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Podofilox (Podophyllotoxin): Drug information

Podofilox (Podophyllotoxin): Drug information
(For additional information see "Podofilox (Podophyllotoxin): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Condylox
Brand Names: Canada
  • Condyline [DSC]
Pharmacologic Category
  • Keratolytic Agent;
  • Topical Skin Product
Dosing: Adult
Genital or perianal warts

Genital or perianal warts: Topical: Gel or solution: Apply twice daily (morning and evening) for 3 days, then withhold use for 4 days; this cycle may be repeated up to 4 times until there is no visible wart tissue; maximum dose: 0.5 g (gel) or 0.5 mL (solution) daily (or ≤10 cm2 of wart tissue) (Ref). Note: Discontinue after 4 treatment cycles if incomplete response and consider alternative treatment; do not repeat use.

Molluscum contagiosum

Molluscum contagiosum (off-label use): Topical: Gel or solution: Apply twice daily (morning and evening) for 3 consecutive days, then withhold use for 4 consecutive days; this cycle may be repeated up to 4 times until lesion resolution (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Gel, topical:

>10%:

Central nervous system: Localized burning (12% to 37%), local pain (12% to 24%)

Dermatologic: Skin erosion (9% to 27%)

Hematologic & oncologic: Local hemorrhage (<1% to 19%)

Local: Local inflammation (9% to 32%), local pruritus (8% to 32%)

1% to 10%:

Central nervous system: Headache (7%)

Dermatologic: Stinging of the skin (7%), erythema (5%)

<1%, postmarketing, and/or case reports: Crusted skin, dermal ulcer, desquamation, edema, skin blister, skin discoloration, skin fissure, skin rash, skin tenderness, tingling of skin, xeroderma

Solution, topical:

>10%:

Central nervous system: Localized burning (female 78%; male 64%), local pain (female 72%; male 50%)

Dermatologic: Skin erosion (67%)

Local: Local inflammation (male 71%; female 63%), local pruritus (female 65%; male 50%)

<1%, postmarketing, and/or case reports: Body odor, dermal ulcer, dizziness, hematuria, insomnia, local hemorrhage, localized edema, localized vesiculation, pain, skin tenderness, tingling of skin, vomiting, xeroderma

Contraindications

Hypersensitivity or intolerance to any component of the formulation.

Canadian labeling: Additional contraindications (not in the US labeling): Concurrent use with other podophyllin-containing products; patients with open wounds or inflamed or bleeding lesions; children <12 years of age; pregnancy; breastfeeding.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• Skin reactions: Most skin reactions are mild to moderate and did not increase during the treatment period, however severe skin reactions can occur. Severe reactions are most frequent within the first two weeks of treatment.

Dosage form specific issues:

• Topical gel and solution: Flammable; keep away from fire or flame.

Other warnings/precautions:

• Appropriate use: For cutaneous use only; avoid contact with eyes. If product comes in contact with the eyes, flush with water and seek medical attention. Not intended for treatment of mucous membrane warts.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Gel, External:

Condylox: 0.5% (3.5 g)

Generic: 0.5% (3.5 g)

Solution, External:

Generic: 0.5% (3.5 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Gel (Condylox External)

0.5% (per gram): $217.15

Gel (Podofilox External)

0.5% (per gram): $195.43

Solution (Podofilox External)

0.5% (per mL): $30.90

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, External:

Condyline: 0.5% ([DSC]) [contains alcohol, usp]

Administration: Adult

Topical: For external use only. Do not apply to mucous membrane warts. Wash hands before and after application. Apply to warts using either the applicator supplied with the drug (gel, solution) or with finger (gel only) while minimizing exposure to surrounding normal tissue. Dispose applicator tip carefully after use. Allow the gel or solution to dry before allowing return of opposing skin surfaces to their normal positions; wash hands after application.

Use: Labeled Indications

Genital warts: Treatment of external genital warts

Perianal warts: Treatment of perianal warts (gel only)

Use: Off-Label: Adult

Molluscum contagiosum

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Podofilox should not be used during pregnancy (CDC [Workowski 2021]).

Breastfeeding Considerations

It is not known if podofilox is present in breast milk.

Due to the potential for adverse reactions in the breastfed infant, the manufacturer recommends a decision be made whether to discontinue breastfeeding or to discontinue the drug, considering the importance of the treatment to the mother.

Monitoring Parameters

Treated areas for adequate healing; tolerability of treatment

Mechanism of Action

Exact mechanism of action is unknown; causes necrosis of visible wart tissue

Pharmacokinetics (Adult Data Unless Noted)

Absorption: No detectable serum levels

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Podofilox;
  • (AR) Argentina: Podoxin;
  • (AT) Austria: Condylox;
  • (AU) Australia: Condyline | Wart | Wartec;
  • (BE) Belgium: Condyline;
  • (BG) Bulgaria: Condyline;
  • (CN) China: Condylox | Podophllotoxin | Wartec | You tuo xin | Youtuoxin;
  • (CO) Colombia: Podox;
  • (CZ) Czech Republic: Wartec;
  • (DE) Germany: Condyline | Condylox | Wartec;
  • (DO) Dominican Republic: Condilex | Podox;
  • (EC) Ecuador: Podox;
  • (EE) Estonia: Condyline | Condylox | Wartec;
  • (ES) Spain: Wartec;
  • (FI) Finland: Condyline | Wartec;
  • (FR) France: Condyline | Wartec;
  • (GB) United Kingdom: Warticon | Warticon cph;
  • (GR) Greece: Podofilox | Wartec;
  • (HK) Hong Kong: Wartec;
  • (HU) Hungary: Condyline;
  • (IE) Ireland: Condyline | Warticon;
  • (IL) Israel: Condylox;
  • (IT) Italy: Condyline;
  • (JO) Jordan: Condyline;
  • (KE) Kenya: Wartec;
  • (KW) Kuwait: Condyline;
  • (LT) Lithuania: Condylox | Wartec;
  • (LV) Latvia: Condyline | Condylox | Wartec | Warticon;
  • (NL) Netherlands: Condyline;
  • (NO) Norway: Condyline | Wartec;
  • (NZ) New Zealand: Condyline;
  • (PL) Poland: Condyline | Wartec;
  • (PR) Puerto Rico: Condylox | Podofilox;
  • (PT) Portugal: Condyline;
  • (RO) Romania: Condyline;
  • (RU) Russian Federation: Condylin | Condyline | Condyline nycomed;
  • (SE) Sweden: Condyline | Wartec;
  • (SG) Singapore: Wartec;
  • (SI) Slovenia: Wartec;
  • (SK) Slovakia: Wartec;
  • (TN) Tunisia: Condyline;
  • (UA) Ukraine: Condylin;
  • (UY) Uruguay: Podoxin;
  • (ZA) South Africa: Wartec
  1. Condylox (podofilox) [prescribing information]. Irvine, CA: Allergan USA Inc; May 2018.
  2. Condylox (podofilox) [product monograph]. Laval, Quebec, Canada: Sanofi-Aventis Canada Inc; July 2021.
  3. Podofilox topical solution [prescribing information]. Parsippany, NJ: Actavis Pharma Inc; June 2018.
  4. Refer to manufacturer's labeling.
  5. Syed TA, Lundin S, Ahmad M. Topical 0.3% and 0.5% podophyllotoxin cream for self-treatment of molluscum contagiosum in males. A placebo-controlled, double-blind study. Dermatology. 1994;189(1):65-68. [PubMed 8003791]
  6. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1 [PubMed 34292926]
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