VEREGEN Ointment (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

PharmaDerm a division of Fougera Pharmaceuticals Inc.

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1. Indications and Usage

1.1 Indication Veregen is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. 1.2 Limitations of ...

2. Dosage and Administration

2.1 General Dosing Information Veregen is to be applied three times per day to all external genital and perianal warts. Apply about an 0.5 cm strand of the Veregen to each wart using the finger(s), dabbing ...

3. Dosage Forms and Strengths

Ointment, 15% w/w. Each gram of Veregen Ointment, 15% contains 150 mg of sinecatechins in a brown ointment base.

4. Contraindications

None.

5. Warnings and Precautions

Veregen has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for the treatment of these conditions. ...

6. Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

8.1. Pregnancy

Risk Summary There are no available data on Veregen use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction ...

8.2. Lactation

Risk Summary There are no data on the presence of sinecatechins in human or animal milk, the effects on the breastfed child, or the effects on milk production. After topical application, Veregen concentrations ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5. Geriatric Use

Seven patients (1.4%), older than 65 years of age were treated with Veregen in clinical studies. This, however, is an insufficient number of subjects to determine whether they respond differently from ...

11. 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 ...

12.1. Mechanism of Action

The mode of action of Veregen involved in the clearance of genital and perianal warts is unknown. In vitro, sinecatechins had anti-oxidative activity; the clinical significance of this finding ...

12.2. Pharmacodynamics

The pharmacodynamics of Veregen is unknown.

12.3. Pharmacokinetics

Systemic exposure to EGCg, EGC, ECg, and EC were evaluated following either topical application of Veregen to subjects with external genital and perianal warts (250 mg applied 3 times a day for 7 days) ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

In an oral (gavage) carcinogenicity study, sinecatechins was administered daily for 26 weeks to p53 transgenic mice at doses up to 500 mg/kg/day. Treatment with sinecatechins was not associated with an ...

14. Clinical Studies

Two randomized, double-blind, vehicle-controlled trials were performed to investigate the safety and efficacy of Veregen in the treatment of immunocompetent subjects 18 years of age and older with external ...

16.1. How Supplied

Veregen is a brown ointment and is supplied in an aluminum tube containing 15 grams (NDC # 10337-450-15) of ointment per tube or 30 grams (NDC # 10337-450-03) of ointment per tube. Manufactured for: PharmaDerm, ...

16.2. Storage and Handling

Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze. KEEP OUT OF THE REACH OF CHILDREN.

17. Patient Counseling Information

See FDA-approved patient labeling (Patient Information) Patients using Veregen should receive the following information and instructions: This medication is only to be used as directed by a physician. ...