Terbinafine 1% Cream 15gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Allylamine Antifungal
Pregnancy Category
Category B
FDA Approved
May 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Terbinafine 1% Cream is an antifungal medicine used to treat common skin infections caused by fungi, such as athlete's foot, jock itch, and ringworm. It works by stopping the growth of the fungus.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Do not apply the medication to your nails or scalp.
Avoid applying the medication to the vagina or anus.
Wash your hands before and after using the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Storage and Disposal
Store the medication at room temperature.
Keep all medications in a safe 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. Check with your pharmacist for guidance on the best disposal method, and consider participating in a drug take-back program in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, rinse the area thoroughly with water.
Do not apply the medication to your nails or scalp.
Avoid applying the medication to the vagina or anus.
Wash your hands before and after using the medication, unless your hand is the treated area. In this case, do not wash your hand after application.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Storage and Disposal
Store the medication at room temperature.
Keep all medications in a safe 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. Check with your pharmacist for guidance on the best disposal method, and consider participating in a drug take-back program in your area.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Wash the affected area and dry it thoroughly before applying the cream.
- Apply a thin layer of cream to the affected skin and the surrounding area, rubbing it in gently.
- Wash your hands thoroughly after applying the cream.
- Do not cover the treated area with bandages or dressings unless directed by your doctor.
- Wear loose-fitting clothing and breathable materials (e.g., cotton) to keep the affected area dry.
- Change socks and underwear daily, especially if treating athlete's foot or jock itch.
- Avoid sharing towels, clothing, or personal items to prevent spreading the infection.
- Continue using the cream for the full prescribed duration, even if symptoms improve, to ensure the infection is fully cleared and to prevent recurrence.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area and immediately surrounding skin once or twice daily.
Condition-Specific Dosing:
tineaPedis:
Apply twice daily for 1 week, or once daily for 2 weeks.
tineaCruris:
Apply once daily for 1 week.
tineaCorporis:
Apply once daily for 1 week.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for OTC use in children under 12 years without physician consultation. For prescription use, consult specific guidelines.
Adolescent:
Apply to affected area and immediately surrounding skin once or twice daily for 1-2 weeks, similar to adult dosing, if medically indicated.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Terbinafine is an allylamine antifungal that inhibits ergosterol biosynthesis in fungi by inhibiting squalene epoxidase. This leads to a deficiency in ergosterol and an intracellular accumulation of squalene, resulting in fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
<5% (systemic after topical application)
Tmax:
Not clinically relevant for topical application (minimal systemic absorption)
FoodEffect:
Not applicable for topical application
Distribution:
Vd:
Not clinically relevant for topical application
ProteinBinding:
Highly protein bound (>99%) if systemically absorbed, but systemic absorption from topical application is minimal.
CnssPenetration:
Limited/No (from topical application)
Elimination:
HalfLife:
Not clinically relevant for topical application (systemic half-life is long, but minimal systemic absorption)
Clearance:
Not clinically relevant for topical application
ExcretionRoute:
Not clinically relevant for topical application (primarily renal and fecal if systemically absorbed)
Unchanged:
Not clinically relevant for topical application
Pharmacodynamics
OnsetOfAction:
Symptomatic improvement typically within a few days; mycological cure may take longer.
PeakEffect:
Local antifungal effect, sustained with continued application.
DurationOfAction:
Continues as long as applied; residual antifungal effect may persist after cessation of treatment.
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 immediate medical attention:
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
Severe irritation at the site where the medication was applied
Other Possible Side Effects
As with all medications, side effects can occur. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or persist, contact your doctor or seek medical help.
Reporting Side Effects
If you experience any side effects, you can report them 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 immediate medical attention:
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
Severe irritation at the site where the medication was applied
Other Possible Side Effects
As with all medications, side effects can occur. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or persist, contact your doctor or seek medical help.
Reporting Side Effects
If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased redness, itching, or irritation at the application site
- Development of blistering, peeling, or oozing
- Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
- No improvement in symptoms after 1-2 weeks of treatment
- Worsening of the infection
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 dosage 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 dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
If this medication is accidentally swallowed, it can be harmful. In such an event, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
If this medication is accidentally swallowed, it can be harmful. In such an event, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Ingestion of topical terbinafine is unlikely to cause serious systemic effects due to low absorption, but may cause gastrointestinal upset (nausea, vomiting, abdominal pain).
What to Do:
If swallowed, call a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. Induce vomiting only if advised by a healthcare professional.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of fungal infection (e.g., extent of rash, presence of scaling, itching)
Rationale: To establish baseline severity and type of infection.
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of symptoms (e.g., itching, redness, scaling)
Frequency: Daily/Weekly
Target: Progressive improvement
Action Threshold: Lack of improvement after 1-2 weeks, or worsening of symptoms, requires re-evaluation by a healthcare professional.
Local skin reactions (e.g., irritation, burning, stinging, dryness)
Frequency: Daily
Target: Minimal to none
Action Threshold: Severe or persistent irritation, blistering, or signs of allergic reaction require discontinuation and medical advice.
Symptom Monitoring
- Reduction in itching
- Decrease in redness
- Reduction in scaling or flaking
- Resolution of rash
- Absence of burning or stinging sensation
- Absence of blistering or oozing
Special Patient Groups
Pregnancy
Terbinafine topical cream is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and systemic absorption in humans after topical application is minimal. It should be used during pregnancy only if clearly needed and after consulting a healthcare professional.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Terbinafine topical cream is considered L3 (Moderately Safe) during lactation. While oral terbinafine is excreted into breast milk, systemic absorption from topical application is very low, making significant exposure to the infant unlikely. Use with caution and consult a healthcare professional.
Infant Risk:
Low risk due to minimal systemic absorption by the mother and low potential for excretion into breast milk.
Pediatric Use
For OTC use, not recommended for children under 12 years of age without consulting a doctor. For prescription use, safety and efficacy in pediatric patients under 12 years have not been fully established, but it may be used off-label under medical supervision. Dosing is generally similar to adults for older children/adolescents.
Geriatric Use
No specific dose adjustment is required for geriatric patients. The safety and efficacy profile is similar to that in younger adults.
Clinical Information
Clinical Pearls
- Emphasize the importance of completing the full course of treatment, even if symptoms improve, to prevent recurrence and ensure complete eradication of the fungal infection.
- Advise patients to keep the affected area clean and dry, as moisture can promote fungal growth.
- For athlete's foot, advise patients to apply the cream to both feet, even if only one appears affected, and to wear clean, dry socks daily.
- Remind patients that topical terbinafine is for external use only and should not be used in the eyes, mouth, or vagina.
- If the infection does not improve after the recommended treatment duration, or if it worsens, advise the patient to consult a healthcare professional for re-evaluation and potential alternative treatments.
Alternative Therapies
- Other topical antifungals (e.g., clotrimazole, miconazole, ketoconazole, econazole, ciclopirox)
- Oral antifungals (e.g., oral terbinafine, fluconazole, itraconazole) for more severe, widespread, or recalcitrant infections, or those involving nails.
Cost & Coverage
Average Cost:
$10 - $30 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.