Podocon-25 (Podophyllin)
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Podocon-25 (Podophyllin)

Podocon-25®
(25% podophyllin in benzoin tincture)

DRUG DESCRIPTION

Podocon-25® is composed of Podophyllin (Podophyllum Resin, American) 25% in Benzoin Tincture. Podophyllum Resin is the powdered mixture of resins removed from the May apple or Mandrake (Podophyllum peltatum Linne'), a perennial plant of northern and middle United States(1). The podophyllin resin used in this product is exclusively the American podophyllin (rather than the Indian resin). American podophyllin typically has a reduced level of podophyllotoxin (see CLINICAL PHARMACOLOGY section).

What are the possible side effects of podophyllum resin topical (Podocon-25)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe burning, stinging, itching, redness, swelling, or skin changes where the medicine was applied;
  • numbness, burning, pain, or tingly feeling;
  • easy bruising or bleeding, weakness;
  • fever; or
  • severe constipation or stomach cramps.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Podocon-25 »

REFERENCE

What are the possible side effects of podophyllum resin topical (Podocon-25)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe burning, stinging, itching, redness, swelling, or skin changes where the medicine was applied;
  • numbness, burning, pain, or tingly feeling;
  • easy bruising or bleeding, weakness;
  • fever; or
  • severe constipation or stomach cramps.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Podocon-25 »

1) Blumgarten, A.F.: Text Book of Materia Medica, Pharmacology and Therapeutics; Ed. 7, New York, The Macmillan Company, 1937, pp. 220 and 223.

What are the possible side effects of podophyllum resin topical (Podocon-25)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe burning, stinging, itching, redness, swelling, or skin changes where the medicine was applied;
  • numbness, burning, pain, or tingly feeling;
  • easy bruising or bleeding, weakness;
  • fever; or
  • severe constipation or stomach cramps.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Podocon-25 »

Last reviewed on RxList: 9/15/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Podocon-25® (25% podophyllin in benzoin tincture) is indicated for the removal of soft genital (venereal) warts (condylomata acuminata)(4).

DOSAGE AND ADMINISTRATION

PODOCON-25® (podophyllin) IS TO BE APPLIED ONLY BY A PHYSICIAN. IT IS NOT TO BE DISPENSED TO THE PATIENT. SHAKE WELL.

Thoroughly cleanse affected area. Use supplied applicator to apply Podocon-25® (podophyllin) sparingly to lesion. Avoid contact with healthy tissue. Allow to dry thoroughly. Only intact (no bleeding) lesions should be treated. As podophyllin is a powerful caustic and severe irritant, it is recommended the first application of Podocon-25® (podophyllin) be left in contact for only a short time (30-40 minutes) to determine patient's sensitivity. To avoid systemic absorption, time of contact should be minimum time necessary to produce the desired result (1 to 4 hours, depending on condition of lesion and of patient), the physician developing his/her own experience and technique. Large areas or numerous warts should not be treated at once.

After treatment time has elapsed, remove dried Podocon-25® (podophyllin) thoroughly with alcohol or soap and water.

HOW SUPPLIED

Podocon-25® (podophyllin) is available in 15-ml bottles with tapered tip applicator attached inside cap. NDC 0574-0601-15

Store at room temperature 15°-30° C (59°-86° F) in tight, light-resistant containers.

REFERENCE

4) Medical Letter; Vol 26, New Rochelle, N.Y., 1984, p10.

Paddock Laboratories, Inc. Minneapolis, MN 55427. (08-05). FDA Rev date: n/a

Last reviewed on RxList: 9/15/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The use of topical podophyllin has been known to result in paresthesia, polyneuritis, paralytic ileus, pyrexia, leukopenia, thrombocytopenia, coma and death(5).

Read the Podocon-25 (podophyllin) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

REFERENCE

5) Fisher: Severe Systemic and Local Reactions to Topical Podophyllum Resins; Cutis, Volume 28, 1981.

Last reviewed on RxList: 9/15/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Podophyllin is a powerful caustic and severe irritant. Keep away from the eyes; if eye contact occurs, flush with copious amounts of warm water and consult physician or poison control center immediately for advice.

PRECAUTIONS

Do not use Podocon-25® (podophyllin) if wart or surrounding tissue is inflamed or irritated. Do not use on bleeding warts, moles, birthmarks or unusual warts with hair growing from them.

Pregnancy: There have been reports of complications associated with the topical use of podophyllin on condylomata of pregnant patients including birth defects, fetal death and stillbirth(6). In the absence of controlled safety studies, podophyllin remains contraindicated for use on pregnant patients.

Nursing Mothers: It is not known whether podophyllin is excreted in human milk following topical application. In the absence of controlled safety studies, podophyllin remains contraindicated for use on nursing patients.

REFERENCE

6) Zackheim: Hazards of Topical Mitotic-Blocking Agents; Arch. Dermat. Volume 113, 1977.

Last reviewed on RxList: 9/15/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

Podocon-25® (podophyllin) is contraindicated in diabetics, patients using steroids or with poor blood circulation. Podocon-25® (podophyllin) should not be used on bleeding warts, moles, birthmarks or unusual warts with hair growing from them. It is recommended that Podocon-25® (podophyllin) not be used during pregnancy (see Pregnancy warning section).

Last reviewed on RxList: 9/15/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Podophyllin is a cytotoxic agent that has been used topically in the treatment of genital warts. It arrests mitosis in metaphase, an effect it shares with other cytotoxic agents such as the vinca alkaloids(2). The active agent is podophyllotoxin, whose concentration varies with the type of podophyllin used; the American source normally containing one-fourth the amount of podophyllotoxin as the Indian source(3).

NOTE: PODOCON-25® (podophyllin) IS TO BE APPLIED ONLY BY A PHYSICIAN. IT IS NOT TO BE DISPENSED TO THE PATIENT.

REFERENCE

2) Green, L.K., Klima, M., Burns, T.; Arch Dermatol. Vol 124, Nov 1988, p. 1718.
3) Martindale, 28th Ed. London, 1982, pp. 1366, 1367.

Last reviewed on RxList: 9/15/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 9/15/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 9/15/2008
This monograph has been modified to include the generic and brand name in many instances.

Podocon-25®
(25% podophyllin in benzoin tincture)

DRUG DESCRIPTION

Podocon-25® is composed of Podophyllin (Podophyllum Resin, American) 25% in Benzoin Tincture. Podophyllum Resin is the powdered mixture of resins removed from the May apple or Mandrake (Podophyllum peltatum Linne'), a perennial plant of northern and middle United States(1). The podophyllin resin used in this product is exclusively the American podophyllin (rather than the Indian resin). American podophyllin typically has a reduced level of podophyllotoxin (see CLINICAL PHARMACOLOGY section).

REFERENCE

1) Blumgarten, A.F.: Text Book of Materia Medica, Pharmacology and Therapeutics; Ed. 7, New York, The Macmillan Company, 1937, pp. 220 and 223.

Last reviewed on RxList: 9/15/2008
This monograph has been modified to include the generic and brand name in many instances.

Podocon-25®
(25% podophyllin in benzoin tincture)

DRUG DESCRIPTION

Podocon-25® is composed of Podophyllin (Podophyllum Resin, American) 25% in Benzoin Tincture. Podophyllum Resin is the powdered mixture of resins removed from the May apple or Mandrake (Podophyllum peltatum Linne'), a perennial plant of northern and middle United States(1). The podophyllin resin used in this product is exclusively the American podophyllin (rather than the Indian resin). American podophyllin typically has a reduced level of podophyllotoxin (see CLINICAL PHARMACOLOGY section).

REFERENCE

1) Blumgarten, A.F.: Text Book of Materia Medica, Pharmacology and Therapeutics; Ed. 7, New York, The Macmillan Company, 1937, pp. 220 and 223.

Last reviewed on RxList: 9/15/2008
This monograph has been modified to include the generic and brand name in many instances.

Podocon-25®
(25% podophyllin in benzoin tincture)

DRUG DESCRIPTION

Podocon-25® is composed of Podophyllin (Podophyllum Resin, American) 25% in Benzoin Tincture. Podophyllum Resin is the powdered mixture of resins removed from the May apple or Mandrake (Podophyllum peltatum Linne'), a perennial plant of northern and middle United States(1). The podophyllin resin used in this product is exclusively the American podophyllin (rather than the Indian resin). American podophyllin typically has a reduced level of podophyllotoxin (see CLINICAL PHARMACOLOGY section).

REFERENCE

1) Blumgarten, A.F.: Text Book of Materia Medica, Pharmacology and Therapeutics; Ed. 7, New York, The Macmillan Company, 1937, pp. 220 and 223.

Last reviewed on RxList: 9/15/2008
This monograph has been modified to include the generic and brand name in many instances.

Podocon-25 Patient Information Including Side Effects

Brand Names: Podocon-25

Generic Name: podophyllum resin (topical) (Pronunciation: pode oh FIL um REZ in)

What is podophyllum resin topical (Podocon-25)?

Podophyllum resin topical is a skin medication made from a powdered mixture of extracts from a plant called Mandrake, or May apple.

Podophyllum resin topical is used to treat genital warts on the outside of the penis or vagina, or on the skin between the rectum and the genitals.

Podophyllum resin topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of podophyllum resin topical (Podocon-25)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • severe burning, stinging, itching, redness, swelling, or skin changes where the medicine was applied;
  • numbness, burning, pain, or tingly feeling;
  • easy bruising or bleeding, weakness;
  • fever; or
  • severe constipation or stomach cramps.

Less serious side effects may include:

  • mild bloating, constipation; or
  • slight stinging or pain where the medicine was applied.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Podocon-25 (podophyllin) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about podophyllum resin topical (Podocon-25)?

This medication can cause birth defects. Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment.

You should not use this medication if you are allergic to podophyllum resin topical.

You may not be able to use podophyllum resin topical if you have certain conditions. Tell your doctor if you a pregnant or breast-feeding, or if you have diabetes, circulation problems, Raynaud's syndrome, or if you use steroid medications.

Do not use podophyllum resin topical in larger amounts or for longer than recommended. Using more of the medication than prescribed will not make it work better, and may increase your risk of unpleasant side effects.

Do not use this medication to treat genital warts inside the rectum, vagina, or penis. Do not apply to bleeding, swollen or irritated skin. Do not use on moles, birthmarks, or any wart your doctor has not instructed you to treat with podophyllum resin.

Avoid getting this medication in your eyes. It can cause severe irritation. If the medication does get in your eyes, rinse with plenty of water and call a doctor right away.

Genital warts are contagious. Avoid having unprotected sex if you have genital warts. Using podophyllum resin will not prevent you from passing genital warts to other people. Talk with your doctor about safe methods of preventing transmission during sex, such as using a condom.

Side Effects Centers

Podocon-25 Patient Information including How Should I Take

What should I discuss with my health care provider before using podophyllum resin topical (Podocon-25)?

You should not use this medication if you are allergic to podophyllum resin topical.

Before using podophyllum resin topical, tell your doctor if you have:

  • diabetes;
  • circulation problems;
  • Raynaud's syndrome;
  • if you use steroid medications such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; or
  • if you are pregnant or breast-feeding.

If you have any of these conditions, you may not be able to use podophyllum resin topical, or you may need a dose adjustment or special tests during treatment.

FDA pregnancy category X. This medication can cause birth defects. Do not use podophyllum resin topical if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication.

It is not known whether podophyllum resin passes into breast milk or if it could harm a nursing baby. Do not use this medication if you are breast-feeding a baby.

How should I take podophyllum resin topical (Podocon-25)?

Use podophyllum resin topical exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Using more of the medication than prescribed will not make it work better, and may increase your risk of unpleasant side effects. Follow the directions on your prescription label.

Wash your hands before and after using this medication.

Apply the medication using the applicator provided, or using a clean cotton swab. You may need to use a hand mirror to guide you in applying the medicine directly to the wart. Throw away the applicator after one use. Do not reuse an applicator.

Apply podophyllum resin topical only to the wart and avoid getting it on the surrounding skin.

Allow the treated wart to dry completely before dressing or allowing treated skin to come into contact with healthy skin.

Do not use this medication to treat genital warts inside the rectum, vagina, or penis. It should only be applied to the outside (external) skin.

Do not apply podophyllum resin topical to warts or surrounding skin that is bleeding, swollen or irritated. Do not use on moles, birthmarks, or any wart your doctor has not instructed you to treat with podophyllum resin.

You may need to use podophyllum resin topical only on certain days of the week. It is important to use the medication regularly to get the most benefit. Follow your doctor's instructions.

Your doctor may want to check your progress at regular intervals while you are using this medication. Do not miss any scheduled appointments.

Store the medication at room temperature, away from moisture and heat.

Side Effects Centers

Podocon-25 Patient Information including If I Miss a Dose

What happens if I miss a dose (Podocon-25)?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Podocon-25)?

Seek emergency medical attention if you think you have used too much of this medicine.

What should I avoid while using podophyllum resin topical (Podocon-25)?

Avoid getting this medication in your eyes. It can cause severe irritation. If the medication does get in your eyes, rinse with plenty of water and call a doctor right away.

Genital warts are contagious. Avoid having unprotected sex if you have genital warts. Using podophyllum resin will not prevent you from passing genital warts to other people. Talk with your doctor about safe methods of preventing transmission during sex, such as using a condom.

What other drugs will affect podophyllum resin topical (Podocon-25)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied podophyllum resin. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about podophyllum resin topical.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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