What is Podofilox used for. How does Podofilox work in treating genital warts. What are the proper usage instructions for Podofilox. What potential side effects should users be aware of when using Podofilox. How can Podofilox interactions with other medications be managed. What important precautions should be taken when using Podofilox.

Understanding Podofilox: A Powerful Treatment for Genital Warts

Podofilox is a topical medication widely recognized for its effectiveness in treating genital warts. This antimitotic drug, available as a 0.5% gel, has gained popularity among patients and medical professionals alike. Its active ingredient, podofilox, can be either chemically synthesized or purified from plant families such as Coniferae and Berberidaceae, specifically from species like Juniperus and Podophyllum.

How does Podofilox work? The medication functions by inhibiting the growth of pathogenic cells responsible for genital warts. By blocking cell division, Podofilox effectively halts the progression of warts, leading to their eventual elimination. However, it’s crucial to note that this treatment is not indicated for perianal or mucosal warts, emphasizing the importance of proper diagnosis and prescription by a healthcare professional.

Proper Application Techniques for Optimal Results

To maximize the efficacy of Podofilox and ensure safe usage, it’s essential to follow the correct application procedures. Here are the key steps to apply Podofilox properly:

1. Wash your hands thoroughly before and after application.
2. Clean and dry the affected area before applying the medication.
3. Use the applicator tip or fingertips to apply a small amount of gel directly to the wart.
4. Allow the gel to dry completely after application.
5. Avoid contact with eyes, nose, mouth, and ears. If accidental contact occurs, rinse immediately with clean water.

What is the recommended treatment schedule for Podofilox? The typical regimen involves applying the medication twice daily, once in the morning and once in the evening, for three consecutive days. This is followed by a four-day break. If necessary, the cycle can be repeated up to four times. Should warts persist after four weeks of treatment, it’s advisable to consult a healthcare provider for alternative options.

Navigating Potential Side Effects of Podofilox

While Podofilox is generally well-tolerated, users should be aware of potential side effects. Common reactions may include:

• Swelling
• Pain or burning sensation
• Itching
• Skin peeling
• Small sores
• Headache

Are there any serious side effects to watch out for? In rare cases, more severe reactions may occur. These can include bleeding or severe allergic reactions characterized by symptoms such as itching or swelling of the tongue and throat, rash, dizziness, facial swelling, and shortness of breath. If any of these symptoms manifest, it’s crucial to seek immediate medical attention.

Managing Drug Interactions with Podofilox

To ensure safe and effective treatment, it’s vital to consider potential drug interactions when using Podofilox. How can patients minimize the risk of adverse interactions? The key lies in open communication with healthcare providers. Before starting Podofilox treatment, patients should inform their doctor or pharmacist about all medications, supplements, and herbal products they are currently using.

Why is this step so important? Interactions between Podofilox and other substances can alter the effectiveness of each medication, potentially leading to decreased efficacy or increased risk of side effects. By disclosing all current treatments, healthcare providers can make informed decisions about the safety and appropriateness of Podofilox for each individual patient.

Essential Precautions and Storage Guidelines

To maintain the integrity and effectiveness of Podofilox, proper storage and handling are crucial. What are the best practices for storing Podofilox? The medication should be kept in its original container, tightly closed, and stored at room temperature away from moisture and direct light. It’s important to keep Podofilox out of reach of children and pets.

How can patients ensure they’re using Podofilox safely? Here are some key precautions to keep in mind:

• Use only as directed by a healthcare professional
• Do not apply to broken skin or open wounds
• Avoid sexual contact while the medication is on the skin
• Do not use internally or on mucous membranes
• If pregnant or breastfeeding, consult a doctor before use

Recognizing and Responding to Podofilox Overdose

While rare, Podofilox overdose can occur, particularly if the medication is misused or applied too frequently. What are the signs of a potential Podofilox overdose? Symptoms may include:

• Nausea and vomiting
• Diarrhea
• Altered mental status
• Unusual weakness or fatigue
• Slow breathing
• Convulsions
• Fainting or difficulty breathing

If any of these symptoms occur, it’s crucial to seek immediate medical attention. How can overdose be prevented? Strictly adhere to the prescribed dosage and application schedule. If a dose is missed, apply it as soon as remembered, unless it’s close to the time for the next dose. In that case, skip the missed dose and resume the regular schedule.

Maximizing Treatment Efficacy and Safety

To ensure the best possible outcomes when using Podofilox, patients should prioritize safety and efficacy. How can users maximize the benefits of their treatment? Here are some key strategies:

1. Read all instructions carefully before beginning treatment
2. Follow the prescribing doctor’s guidance precisely
3. Monitor for any changes in the treated area or overall health
4. Keep all follow-up appointments with healthcare providers
5. Report any concerning symptoms or side effects promptly

What should patients do if Podofilox doesn’t seem to be working? If after the recommended treatment period (typically four weeks) there’s no improvement or if warts worsen, it’s essential to consult with a healthcare provider. They may recommend alternative treatments or adjust the current regimen to better suit the individual’s needs.

The Importance of Professional Medical Guidance

While Podofilox is an effective treatment for genital warts, its success relies heavily on proper use and medical supervision. Why is ongoing communication with healthcare providers crucial? Regular check-ins allow for timely adjustments to treatment plans, early detection of potential complications, and comprehensive management of the condition.

How can patients ensure they’re getting the most appropriate care? Be proactive in seeking information, asking questions, and reporting any concerns or changes in symptoms. Remember, healthcare providers are there to support patients throughout their treatment journey and can offer valuable insights and adjustments to optimize outcomes.

Exploring Alternative and Complementary Treatments

While Podofilox is a primary treatment option for genital warts, it’s not the only approach available. What other treatments might be considered alongside or instead of Podofilox? Healthcare providers may recommend:

• Cryotherapy (freezing the warts)
• Electrocautery (burning the warts)
• Laser therapy
• Surgical excision
• Immunomodulators like imiquimod

How do these alternatives compare to Podofilox? Each treatment has its own set of benefits and potential side effects. The choice often depends on factors such as the size and location of warts, the patient’s overall health, and personal preferences. In some cases, a combination of treatments may be recommended for optimal results.

Lifestyle Considerations During Treatment

In addition to medical treatments, certain lifestyle adjustments can support the healing process and reduce the risk of spreading or reinfecting with genital warts. What steps can patients take to complement their Podofilox treatment?

• Practice safe sex by using barrier methods like condoms
• Avoid sexual contact when warts are visible or during treatment
• Maintain good hygiene in the affected area
• Boost immune health through diet, exercise, and stress management
• Quit smoking, as it can impair immune function and slow healing

How can these lifestyle changes impact treatment outcomes? By reducing the risk of reinfection and supporting overall health, these measures can enhance the effectiveness of Podofilox and other treatments, potentially leading to faster resolution of warts and a lower likelihood of recurrence.

Long-Term Management and Prevention Strategies

While Podofilox can effectively treat existing genital warts, prevention and long-term management are equally important. How can individuals reduce their risk of developing genital warts in the future? Consider these strategies:

1. Get vaccinated against HPV, the virus responsible for genital warts
2. Practice safe sex consistently, including the use of barrier methods
3. Limit the number of sexual partners
4. Undergo regular sexual health screenings
5. Maintain a strong immune system through healthy lifestyle choices

What role does ongoing monitoring play in managing genital warts? Even after successful treatment with Podofilox, it’s important to remain vigilant. Regular self-examinations and follow-up appointments with healthcare providers can help detect any recurrence early, allowing for prompt intervention if needed.

The Psychological Impact of Genital Warts and Treatment

Dealing with genital warts can be emotionally challenging for many individuals. How can patients cope with the psychological aspects of diagnosis and treatment? Here are some helpful approaches:

• Seek support from trusted friends, family, or support groups
• Consider counseling or therapy to address any anxiety or stress
• Educate yourself about the condition to feel more in control
• Practice self-care and stress-reduction techniques
• Communicate openly with sexual partners about the condition and treatment

Why is addressing the emotional impact important? Mental well-being can significantly affect overall health and treatment outcomes. By managing stress and maintaining a positive outlook, patients can better adhere to treatment regimens and cope with any challenges that arise during the healing process.

Advancing Research and Future Treatments

The field of genital wart treatment is continuously evolving, with ongoing research into new and improved therapies. What potential advancements are on the horizon for treating genital warts? Researchers are exploring several promising avenues:

• Novel topical medications with enhanced efficacy and fewer side effects
• Immunotherapy approaches to boost the body’s natural defenses against HPV
• Combination therapies that target multiple aspects of wart development
• Improved delivery methods for existing medications like Podofilox
• Personalized treatment protocols based on genetic factors and virus strains

How might these advancements impact future treatment options? As research progresses, patients may benefit from more effective, less invasive, and more personalized treatment approaches. This could lead to higher success rates, reduced treatment times, and improved quality of life for those affected by genital warts.

The Role of Patient Feedback in Improving Treatments

Patient experiences and feedback play a crucial role in advancing treatments like Podofilox. How can individuals contribute to the improvement of genital wart treatments? Consider these options:

1. Participate in clinical trials for new treatments
2. Provide detailed feedback to healthcare providers about treatment experiences
3. Share experiences (anonymously if preferred) through patient support groups or forums
4. Respond to surveys or questionnaires about treatment outcomes
5. Advocate for increased research funding and awareness of genital wart treatments

Why is patient input so valuable? Real-world experiences can highlight aspects of treatments that may not be apparent in clinical settings, leading to refinements in medication formulations, application methods, and treatment protocols. This collaborative approach between patients, healthcare providers, and researchers can drive meaningful improvements in genital wart management.

Podofilox: Uses, indications and cautions when using

This is an automatically translated article.

Sensitive diseases are often hidden by people until they get worse, including genital warts. Currently, Podofilox is known to be a product of choice for many users and is recommended by doctors to treat genital warts. Let’s find out together what Podofilox has and the notes when using Podofilox.

1. What is Podofilox?

The main ingredient of Podofilox is Podofilox, which is produced in the form of a topical gel with a concentration of 0.5%. Podofilox may be chemically synthesized or purified from the plant families Coniferae and Berberidaceae (e.g. species Juniperus and Podophyllum). Podofilox is an anti-mitotic drug that blocks the growth of pathogenic cells and is used in the treatment of genital warts. However, Podofilox is not indicated for the treatment of perianal or mucosal warts.
2. How to use Podofilox correctly? Proper use will help increase the absorption of active ingredients and Podofilox will promote its maximum effect, ensuring effective treatment for users. Therefore, patients should pay attention to the following notes when using Podofilox:
Podofilox is only used on the skin, used by topical application. Podofilox is usually applied once in the morning and again in the evening for 3 days, followed by a 4-day break. If the wart does not go away, repeat up to 4 times. If after 4 weeks of treatment the wart is still not gone, contact your doctor for other options. You should wash your hands and clean and dry the affected skin before applying the medicine. Use the tip of the applicator or your fingertips to apply a small amount of Podofilox to the wart and allow the gel to dry. Avoid contact of Podofilox with eyes, nose, mouth and ears. If Podofilox gets in your eyes, nose, mouth, or ears, wash it off immediately with clean water. Wash your hands immediately after using Podofilox.

Thuốc Podofilox được biết đến là một sản phẩm được nhiều người dùng lựa chọn và được các bác sĩ khuyên sử dụng để điều trị mụn cóc sinh dục

3.

What are the side effects of Podofilox?

In addition to the therapeutic effect, the use of Podofilox can lead to unwanted effects. Common side effects of Podofilox include: swelling, pain, burning, itching, peeling skin, small sores, or headache.
Tell your doctor right away if while taking Podofilox you experience any serious side effects including:
Bleeding, Severe allergic reactions that are classified as Podofilox are very rare. with symptoms including: itching and/or swelling of the tongue and throat, rash, dizziness, itchy facial swelling, feeling short of breath. These are not all the possible side effects of Podofilox. Before using Podofilox, tell your doctor or pharmacist if you have any allergies to Podofilox or other drugs in its class, or any other skin problems (e.g., skin cancer).
While taking Podofilox, if you notice other unwanted effects not listed above or if any of these side effects get worse or last longer, don’t be subjective, see your doctor again.

4. What drug interactions can occur when taking Podofilox?

Interactions between Podofilox and other drugs, when taken at the same time or for a short period of time, can affect each other’s activities, effects, and effectiveness, or even increase the risk of side effects. serious want of each drug. So, before using Podofilox, tell your doctor about all other medicines and products you are using.

Trước khi sử dụng thuốc Podofilox, hãy cho bác sĩ biết tất cả các thuốc và sản phẩm khác bạn đang sử dụng

5. What are some other notes when using Podofilox?

Abuse of Podofilox can lead to overdose and serious symptoms such as nausea, vomiting, diarrhea, altered mental status, weakness or fatigue, unusually slow breathing and convulsions, even fainting or difficulty breathing.
If you have missed a dose of Podofilox, use it as soon as you remember if it is not time for your next dose. Conversely, if it is time for your next dose of Podofilox, skip the missed dose and take your next dose as usual.
To prevent the drug Podofilox from being degraded leading to quality deterioration and possibly losing the required therapeutic and safety effects, you need to store the drug in the conditions as directed.
To ensure safety and avoid side effects of Podofilox, patients should carefully read the instructions before using or follow the instructions of the doctor or pharmacist. In case the use of Podofilox is not effective, the patient should go to the medical facility for examination and treatment.

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Podofilox – Topical Solution | HealthLink BC

Uses

Podofilox solution is used to treat warts on the outside of the genitals. It stops the growth of the wart and the wart eventually falls off. Podofilox belongs to a group of drugs called antimitotics.

Other Uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for a skin infection called molluscum contagiosum.

How To Use

Read the Patient Information Leaflet available from your pharmacist before you start using podofilox solution and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is for use on the skin only. Only apply this medication to the genital warts that your doctor has identified for you. Do not use this medication on warts around the anus or on the mucous membranes (such as in the urethra, rectum, and vagina), inside your body, or on any other skin growths.

Use this medication usually twice daily (once in the morning and once in the evening, every 12 hours), for 3 days in a row, followed by no treatment for the next 4 days. If the warts do not go away, you may repeat this 7-day cycle up to a total of 4 treatment weeks in a row. Follow your doctor’s directions exactly.

First wash the area to be treated with soap and water, and dry thoroughly. Use an applicator that comes with this product, dip it into the solution just enough to wet it, but not so much that solution is dripping from the tip. Apply this medication only to the warts your doctor has directed you to treat. Do not apply it to the area surrounding the warts. It may help to use a hand mirror.

For warts within skin folds, pull the skin fold open and apply the medication. Let the medication dry before allowing the skin folds around the warts to return to their normal position.

Only use the applicator once. Do not dip it into the solution again. Throw it away in a safe place after use. Wash your hands with soap and water after each application.

Do not cover the treated area with bandages or other waterproof dressings. Covering the area with cotton gauze, or cotton underwear for the genital area, is permitted.

Use this medication regularly to get the most benefit from it. To help you remember, use a calendar to mark the days you will be applying the medication each week.

Avoid getting this medication in the eyes/nose/mouth, on healthy skin, or on other areas as mentioned above. If the medication gets on healthy skin, wipe it off right away and wash the area thoroughly with soap and water and rinse off. If the medication gets in your eyes, nose, or mouth, flush the area with plenty of water for 15 minutes and contact your doctor.

Do not apply a large amount of this medication or apply it to a large area. Ask your doctor or pharmacist for details. Do not use it more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Tell your doctor if your condition persists after 4 weeks of treatment, or if it worsens, or if new growths appear during treatment. Genital warts often return after treatment.

Side Effects

Redness, itching, burning, and pain may occur in the treated area. If any of these effects persist or worsen, or if you have bleeding, severe swelling, or severe pain, wash the medication off with soap and water. Stop using this medication and tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US –

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using podofilox, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• injured/irritated/inflamed skin around the treated area
• recent surgery on the treated area

This medication is not a cure for genital warts. These warts are caused by a virus called human papillomavirus (HPV). Podofilox does not destroy the virus. It only helps to remove the warts, but new warts may form or old warts may return, during and after treatment.

Do not have sexual intercourse on the days you have applied this medication.

Genital warts are spread by sexual contact. Condoms (such as latex or polyurethane types) may help prevent the spread of genital warts to your partner. Consult your doctor or pharmacist for more details.

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor’s approval.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

Overdose

This product may be harmful if swallowed. If too much of this medication is applied to the skin, wash it off with plenty of soap and water. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: nausea, vomiting, diarrhea, fever, coma, trouble breathing, seizures.

Notes

Do not share this medication with others.

Keep all medical appointments.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from high heat and open flame. Do not freeze. Keep the container cap tightly closed. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Podofilox Topical Solution (Podofilox): Uses, Dosage, Side Effects, Interactions, Warning

• Generic Name: Podofilox
• Brand Name: Podofilox Topical Solution

• Product Description
• Indications 9000 4
• Dosage
• Side effects and drug interactions
• Warnings and precautions
• Overdose and contraindications
• Clinical pharmacology
• Medication guide

Product description

Podofilox
Topical solution 0.5%

DESCRIPTION

900 28 Podofilox (podofilox) topical solution is an antimitotic drug that can be chemically synthesized or purified from plants of the Coniferae and Berberidaceae families (eg Juniperus and podophyllum species). Podofilox (podofilox) 0.5% topical solution is formulated for topical use. Each milliliter of solution contains 5 mg of podofilox (podofilox) in a carrier containing lactic acid and sodium lactate in 95% alcohol, USP.

Podofilox (podofilox) has a molecular weight of 414.4 daltons, soluble in alcohol and slightly soluble in water. Its chemical name is 5,8,8a,9-Tetrahydro-9-hydroxy-5-(3,4,5-trimethoxylphenyl)furo[3†,4†:6.7]naphtho[2,3,d]-1 ,3-dioxol-6 (5aH) -one.

Indications

INDICATIONS

Podophilox (Podophilox) Topical Solution 0.5% is indicated for the topical treatment of external genital warts (Condyloma acuminatum). This product is not indicated for the treatment of perianal or mucosal warts (see PRECAUTIONS ).

Diagnosis
Although genital warts have a characteristic appearance, histopathological confirmation should be obtained if there is any doubt about the diagnosis. Of particular concern is the differentiation of warts from squamous cell carcinoma (called “bovenoid papulosis”). Squamous cell carcinoma can also be associated with human papillomavirus but should not be treated with Podophilox 0.5% topical solution.

Dosage

DOSAGE AND ADMINISTRATION

To ensure that the patient is fully aware of the correct method of therapy and to determine which warts should be treated, the prescriber must demonstrate the method of initial application of the drug.

Apply twice a day in the morning and evening (every 12 hours) for 3 consecutive days, then off for 4 consecutive days. This one-week treatment cycle can be repeated up to four times until there is no visible wart tissue. If there is an incomplete response after four weeks of treatment, alternative treatment should be considered. Safety and efficacy beyond four weeks of treatment have not been established.

Podofilox (podofilox) 0.5% topical solution is applied to warts using the applicator supplied with the drug. The drug-moistened applicator should be touched to the wart to be treated, applying the minimum amount of solution necessary to cover the lesion. Processing should be limited to less than 10 cm. ^two wart tissues and not more than 0.5 ml of solution per day. There is no evidence that more frequent use will increase efficacy, but additional applications can be expected to increase the incidence of local adverse reactions and systemic absorption.

Care must be taken to allow the solution to dry before allowing opposing skin surfaces to return to their normal position. After each treatment, the used applicator should be carefully disposed of and the patient’s hands should be washed.

HOW SUPPLIED

3.5 ml Podofilox 0.5% solution for topical application is supplied as a clear liquid in amber glass bottles with child-resistant screw caps. NDC 0574-0611-05. Store at controlled room temperature between 15° and 30°C (59° and 86°F). Avoid excessive heat. Do not freeze.

RECOMMENDATIONS
1. Berenblum, 1951. J. Natl. Cancer Inst. 11:839-841.
2. H.A. Kaminetsky, M. Sverdlow, 1965 Am. J. Obst. Gyn. 93: 486-490.
3. McGrew E.A., Kaminetsky H.A., 1961. Am.J.Clin.Pathol. 35:538-545.
4.F.J.C. Rowe and M. H. Salaman, 1955 British J. Cancer. 9:177-203.
5. Conus H.S., 1977. Z. Krebsforsch. 90:197-210.
6. Kaminetsky Kh.A. McGrew, R.L. Phillips, 1959. Am.J. Obst.Gyn.
14:1-3
7. Kaminetsky H.A., McGrew E.A., 1963. Arch.Path.73:481-485.
8. C. Didcock, D. Jackson, and J. M. Robeson, 1956, Brit. J. Pharmacol.
11: 437-441
9. J.Thiersch, 1963.Soc.Exptl.Biol.Med.Proc.113:124-127.

Paddock Laboratories, Inc.
Minneapolis, MN 55427 124159 (04-01)
www.paddocklabs.com 0611-01-0101

Side effects and drug interactions

SIDE EFFECTS

at that time during treatment, the following local adverse reactions.

90 119

Adverse experiences	Diseases	Females
Burning	64%	78%
Pain	5 0%	72%
Inflammation	71%	63%
Erosion	67%	67%
Itching	50%	65% pain was more frequent and more severe in women than in men. Adverse effects reported in less than 5% of patients included pain during intercourse, insomnia, tingling, bleeding, soreness, chafing, odor, dizziness, scarring, blistering, crusting edema, dryness/scaling, foreskin retraction , hematuria, vomiting. and ulceration. ophthalmic eye drops for pink eye DRUG INTERACTIONS No information provided. Warnings and Precautions WARNINGS Proper diagnosis of the lesions to be treated is very important. See Diagnostics Subsection INDICATIONS AND USAGE approval. Podofilox (Podofilox) 0.5% topical solution is for dermal use only. Avoid contact with eyes. In case of contact with the eyes, the patient should immediately rinse the eyes with plenty of water and seek medical advice. PRECAUTIONS General There are no data on the safe and effective use of this product for the treatment of warts that occur in the perianal region or on the mucous membranes of the genital organs (including the urethra, rectum and vagina). The recommended method of application, frequency of application and duration of use should not be exceeded (see DOSAGE AND ADMINISTRATION ). Carcinogenesis, Mutagenesis and Impairment of Fertility There are no reports of lifetime carcinogenicity studies in mice. Published animal studies have generally shown no carcinogenic properties of the medicinal substance podofilox (podofilox). 1,2,3,4,5 There are published reports that, in studies in mice, crude podophyllin resin (containing podofilox (podofilox)) applied topically to the cervix caused changes resembling carcinoma. in place of . 6 These changes were reversible five weeks after treatment was stopped. In one of the experiments described, epidermal carcinoma of the vagina and cervix was found in 1 of 18 mice after 120 applications of podophyllin. 7 (the drug was used twice a week for 15 months). Podophilox (Podophilox) was not mutagenic in the Ames plate reverse mutation assay at concentrations up to 5 mg/dish, with and without metabolic activation. In BALB/3T3 cells, after exposure to podofilox (podofilox) at concentrations up to 0.008 µg/mL without metabolic activation and 12 µg/mL of podofilox (Podophilox) with metabolic activation, no cellular transformation associated with potential oncogenicity was observed. Results from mouse micronucleus in vivo Analysis using a 0.5% solution of podofilox (podofilox) at concentrations up to 25 mg/kg indicates that podofilox (podofilox) should be considered as a potential clastogen (a chemical that causes chromosome disruption). Daily topical application of a 0.5% solution of podofilox (podofilox) for topical application at doses equivalent to 0.2 mg/kg (5 times the maximum recommended human dose) in rats during gametogenesis, mating, pregnancy, parturition and lactation for two generations did not reveal any violations. fertility. Pregnancy Teratogenic effects: Pregnancy category C: podofilox (podofilox) was not teratogenic in rabbits after topical application up to 0. 21 mg/kg (5 times the maximum human dose) once a day in within 13 days. There are references in the scientific literature that podofilox (podofilox) is embryotoxic in rats when administered systemically at a dose approximately 250 times the recommended maximum human dose. 8.9 Teratogenicity and embryotoxicity have not been studied with intravaginal use. Many antimitotic drugs are known to be embryotoxic. There are no adequate and well-controlled studies in pregnant women. Podofilox (podofilox) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing mothers It is not known if this drug is excreted in breast milk. Because of the potential for serious adverse reactions in infants from podofilox (podofilox), a decision should be made to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric use Safety and efficacy in pediatric patients have not been established. Overdose and contraindications OVERDOSAGE When applied topically, podofilox (podofilox) can be absorbed systemically (see CLINICAL PHARMACOLOGY section). Toxicity reported following systemic administration of Podofilox (Podophilox) for cancer research purposes included: nausea, vomiting, fever, diarrhea, bone marrow depression, and oral ulcers. After 5-10 daily intravenous doses of 0.5 to 1 mg/kg/day, significant hematological toxicity was observed, but it was reversible. Other toxic effects have been observed at lower doses. Toxicity reported after systemic administration of podophyllum resin included: nausea, vomiting, fever, diarrhea, peripheral neuropathy, mental status changes, lethargy, coma, tachypnea, respiratory failure, leukocytosis, pancytosis, hematuria, renal failure, and seizures. Treatment of overdose for topical application should include washing the skin from the remnants of the drug, as well as symptomatic and supportive therapy. CONTRAINDICATIONS Podofilox (Podofilox) 0. 5% topical solution is contraindicated in patients who develop hypersensitivity or intolerance to any component of the drug. Clinical pharmacology CLINICAL PHARMACOLOGY Mechanism of action Treatment of genital warts with podofilox (podofilox) results in necrosis of the visible wart tissue. The exact mechanism of action is unknown. Pharmacokinetics. In a systemic absorption study involving 52 patients, topical application of 0.05 ml of a 0.5% solution of podofilox (podofilox) to the external genitalia did not result in detectable serum levels. Application of 0.1-1.5 ml resulted in peak serum levels of 1 to 17 ng/ml one to two hours after application. The half-life is from 1.0 to 4.5 hours. Accumulation of the drug after several sessions of treatment was not detected. CLINICAL STUDIES In clinical studies with Podophilox Solution (Podophilox), the test product and its vehicle were used in a double-blind manner in comparable groups of patients. Patients received treatment for two to four weeks and were re-evaluated at a two-week follow-up. Although the number of patients and warts assessed in each time period varied, the results of the investigators were relatively stable. The following table presents responses marked in terms of response rates of treated lesions and overall patient response. Data are presented for 2-week follow-up only for those patients examined at that time point. Cleared *	Repeat after Clearing *	Cleared at 2-week follow-up *
% Warts (n = 524)	79% (412/524)	35% ( 146/412)	60% (269/449)
% of patients (n = 70)	50% (35/70)	60% (21/35)	25% (14/57 )

* Cleansing and cleansing means that no visible wart tissue remains on the treated areas.

Medication Guide

PATIENT INFORMATION

A Patient Information Sheet must be provided to the patient when completing a prescription for Podofilox (Podophilox) Topical Solution.

Condyline instructions for use: indications, contraindications, side effects – description of Condyline Solution for external use (5686)