podofilox (Rx)

Brand and Other Names:Condylox
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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

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Adverse Effects

>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%)

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Warnings

Contraindications

Hypersensitivity

Cautions

Keep product away from open flame

Avoid contact with eyes

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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.

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Pharmacology

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

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Images

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

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
podofilox topical

PODOFILOX GEL - TOPICAL

(poe-DOF-il-ox)

COMMON BRAND NAME(S): Condylox

USES: This medication is used on the skin to treat external genital warts.

HOW TO USE: This medication is for topical use only. Apply it on the warts pointed out by your doctor. It is usually applied once in the morning and again in the evening for 3 days followed by a 4 day rest period. If the warts do not go away, then this cycle is repeated up to 4 times. Contact your doctor for other options if the warts do not go away after 4 weeks of treatment.To apply, use the provided applicator tip or your finger. Apply a small amount of medication to the wart to cover it. Allow the gel to dry. Wash your hands thoroughly afterwards. Be careful with this medication because it can irritate normal skin around the application site.Do not use large amounts, apply more often or use for a longer period than directed. Your condition will not clear faster, and the chance for side effects may be increased.Avoid contact with the eyes and mucous membranes. If contact occurs, immediately wash with plenty of water and contact your doctor.Read the Patient Information Leaflet available from your pharmacist. Consult your doctor or pharmacist if you have any questions.

SIDE EFFECTS: Swelling, pain, burning, itching, peeling skin, small sores, or headache may occur. If any of these effects persist or worsen, notify 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.Tell your doctor right away if this serious side effect occurs: bleeding.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 taking 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: other skin problems (e.g., skin cancer).This medication must not be used during pregnancy. Women of child-bearing age should use a reliable form of birth control while using this medication. If you become pregnant or think you may be pregnant, inform your doctor right away.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: 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. This medicine may be harmful if swallowed. If accidentally swallowed, you may experience symptoms such as: nausea, vomiting, diarrhea, change in mental status, weakness or fatigue, unusually slowed breathing, and seizures.

NOTES: This medication is prescribed for your current condition only. Do not use it later for another skin problem unless directed by your doctor. A different medication may be necessary in those cases.Do not share this medication with others.This medication is not a cure. New warts or return of old warts may occur, especially in the first 3 months after treatment. Follow-up medical visits may be periodically necessary to monitor your progress or check for side effects. Consult your doctor for more details.Refrain from sexual intercourse on the days you apply this drug. Using condoms may help prevent the spread of genital warts to your partner.

MISSED DOSE: If you miss a dose, apply 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 heat or open flame. Do not freeze. Replace the cap tightly after use. Do not store in the bathroom. 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.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

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.

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

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