Podophyllotoxin

South African indications:

• Warts

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Children <6 years
• Cancer chemotherapy cycles
• Inflamed or bleeding lesions
• Open wounds
• Peripheral vascular disease
• Diabetes mellitus
• Coadministration with corticosteroids
• Coadministration with other podophyllin containing preparations

Cautions

• Breastfeeding
• Treatment area >4cm²   
• Contact with mucous membranes
• Contact with eyes
• Contact with healthy skin
• Sexual intercourse
• Occlusive dressing
• Human papillomavirus infections

Forms avail. in SA and covered in this monograph: sol

Dosages below include:

• South African Standard Treatment Guidelines indications and dosages
• Indications and dosages registered in other jurisdictions

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

South African Standard Treatment Guidelines indications and dosages

Anogenital warts

• Topical (sol): Apply to affected area(s), 12hrly; Treatment duration: 3 days until lesions disappear; Repeat weekly if necessary for a total of four 3-day treatment courses
  (STG, Adult 2019)

Apply petroleum jelly to surrounding skin and mucous membrane for protection

Indications and dosages registered in other jurisdictions

Warts

• Topical (sol): Apply to affected area(s), 12hrly; Treatment duration: 3 days

Repeat treatment at weekly intervals if residual warts persist for up to 4-5 weeks 

First application should be left for 30-40 minutes in order to determine a patient’s sensitivity 

Treatment should be suspended if severe irritation of the surrounding skin occurs

No information available

Pregnancy

• Contraindicated
• Although there is very limited systemic absorption from topically applied podophyllotoxin, antimitotic products such as podophyllotoxin are known to be embryotoxic. Podophyllotoxin is not recommended during pregnancy or in women of childbearing potential not using contraception

Breastfeeding

• Caution; not recommended
• Podophyllotoxin is not recommended for use during breastfeeding. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from podophyllotoxin therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not yet classified (NC)

Drugs in Sport

• Permitted - No warnings

Genitourinary Disorders

• Balanoposthitis

Skin and Subcutaneous Tissue Disorders

• Skin erosion
• Application site irritation
• Application site bleeding
• Skin discolouration
• Dry skin
• Severe local itching and redness

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Bone marrow suppression

• Other podophyllin containing preparations
• Corticosteroids

None routine

Podophyllotoxin is a metaphase inhibitor in dividing cells binding to at least one binding site on tubulin. Binding prevents tubulin polymerisation required for microtubule assembly. At higher concentrations, podophyllotoxin also inhibits nucleoside transport through the cell membrane. The chemotherapeutic action of podophyllotoxin is assumed to be due to inhibition of growth and the ability to invade the tissue of the viral infected cells.

Solution (per ml) 5mg

• Wartec (GSK) originator