Sinecatechins (Topical)

Sinecatechins is an extract from green tea leaves which is used in the treatment of warts caused by the human papilloma virus.

Overview:

Sinecatechins, which is often marketed as Veregen or Polyphenon E, is a water extract taken from the camellia sinensis plant. It is the active ingredient in an ointment used to treat genital warts, which is the first botanical drug to be approved by the FDA.

Sinecatechins method of action is currently undetermined. However, its use in the treatment of genitals warts appears to have much more successful clearance rates than non-botanical treatments such as imiquimod or podophyllotoxin. It also causes less local irritation that these compounds, although the clearance of lesions may take slightly longer with this natural product.

Although this medicine helps to treat the appearance of genital and anal warts in adults, it should not be used inside the cervix, vagina, rectum or urethra. It will not cure genital warts, meaning that patients could potentially develop new warts either during or after treatment with Sinecatechins. This medication will not stop the patient from spreading genital warts to other people via intercourse or direct skin contact, either, and other medicines may be required to prevent infection or recurring warts.

Type of medicine:

  • Topical ointment

Conditions treated:

  • Genital warts

Side effects:

Along with the desired effects, Sinecatechins can also potentially cause some unwanted side effects. The most common side effects reported by users undergoing treatment with this medication include: blistering/peeling/loosening of the skin, breakdown of the skin, burning of the affected area, cracked skin, flushing, hardening or thickening of the skin, pain or discomfort, unusually warm skin.

As the patient continues treatment with the Sinecatechins as prescribed, many (if not all) of these side effects should lessen. If side effects persist over time or get worse, the patient is advised to follow this up with their doctor or healthcare provider as soon as possible. A doctor may be able to recommend ways and means of alleviating certain side effects using natural or over the counter remedies.

Most patients only experience minimal side effects when undergoing treatment with Sinecatechins, if they experience any whatsoever. The drug is designed to alleviate many of the side effects associated with it. Because of this, many healthcare professionals are of the opinion that the benefits of treatment with this medicine outweigh the risks of allowing genital warts caused by the human papilloma virus being left untreated.

Other side effects experienced rarely, but often enough to warrant mentioning, include the following: blood in urine, burning or itching around the anus, discharge from skin, subtle changes to skin color or tone, increased sensitivity to pain, pelvic pain, scarring of the skin, encrusted/scaly/oozing skin, breaks in the skin associated with blue-black discoloration, swelling, painful or swollen lymph glands in the armpit/neck/groin, rash on the face. Patients who experience these side effects to the point of discomfort are advised to contact their healthcare provider immediately.

During clinical trials, 5 per cent of patients experienced localized adverse reactions which led to dose interruption, dose reduction or complete discontinuation of Sinecatechins-based ointment. These events included the following reactions: localized pain, vesicles, skin ulceration, phimosis, inguinal lymphadenitis, dysuria, urethral meatal stenosis, genital herpes simplex, hypersensitivity, pruritus and superinfection of warts and ulcers.

Approximately 10 per cent of patients undergoing treatment with Sinecatechins reported burning pain or discomfort, although these sensations were deemed likely to lessen over time and could potentially be attributed to the presence of warts without treatment.

Dosage:

As with all medicines, it is extremely important to apply Sinecatechins-based ointment as prescribed by a qualified healthcare professional. This means that patients should avoid administering more of the medication than advised, either in frequency or dose size. In addition to this, patients should cease treatment with Sinecatechins topical cream if advised to do so by their doctor, even if they still have a supply of the medicine remaining.

For treatment of condylomata acuminate (genital warts), the patient should apply a thin layer (5mm) of the ointment to all genital and anal warts, at least three times a day. Therapy should be continued until all warts have completely cleared. If warts have not dissipated after 16 weeks, the patient should consult their doctor for advice.

  • Ointment should be left on the treatment areas and does not need to be washed off prior to the next application.
  • Localized reactions at the application site are common during treatment with Sinecatechins, and patients should not discontinue treatment due to broken skin or mild to moderate skin issues. If the severity of the condition becomes unacceptable, the patient should consult a doctor who may suggest that treatment is discontinued.
  • Safety and effectiveness of Sinecatechins cream have not been established beyond 16 weeks of treatment.
  • Patients are advised to wash their hands before and after application of this medicine, in order to prevent the spread of infection.
  • The treatment area should not be covered, wrapped or bandaged during Sinecatechins use.
  • Uncircumcised males undergoing treatment with this medicine for warts under the foreskin should retract the skin and clean the area on a daily basis.
  • Menstruating women who use tampons should insert the tampon prior to applying the ointment. If a tampon must be changed while Sinecatechins ointment is on the skin, the patient should avoid getting the ointment inside the vagina.
  • Patients are advised to avoid sexual contact when using this medicine, as it may weaken contraceptive measures like condoms and vaginal diaphragms. This increases the risk of pregnancy, as well as increasing the risk of passing sexually transmitted infections, including genital warts, to others.
  • Sinecatechins cream should be washed off prior to sexual activity.
  • This cream may cause discoloration to sheets or clothing. Patients are advised to wear black or dark clothing while undergoing treatment with Sinecatechins.

Patients are warned against using excess amounts of this cream or applying it in increased frequencies. If a patient misses a dose, they are advised to apply the cream as soon as possible before resuming normal dosage times and frequencies.

Although overdose is unlikely with Sinecatechins topical ointment, if a patient experiences sign of overdose on any medicine (slow or fast heartbeat, difficulty breathing, loss of consciousness, seizures) they (or their caregiver) are advised to contact their local poison control center on 1800-222-222 or to contact emergency services via 911 immediately.

Interactions:

All drugs can potentially interact with other medicines or chemicals within the body. These interactions can cause one or more medicines to become ineffective in treating the condition(s) they were prescribed for. In some circumstances, an interaction between two medications can cause potentially dangerous side effects. Because of this, it is incredibly important for patients to keep a full and detailed list of all drugs they are currently taking. This extends to over the counter remedies, herbal supplements, vitamins and complementary medicines.

The following is a list of drugs which could potentially interact with Sinecatechins:

  • Hydrocortisone
  • Prednisone
  • Chemotherapy

Although the likelihood of this medicine interacting with other medications is low, it does not mean that no interactions exist. Patients who think they may have experienced an unwanted interaction should contact their healthcare provider or the FDA.

Warnings:

Genital warts are caused by the human papilloma virus. Infection with HPV is known to increase the risk of cancer of the cervix. It is therefore important that women who suffer from genital warts have regular PAP tests in order to rule out cervical cancer.

Before undergoing treatment with Sinecatechins ointment, patients are advised to tell their doctor if they are allergic to green tea, or if they have any other allergies. This product can potentially contain inactive ingredients known to cause allergic reactions. It is therefore advisable that the patient discusses any previous allergic reactions or health conditions with their doctor or healthcare provider before beginning treatment with this medication.

When undergoing treatment with Sinecatechins, patients should not expose the affected area to sunlight, sunlamps, UV light or tanning booths. Each of these may increase burning, cracking or other damage to the skin. The cream should not be used on open wounds.

Patients with genital warts may also be able to infect sexual partners who come into contact with affected areas of the skin with the human papilloma virus. To reduce this risk, patients should always opt to use barrier protections while infected with the virus, such as dental dams or latex condoms, during all sexual activity.

Sinecatechins-based ointment does not treat infection of HPV. While it alleviates symptoms of genital warts, an alternate medication should be used to eliminate the virus.

Patients who have a weakened immune system (either as a side-effect of medication use or as a result of an ongoing condition such as HIV) may experience over-sensitive reactions to Sinecatechins cream.

This medicine could potentially cause problems in pregnant mothers. In the presence of maternal toxicity, reduced fetal body weights were noted in animal studies, along with an increased incidence of still births. However, there have been no controlled studies of the affects in human pregnancy. Therefore, women who are pregnant or intending on becoming pregnant in the near future are advised to discuss Sinecatechins use with their doctor. In some instances, the potential benefits of the medication may outweigh the risks.

The manufacturer of this medicine makes no recommendations regarding its use during breastfeeding. It is not known whether Sinecatechins is excreted into human milk, although patients are advised to proceed with caution when nursing infants.

Storage:

  • Sinecatechins ointment should be stored in the refrigerator or at temperatures of up to 25C. It should not be frozen.
  • After use, the patient should ensure that the cap is tightly-closed on the top of the tube.
  • Sinecatechins cream should not be used if the original seal above the container opening missing or broken. In this instance, it should be exchanged for a brand-new tube at the local pharmacy.
  • If this medicine is expired or no longer needed, it should be disposed of in conjunction with FDA guidelines on medication disposal.
  • This medicine should be stored outside of the reach of children and pets.

Summary:

Sinecatechins is a naturally-occurring compound which is manufactured from green tea leaves. It is effective in the treatment of genital warts caused by the human papilloma virus, and when used correctly can help the patient to defeat unsightly contagious warts. Although manufacturers guidelines typically dictate the volume and frequency of topical application of this cream, doctor and patient should work together to determine the best possible programme of Sinecatechins use.

Although it is useful in reducing the appearance of warts, it does not attack the virus which causes the warts. Patients should, therefore, consult with their healthcare provider to establish an effective HPV treatment, as this virus, if left untreated, can potentially cause cancer.

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Last Reviewed:
December 23, 2017
Last Updated:
April 05, 2018
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