Podofilox 0.5% Solution 3.5ml
It is used to treat genital warts.
Drug Class
Antimitotic agent
Pharmacologic Class
Podophyllotoxin derivative
Pregnancy Category
Category C
FDA Approved
Dec 1990
DEA Schedule
Not Controlled
Overview
What is this medicine?
Podofilox solution is a medicine applied directly to external genital warts. It works by stopping the growth of the wart cells, causing the warts to shrink and eventually disappear. It is important to apply it only to the warts and avoid 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 exposure 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, covering only the warts as instructed by your doctor. Be careful not to apply it to healthy skin.
Allow the treated skin to dry completely before touching untreated skin.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep the container tightly closed when not in use.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If the missed dose 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 application.
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 exposure 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, covering only the warts as instructed by your doctor. Be careful not to apply it to healthy skin.
Allow the treated skin to dry completely before touching untreated skin.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures.
Protect the medication from heat sources.
Keep the container tightly closed when not in use.
Missed Dose Instructions
If you miss a dose, apply it as soon as you remember.
If the missed dose 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 application.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the solution.
- Apply only to the warts using the provided applicator, avoiding contact with healthy skin or mucous membranes.
- Allow the solution to dry completely after application.
- Do not wash off the treated area for at least 6-10 hours after application.
- Avoid sexual contact while warts are present and during treatment to prevent transmission and irritation.
- Practice safe sex (e.g., use condoms) to reduce the risk of transmitting HPV.
- Do not use on internal warts (e.g., inside the vagina, anus, or urethra).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to warts twice daily for 3 consecutive days, followed by 4 consecutive days without treatment. This 7-day cycle may be repeated weekly for a maximum of 4 cycles.
Condition-Specific Dosing:
external_genital_warts:
Apply to affected area using an applicator. Maximum treatment area should not exceed 10 cm² and total solution applied should not exceed 0.5 mL per day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (safety and efficacy not established in pediatric patients)
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.
Dialysis:
No specific considerations due to minimal systemic absorption.
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.
Pharmacology
Mechanism of Action
Podofilox is an antimitotic agent that arrests cell division in metaphase by binding to tubulin, thereby inhibiting microtubule assembly. This leads to necrosis of the wart tissue.
Pharmacokinetics
Absorption:
Bioavailability:
Less than 5% (systemic after topical application)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical administration)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
Not applicable (minimal systemic absorption)
CnssPenetration:
No
Elimination:
HalfLife:
Not applicable (minimal systemic absorption)
Clearance:
Not applicable (minimal systemic absorption)
ExcretionRoute:
Not applicable (minimal systemic absorption)
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Local cytotoxic effect observed within days, clinical resolution typically over weeks.
PeakEffect:
Not applicable (local effect)
DurationOfAction:
Not applicable (local effect)
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, consult 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. 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, consult 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:
- Severe pain, burning, itching, or swelling at the application site.
- Development of open sores, bleeding, or signs of infection (pus, fever) at the treated area.
- Systemic symptoms if accidentally ingested (e.g., nausea, vomiting, diarrhea, abdominal pain, dizziness, confusion).
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 other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any 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 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 other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 suitable 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 thorough discussion about the potential benefits and risks of the medication to both you and your baby.
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 suitable 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 thorough discussion about the potential benefits and risks of the medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe local irritation, pain, burning, and erosion at the application site.
- If ingested: Nausea, vomiting, diarrhea, abdominal pain, dizziness, confusion, bone marrow suppression, peripheral neuropathy, and potentially coma.
What to Do:
For topical overdose, wash the area thoroughly with soap and water. For accidental ingestion, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Management is supportive, focusing on symptom control and monitoring for systemic effects.
Drug Interactions
Monitoring
Baseline Monitoring
Visual inspection of warts
Rationale: To assess size, number, and location of warts before treatment.
Timing: Prior to initiation of treatment
Skin integrity assessment
Rationale: To ensure no open wounds or severe irritation at application site.
Timing: Prior to initiation of treatment
Routine Monitoring
Local skin reactions (erythema, pain, burning, itching, erosion)
Frequency: Daily during treatment cycles
Target: Mild to moderate
Action Threshold: Severe reactions, ulceration, or signs of infection warrant discontinuation and medical evaluation.
Wart resolution
Frequency: Weekly during treatment cycles and at follow-up
Target: Decrease in size/number, eventual clearance
Action Threshold: No improvement after 4 cycles may indicate need for alternative therapy.
Symptom Monitoring
- Local irritation
- Pain
- Burning sensation
- Itching
- Inflammation
- Erosion
- Ulceration
- Bleeding
Special Patient Groups
Pregnancy
Podofilox is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown embryotoxicity and teratogenicity at doses higher than human topical exposure.
Trimester-Specific Risks:
First Trimester:
Potential for embryotoxicity and teratogenicity based on animal data; use with caution and only if clearly needed.
Second Trimester:
Use with caution; minimal systemic absorption reduces risk but not eliminated.
Third Trimester:
Use with caution; minimal systemic absorption reduces risk but not eliminated.
Lactation
It is not known whether podofilox is excreted in human milk. Due to minimal systemic absorption, infant exposure is expected to be low. However, caution should be exercised when administering to a nursing mother. Avoid applying to areas where the infant might come into direct contact.
Infant Risk:
Low risk, but caution advised (L3).
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Generally not recommended for use in children.
Geriatric Use
No specific dose adjustments are necessary for geriatric patients. The minimal systemic absorption suggests that age-related changes in renal or hepatic function are unlikely to significantly impact drug exposure.
Clinical Information
Clinical Pearls
- Podofilox is for external use only and should not be used on mucous membranes (e.g., inside the anus, vagina, or urethra) or on bleeding, friable, or freshly biopsied warts.
- Patients should be instructed on the correct application technique to minimize contact with healthy skin, which can lead to severe irritation.
- The solution should be applied with the provided applicator, allowing it to dry completely before contact with clothing.
- Treatment cycles must be strictly followed (3 days on, 4 days off) to allow for healing and minimize local adverse reactions.
- Patients should be advised that local irritation (e.g., burning, pain, redness) is common and usually mild to moderate. Severe reactions warrant discontinuation.
- Not effective for internal warts or for preventing the transmission of HPV.
Alternative Therapies
- Imiquimod cream (Aldara, Zyclara)
- Cryotherapy (liquid nitrogen)
- Trichloroacetic acid (TCA) or Bichloroacetic acid (BCA)
- Surgical excision
- Laser therapy
- Electrocautery
Cost & Coverage
Average Cost:
Varies, typically $50-$150 per 3.5ml solution
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often covered by most prescription plans)
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.