Podofilox 0.5% Gel 3.5gm
It is used to treat genital warts.It is used to treat perianal warts.
Drug Class
Antimitotic agent
Pharmacologic Class
Podophyllotoxin derivative
Pregnancy Category
Category X
FDA Approved
Jun 1990
DEA Schedule
Not Controlled
Overview
What is this medicine?
Podofilox gel is a medicine applied directly to skin warts caused by the human papillomavirus (HPV). It works by stopping the growth of the wart cells, causing the warts to shrink and eventually disappear. It's important to apply it only to the warts and not to healthy skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, flush the affected area with cool water immediately and seek medical attention.
Wash your hands thoroughly before and after applying the medication.
Apply a thin layer of the medication to the affected skin area, as instructed by your doctor. Be sure to only apply it to the warts and avoid putting it on healthy skin.
Allow the treated skin to dry completely before touching untreated skin.
Important Safety Precautions
This medication is flammable, so avoid using it near an open flame or while smoking.
Storage and Disposal
Store the medication at room temperature, away from heat and open flames. Do not freeze.
Keep the lid tightly closed when not in use.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled 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 accompanying information carefully. It is essential to use this medication as directed.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not ingest it.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If accidental contact occurs, flush the affected area with cool water immediately and seek medical attention.
Wash your hands thoroughly before and after applying the medication.
Apply a thin layer of the medication to the affected skin area, as instructed by your doctor. Be sure to only apply it to the warts and avoid putting it on healthy skin.
Allow the treated skin to dry completely before touching untreated skin.
Important Safety Precautions
This medication is flammable, so avoid using it near an open flame or while smoking.
Storage and Disposal
Store the medication at room temperature, away from heat and open flames. Do not freeze.
Keep the lid tightly closed when not in use.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled 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 gel.
- Apply only to the warts, avoiding healthy skin. If gel gets on healthy skin, wash it off immediately.
- Do not apply to bleeding, irritated, or open skin.
- Avoid contact with eyes. If contact occurs, flush eyes thoroughly with water and seek medical attention.
- Do not use internal warts (e.g., inside the vagina, anus, or urethra).
- Allow the gel to dry completely before clothing comes into contact with the treated area.
- Follow the dosing schedule precisely: 3 days on, 4 days off. Do not apply more often or for longer than prescribed.
- Sexual activity should be avoided while the gel is on the skin. Condoms may not fully protect partners from exposure to the medication or HPV.
- This medication does not cure HPV and does not prevent the spread of HPV.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply Podofilox 0.5% gel to the affected area twice daily for 3 consecutive days, followed by 4 consecutive days without treatment. This 7-day cycle may be repeated for a total of up to 4 cycles.
Condition-Specific Dosing:
external_genital_perianal_warts:
Apply a small amount of gel with a finger to cover each wart. Allow the gel to dry completely before contact with clothing. Treatment should not exceed 0.5 grams of gel per day and should not be used for more than 3 consecutive days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in pediatric patients under 18 years of age. Use in adolescents should be considered only if benefits outweigh risks and under strict medical supervision, given the potential for systemic absorption and toxicity.)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption.
Moderate:
No specific adjustment recommended due to minimal systemic absorption.
Severe:
No specific adjustment recommended due to minimal systemic absorption. However, caution is advised if large areas are treated or if skin integrity is compromised, as systemic absorption could increase.
Hepatic Impairment:
Mild:
No specific adjustment recommended due to minimal systemic absorption.
Moderate:
No specific adjustment recommended due to minimal systemic absorption.
Severe:
No specific adjustment recommended due to minimal systemic absorption. However, caution is advised if large areas are treated or if skin integrity is compromised, as systemic absorption could increase.
Pharmacology
Mechanism of Action
Podofilox is an antimitotic agent that arrests cell division in metaphase by binding to tubulin and inhibiting microtubule assembly. This leads to necrosis of the wart tissue. It is a purified lignan extracted from the plant Podophyllum peltatum.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic absorption (approximately 6% of applied dose) after topical application to condyloma acuminata.
Tmax:
Approximately 1-9 hours (after topical application)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not extensively studied for topical application; minimal systemic distribution.
ProteinBinding:
Not extensively studied for topical application.
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Approximately 1-4.5 hours (systemic half-life after topical application)
Clearance:
Not precisely quantified for topical application.
ExcretionRoute:
Primarily renal (as metabolites)
Unchanged:
Less than 1% of absorbed dose excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Wart regression typically observed within the first few weeks of treatment.
PeakEffect:
Not applicable in terms of a single peak effect; cumulative effect over treatment cycles.
DurationOfAction:
Effect persists as long as treatment is continued and for a period after cessation, leading to wart resolution.
Confidence:
Medium
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
Bleeding at the site where the medication is administered
Swelling at the site where the medication is administered
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, or if they persist or bother you, contact your doctor:
Headache
* Skin reactions at the site where the medication is administered, such as:
+ Burning or stinging
+ Itching
+ Pain
+ Redness
If you experience severe skin reactions or those that persist or bother you, contact your doctor for guidance.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
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
Bleeding at the site where the medication is administered
Swelling at the site where the medication is administered
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, or if they persist or bother you, contact your doctor:
Headache
* Skin reactions at the site where the medication is administered, such as:
+ Burning or stinging
+ Itching
+ Pain
+ Redness
If you experience severe skin reactions or those that persist or bother you, contact your doctor for guidance.
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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 burning, stinging, pain, or swelling at the application site.
- Bleeding or ulceration of the treated area.
- Signs of systemic absorption (rare, but serious): nausea, vomiting, abdominal pain, diarrhea, dizziness, confusion, numbness or tingling in hands/feet.
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) medications, natural products, and vitamins. This information will help your doctor assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken 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) medications, natural products, and vitamins. This information will help your doctor assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken 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. To minimize the risk of transmission, avoid engaging in any sexual activity when the drug is present on your genital or anal skin.
Adhere to your doctor's prescribed treatment duration and do not use this medication for an extended period beyond the recommended timeframe. If your symptoms do not improve or worsen within 4 weeks, consult your doctor to reassess your treatment plan.
Note that this medication does not prevent the spread of warts to others. Discuss with your doctor the necessary precautions to prevent the transmission of genital warts. Additionally, talk to your doctor about the appropriate use of birth control methods to prevent pregnancy while taking this medication. If you become pregnant, notify your doctor immediately.
Before starting treatment, inform your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. This will enable a discussion about the potential benefits and risks of the medication to both you and your baby, allowing for an informed decision about your treatment.
Adhere to your doctor's prescribed treatment duration and do not use this medication for an extended period beyond the recommended timeframe. If your symptoms do not improve or worsen within 4 weeks, consult your doctor to reassess your treatment plan.
Note that this medication does not prevent the spread of warts to others. Discuss with your doctor the necessary precautions to prevent the transmission of genital warts. Additionally, talk to your doctor about the appropriate use of birth control methods to prevent pregnancy while taking this medication. If you become pregnant, notify your doctor immediately.
Before starting treatment, inform your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. This will enable a discussion about the potential benefits and risks of the medication to both you and your baby, allowing for an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- Severe local reactions (pain, burning, ulceration)
- Systemic toxicity (if ingested or applied to large areas/broken skin): nausea, vomiting, diarrhea, abdominal pain, fever, lethargy, dizziness, confusion, headache, paresthesias, peripheral neuropathy, bone marrow suppression (leukopenia, thrombocytopenia), liver and kidney dysfunction, coma, seizures.
What to Do:
Immediately wash the treated area with soap and water. If ingested, seek emergency medical attention or call a Poison Control Center (1-800-222-1222) immediately. Treatment is supportive. There is no specific antidote.
Drug Interactions
Monitoring
Baseline Monitoring
Visual inspection of warts
Rationale: To assess size, number, and location of warts before initiating treatment.
Timing: Prior to first application
Routine Monitoring
Visual inspection of warts and surrounding skin
Frequency: Before each new treatment cycle (e.g., weekly)
Target: Reduction in wart size/number, absence of new lesions
Action Threshold: If irritation or inflammation occurs, temporarily discontinue treatment. If warts persist after 4 cycles, consider alternative therapies.
Local skin reactions (e.g., irritation, inflammation, erosion, pain)
Frequency: Daily during treatment days
Target: Mild to moderate reactions are common and expected. Severe reactions should prompt discontinuation.
Action Threshold: Severe pain, burning, swelling, or ulceration; discontinue treatment and seek medical advice.
Symptom Monitoring
- Local irritation (burning, stinging, redness, soreness)
- Pain at application site
- Inflammation
- Erosion or ulceration of skin
- Bleeding
- Itching
- Systemic symptoms (rare, but indicate excessive absorption): nausea, vomiting, abdominal pain, diarrhea, dizziness, confusion, peripheral neuropathy, bone marrow suppression (in cases of severe overdose/misuse)
Special Patient Groups
Pregnancy
CONTRAINDICATED in pregnancy (Pregnancy Category X). Podofilox can cause fetal harm when administered to a pregnant woman. It is embryotoxic and teratogenic in animals. Women of childbearing potential should be advised to use effective contraception during treatment.
Trimester-Specific Risks:
First Trimester:
High risk of teratogenicity and embryotoxicity.
Second Trimester:
High risk of fetal harm.
Third Trimester:
High risk of fetal harm.
Lactation
Use is generally not recommended during breastfeeding (Lactation Risk L3 - Moderately Safe). It is unknown whether podofilox is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Potential for serious adverse reactions due to systemic absorption in the infant, though systemic absorption in the mother is low. Risk of direct exposure to the infant if applied to areas that could come into contact with the infant.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 18 years of age. Use is generally not recommended.
Geriatric Use
No specific dose adjustments are required for geriatric patients. However, caution should be exercised due to potentially thinner skin and increased susceptibility to local irritation. Systemic absorption is minimal, so age-related changes in renal or hepatic function are unlikely to significantly impact drug clearance.
Clinical Information
Clinical Pearls
- Podofilox is for external use only. It should not be used on mucous membranes (e.g., inside the mouth, nose, vagina, anus, or urethra).
- Patients should be instructed on the correct application technique to minimize exposure to healthy skin and prevent systemic absorption.
- The treatment cycle (3 days on, 4 days off) is crucial for efficacy and to allow for recovery of healthy skin.
- Local irritation (burning, redness, soreness) is common and usually mild to moderate. Patients should be advised that this is an expected part of the treatment.
- If warts do not respond after 4 cycles, alternative treatment modalities should be considered.
- Podofilox does not prevent the transmission of HPV or other sexually transmitted infections.
Alternative Therapies
- Imiquimod cream (Aldara, Zyclara)
- Sinecatechins ointment (Veregen)
- Cryotherapy (liquid nitrogen)
- Trichloroacetic acid (TCA) or Bichloroacetic acid (BCA)
- Surgical excision
- Electrocautery
- Laser therapy
Cost & Coverage
Average Cost:
$150 - $300 per 3.5gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (often requires prior authorization or step therapy for brand, generic usually covered)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 occurred.