medication
* Changing the dosage of any medication
Your doctor and pharmacist need to be aware of all your medications and health issues to confirm that it is safe for you to take this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to follow the doctor's instructions regarding the duration of treatment and do not exceed the recommended treatment period. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Abdominal discomfort
- Dizziness
What to Do:
Overdose is unlikely due to minimal systemic absorption. If accidental ingestion of a large quantity occurs, symptomatic and supportive measures should be initiated. Call 1-800-222-1222 for poison control advice.
Drug Interactions
Major Interactions
- Tacrolimus (increased tacrolimus levels due to CYP3A4 inhibition, though minimal with troche)
- Sirolimus (increased sirolimus levels due to CYP3A4 inhibition, though minimal with troche)
- Everolimus (increased everolimus levels due to CYP3A4 inhibition, though minimal with troche)
Moderate Interactions
- Other CYP3A4 substrates (e.g., some HMG-CoA reductase inhibitors like simvastatin, calcium channel blockers like felodipine, benzodiazepines like midazolam) - potential for increased levels, but clinically significant interactions are rare due to minimal systemic absorption of clotrimazole troche.
Monitoring
Baseline Monitoring
Diagnosis of Oropharyngeal Candidiasis
Rationale: Confirm fungal infection before initiating antifungal therapy.
Timing: Prior to treatment initiation
Routine Monitoring
Clinical response (e.g., resolution of white patches, reduced oral pain)
Frequency: Daily during treatment, at follow-up
Target: Complete resolution of symptoms and lesions
Action Threshold: Lack of improvement or worsening symptoms after 7 days may indicate treatment failure or resistant infection.
Adherence to treatment regimen
Frequency: At follow-up
Target: Completion of full 14-day course
Action Threshold: Non-adherence may lead to treatment failure or recurrence.
Symptom Monitoring
- Resolution of white patches or lesions in the mouth and throat
- Decrease in oral pain or discomfort
- Improved ability to eat and swallow
- Development of new or worsening symptoms (e.g., rash, severe GI upset, signs of liver dysfunction - rare)
Special Patient Groups
Pregnancy
Clotrimazole is generally considered safe for use during pregnancy due to minimal systemic absorption from the oral troche formulation. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk, Category B.
Second Trimester:
Low risk, Category B.
Third Trimester:
Low risk, Category B.
Lactation
Clotrimazole is considered to have a low risk to the nursing infant due to minimal systemic absorption by the mother. It is unlikely to be excreted in breast milk in clinically significant amounts.
Infant Risk:
L3 (Moderately safe)
Pediatric Use
Safe and effective for children 3 years of age and older. Dosing is similar to adults. Safety and efficacy in children younger than 3 years have not been established.
Geriatric Use
No specific dose adjustments are typically required for elderly patients. Use with caution in patients with dentures, as they may harbor Candida and require separate treatment or cleaning protocols.
Clinical Information
Clinical Pearls
- Instruct patients to allow the troche to dissolve slowly and completely in the mouth, without chewing or swallowing it whole, to maximize local contact time.
- For optimal effect, patients should avoid eating or drinking immediately after the troche has dissolved.
- Emphasize the importance of completing the full 14-day course of therapy, even if symptoms resolve earlier, to prevent relapse.
- If symptoms do not improve after 7 days of treatment, re-evaluate the diagnosis or consider alternative antifungal therapy.
Alternative Therapies
- Nystatin oral suspension (swish and swallow)
- Fluconazole (oral tablet, for more severe or refractory cases)
Cost & Coverage
Average Cost:
Varies, typically $20-$50 per 70 troches (14-day supply)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (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 your 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.