Terbinafine 1% Cream 30gm
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Allylamine Antifungal
Pregnancy Category
B
FDA Approved
May 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Terbinafine 1% Cream is an antifungal medicine used on the skin to treat common fungal infections like athlete's foot, jock itch, and ringworm. It works by stopping the growth of the fungus that causes these infections.
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 affected 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 dry it thoroughly.
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 local drug take-back programs.
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 application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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 affected 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 dry it thoroughly.
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 local drug take-back programs.
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 application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the cream.
- Clean and dry the affected area completely before application.
- Apply a thin layer of cream to the affected skin and the surrounding healthy skin.
- Do not cover the treated area with bandages or dressings unless directed by a doctor.
- Wear loose-fitting clothing and breathable footwear (e.g., cotton socks) to keep the area dry.
- Change socks and underwear daily.
- Avoid sharing towels, clothing, or footwear to prevent spreading the infection.
- Continue using the cream for the full prescribed duration, even if symptoms improve, to prevent recurrence.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected area and surrounding skin once or twice daily.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
Tinea Pedis (interdigital):
Once daily for 1 week
Tinea Cruris:
Once daily for 1 week
Tinea Corporis:
Once daily for 1 week
Tinea Pedis (plantar/moccasin type):
Twice daily for 2 weeks
Tinea Versicolor:
Once or twice daily for 1-2 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not fully established for children under 12 years; consult physician. For children 12 years and older, dosing is generally similar to adults.
Adolescent:
Apply to affected area and surrounding skin once or twice daily for 1-2 weeks, similar to adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Dialysis:
No adjustment needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment needed due to minimal systemic absorption.
Moderate:
No adjustment needed due to minimal systemic absorption.
Severe:
No adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Terbinafine is an allylamine antifungal that inhibits ergosterol biosynthesis by inhibiting squalene epoxidase, an enzyme in the fungal sterol synthesis pathway. This leads to a deficiency in ergosterol and an intracellular accumulation of squalene, resulting in fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 5% (systemic absorption after topical application)
Tmax:
Not applicable for topical therapeutic effect; systemic Tmax is variable and low.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not applicable for topical therapeutic effect; minimal systemic distribution.
ProteinBinding:
Not applicable for topical therapeutic effect; minimal systemic protein binding.
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Not applicable for topical therapeutic effect; systemic half-life is prolonged due to accumulation in skin/nails.
Clearance:
Not applicable for topical therapeutic effect; minimal systemic clearance.
ExcretionRoute:
Not applicable for topical therapeutic effect; minimal systemic excretion.
Unchanged:
Not applicable for topical therapeutic effect.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within a few days.
PeakEffect:
Full therapeutic effect may take 1-2 weeks of treatment.
DurationOfAction:
Residual antifungal activity may persist in the skin for several days after discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 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
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, 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.
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 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
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you have any side effects that bother you or do not go away, 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 or irritation at the application site
- Severe itching or burning
- Swelling or blistering
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat) - seek immediate medical attention.
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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate existing health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
Existing health problems or conditions
Before making any changes to your medication regimen, consult with your doctor to confirm that it is safe to:
Start taking this medication
Stop taking this medication
Change the dosage of this medication or any other medication you are taking
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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate existing health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
Existing health problems or conditions
Before making any changes to your medication regimen, consult with your doctor to confirm that it is safe to:
Start taking this medication
Stop taking this medication
Change the dosage of this medication or any other medication you are taking
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 this medication is accidentally swallowed, it can be harmful. In such cases, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are currently 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 cases, immediately contact a doctor or a poison control center for assistance.
If you are pregnant, planning to become pregnant, or are currently 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:
- Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Excessive application may lead to local irritation.
What to Do:
If accidentally ingested, contact a poison control center or emergency room. For local irritation, discontinue use and wash the area. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of fungal infection (type, extent, severity)
Rationale: To confirm diagnosis and establish baseline for treatment efficacy.
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of signs and symptoms (e.g., itching, redness, scaling)
Frequency: Daily by patient, weekly by clinician if follow-up is needed
Target: Complete resolution or significant improvement
Action Threshold: Lack of improvement after 1-2 weeks, or worsening symptoms, indicates need for re-evaluation.
Local skin reactions (e.g., irritation, burning, stinging, dryness)
Frequency: Daily by patient
Target: Minimal to no irritation
Action Threshold: Severe irritation, rash, or allergic reaction requires discontinuation and medical advice.
Symptom Monitoring
- Itching
- Redness
- Scaling
- Burning sensation
- Stinging sensation
- Dryness
- Blistering
- Peeling
- Swelling
Special Patient Groups
Pregnancy
Terbinafine topical is Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. Due to minimal systemic absorption, the risk to the fetus is considered low.
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 is excreted in breast milk after oral administration. However, systemic absorption after topical application is minimal, making the risk to a breastfed infant low. Use with caution; avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
L3 (Moderately Safe) - Low risk due to minimal systemic absorption, but caution advised.
Pediatric Use
Safety and efficacy have not been fully established for children under 12 years of age. For children 12 years and older, dosing is generally similar to adults. Consult a healthcare professional before use in younger children.
Geriatric Use
No specific dose adjustments or precautions are necessary 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.
- Advise patients that improvement may be seen within a few days, but full resolution can take 1-2 weeks.
- Stress the importance of good hygiene, keeping the affected area clean and dry, and wearing breathable clothing/footwear.
- For athlete's foot, advise applying the cream to both feet, even if only one appears affected, to prevent spread.
- Inform patients that topical terbinafine is for external use only and should not be used in the eyes, mouth, or vagina.
Alternative Therapies
- Clotrimazole 1% cream
- Miconazole 2% cream
- Tolnaftate 1% cream
- Ketoconazole 2% cream
- Econazole 1% cream
Cost & Coverage
Average Cost:
$15 - $40 per 30gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (for 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 details. 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 reporting the incident, be prepared to provide information about the medication taken, the amount, and the time it occurred.