Pronunciation:

sin-e-KAT-e-kins

Brand Names:

• Veregen

Dosage Forms:

• Ointment

Classifications:

Therapeutic—

Keratolytic

Uses of This Medicine:

Sinecatechins 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 .

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—

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 .

Older adults—

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 .

Breast-feeding—

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.

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:

• 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 Use of This Medicine:

Use the medicine only as directed by your doctor. 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 this medicine .

Keep using this medicine until all the 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 an 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.

Precautions While Using This Medicine:

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 .

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:

More common

Blistering, peeling, or loosening of the skin

breakdown of skin

burning of skin

cracking of skin

flushing, redness of skin

hardening or thickening of skin

irritation of skin

itching skin

pain or discomfort in skin

swelling of 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 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 of one area of skin

pelvic pain

problems with foreskin of penis

rash with flat lesions or small raised lesions on the skin

scarring of skin

skin rash, encrusted, scaly and oozing

skin rash on the face

swollen, painful, or tender lymph glands in 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.