PODOFILOX 5 mg/mL
PODOFILOX · SOLUTION · Padagis US LLC
PODOFILOX is a solution containing podofilox at 5 mg/mL, taken topical. Manufactured by Padagis US LLC.
Key Facts
- Brand Name
- PODOFILOX
- Generic Name
- PODOFILOX
- NDC Code (Product)
0574-0611- Manufacturer
- Padagis US LLC
- Strength
- 5 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA075600
- Marketing Start
- 01/29/2002
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Podofilox Topical Solution 0.5% is indicated for the topical treatment of external genital warts (Condyloma acuminatum). This product is not indicated in the treatment of perianal or mucous membrane warts (see PRECAUTIONS ). Diagnosis Although genital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma (so-called "Bowenoid papulosis") is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus but should not be treated with Podofilox Topical Solution 0.5%.
Dosage & Administration
DOSAGE AND ADMINISTRATION In order to ensure that the patient is fully aware of the correct method of therapy and to identify which specific warts should be treated, the technique for initial application of the medication should be demonstrated by the prescriber. Apply twice daily morning and evening (every 12 hours), for 3 consecutive days, then withhold use for 4 consecutive days. This one week cycle of treatment may be repeated up to four times until there is no visible wart tissue. If there is incomplete response after four treatment weeks, alternative treatment should be considered. Safety and effectiveness of more than four treatment weeks have not been established. Podofilox Topical Solution 0.5% is applied to the warts with an applicator supplied with the drug. The drug-dampened applicator should be touched to the wart to be treated, applying the minimum amount of solution necessary to cover the lesion. Treatment should be limited to less than 10 cm 2 of wart tissue and to no more than 0.5 mL of the solution per day. There is no evidence to suggest that more frequent application will increase efficacy, but additional applications would be expected to increase the rate of lo…
Warnings
WARNINGS Correct diagnosis of the lesions to be treated is essential. See the " Diagnosis " subsection of the INDICATIONS AND USAGE statement. Podofilox Topical Solution 0.5% is intended for cutaneous use only. Avoid contact with the eye. If eye contact occurs, patient should immediately flush the eye with copious quantities of water and seek medical advice.
Contraindications
CONTRAINDICATIONS Podofilox Topical Solution 0.5% is contraindicated for patients who develop hypersensitivity or intolerance to any component of the formulation.
Adverse Reactions
ADVERSE REACTIONS In clinical trials, the following local adverse reactions were reported at some point during treatment. Adverse Experience Males Females Burning 64% 78% Pain 50% 72% Inflammation 71% 63% Erosion 67% 67% Itching 50% 65% Reports of burning and pain were more frequent and of greater severity in women than in men. Adverse effects reported in less than 5% of the patients included pain with intercourse, insomnia, tingling, bleeding, tenderness, chafing, malodor, dizziness, scarring, vesicle formation, crusting edema, dryness/peeling, foreskin irretraction, hematuria, vomiting and ulceration.
Frequently Asked Questions
What is PODOFILOX used for?
PODOFILOX contains PODOFILOX. It is a solution taken topical. Consult your doctor for specific uses.
Is PODOFILOX a controlled substance?
PODOFILOX is not classified as a controlled substance by the DEA.
What is the generic name for PODOFILOX?
The generic name for PODOFILOX is PODOFILOX. There are 2 other brand versions of PODOFILOX.
What is the NDC code for PODOFILOX 5 mg/mL?
The NDC (National Drug Code) for PODOFILOX 5 mg/mL is 0574-0611, listed by Padagis US LLC.