Zyclara 3.75%
Zyclara 3.75% Uses, Dosage, Side Effects, Food Interaction and all others data.
Zyclara 3.75%'s mechanism of action is via stimulation of innate and acquired immune responses, which ultimately leads to inflammatory cell infiltration within the field of drug application followed by apoptosis of diseased tissue. Zyclara 3.75% does not have direct antiviral activity. Studies of mice show that imiquimod may induce cytokines, including interferon-alpha (IFNA) as well as several IFNA genes (IFNA1, IFNA2, IFNA5, IFNA6, and IFNA8) as well as the IFNB gene. Zyclara 3.75% also induced the expression of interleukin (IL)-6, IL-8, and tumor necrosis factor alpha genes. In the treatment of basal cell carcinoma, Zyclara 3.75% appears to act as a toll-like receptor-7 agonist, and is thought to exert its anti-tumor effect via modification of the immune response and stimulation of apoptosis in BCC cells. In treating basal cell carcinoma it may increase the infiltration of lymphocytes, dendritic cells, and macrophages into the tumor lesion.
Zyclara 3.75% is an immune response modifier that acts as a toll-like receptor 7 agonist. Zyclara 3.75% is commonly used topically to treat warts on the skin of the genital and anal areas. Zyclara 3.75% does not cure warts, and new warts may appear during treatment. Zyclara 3.75% does not fight the viruses that cause warts directly, however, it does help to relieve and control wart production. It is not used on warts inside the vagina, penis, or rectum. Zyclara 3.75% is also used to treat a skin condition of the face and scalp called actinic keratoses. Zyclara 3.75% can also be used to treat certain types of skin cancer called superficial basal cell carcinoma. Zyclara 3.75% is particularly useful on areas where surgery or other treatments may be difficult, complicated or otherwise undesirable, especially the face and lower legs.
Trade Name | Zyclara 3.75% |
Generic | Imiquimod |
Imiquimod Other Names | Imiquimod, Imiquimodum |
Type | |
Formula | C14H16N4 |
Weight | Average: 240.3036 Monoisotopic: 240.137496532 |
Groups | Approved, Investigational |
Therapeutic Class | Immunosuppressant, Miscellaneous topical agents |
Manufacturer | |
Available Country | Austria, Finland, Ireland, United Kingdom |
Last Updated: | September 19, 2023 at 7:00 am |
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Uses
Zyclara 3.75% Cream is used for the topical treatment of:
- Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on he face or scalp in immunocompetent adults
- Biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults; maximum tumor diameter of 2.0 cm on trunk, neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured
- External genital and perianal warts/condyloma acuminata
Zyclara 3.75% is also used to associated treatment for these conditions: Actinic Keratoses of the face, Actinic Keratoses of the scalp, Condylomata Acuminata, Herpes Simplex Infection, Molluscum Contagiosum, Superficial Basal Cell Carcinoma
How Zyclara 3.75% works
Zyclara 3.75%'s mechanism of action is via stimulation of innate and acquired immune responses, which ultimately leads to inflammatory cell infiltration within the field of drug application followed by apoptosis of diseased tissue. Zyclara 3.75% does not have direct antiviral activity. Studies of mice show that imiquimod may induce cytokines, including interferon-alpha (IFNA) as well as several IFNA genes (IFNA1, IFNA2, IFNA5, IFNA6, and IFNA8) as well as the IFNB gene. Zyclara 3.75% also induced the expression of interleukin (IL)-6, IL-8, and tumor necrosis factor alpha genes. In the treatment of basal cell carcinoma, Zyclara 3.75% appears to act as a toll-like receptor-7 agonist, and is thought to exert its anti-tumor effect via modification of the immune response and stimulation of apoptosis in BCC cells. In treating basal cell carcinoma it may increase the infiltration of lymphocytes, dendritic cells, and macrophages into the tumor lesion.
Dosage
Zyclara 3.75% dosage
Zyclara 3.75% Cream is not for oral, ophthalmic, or intravaginal use
- Actinic keratosis: 2 times per week for a full 16 weeks
- Superficial basal cell carcinoma: 5 times per week for a full 6 weeks
- External genital warts (EGW): 3 times per week until total clearance or a maximum of 16 weeks
Side Effects
Most common adverse reactions (incidence >28%) are application site reactions or local skin reactions: itching, burning, erythema, flaking/scaling/dryness, scabbing/crusting, edema, induration, excoriation, erosion, ulceration. Other reported reactions (≥ 1%) include fatigue, fever, and headache
Toxicity
Symptoms of overdose include flu-like symptoms, such as fever, fatigue, headache, nausea, diarrhoea and muscle pain.
Precaution
Intense local inflammatory reactions can occur (e.g., skin weeping, erosion). Dosing interruption may be required
Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling. Severe vulvar swelling can lead to urinary retention; dosing should be interrupted or discontinued.
Flu-like systemic signs and symptoms including malaise, fever, nausea, myalgias and rigors may occur. Dosing interruption may be required
Avoid exposure to sunlight and sunlamps. Wear sunscreen daily
Safety and efficacy have not been established for repeat courses of treatment to the same area for AK
Aldara Cream is not recommended for treatment of BCC subtypes other than the superficial variant, i.e., sBCC
Treatment of urethral, intra-vaginal, cervical, rectal or intra-anal viral disease is not recommended
Safety and efficacy in immunosuppressed patients have not been established
Food Interaction
- Take with or without food.
Elimination Route
Well absorbed through skin (as a cream)
Half Life
20 hours (topical dose), 2 hours (subcutaneous dose)
Pregnancy & Breastfeeding use
Pregnancy Category C. It is not known whether imiquimod is excreted in human milk following use of Zyclara 3.75% Cream. Because many drugs are excreted in human milk, caution should be exercised when Zyclara 3.75% Cream is administered to nursing women.
Special Warning
Pediatric Use: AK and sBCC are not conditions generally seen within the pediatric population. The safety and efficacy of Zyclara 3.75% Cream for AK or sBCC in patients less than 18 years of age have not been established. Safety and efficacy in patients with external genital/perianal warts below the age of 12 years have not been established
Storage Condition
Store at 4 - 25°C
Innovators Monograph
You find simplified version here Zyclara 3.75%
Zyclara 3.75% contains Imiquimod see full prescribing information from innovator Zyclara 3.75% Monograph, Zyclara 3.75% MSDS, Zyclara 3.75% FDA label