Veregen (sinecatechins)
Topical Sinecatechins Topical Ointment (Gram)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Sinecatechins, a green tea extract consisting predominantly of catechins, is an antioxidant.
Sinecatechins, a botanical drug product, is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze. The drug preparation consists primarily of catechins (85-95% by weight), including more than 55% epigallocatechin gallate (EGCg); other catechin derivatives present include epicatechin (EC), epigallocatechin (EGC), epicatechin gallate (ECg), gallocatechin gallate (GCg), gallocatechin (GC), catechin gallate (Cg) and catechin (C). Other components, which together account for 2.5% of the total drug substance, include gallic acid, caffeine, and theobromine.
The mechanism of action of sinecatechins in the treatment of external genital and perianal human papillomavirus (HPV) warts is unknown. Sinecatechins has been shown to have antioxidant activity in vitro; the clinical importance of this finding is unknown. In addition, some clinicians suggest that green tea catechins may have immunostimulant, antitumor, and potent antiviral properties that may contribute to the therapeutic effect of sinecatechins ointment.
Data suggest that systemic exposure to catechins following repeated topical application of sinecatechins ointment probably is less than that observed after a single oral intake of 400 mL of green tea.
USES: Sinecatechins are used to treat warts on and around the genitals and anus. These warts are caused by the human papillomavirus (HPV). Sinecatechins are natural substances found in certain green tea leaves.
It is not known how this medication works. This medication does not cure warts, but it may help the infection clear faster. New warts may occur during or after treatment.
This medication does not prevent the spread of warts through sexual contact, and it may weaken condoms and diaphragms. Talk to your doctor about safer sex practices.
Generic name: sinecatechins
Pronunciation: (sin-e-KAT-e-kins/kuh-MEE-lee-uh SI-nuhn-sis)
Drug class: Topical Sinecatechins
Therapeutic class: Dermatological
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
The following indications are listed for Veregen:
- External Condylomata Acuminata
Also known as: External Condyloma Acuminatum.
Dosing
No dosing information is available for this tab.
Sinecatechins is applied topically to the skin as a 15% ointment. The topical ointment is for external use only. Contact with the eyes should be avoided and the drug should not be administered orally, intravaginally, or intra-anally. Sinecatechins ointment should not be applied on open wounds.
Patients should wash their hands before and after application of sinecatechins ointment. The ointment should be applied to each wart with the finger(s), dabbing to ensure complete coverage and leaving a thin layer of ointment on the warts. Bandages, occlusive dressings, or wrappings should not be used.
The effect of treatment with sinecatechins ointment on the transmission of genital or perianal warts is unknown. Uncircumcised males should be advised to retract the foreskin and clean the area daily. The manufacturer states that it is not necessary to wash off the ointment from the treated area prior to the next application.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Veregen 15% Ointment | Maintenance | Apply to the affected area(s) by topical route 3 times per day. |
No dosing information is available for this tab.
Drug interactions
No formal drug interaction studies have been performed to date.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
The manufacturer states that there are no known contraindications to the use of sinecatechins ointment.
There are no contraindication contraindications for this drug.
- Large open wound
There are no moderate contraindications for this drug.
Adverse reactions
Adverse effects occurring in more than 1% of patients receiving topical sinecatechins include erythema, pruritus, burning, pain/discomfort, erosion/ulceration, edema, induration, vesicular rash, regional lymphadenitis, desquamation, discharge, phimosis in uncircumcised males, bleeding, local reaction, scarring, irritation, and rash.
More Frequent
- Blistering skin
- Superficial skin ulcer
Less Frequent
- Acquired phimosis
- Skin rash
Rare or Very Rare
- Dermal necrosis
- Eczema
- Skin and skin structure infection
- Skin ulcer
More Frequent
- Edema
- Erythema
- Genital organ pruritus
- Induration of skin
- Skin irritation
Less Frequent
- Abnormal desquamation
- Lymphadenopathy
Rare or Very Rare
- Dry skin
- Dyschromia
- Dysuria
- Hypoesthesia
- Pelvic pain
- Urethritis
Precautions
No enhanced messaging available.
Safety and efficacy of sinecatechins in pediatric patients have not been established. The manufacturer states that a clinician should be consulted for use of the drug in children younger than 12 years of age.
Category C. (See Users Guide.)
Not known whether topical sinecatechins is distributed into human milk.
Experience in those 65 years of age or older is insufficient to determine whether they respond differently from younger adults.
ICD codes
| Code | Type | Description |
|---|---|---|
| External condylomata acuminata | ||
| A63.0 | ICD10CM | Anogenital (venereal) warts |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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