Veregen

Generic name: sinecatechins (topical)
Drug classes: Anorectal preparations, Topical anti-infectives

Medically reviewed by  A Ras MD.

What is Veregen?

Veregen is a prescription medicine that is used to treat genital warts. It is used to treat perianal warts.

Description

Veregen® (sinecatechins) Ointment, 15% is a botanical drug product for topical use. The drug substance in Veregen® is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze, and is a mixture of catechins and other green tea components. Catechins constitute 85 to 95% (by weight) of the total drug substance which includes more than 55% of Epigallocatechin gallate (EGCg), other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg), and some additional minor catechin derivatives i.e. Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin (C). In addition to the known catechin components, it also contains gallic acid, caffeine, and theobromine which together constitute about 2.5% of the drug substance. The remaining amount of the drug substance contains undefined botanical constituents derived from green tea leaves.

The structural formulae of catechins are shown below.

General Structure of Catechins

Each gram of the ointment contains 150 mg of sinecatechins in a water free ointment base consisting of isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.

Mechanism of Action

The mode of action of Veregen® involved in the clearance of genital and perianal warts is unknown. In vitro, sinecatechins had anti-oxidative activity; the clinical significance of this finding is unknown.

Before taking Veregen, tell your doctor:

• If you are allergic to Veregen; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Veregen with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Veregen?

• Tell all of your health care providers that you take Veregen. This includes your doctors, nurses, pharmacists, and dentists.
• People using Veregen may get skin reactions where Veregen is used. These reactions may include burning or stinging, itching, pain, or redness. Call your doctor if you have skin reactions that are very bad, bother you, or do not go away.
• This medicine will not cure your genital or perianal warts. You may get new warts while using Veregen. Tell your doctor if you see any new warts.
• Make sure sores near the area to be treated are healed before using Veregen.
• This medicine may stain clothing or fabric.
• Avoid sun, sunlamps, and tanning beds on the treated area.
• This medicine does not stop the spread of warts to others. Talk with your doctor about how to prevent the spread of genital warts to others.
• Do not have any kind of sex when Veregen is on your genital or anal skin.
• If you choose to have any kind of sex, use safe sex methods (condoms) until all warts are gone. You must wash off Veregen before having sex. Be sure the drug is washed off well. This medicine may weaken condoms and diaphragms. You may need an extra form of birth control while you are using Veregen. Talk to your doctor about safe sex.
• If you use tampons, put the tampon in before using Veregen. Do not get Veregen in the vagina when putting in a tampon.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Veregen best taken?

Use Veregen as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not use longer than you have been told by the doctor.
• Do not take Veregen by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn).
• Do not put in the vagina or anus.
• Do not put on open wounds.
• Wash your hands before and after use.
• You do not need to wash Veregen off the treated area before putting on the next dose. When the area is washed or you bathe, put Veregen on after you wash or bathe.
• Put a thin layer on the affected part.
• Avoid putting on healthy skin.
• Do not cover with dressings.
• If you are an uncircumcised man with warts under the foreskin, pull back the foreskin and clean every day.

What do I do if I miss a dose?

• Put on a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not put on 2 doses at the same time or extra doses.

What are the side effects of Veregen that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Blisters or sores.
• Oozing or bleeding.
• Pain when passing urine.
• Trouble passing urine.
• Groin or pelvic pain or swelling.

What are some other side effects of Veregen?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Veregen?

• Store at room temperature or in a refrigerator. Do not freeze.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL

Package Label – Principal Display Panel – 30g Tube Label