ALDARA 250MG 12 SACHETS

Please note: that prescription orders to RD addresses will incur additional $2.95 due to the recent changes in freight by the courier company.

Classification
Prescription Only Medicine

Dosage
ALDARA cream is patient-applied prior to bedtime, every other day, three times per week. It is left on the skin for 6 to 10 hours. Following the treatment period, the cream is removed by washing the treated area with mild soap and water. Treatment should continue until there is a total clearance of the external genital/perianal warts or for a maximum of 16 weeks. Each gram of the 5% cream contains 50 mg of imiquimod in a vanishing cream base.

Ingredients
Aldara? (imiquimod) Cream, 5%

Purpose/Usage
Aldara (imiquimod) Cream, 5% is the newest in a class of drugs called immune response modifiers (The exact mechanism of action of is unknown) and represents the first new therapeutic approach to genital warts in five years.

ALDARA cream provides an effective treatment alternative to an estimated 4 million Americans who have genital warts. Genital warts are caused by the human papilloma virus (HPV), and is the fastest growing sexually transmitted disease with 750,000 new cases each year. Most treatments are performed in the physician's office and involve surgical or chemical office procedures often associated with pain, tissue destruction and scarring. ALDARA cream is applied by the patient and is available by prescription only.

Genital warts is a sexually transmitted disease caused by the human papilloma virus (HPV). HPV is one of the most common -- and least talked about -- of all sexually transmitted diseases (STDs). The HPV virus can cause warts in the genital and perianal areas in females and males. The warts may cause itching, burning, pain and tenderness. In women, genital warts can occur on the vulva, perianal area, vagina, and cervix. In men, genital warts can appear on the tip or shaft of the penis, urethra, scrotum, and perianal area.

Genital warts often appear as groups of warts. They can be very small or can form large masses on genital tissue. Left untreated, genital warts may cause discomfort and pain, interfere with sexual activity and may eventually develop a fleshy, cauliflower-like appearance.

Transmission of Genital Warts
Genital warts are spread through sexual contact with an infected partner and are very contagious. Many HPV infections are asymptomatic-that is, they do not cause recognizable warts. Such persons with subclinical infection can nonetheless infect their sexual partner(s). It is likely that individuals may harbor HPV in surrounding normal tissue even after the warts have been removed. The period of communicability, however, is unknown. No practical screening tests for subclinical infection are available.

Risk Factors
Adolescents: Estimates of genital warts among sexually active adolescent populations are as high as 30%. A recent cross-sectional study demonstrated that the prevalence of HPV among sexually active university students was 46%. In teenage girls, the vast majority of abnormal Pap smears are related to HPV infection.

Pregnant Women:
Genital warts may be difficult to control in pregnant women. Cesarean delivery is sometimes necessary since warts may obstruct the birth canal.

Symptoms of HPV Infection
Infection with HPV can cause such symptoms as itching, burning, pain, and tenderness, although cervical and vaginal warts are usually asymptomatic. Many genital warts, especially those that are flat, can only be seen with specialized magnifying equipment.

Almost half of the women infected with HPV had no obvious symptoms. Therefore, a person may be unaware of infection and the potential risk of complications and transmission of the virus.

Implications of Genital Warts
Psychological Effects: In addition to the physical discomforts associated with genital warts, feelings of embarrassment, worry, fear, and anger are common, often leading to self-inflicted blame, mental anguish, and low self-esteem, especially because of the recurrent nature of the disease.

Treatment Options for Genital HPV Infection
Treatment of genital warts traditionally focuses on removal of the warts, which can be painful. Currently, no available treatment effectively eliminates genital HPV infection and replication. Since areas surrounding warts often contain HPV virus without visible signs or symptoms, therapies aimed at the virus itself rather than at the wart appear promising.

Many of the current treatments for genital warts are tissue destructive including standard surgery, laser surgery (vaporizing the wart with a beam of high-powered light), cryosurgery (freezing the wart with liquid nitrogen) and application of acid or drugs such as podofilox and podophyllin. Other treatments include interferon injection.

Limitations of Current HPV Therapies
The principal shortcoming of all currently available therapies for genital HPV infection is that no one method eradicates warts, maintains clearance and eliminates the virus. Treatments may be associated with local skin reactions; pain, burning, and itching are the most commonly reported adverse effects.

In many cases, aggressive therapy for removal of wart tissue is unwarranted because it is not extremely successful and may often be worse than the actual disease. Surgical techniques for removing genital warts can be painful, disfiguring and impractical for many patients. In addition, some treatment regimens require multiple doctors visits and thus, are not convenient for the patient.

Efficacy, convenience and potential for adverse effects should all be considered when choosing a therapy for genital warts.

Precautions
There are no know contraindications to the use of ALDARA cream. It has not been evaluated for the treatment of internal genital/anal disease such as urethral, intravaginal, cervical, rectal, or intraanal HPV, however, and is not recommended for these conditions.

Adverse Effects
Only 4% of clinical trial patients reported pain and less than 2% of patients discontinued due to skin reactions. Most local skin reactions were mild to moderate and included erythema, erosion, flaking, edema, scabbing, and induration at the wart site. Most common application-site reactions were itching (26%), burning (16%), and pain (4%) at the wart site. New warts may develop during treatment. The effect of ALDARA cream on the transmission of genital warts is unknown. ALDARA cream may weaken condoms and diaphragms. Sexual contact should be avoided while the cream is on the skin.

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