Pronunciation:

pode-oh-FIL-um REZ-in

Brand Names:

• Podofilm

Uses of This Medicine:

Podophyllum is used to remove benign (not cancer) growths, such as certain kinds of warts. It works by destroying the tissue of the growth.

A few hours after podophyllum is applied to a wart, the wart becomes blanched (loses all color). In 24 to 48 hours, the medicine causes death of the tissue. After about 72 hours, the wart begins to slough or come off and gradually disappears.

Podophyllum is usually applied only in a doctor's office because it is a poison and can cause serious side effects if not used properly. However, your doctor may ask you to apply this medicine at home. If you do apply it at home, be sure you understand exactly how to use it.

Podophyllum is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Although there is no specific information comparing use of topical podophyllum in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of topical podophyllum in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Crumbling or bleeding warts or warts that have recently had surgery on them—Using podophyllum on these warts may increase the chance of absorption of the medicine through the skin

Proper Use of This Medicine:

Podophyllum is a poison. Keep it away from the mouth because it is harmful if swallowed.

Also, keep podophyllum away from the eyes and other mucous membranes, such as the inside of the nose, mouth, or vagina. This medicine may cause severe irritation. If you get some in your eyes, immediately flush the eyes with water for 15 minutes. If you get some on your normal skin, thoroughly wash the skin with soap and water to remove the medicine. However, if this medicine contains tincture of benzoin, it may be removed more easily from the skin by swabbing with rubbing alcohol.

This medicine may contain alcohol and therefore may be flammable. Do not use near heat, near open flame, or while smoking.

Use podophyllum only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

Do not use podophyllum on moles or birthmarks. To do so may cause severe irritation.

Also, do not apply this medicine to crumbling or bleeding warts or to warts that have recently had surgery on them. To do so may increase the chance of absorption through the skin.

To use:

• Podophyllum can cause severe irritation of normal skin. Therefore, apply petrolatum around the affected area before you apply podophyllum, and/or apply talcum powder to the treated area immediately after you apply podophyllum. This is to prevent the medicine from spreading to the normal skin.
• Use a toothpick or a cotton-tipped or glass applicator to apply this medicine. Apply 1 drop at a time, allowing time for drying between drops, until the affected area is covered.
• After podophyllum is applied, allow it to remain on the affected area for 1 to 6 hours as directed by your doctor. Then, remove the medicine by thoroughly washing the affected area with soap and water. If this medicine contains tincture of benzoin, it may be removed more easily by swabbing the affected area with rubbing alcohol. However, this may be more irritating than washing with soap and water.
• Immediately after applying this medicine, wash your hands to remove any medicine that may be on them.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical solution dosage form:
  • For venereal warts:
    • Adults and children—Apply to the affected area(s) of the skin and leave on the skin for one to six hours. Treatment may be repeated every week for up to six weeks.
  • For other warts or benign growths:
    • Adults and children—Apply to the affected area(s) of the skin once a day.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Early symptoms of too much medicine being absorbed into the body

Abdominal or stomach pain

clumsiness or unsteadiness

confusion

decreased or loss of reflexes

diarrhea (may be severe and continuing)

excitement, irritability, or nervousness

hallucinations (seeing, hearing, or feeling things that are not there)

muscle weakness

nausea or vomiting

sore throat and fever

unusual bleeding or bruising

Late symptoms of too much medicine being absorbed into the body

Constipation

convulsions (seizures)

difficult or painful urination

difficulty in breathing

dizziness or lightheadedness, especially when getting up from a lying or sitting position

drowsiness

fast heartbeat

numbness, tingling, pain, or weakness in hands or feet (may not occur for about 2 weeks after medicine is used)

pain in upper abdomen or stomach (mild, dull, and continuing)

Check with your doctor as soon as possible if any of the following side effects occur:

Burning, redness, or other irritation of affected area

skin rash or itching

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.