Imiquimod 5% cream or 12.5mg cream (Recommendation -Grade A)
(Imiquimod 5% (or 12.5 mg cream in 0.25gm sachet) is same as 5% imiquimod is 5mg in 100 mg cream base, that means 10 mg in 200 mg cream base or 12.5 mg in 250 mg cream base or 12.5mg in 0.25gm cream in sachet) - is a patient-applied topical immunomodulatory agent, applied at bedtime 3 times weekly for up to 16 weeks; the treatment area should be washed with soap and water 6-10 hours after the application.
Imiquimod cream should be applied 3 times per week (example: Monday, Wednesday, and Friday; or Tuesday, Thursday, and Saturday) prior to normal sleeping hours, and should remain on the skin for 6 to 10 hours.
Imiquimod cream treatment should continue until the clearance of visible genital or perianal/genital warts or for a maximum of 16 weeks per episode of warts.
If a dose is missed, the patient should apply the cream as soon as he/she remember and then he/she should continue with the regular schedule. However the cream should not be applied more than once a day. Imiquimod cream should be applied in a thin layer and rubbed on the clean wart area until the cream vanishes.
Application of an excess of cream or prolonged contact with the skin may result in a severe application site reaction. A single-use sachet is sufficient to cover a wart area of 20 cm2 (approx. 3 inches2).
Sachets should not be re-used once opened. Hands should be washed carefully before and after application of cream.
Imiquimod cream therapy is not recommended until the skin has healed after any previous drug or surgical treatment. Application to broken skin could result in increased systemic absorption of imiquimod leading to a greater risk of adverse events.
The use of an occlusive dressing is not recommended with imiquimod cream therapy.
Imiquimod is a synthetic agent with immune response modifying activity.
Imiquimod 5% cream has been used in the treatment of a variety of skin conditions, including basal cell carcinomas and actinic keratoses. Although its precise mechanism of action remains unclear, imiquimod is believed to activate immune cells by binding to the membranous toll-like receptor. This leads to the secretion of multiple cytokines, such as interferon-α, interleukin-6, and tumor necrosis factor-α, which are critical in the induction of an inflammatory response promoting wart clearance.
Imiquimod cream should be used with caution in patients with autoimmune conditions. and inflammatory conditoins. In addition, imiquimod-treated patients have been shown to have a decrease in viral load measured by HPV DNA, a decrease in messenger ribonucleic acid (mRNA) expression for markers of keratinocyte proliferation, and an increase in mRNA expression for markers of tumor suppression.
As an immune response modifier (IRM), imiquimod stimulates cytokine production, especially interferon production. Imiquimod does not cure warts, and new warts may appear during treatment. Imiquimod does not fight the viruses that cause warts directly, however, it does help to relieve and control wart production.
For the treatment of Condylomata Acuminata, imiquimod is applied at bedtime three times per week for up to 16 weeks.
Commonly encountered local inflammatory side effects, such as itching, erythema, burning, irritation, tenderness, ulceration, and pain, have been long-standing issues with the 5% cream.
Occasionally, patients may experience systemic side effects of headaches, muscle aches, fatigue, and general malaise.
Rarely, intense local inflammatory reactions including skin weeping or erosion can occur after only a few applications of imiquimod cream. Local inflammatory reactions may be accompanied, or even preceded, by flu-like systemic signs and symptoms including malaise, pyrexia, nausea, myalgias and rigors, the application of the cream should be stopped immediately.
external genital wart
a skin surface basal cell carcinoma
a type of skin cancer
a roughened red patch of skin called actinic keratosis
vulvar intraepithelial neoplasia
This medication is used to treat certain types of growths on the skin. These are precancerous growths (actinic keratoses), a certain type of skin cancer (superficial basal cell carcinoma), and warts on the outside of the genitals/anus. Treating these conditions can decrease complications from them. Imiquimod belongs to a group of drugs called immune response modifiers. It is believed to work by helping to activate your immune system to fight these abnormal skin growths.
This product is not recommended for use on children under 12 years of age
Use this medication on the skin only. Apply this medication to the affected area(s) as directed, usually just before you go to sleep for the night. If you are using the single-use packets, use a new packet for each dose. If you are using the pump, prime the pump as directed before using it for the first time.
Before applying, wash your hands and the area to be treated with mild soap and water. Dry the area well. Apply a thin layer of medication on the affected area(s) as directed and rub in. Wash your hands with soap and water after each application. Do not cover the treated area with bandages or waterproof coverings. However, you may cover the area with cotton gauze, or wear cotton underwear if treating the genital area. Leave the cream on overnight, usually for about 8 hours if treating actinic keratoses or basal cell carcinoma, or 6 to 10 hours for warts. Do not shower or bathe during this time. In the morning, wash the treated area with soap and water to remove the cream. Do not leave imiquimod cream on longer than prescribed.
When treating warts, this medication is usually applied 3 times a week for up to 16 weeks.
Use this medication regularly to get the most benefit from it. To help you remember, it may help to mark your calendar.
Do not apply this medication in the eyes, nose, mouth, rectum, or vagina. If you get this medication in those areas, flush with plenty of water. If irritation occurs, contact your doctor right away.
Treatment area reactions may include redness, swelling, itching, burning, pain/tenderness, thickening/hardening of the skin, peeling/flaking/scabbing/crusting, or leaking a clear fluid. Also, changes in skin color may occur and may not go away. The most frequently reported local skin reactions were erythema, other skin reactions are excoriation, itching, erosions, excoriation and pain can be present. The local reactions noted with imiquimod are most likely due to cytokine-induced inflammation and/or an immune response. An inflammatory response was not required to achieve clearance of the
warts; however, patients with such a response were more likely to have wart clearance.
If the skin reaction is severe (bleeding, formation of sores/blisters/ulcers), imiquimod may need to be temporarily stopped so that the skin can heal.
Flu-like symptoms (such as fever, tiredness, muscle aches), runny/stuffy nose, cough, diarrhea, nausea, and back pain may also occur.
Rare but serious side effects occur: swollen glands (lymph nodes), new unusual skin growths/changes, chest pain, trouble urinating.
A very serious allergic reaction to this drug is rare.
However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.
Genital/anal warts are caused by a virus called human papillomavirus (HPV). Since imiquimod does not destroy the virus but only helps to eliminate the wart, new warts may form, even while you are being treated. You may also be able to infect any sexual partner who comes into contact with the areas of skin infected with HPV.
To reduce the risk of spreading HPV to others, always use effective barrier protections (such as latex or polyurethane condoms, dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.
During treatment of genital/anal warts, avoid all sexual contact while the cream is on the skin. Condoms, dental dams, and diaphragms may be weakened by the cream, and therefore they may not work as well to prevent pregnancy or spreading of HPV or HIV.
Overdose
This medicine may be harmful if swallowed.
If you miss a dose, wait until the next night to apply it. Do not double the dose to catch up. Continue with your regular scheduled doses as directed.
The exact mechanism of action through which imiquimod and its analogs activate the immune system is not known. However, imiquimod activates immune cells through the toll-like receptor 7none (TLR7), commonly involved in pathogen recognition, on the cell surface. Cells activated by imiquimod via TLR-7 secrete cytokines [primarily interferon-α (IFN-α), interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α)]. Imiquimod, when applied to skin, can lead to the activation of Langerhans cells, which subsequently migrates to local lymph nodes to activate the adaptive immune system. Other cell types activated by imiquimod include natural killer cells, macrophages and B-lymphocytes. Topical application of imiquimod elevates the production of cytokines, including the principal cytokine for antiviral activity, interferon-α. This is the initial event in an immunological cascade resulting in the stimulation of the innate immune response as well as the cell-mediated pathway of acquired immunity. This immune modification mediates the indirect antiviral, antiproliferative and antitumor activity of imiquimod. These properties are responsible for imiquimod to be effective treatment for genital warts and Molluscum Contigiosum.
Imiquimod, an imidazoquinoline amine, is an immune response modifier, which acts as a stimulator of a local cell-mediated immune response and in addition induces the production of antiviral cytokines.23 The imiquimod acts as agonist on Toll-like receptor 7, stimulating the dermal dendritic cells to express cytokines, such as tumor necrosis factor-a, interferon-a (IFN-a), as well as interleukins 1, 6, 8, and 12. The immediate effect of the cytokines is that initially plasmacytoid dendritic cells are attracted from the bloodstream and second great amounts of IFN-a are being produced. As consequence, the increased levels of cytokines stimulate natural killer cells to target both the HPV-infected and the carcinogenic cells. Furthermore, imiquimod also induces the Langerhans cells to mature and migrate to the lymph nodes, where they present antigen and induce a Th1 response. Tumor-specific T-cells are multiplied and infiltrate the affected area3.
B-cells start producing antibodies that subsequently increase antigen presentation. Conversely, the innate immune response can also lead to adverse events like edema, local redness, burning sensation, and itching. These synergistic effects exert the antiviral and antitumor qualities of imiquimod3.
What is Imiquimod cream?
It is a cream used to treat genital warts and has also proven to be an effective treatment for Anal warts / anal intra-epithelial neoplasia (AIN). AIN is caused by the human papilloma virus (HPV) which is generally passed from person to person through sexual contact.
Is Imiquimod cream like other treatments?
Imiquimod cream works differently to other treatments. It helps your body’s own immune system to fight HPV, which in turn helps to clear the AIN.
How do I use Imiquimod Cream packets?
How do I Apply Imiquimod Cream:
When using Imiquimod Cream for external genital warts what precautions do I take?
What should I avoid while using Imiquimod Cream?
What are the possible side effects of Imiquimod Cream?
Imiquimod Cream may cause serious side effects, including:
The most common side effects of Imiquimod Cream include:
References
1. Minh PPT, Thi LP, Lan AT, Van TN, Van HL, Cam VT, Gandolfi M, Feliciani C, Satolli F, Tirant M, Vojvodic A, Lotti T. Early Treatment with Imiquimod 5% Cream of Periungual Warts in Vietnam: The Poorer, the Better. Open Access Maced J Med Sci. 2019 Jan 25;7(2):214-216. doi: 10.3889/oamjms.2019.053. PMID: 30745962; PMCID: PMC6364714.
2. Puri N. A study on the use of imiquimod for the treatment of genital molluscum contagiosum and genital warts in female patients. Indian J Sex Transm Dis AIDS. 2009 Jul;30(2):84-8. doi: 10.4103/0253-7184.62763. PMID: 21938126; PMCID: PMC3168064
3.Gkegkes ID, Iavazzo C, Stamatiadis AP. Intra-anal use of imiquimod: what is the clinical evidence? Int J STD AIDS. 2019 Sep;30(10):1018-1024. doi: 10.1177/0956462419855828. Epub 2019 Jul 8. PMID: 31284838.
In 2001, imiquimod was for the first time applied intra-anally, as off-label use, for the treatment of HPV-related anal lesions3,4. Nevertheless, until now the intra-anal use of imiquimod has not been officially approved and is considered off-label 3.
Most HPV infections are cleared spontaneously by the innate immune system. Imiquimod is an immune response modifier that works by stimulating both innate and adaptive immunity, as well as inducing apoptosis.
Local adverse events are common and may include burning, itching, and pain at the application site due to mucocutaneous inflammation after application of imiquimod. The problem arises in intra-anal warts as the imiquimod is not recommended for intra-anal use due to increased risk of absorbtion and inflammation.
Intra-anal application of imiquimod has been shown to be effective against intra-anal warts and but also associated with increased risk of burning, itching and swelling. To reduce the adverse effect of intra-anal imiquimod half dose of the recommended dose is used intra-anally every alternate day for 4 months and further maintainence was used once a week for 48 week (almost 1 year) was shown to be effective in removing the HPV virus from the body
Imiquimod therapy generally leads to a rapid decrease in high-risk HPV DNA loads within the first 4 to 8 weeks of therapy2.
Regimen intra-anal imiquad therapy for HIV + person is to apply 6.25 mg imiquimod intra-anally and peri-anally 3 doses per week for 16 weeks initially and then one dose per week for a further 48 weeks in followup period1.
The cream is inserted into the anal canal, using half a sachet (half the dose used for anogenital warts) to reduce the likelihood of systemic absorption through the anal mucosa. The adverse effect experienced are irritation, itching and tenderness (Pain).
The absorption of imiquimod from the rectal mucosa can cause flulike symptoms, a sign of systemic immune activation. In addition, in order to avoid the absorption from the rectal mucosa, imiquimod is advised to be intra-anally inserted till the dentate line of the anus3.
The adverse effects correlated to the intra-anal use of imiquimod seem to be minor in comparison to its effect on both anal HSIL and on benign anal HPV lesions (warts). The intra-anal administration of imiquimod either as anal tampon or as self-applied cream seems to be well tolerated. The present clinical evidence suggests that imiquimod may be proposed as effective as well as safe, when applied intra-anally for HPV related lesions (warts).
Application of imiquimod cream intra-vaginally either directly or as tampons is associated with number of adverse reactions like Malaise, Persisting nausea, Mild diarrhoea, Asymptomatic hyponatremia, Leukopenia, headache, Light-headedness, Abdominal pain, Fatigue, Fever, Erosion of the cornea5. These adverse effects reverse on stopping application of imiquimod cream.
How to use Imiquimod cream to treat Intra-anal warts / anal intraepithelial neoplasia (AIN).
How do I use Imiquimod cream intra-anally?
It should be applied in the anal canal (the first 4-5 centimetres (cm) inside your anus). Do not take it by mouth or use it in or near your eyes.
When do I apply Imiquimod cream?
Use it three times a week, just before going to bed. Apply it on either Mondays, Wednesdays and Fridays or Tuesdays, Thursdays and Saturdays, using it more often than that does not have greater effect.
How long should I use the cream for?
As Imiquimod works with your immune system it takes time to be effective. We usually recommend a course of 16 weeks of treatment.
How do I apply Imiquimod cream?
What changes will I notice?
Reddening, soreness and wearing away of the skin around the anus is normal. Not all patients will notice this, but the cream may still be working inside. Rarely, you can develop more significant blistering, pain and flu-like symptoms.
What should I do if undesirable effects occur?
If you notice severe itching or burning when the cream is applied, then stop the treatment and contact your doctor.
Can I have sex whilst using Imiquimod cream?
| Structure |
 |
|---|---|
| Molecular Formula | C14H16N4 |
| Synonyms |
IMIQUIMOD 99011-02-6 1-isobutyl-1H-imidazo[4,5-c]quinolin-4-amine |
| Molecular Weight |
240.30 |
|
It is a cream for topical use only, approved for the treatment of certain skin conditions, including: Actinic keratosis (a skin condition that may develop into skin cancer) Superficial basal cell carcinoma (a type of skin cancer) External genital warts (warts on the outside of the genitals) and perianal warts (warts around the outside of the anus) |
|
Imiquimod is a synthetic agent with immune response modifying activity. As an immune response modifier (IRM), imiquimod stimulates cytokine production, especially interferon production, and exhibits antitumor activity, particularly against cutaneous cancers. Imiquimod's proapoptotic activity appears to be related to Bcl-2 overexpression in susceptible tumor cells. (NCI04)
Imiquimod is an imidazoquinoline fused [4,5-c] carrying isobutyl and amino substituents at N-1 and C-4 respectively. it acts as an immune response modifier and is used to treat genital warts, superficial basal cell carcinoma, and actinic keratosis. It has a role as an antineoplastic agent and an interferon inducer.
Molecular Weight: 240.30
Imiquimod 5% cream is a topical immune-response modifier indicated in the treatment of multiple cutaneous conditions including actinic keratoses, superficial basal cell carcinoma, and condylomata acuminata. In children, it has been approved only for ages 12 and older in the treatment of external genital and perianal warts. It has also been used off label for a variety of pediatric skin disorders, including molluscum contagiosum (MC), trichoepitheliomas, verrucae plana, and verrucae vulgaris.
Following topical application to the skin in adults with actinic keratosis (75-mg doses 3 times weekly for 16 weeks), 0.08-0.15% of the dose is eliminated in urine as unchanged drug and metabolites. Following topical application in patients with HPV warts, 0.11 or 2.41% of the dose is eliminated in urine as unchanged drug and metabolites in men or women, respectively.
Imiquimod is absorbed systemically following topical application to skin. In adults with actinic keratosis who received topical imiquimod 5% cream 3 times weekly for 16 weeks, mean peak serum concentrations at the end of week 16 were approximately 0.1, 0.2, or 3.5 ng/mL in those treated on the face (12.5-mg doses), scalp (25-mg doses), or hands/arms (75-mg doses), respectively. Systemic exposure appeared to depend more on the surface area of the application site than on the total applied dose. In patients with external genital and perianal human papillomavirus (HPV) warts who received topical imiquimod 5% cream (average dose 4.6 mg), mean peak serum concentrations were 0.4 ng/mL.
Cystatin A, a host cysteine protease inhibitor, was strongly upregulated by imiquimod and took a major part in the anti-HSV-1 activity deduced by the suppression experiment using its small interfering RNA. Upregulation of cystatin A was suggested to be mediated by antagonizing adenosine receptor A(1) and activating the protein kinase A pathway.These results indicated that imiquimod acted as an antagonist for adenosine receptor A(1) and induced a host antiviral protein, cystatin A.
Imiquimod is used topically for the
Adverse local reactions, including erythema, erosion, excoriation/flaking, and edema, commonly occur at the site of application of imiquimod and/or surrounding areas. These reactions usually are mild to moderate in severity; however, severe local reactions have been reported.
In controlled studies in adults with actinic keratosis, the most frequently reported local skin reactions in those receiving imiquimod 5% cream (twice weekly for 16 weeks) were erythema (97%), flaking/scaling/dryness (93%), scabbing/crusting (79%), edema (49%), erosion/ulceration (48%), weeping/exudate (22%), and vesicles (9%). Application site reactions (e.g., bleeding, burning, induration, irritation, pain, pruritus, stinging, tenderness) occurred in 33% of those receiving topical imiquimod compared with 14% of those receiving placebo. In these studies, 16% of patients discontinued imiquimod treatment because of local or application site reactions and 91% of these were able to resume treatment after a rest period.
Adverse dermatologic reactions at sites away from the site of application have been reported in some patients receiving topical imiquimod. Remote site reactions have included bleeding, burning, edema, erosion, erythema, excoriation/flaking, induration, pain, pruritus, tenderness, tinea cruris, and ulceration.
When imiquimod 5% cream was used in controlled studies in patients with genital and perianal HPV warts (3 times weekly for up to 16 weeks), erythema occurred in 58-65%, erosion in 30-31%, excoriation/flaking in 18-26%, edema in 12-18%, scabbing in 4-13%, induration in 5-7%, ulceration in 4-8%, and vesicles in 2-3% of those receiving the drug. In addition, application site reactions in those receiving the drug included pruritus (22-32%), burning (9-26%), pain (2-8%), and soreness (0-3%). In addition, fungal infections occurred in 2-11% of patients receiving the drug. Overall, 1.2% of patients in these studies discontinued treatment because of local or application site reactions.
Localized hypopigmentation or hyperpigmentation also has been reported. Available follow-up data suggest that skin color changes (i.e., hypopigmentation, hyperpigmentation) may be permanent in some patients.
In controlled studies in patients with external genital and perianal human papilloma virus (HPV) warts, adverse systemic effects reported in more than 1% of those who received imiquimod cream were headache (4%) and influenza-like symptoms (3%). while in some studies in adults with superficial basal cell carcinoma, adverse systemic effects reported in more than 1% of those receiving imiquimod 5% cream (5 times weekly for 6 weeks) were headache (8%), back pain (4%), upper respiratory tract infection (3%), rhinitis (3%), lymphadenopathy (3%), fatigue (2%), sinusitis (2%) dyspepsia (2%), coughing (2%), and fever (2%).
Adverse systemic effects have been reported rarely in patients receiving topical imiquimod. Flu-like signs and symptoms may accompany or precede local inflammatory reactions and may include fever, malaise, myalgias, nausea, and rigors. These symptoms may be severe enough to require temporary discontinuance of the drug.
It is not known whether imiquimod is excreted in human milk following use of Aldara Cream. Because many drugs are excreted in human milk, caution should be exercised when Aldara Cream is administered to nursing women.
Exposure to sunlight (including sunlamps) should be avoided or minimized during use of Imiquimod Cream because of concern for heightened sunburn susceptibility. Patients should be warned to use protective clothing (e.g., a hat) when using Imiquimod Cream. Patients with sunburn should be advised not to use imiquimod Cream until fully recovered.
Administration of Imiquimod Cream is not recommended until the skin is completely healed from any previous drug or surgical treatment.
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 for severe vulvar swelling.
Intense local inflammatory reactions including skin weeping or erosion can occur after few applications of imiquimod Cream and may require an interruption of dosing. Imiquimod Cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease.
The following adverse reactions have been identified during post-approval use of imiquimod Cream. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Application Site Disorder: tingling at the application site. Body as a Whole: angioedema. Cardiovascular: capillary leak syndrome, cardiac failure, cardiomyopathy, pulmonary edema, arrhythmias (tachycardia, atrial fibrillation, palpitations), chest pain, ischemia, myocardial infarction, syncope. Endocrine: thyroiditis. Gastro-Intestinal System Disorders: abdominal pain. Hematological: decreases in red cell, white cell and platelet counts (including idiopathic thrombocytopenic purpura), lymphoma. Hepatic: abnormal liver function. Infections and Infestations: herpes simplex. Musculo-Skeletal System Disorders: arthralgia. Neuropsychiatric: agitation, cerebrovascular accident, convulsions (including febrile convulsions), depression, insomnia, multiple sclerosis aggravation, paresis, suicide. Respiratory: dyspnea. Urinary System Disorders: proteinuria, dysuria, urinary retention. Skin and Appendages: exfoliative dermatitis, erythema multiforme, hyperpigmentation, hypertrophic scar. Vascular: Henoch-Schonlein purpura syndrome.
FDA Pregnancy Risk Category: C /RISK CANNOT BE RULED OUT. Adequate, well controlled human studies are lacking, and animal studies have shown risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is given during pregnancy; but the potential benefits may outweigh the potential risk./
Imiquimod cream should be used with caution in organ transplant patients. Consideration should be given to balancing the benefit of imiquimod treatment for these patients with the risk associated with the possibility of organ rejection or graft-versus-host disease.
The use of an occlusive dressing is not recommended with imiquimod cream therapy.
Imiquimod cream should be used with caution in patients with autoimmune conditions. Consideration should be given to balancing the benefit of imiquimod treatment for these patients with the risk associated with a possible worsening of their autoimmune conditions.
Rare cases of remote site dermatologic drug reactions, including erythema multiforme, have been reported from clinical trials. Serious skin reactions reported from postmarketing experience include erythema multiforme, Stevens Johnson syndrome and cutaneous lupus erythematosus.
Rare reports have been received of exacerbation of autoimmune conditions.
Reductions in hemoglobin, white blood cell count, absolute neutrophils and platelets have been observed in clinical trials. These reductions are not considered to be clinically significant in patients with normal hematologic reserve. Patients with reduced hematologic reserve have not been studied in clinical trials.
Erosive pustular dermatosis of the scalp (EPDS) is a rare condition characterized by sterile pustules, erosions, and crusted lesions on the scalp of elderly patients.
SIGNS AND SYMPTOMS/ Topical overdosing of imiquimod Cream could result in an increased incidence of severe local skin reactions and may increase the risk for systemic reactions. The most clinically serious adverse event reported following multiple oral imiquimod doses of >200 mg (equivalent to imiquimod content of >16 packets) was hypotension, which resolved following oral or intravenous fluid administration.
Dosage form: cream
Drug classes: Topical anti-infectives, Topical antineoplastics
Imiquimod Cream, 3.75% is indicated for the topical treatment of clinically typical visible or palpable, actinic keratoses (AK) of the full face or balding scalp in immunocompetent adults.
Imiquimod Cream, 3.75% is indicated for the treatment of external genital and perianal warts (EGW)/condyloma acuminata in patients 12 years or older.
Treatment with Imiquimod Cream has not been studied for prevention or transmission of human papillomavirus (HPV).
The safety and efficacy of Imiquimod Cream have not been established in the treatment of:
For topical use only; Imiquimod Cream is not for oral, ophthalmic, intra-anal or intravaginal use.
Imiquimod Cream should be applied once daily before bedtime to the skin of the affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. Imiquimod Cream should be applied as a thin film to the entire treatment area and rubbed in until the cream is no longer visible. Up to 0.5 grams (two packets or two full actuations of the pump) of Imiquimod Cream may be applied to the treatment area at each application.
Imiquimod Cream should be left on the skin for approximately 8 hours, after which time the cream should be removed by washing the area with mild soap and water.
Patients should wash their hands before and after applying Imiquimod Cream.
Store at 20° to 25°C (68° to 77°F)