Venerex Ointment is a topical botanical product made from sinecatechins, a partially purified fraction of the water extract of green tea. Its content consists of catechins from the leaves of Camellia sinensis.
Catechins constitute 85-95% of the drug by weight. The substance contains more than 55% Epigallocatechin gallate (EGCg) and other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg), and some additional minor catechin derivatives, namely Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin (C). In addition to known catechin components, it also contains gallic acid, caffeine, and theobromine, which together comprise approximately 2.5% of the active substance. The structural formulas of the catechins are shown below.
General Structure of Catechins
Each gram of the ointment contains 150 mg of sinecatechins in an anhydrous ointment. The base consists of isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.
Indications and Usage
Venerex Ointment is a topical product used for the treatment of common warts, genital warts, and perianal warts (condylomata).
Contraindications
It is recommended that individuals who show hypersensitivity or allergy to any of the active ingredients in Venerex Ointment discontinue use.
Warnings
If irritation develops due to Venerex Ointment and the irritation is mild, usage should be continued. If irritation continues to increase, usage should be reduced and, if necessary, the amount used should be decreased. As irritation may occur more frequently in the urethra, inside the vagina, cervix, rectum, or anus, Venerex Ointment should not be used for HPV (human papillomavirus) disease in these areas.
Precautions
General
- The use of Venerex ointment should be avoided on open wounds.
- Its efficacy has not yet been proven for the safety of immunocompromised patients.
- The efficacy of multiple treatment courses for genital, common, and perianal warts lasting more than 16 weeks has not been proven.
- Due to incomplete testing of Venerex Ointment, patients are not recommended to be directly exposed to sunlight/UV rays.
Patients Using Venerex
- Venerex is suitable for external use only and should be used in the dose and manner recommended by a doctor.
- The ointment can be applied directly at each application without the need to wash off the previous medication.
- If a shower is taken or the medication is washed off, the same dose should be reapplied.
- Localized skin reactions such as redness are common in users. If serious reactions such as erosion, edema, itching, or burning occur in the applied area, stop using the medication and consult your doctor immediately.
- If severe skin reactions are observed, discontinue treatment by washing the area where the ointment was applied with mild soap and water.
- Avoid contact (genital, anal, or oral) while the ointment is still on the skin. The application area should be washed before intercourse. Additionally, it should be noted that Venerex ointment may weaken condoms and vaginal diaphragms.
- Female patients using tampons should apply the ointment before using a tampon.
- Since the product has a dark brown color, it may stain clothing, furniture, or bed linens.
- New warts may appear during or after treatment of warts. If new warts develop within the 16-week period, they can be treated with Venerex.
- The effect of Venerex ointment on the contagiousness of genital/perianal warts is unknown.
- Its reaction under conditions such as sunlight/UV light has not been tested.
- Do not bandage or cover the area where the ointment is applied.
- For men with warts under the foreskin, uncircumcised men should retract the foreskin and apply the cream daily after cleaning.
The dose of Venerex Ointment (MRHD) has been adjusted for topical application three times daily to contain 112.5 mg of 15% sinecatechins, totaling 750 mg per day, with 250 mg per application. Exposure calculations and labeling doses for sinecatechins in humans have been calculated from animal studies based on human equivalent doses.
In a carcinogenicity study, Kunecatechins were administered daily for 26 weeks to p53 transgenic mice at doses up to 500 mg/kg/day (22 times MRHD). Treatment with Kunecatechins did not result in the development of cancer in the organs and tissues examined.
Kunecatechins tested negative in the Ames test, in vivo rat micronucleus test, UDS test, and transgenic mouse mutation test.
Daily vaginal application of 15% catechin to rats from day 4 did not result in adverse effects on mating or pregnancy until day 17 of gestation during mating and throughout gestation. Doses up to 0.15 mL/rat/day did not adversely affect mating performance and fertility. This dose was administered at 8 times the human therapeutic dose.
Can Nursing Mothers Use It?
There are no restrictions on use in nursing mothers, but there have been insufficient scientific studies conducted in pregnant women. It is believed to be non-harmful, but due to insufficient scientific research, it falls into category C.
Pediatric Use
No studies have been conducted on the safety and efficacy in pediatric patients.
Geriatric (Elderly) Use
Seven patients over the age of 65 (1.4%) were treated in the clinic, but this number is insufficient to make a decision.
Presentation
Venerex Ointment is a brown ointment containing 15% sinecatechins. It is sold in aluminum tubes, with each tube containing 30 grams of ointment.
How to Obtain Venerex?
Venerex is distributed to all pharmacies in Turkey through Sancak Ecza Deposu, Hedef Ecza Deposu, Selçuk Ecza Deposu, As Ecza Deposu, and Eczakoop, which provide services in Turkey. In cases where it is not available at your preferred pharmacy, pharmacists can obtain it from pharmacy depots within 1-2 hours.
What is Venerex Ointment 15%?
Venerex Ointment 15% is a topical medication that is only used for the skin. It is an ointment applied to treat warts that are widespread enough to be untreatable with other methods, located on the outer parts of the genitalia, edges of the anus, and other areas.
Who Should Not Use Venerex Ointment 15%?
Those who have allergies (sensitivities) to its components should not use it.
How to Use Venerex Ointment?
- Apply Venerex ointment to the correct area where the warts are located as prescribed by your doctor.
- Before and after application, be sure to wash your hands thoroughly. Apply a small amount of ointment to the area by squeezing it onto your fingers to form a thin layer.
- If your doctor has not recommended a different application, apply it in the morning, noon, and evening.
- Do not wash the area if there is still ointment remaining before the next application; apply it over the existing ointment.
- If you take a shower, reapply the ointment without considering the daily usage count.
- Do not discontinue the application of 15% Venerex Ointment until all warts have healed. The treatment period should not exceed 16 weeks.
Precautions and Avoidance
- Do not apply to open wounds, inside the vagina, or anus. If applied accidentally, there is no need to wash it off.
- Do not engage in sexual intercourse without consulting your doctor, as there is a high risk of transmission to your partner.
- Carefully wash and clean the genital, anal, and oral areas without allowing the ointment to come into contact.
- Remember that it may weaken condoms and vaginal diaphragms.
- Avoid contact with your eyes, mouth, and nostrils after applying the ointment.
- If you use vaginal tampons, insert them before applying the ointment.
- For the treatment of warts located under the foreskin, retract the foreskin first and then apply the ointment.
- Do not cover, bandage, or wrap the area where the ointment is applied. It is recommended to wear loose-fitting underwear.
- Since the ointment is dark in color, it may stain light-colored clothing and bed linens. It is recommended to use dark-colored clothing.
- The ointment should be used by only one person and should not be shared.
- After opening, the ointment can be used for up to 2 years. If 2 years have passed or if you do not remember when it was opened, it is not recommended to use it.
What Are the Side Effects?
Rarely observed side effects include:
- Redness
- Swelling
- Superficial sores or blisters
- Burning
- Itching
- Pain
If these side effects are mild, do not worry. If they are bothersome, reduce the dose and amount. If they worsen or persist, consult your doctor.
What Are the Storage Conditions for Venerex Ointment?
- Store at room temperature.
- After opening, it can be stored in the refrigerator; if it becomes too hard to apply, store it at room temperature.
- Do not freeze.
- Ensure that the tube cap is tightly closed.
- Store all medications out of the reach of children.