Clotrimazole 10mg Lozenge
It is used to treat or prevent fungal infections in the mouth.
Drug Class
Antifungal
Pharmacologic Class
Imidazole antifungal
Pregnancy Category
Category C
FDA Approved
Jan 1982
DEA Schedule
Not Controlled
Overview
What is this medicine?
Clotrimazole lozenges are antifungal medicines used to treat fungal infections in the mouth and throat, like oral thrush. You dissolve the lozenge slowly in your mouth, allowing the medicine to work directly on the infection.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. When taking this medication, dissolve it slowly in your mouth, without swallowing it whole, chewing, breaking, or crushing it. Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store this medication at room temperature, avoiding freezing temperatures. Keep it in a dry location, away from bathrooms. Ensure that all medications are stored in a secure place, out of 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 a missed dose.
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. When taking this medication, dissolve it slowly in your mouth, without swallowing it whole, chewing, breaking, or crushing it. Continue using this medication as directed by your doctor or healthcare provider, even if you start feeling well.
Storing and Disposing of Your Medication
Store this medication at room temperature, avoiding freezing temperatures. Keep it in a dry location, away from bathrooms. Ensure that all medications are stored in a secure place, out of 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 a missed dose.
Lifestyle & Tips
- Dissolve the lozenge slowly in the mouth, do not chew or swallow whole.
- Do not eat or drink immediately after dissolving the lozenge to allow the medication to remain in contact with the oral mucosa.
- Maintain good oral hygiene.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
Available Forms & Alternatives
Available Strengths:
- Clotrimazole 1% Cream 15gm
- Clotrimazole 1% Cream 30gm
- Clotrimazole 1% Cream 45gm
- Clotrimazole 1% Solution 30ml
- Clotrimazole 1% Vaginal Cream 45gm
- Clotrimazole 10mg Lozenge
- Clotrimazole 10mg Lozenge
- Clotrimazole 1% Solution 10ml
- Clotrimazole 1% Cream (otc) 30gm
- Clotrimazole 2% 3 Day Vag Crm 21gm
- Clotrimazole 1% Cream 2x45gm
- Clotrimazole 1% Solution 10ml
- Clotrimazole 1% Cream (otc) 14gm
- Clotrimazole 1% Cream (otc) 14.17gm
- Clotrimazole A/f 1% Cream 28gm
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg lozenge, 5 times daily for 14 consecutive days
Dose Range:
10 - 10 mg
Condition-Specific Dosing:
oropharyngeal_candidiasis:
10 mg lozenge, 5 times daily for 14 consecutive days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Children > 3 years: 10 mg lozenge, 5 times daily for 14 consecutive days (or as directed by physician)
Adolescent:
10 mg lozenge, 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 inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. This leads to structural and functional impairment of the cytoplasmic membrane, resulting in leakage of cellular contents and ultimately fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
<10% (systemic absorption from lozenge is minimal)
Tmax:
Not applicable (primarily local action)
FoodEffect:
Not significant for local action; lozenge should be dissolved slowly in the mouth.
Distribution:
Vd:
Not applicable (minimal systemic distribution)
ProteinBinding:
Not applicable (minimal systemic distribution)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Biliary/fecal (if systemically absorbed)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Days (clinical improvement typically seen within 7 days)
PeakEffect:
Not applicable (local antifungal effect)
DurationOfAction:
Maintained as long as lozenge is used as directed
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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious side effect:
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. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
Itching
Upset stomach or vomiting
* Numbness or tingling in the mouth
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious side effect:
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. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
Itching
Upset stomach or vomiting
* Numbness or tingling in the mouth
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice 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
- New or severe mouth irritation
- Allergic reaction symptoms (rash, itching, swelling, severe dizziness, trouble breathing)
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 a child under 3 years old. This medication is not recommended 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 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 change the dose of any medication without consulting your doctor first.
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 a child under 3 years old. This medication is not recommended 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 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 change the dose of any medication without consulting your doctor first.
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 discuss any concerns or questions with your doctor. Do not exceed the prescribed duration of treatment, and only use this medication for the length of time specified by your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. 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
- Abdominal discomfort
What to Do:
Due to minimal systemic absorption, overdose is unlikely to cause severe systemic toxicity. Symptomatic and supportive care. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- Tacrolimus (potential for increased tacrolimus levels if significant systemic absorption occurs, though unlikely with lozenge)
- Sirolimus (potential for increased sirolimus levels if significant systemic absorption occurs, though unlikely with lozenge)
Monitoring
Routine Monitoring
Clinical signs and symptoms of oral candidiasis (e.g., white patches, soreness)
Frequency: Daily
Target: Resolution of symptoms
Action Threshold: Lack of improvement after 7 days or worsening symptoms; consider alternative diagnosis or treatment.
Symptom Monitoring
- Resolution of white patches in the mouth and throat
- Decrease in oral soreness or discomfort
- Improvement in swallowing
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal.
Trimester-Specific Risks:
First Trimester:
Limited data, but minimal systemic absorption suggests low risk.
Second Trimester:
Limited data, but minimal systemic absorption suggests low risk.
Third Trimester:
Limited data, but minimal systemic absorption suggests low risk.
Lactation
Considered low risk during breastfeeding due to minimal systemic absorption by the mother, making infant exposure unlikely.
Infant Risk:
Low
Pediatric Use
Approved for children 3 years of age and older who are able to dissolve the lozenge slowly in the mouth. Safety and efficacy not established in children younger than 3 years.
Geriatric Use
No specific dose adjustments are necessary. Use with caution in patients with dentures, as they can harbor Candida and may require denture cleaning/treatment.
Clinical Information
Clinical Pearls
- Instruct patients to allow the lozenge to dissolve slowly and completely in the mouth, typically over 15-30 minutes, without chewing or swallowing it whole.
- Advise patients not to eat or drink immediately after dissolving the lozenge to maximize contact time with the oral mucosa.
- Emphasize the importance of completing the full 14-day course of treatment, even if symptoms resolve earlier, to prevent relapse.
- For patients with dentures, advise them to remove and clean their dentures thoroughly, as dentures can be a reservoir for Candida.
- Clotrimazole lozenges are generally well-tolerated, with the most common side effects being mild gastrointestinal upset or local irritation.
Alternative Therapies
- Nystatin oral suspension (swish and swallow)
- Fluconazole (oral tablet, for more severe or refractory cases)
- Itraconazole oral solution
Cost & Coverage
Average Cost:
$50 - $150 per 70 lozenges (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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.