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

Correct diagnosis of lesions to be treated essential

Intended for cutaneous use only

Avoid contact with eyes; if contact with eyes occurs, patients should immediately flush their eyes with copious amounts of water and seek medical advice

Product is flammable; keep away from open flame

Data on the safe and effective use of this product for treatment of warts occurring on mucous membranes of the genital area (including urethra, rectum, and vagina), not available

Do not exceed frequency of application, duration of usage, and method of application

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 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 last or get worse, 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.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 (such as skin cancer).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: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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.

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

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.

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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