Sinecatechins Ointment - Uses, Contraindications, and Side Effects

Introduction

Genital warts called condyloma acuminatum are a sexually transmitted infection caused by types 6 and 11 human papillomavirus (HPV). They are usually spread by skin-to-skin contact during sex and are found in the anal or genital area, vagina, labia majora, penile shaft, and scrotum. Catechins are chemical compounds naturally found in green tea leaves, and they have been incorporated into various areas of medicine for their therapeutic benefits. Topical Sinecatechins ointment (15 percent) is the first FDA-approved botanical agent used for the treatment of anal and genital warts.

What Is Sinecatechins Ointment?

Sinecatechins is a botanical product available for topical use for patients above 18 years of age, suffering from genital or perianal warts. It was approved by the United States Food and Drug Administration (USFDA) in 2006. The active ingredient in the drug is an extract derived from Camellia sinensis, which contains a mixture of catechins and green tea extracts. Other inactive ingredients include white petroleum, isopropyl myristate, propylene glycol palmitostearate, cera alba or white wax, and oleyl alcohol. It is available as an ointment (15 percent) and must be used only for external warts near the genital or rectal areas and must not be applied inside the rectum, vagina, or the penis.

How Does Sinecatechins Ointment Work?

The exact mechanism of action of Sinecatechins ointment is unknown; however, studies have shown that catechins have antiviral, antioxidant, and immune-stimulating properties. Catechins exhibit multiple biological activities and work by inhibiting various proteins and enzymes in cell proliferation and decreasing viral protein expression. Due to these mechanisms, the drug enhances the immune system to manage external genital and perianal warts induced by human papillomavirus.

How Effective Is Sinecatechins Ointment?

Sinecatechins ointment is a prescription medicine that does not completely cure genital warts but helps to effectively control the infection. Two double-blind, randomized, vehicle-controlled studies were conducted to determine the safety and efficacy of Sinecatechins ointment in 600 immunocompetent patients aged above 18 years and suffering from genital and perianal warts. Most patients applied Sinecatechins ointment for 16 weeks, three times a day, but the duration of treatment also depended on how quickly the warts were cleared. In both studies, approximately 53 percent followed the exact treatment regimen and showed complete clearance of genital and anal warts. These patients were rechecked after 12 weeks; more than 90 percent had no recurrence of the condition then.

How Is Sinecatechins Ointment Used?

• Sinecatechins ointment must be applied three times daily (morning, noon, and evening) to the affected area precisely as the doctor prescribes. Hands must be washed thoroughly before and after the application.

• A small amount of ointment must be taken on the finger and applied to all warts by dabbing on it and leaving a thin layer of medication but ensuring complete coverage of the affected area.

• Washing the ointment from the treated area before the next application is unnecessary. However, when cleaned during bathing, it must be applied after drying the area thoroughly.

• Treatment with Sinecatechins ointment can be continued for 16 weeks, but if the warts are not completely healed or relapse, the doctor must be consulted immediately.

What Are the Contraindications of Sinecatechins Ointment?

• Sinecatechins ointment must not be used by patients allergic to the drug or its components. The leaflet attached with the ointment can be referred to check the list of ingredients.

• The safety and effectiveness of Sinecatechins ointment are not established in immunosuppressed patients, in multiple treatment courses, and in the management of genital and perianal warts beyond 16 weeks.

• Sinecatechin ointment must not be used internally or in case of open wounds.

• Sinecatechin ointment is not recommended for pregnant females or if planning to get pregnant as it may cause harm to the fetus.

• It is not known whether Sinecatechins ointment can enter into breast milk. Therefore, it is contraindicated in lactating mothers.

• Sinecatechin ointment must not be used if other medications are applied to the same area until the skin has healed.

What Are the Side Effects of Sinecatechins Ointment?

Some of the possible side effects of Sinecatechins ointment include:

• Itching or irritation at the affected area.

• Pain.

• Burning sensation.

• Redness.

• Swelling.

• Blisters or sores.

• Unusual bleeding or discharge.

• Scarring or change in skin color.

What Are the Precautions to Be Followed While Using Sinecatechins Ointment?

• The doctor may recommend screening tests or examination of the genital areas before starting treatment with Sinecatechins ointment.

• Sexual contact must be avoided when Sinecatechins ointment is applied to the genital skin. The ointment can be washed off entirely before the protected sexual activity as it may weaken the condoms or vaginal diaphragms. The medication must be reapplied after washing the hands and the affected area thoroughly with soap and water.

• Sinecatechin ointment must be stored in a refrigerator at 2 to 8 degrees Celcius before dispensing and up to 25 degrees Celsius (77 degrees Fahrenheit) after dispensing the medicine, but it must not be frozen.

• The tube cap must be tightly closed after each use to prevent contamination.

• Sinecatechin ointment must not be used for conditions other than prescribed or by others, even if they have the same symptoms.

• New warts may develop during the treatment with Sinecatechins ointment as it does not completely cure the condition.

• The skin treated with Sinecatechins ointment must not be exposed to sunlight, sunlamps, or tanning beds.

• If females use tampons during menstruation, they must be inserted before applying the ointment. Caution must be excised while changing the tampon to avoid the ointment entering into the vagina.

• The treated area must not be covered tightly, and loose-fitting clothing or undergarments must be worn after application. Sinecatechin ointment can stain light-colored clothes and bedding; dark clothing is recommended.

• Uncircumcised males must retract the foreskin and clean the genital area daily while treating warts.

Conclusion

Sinecatechins ointment is a botanical product made from green tea extracts and used in the management of genital and perianal warts. It must be applied three times a day for