Veregen

DRUG 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

Veregen® (sinecatechins) Structural Formula Illustration

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.

What are the precautions when taking sinecatechins ointment (Veregen)?

Before using this product, tell your doctor or pharmacist if you are allergic to it; or if you are allergic to green tea; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: open sores in the area being treated, recent/unhealed treatment or wound on the wart area (e.g., podophyllin, liquid nitrogen, surgery), immune system problem.

This product may stain clothing and bedding.

Do not expose the treated area to sunlight, tanning booths, or sunlamps.

Genital/anal warts are caused by a virus called human papillomavirus (HPV). This product...

Read All Potential Precautions of Veregen »


Veregen Consumer (continued)

SIDE EFFECTS: Mild skin reactions such as itching/burning/pain/swelling/reddening of the treated area frequently occur. If any of these effects persist or worsen, wash off the ointment with soap and water, stop using this product, and call your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering/oozing/peeling skin in treated area, open sore in treated area (skin ulcer).

If you are an uncircumcised male who is using this drug to treat warts on the penis, narrowing of the foreskin (phimosis) may infrequently occur. If you notice tightening/pain in your foreskin, tell your doctor immediately.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to it; or if you are allergic to green tea; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: open sores in the area being treated, recent/unhealed treatment or wound on the wart area (e.g., podophyllin, liquid nitrogen, surgery), immune system problem.

This product may stain clothing and bedding.

Do not expose the treated area to sunlight, tanning booths, or sunlamps.

Genital/anal warts are caused by a virus called human papillomavirus (HPV). This product does not destroy the virus but only helps to get rid of the wart. Therefore, new warts may form even while you are being treated.

You may also be able to infect any sexual partner who comes into contact with the areas of skin infected with HPV. To reduce the risk of spreading HPV to others, always use effective barrier protections (e.g., latex or polyurethane condoms, dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.

During treatment of genital/anal warts, avoid all sexual contact while the ointment is on the skin. Condoms, dental dams, and diaphragms may be weakened by the ointment. Therefore, they may not work as well to prevent pregnancy or the spread of HPV or other sexually transmitted diseases (e.g., HIV).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.



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