Introduction:
Podofilox is a 0.5 percent gel or solution containing a purified extract of the most active compound of podophyllin. Patients should let the solution dry before moving to prevent any local irritation. The solution should be applied with the help of a cotton swab; the gel should be used with a finger. Physicians should perform the first application. Podofilox is not advisable for treating perianal, rectal, urethral, or vaginal lesions.
Five randomized trials comparing Podofilox with podophyllin found no difference in wart clearance rates.
What Are the Uses of Podofilox Gel?
It is used to treat genital warts and perianal warts. A lignan is found in podophyllin resin obtained from the roots of podophyllum plants. It is a potent poison, toxic, and is used as a cathartic. In addition, it is highly irritating to the skin, and mucous membranes have keratolytic actions, have been used to treat warts and keratosis (growth of dark pigmented scaly patches), and may have antineoplastic properties, as do some of its congeners and derivatives.
Pharmacodynamics:
Podofilox, also called podophyllotoxin, is a pure and stable form of podophyllin. The biologically active part of the compound is utilized. Podofilox is used to remove some types of warts on the skin of the genital areas.
Mechanism of Action:
The exact mechanism of action is not well understood. However, its derivatives may bind and inhibit topoisomerase II during the late S and G2 stages. This disrupts the preparation of the breakthrough which the double-stranded DNA passes through.
Absorption:
Topical application of 0.05 mL of 0.5 % Podofilox solution to external genitalia did not have detectable serum levels. However, applying 0.1 to 1.5 mL resulted in peak serum levels of 1 to 17 ng/mL one to two hours after application.
Half-life:
The half-life of Podofilox gel is about 1 to 4.5 hours.
What Are the Precautions to Be Followed Before Application of Podofilox Gel?
The doctor should be informed about an allergy to Podofilox or any other part of Podofilox gel, any other drugs, foods, or substances, breastfeeding, or plan to breastfeed. This medicine can interact with other drugs or health problems.
Tell the doctor and pharmacist about prescribed drugs, over-the-counter natural products, vitamins, and health problems. Ensure it is safe to take Podofilox gel with all the medicines and other health problems. Do not start, stop, or change the drug dose without consulting a physician.
Pregnancy:
0.5% Podofilox solution was not found to be teratogenic in the rabbit after the topical application of around 0.21 mg/kg 2 times the maximum human dose once a day for 13 days. The scientific literature suggests Podofilox is embryotoxic in rats intraperitoneally at a dose of 5 mg/kg, 19 times the recommended maximum human dose. Condylox Gel 0.5 % should be used during pregnancy only if the benefit is less than the potential risk to the fetus.
Nursing Mothers:
It is not known whether a drug is excreted in human milk. Because of the risk of severe adverse reactions in nursing infants from Podofilox, discontinue nursing or discontinue the drug to the nursing mother.
Pediatric Use:
Safety and effectiveness in pediatric patients are not known.
What Should Be Known About Podofilox Gel?
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Tell all the healthcare providers about the use of Podofilox gel. This includes doctors, nurses, pharmacists, and dentists.
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Do not have sex when Podofilox gel is applied to genital or anal areas.
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Do not use Podofilox gel for longer durations than instructed by the doctor.
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If signs do not get better or if they worsen within four weeks, consult the doctor.
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People who use Podofilox gel can get skin reactions in the areas where Podofilox gel is used. These reactions include burning, stinging, itching, pain, or redness. Inform the doctor if terrible skin reactions are seen and do not go away.
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Know the benefits and risks of using Podofilox gel while pregnant.
How Is the Podofilox Gel Best Taken?
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Use Podofilox gel as instructed by the doctor. Read all information, follow all the instructions correctly, and take Podofilox gel as recommended by the doctor.
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Do not use more than the prescribed dosage.
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Do not take Podofilox gel by mouth. Instead, use it on the skin only. Avoid contact with the medication with the mouth, nose, and eyes, as it can cause burning.
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If Podofilox gel is in contact with the eyes, flush with cool water and seek medical help.
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Wash hands thoroughly before and after the use of the solution.
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Put a thin layer of the solution on the affected skin.
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Put Podofilox gel according to the doctor's instructions or the package labeling.
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Avoid putting the gel on healthy skin.
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Let the treated skin dry completely before it touches the untreated skin.
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This medicine can catch fire. Avoid using the medicine near an open fire flame or during smoking.
How to Manage Missed Podofilox Doses?
Consume the missed whenever you remember it. Then, if it is time for the next dose, avoid taking the missed dose and return to the routine dose. Do not put on two doses at the same time or extra doses.
When Doctor Should Be Informed About Side Effects?
Although rare, some people have harmful and deadly side effects when taking a drug. Inform the doctor or seek medical help if any of the following signs or symptoms are noticed.
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An allergic reaction shows the following signs.
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Rash, hives, itching, along with red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
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Bleeding and swelling at the site where Podofilox gel is applied.
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What Are the Other Side Effects of Podofilox Gel?
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All drugs can cause side effects. Many people, however, have no side effects or minor side effects. Contact the doctor or seek medical help if any of these side effects bother or do not go away.
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Call the poison control center or get medical care if an overdose is suspected. Know what was taken, how much quantity was applied, and when it happened.
What Are the Side Effects Requiring Immediate Medical Attention?
Along with the needed effects, Podofilox topical can cause some unwanted effects. More commonly seen side effects are as follows.
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Bad odor.
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Bleeding over treated skin
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Blistering, crusting, or scabbing on the treated skin.
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Bloody urine.
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Burning sensation over treated skin
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Dizziness.
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Headache.
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Itching of treated skin.
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Pain during sexual intercourse.
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An issue with the foreskin of the penis.
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Redness or swelling of treated skin.
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Scarring of treated skin.
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Skin ulcers of treated skin.
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Vomiting.
Symptoms of Overdose:
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Nausea.
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Vomiting.
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Diarrhea.
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Chills.
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Fever.
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Sore throat.
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Unusual bleeding or bruising.
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Oral ulcers.
Side Effects Not Requiring Immediate Medical Attention:
Some side effects of Podofilox topical do not need medical attention. The side effects disappear during treatment as the body adjusts to the medicine. Healthcare professionals can guide methods to prevent or reduce some side effects.
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Dry treated skin.
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Peeling of skin.
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Soreness or tenderness of the skin.
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Stinging or tingling of treated skin.
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Trouble sleeping.
Less Common Side Effects:
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Changes in the color of treated skin.
Gastrointestinal:
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Gastrointestinal side effects include vomiting.
Local:
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Local side effects include burning, pain, inflammation, erosion, itching, and bleeding.
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Tenderness, chafing, malodor, dryness, peeling, ulceration scarring, vesicle formation, and crusting edema are seen.
Genitourinary:
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Genitourinary side effects include pain with intercourse, foreskin retraction, and hematuria.
Nervous System:
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Nervous system side effects include headache, insomnia, and dizziness.
How to Store and Throw Out Podofilox Gel?
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Store Podofilox gel at room temperature. Do not freeze.
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Protect from heat and open flame.
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Keep the lid tightly closed.
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Store all the drugs in a safe place. Keep the drugs out of the reach of children and pets.
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Throw unused or expired drugs immediately. Do not flush the medications down a toilet or pour them down a drain. Instead, check with the pharmacist about the best way to throw out drugs. There may be drug take-back programs in surrounding areas.
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If symptoms or health problems do not get better or worsen, call and inform the doctor.
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Do not share drugs with others, and do not take drugs prescribed to anyone else.
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Some drugs have another patient information leaflet. Check with the pharmacist. Contact the doctor, nurse, pharmacist, or other health care provider for questions about the Podofilox gel.
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Contact the poison control center in an emergency or overdose, or seek medical care immediately.
Review of Literature.
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Efficacy and safety of 0.5% Podofilox solution in treating and suppressing anogenital warts for the patient-administered treatment of anogenital warts, 0.5% Podofilox (podophyllotoxin), one of the active compounds of podophyllin, is more effective. This study evaluated the safety and efficacy of 0.5% Podofilox treatment followed by prevention. This study confirms the effectiveness and good tolerance of 0.5% Podofilox in treating anogenital warts. It also establishes the safety and superior efficacy of patient-administered Podofilox over the vehicle alone as prophylaxis against the recurrence of lesions. Although long-term efficacy and tolerance remain established, Podofilox helps control this disease.
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Podophyllin in Dermatology: Revisiting a Historical Drug by Ajeet Singh explains Podophyllin as a cytotoxic material obtained from Podophyllum peltatum and Podophyllum hexandrum and used in treating genital warts. The above article reviews podophyllin's chemistry of podophyllin and its active components, the mechanism of action, and the uses of podophyllin in many dermatological disorders with the side effects of the drug. Based on the literature, a clinical guideline is proposed to minimize the side effects. Further studies need to be carried out on use in a lower concentration in premalignant and malignant skin diseases.