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podofilox (Condylox)

 

Classes: Keratolytic Agents

Dosing and uses of Condylox (podofilox)

 

Adult dosage forms and 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

 

Pediatric dosage forms and strengths

Safety & efficacy not established

 

Condylox (podofilox) adverse (side) 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%)

 

Warnings

Contraindications

Hypersensitivity

 

Pregnancy and 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.

 

Pharmacology of Condylox (podofilox)

Half-Life: 1-4.5 hr

Absorption: little systemic

 

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