Condylox (podofilox) dosing, indications, interactions, adverse effects, and more.

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Sections podofilox
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

topical solution/gel

0.5%

Anogenital Warts

Apply with cotton-tipped applicator (solution) or finger (gel) q12hr for 3 days then no treatment for 4 days

May repeat in 1 week, cycle up to 4 times

Safety & efficacy not established

>10%

Mild to moderate inflammation (63%)

Mild to moderate burning (63%)

Mild to moderate erosion (44-48%)

Mild to moderate pain (44-48%)

Mild to moderate pruritus (44-48%)

Mild to moderate bleeding (22%)

1-10%

Stinging (7%)

Erythema (5%)

Severe inflammation (8-12%)

Severe burning (8-12%)

Severe erosion (8-12%)

Severe pain (8-12%)

Severe pruritus (8-12%)

Headache (6-9%)

Insomnia

Dizziness

Hematuria

Nausea

Vomiting (5%)

Severe bleeding (1%)

Contraindications

Hypersensitivity

Cautions

Keep product away from open flame

Avoid contact with eyes

Pregnancy & Lactation

Pregnancy Category: C

Lactation: not known whether topically applied podofilox is distributed into human milk; potential for serious adverse reactions in nursing infants

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Antimitotic agent from plant families Coniferae and Berberidaceae

Interference with microtubular function of the keratinocytes contained in the warts and local vascular structures; local immunomodulating effects; therapy results in necrosis of visible wart tissue

Pharmacokinetics

Half-life: 1 - 4.5 hours

Peak plasmat time: 1-2 hr after application

BRAND	FORM.	UNIT PRICE	PILL IMAGE
podofilox topical -	0.5 % solution
podofilox topical -	0.5 % solution
Condylox topical -	0.5 % gel

Patient Handout

PODOFILOX - TOPICAL SOLUTION

(poh-DOFF-ih-lox)

COMMON BRAND NAME(S): Condylox

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.

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.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Formulary

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View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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