Veregen

Veregen is used to treat external warts around the genital and rectal areas called condylomata acuminata. It is not used to treat warts that occur inside the vagina, penis, or rectum.

This medicine is available only with your doctor's prescription . This product is available in the following dosage forms:

• Ointment

Before using Veregen, you must know all about the risks and complications associated with it. 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.

Pediatric Population: Appropriate studies have not been performed on the relationship of age to the effects of sinecatechins in the pediatric population. Safety and efficacy have not been established .

Geriatric Population: Insufficient information is available on the relationship of age to the effects of sinecatechins in geriatric patients. It may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people .

Pregnancy: All Trimesters: Category C: Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: 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:

• Inflamed, irritated, or infected skin—Use with caution. This medicine may make this condition worse
• Weakened immune system—It is not known if this medicine is safe to use with this condition

Proper usage of Veregen requires strict adherence to your doctor’s orders. Do not use more of it, do not use it more often, and do not use it longer than directed .

Wash your hands with soap and water before and after using this medicine. This medicine is for use on the skin only. Do not get it inside your eyes, nose, mouth, vagina, or anus. 

Do not use on open wounds or on skin areas that have cuts or scrapes. If it does get on these areas, rinse it off right away. Do not use this medicine on moles, birthmarks, or any other warts until you discuss it with your doctor .

Women using tampons should insert the tampon first before applying the ointment. If the tampon needs to be changed while the ointment is on the skin, avoid getting the ointment into the vagina .

Men who are not circumcised and treating genital warts under the foreskin should draw back the foreskin and clean the area daily .

Do not wash off the ointment from the treated area before you apply the next dose. When you wash the treatment area or bathe, apply the ointment afterwards .

Do not cover the treated area with a bandage unless your doctor has told you to. You may wear loose-fitting underwear after applying for this medicine .

Keep using this medicine until all warts have cleared up. However, you should not use this medicine for longer than 16 weeks .

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 dosage form (ointment):
• For warts on the genital or rectal areas:
  • Adults—Apply a thin layer (about a 0.5 cm strand) to the affected area three times a day. Rub it in gently.
  • Children—Use and dose must be determined by your doctor .

Missed Dose: If you miss a dose of this medicine, apply 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.

Storage: Store in the refrigerator. Do not freeze. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Ask your healthcare professional how you should dispose of any medicine you do not use. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed.

In using Veregen, you must be careful and take some precautions as advised by your doctor. This medicine may make your skin more sensitive to sunlight. Do not expose the area being treated with this medicine to sunlight, sunlamps, or tanning beds.

Avoid having genital, oral, or anal sex while the medicine is on your skin. Make sure you wash the ointment off your skin before you engage in any sexual activity. 

Also, the medicine contains oils that can weaken latex (rubber) condoms, or diaphragms causing them not to work properly. Sinecatechins will not keep you from spreading genital warts to other people. Talk with your doctor about safe sex practices.

This medicine is not a cure for genital or anal warts. You may still develop new warts during or after your treatment. This medicine may stain your clothes and bedding.

Do not use cosmetics or any other skin care products on the same skin area on which you use this medicine, unless directed otherwise by your doctor. If your condition does not improve within 16 weeks, or if it becomes worse, check with your doctor.

Many patients experience redness, swelling, sores or blisters, burning, or itching after using this medicine. If you experience a severe skin reaction, remove the ointment by washing the area with mild soap and water and contact your doctor right away.

As with many medications, there are several potential side effects associated with Veregen. 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:

More common:

• Blistering, peeling or loosening of the skin
• breakdown of skin
• burning of the skin
• cracking of the skin
• flushing, redness of the skin
• hardening or thickening of the skin
• irritation of the skin
• itching skin
• pain or discomfort in skin
• swelling of the skin
• unusually warm skin

Less common:

• Bleeding of skin
• blood in urine
• break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid
• burning or itching around the anus
• changes in skin coloring
• discharge from skin
• dryness of skin
• increased frequency of urination
• increased sensitivity to pain
• increased sensitivity to touch
• pain or burning during urination
• peeling off one area of skin
• pelvic pain
• problems with the foreskin of the penis
• rash with flat lesions or small raised lesions on the skin
• scarring of the skin
• skin rash, encrusted, scaly and oozing
• skin rash on the face
• swollen, painful, or tender lymph glands in the neck, armpit, or groin
• tingling in the hands and feet

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.