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Imiquimod (Imiquimod)

Trade Name : imiquimod

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

CREAM

Strength 50 mg/g

IMIQUIMOD Increased Cytokine Activity [PE],Increased Cytokine Production [PE],Interferon Inducers [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Imiquimod (Imiquimod) which is also known as imiquimod and Manufactured by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. It is available in strength of 50 mg/g per ml. Read more

Imiquimod (Imiquimod) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Imiquimod Cream is indicated for the topical treatment of:
  • Limitations of Use: Efficacy was not demonstrated for molluscum contagiosum in children aged 2 to 12 (, )
  • The application frequency for Imiquimod Cream is different for each indication.
  • Imiquimod Cream is not for oral, ophthalmic, or intravaginal use.
  • Imiquimod Cream is not for oral, ophthalmic, or intravaginal use. ()
  • Imiquimod Cream 5%, is supplied in single-use packets each of which contains 250 mg of the cream, equivalent to 12.5 mg of imiquimod. Imiquimod Cream is supplied in boxes of 24 packets each.
  • u2022
  • 3
  • None.
  • u2022
  • 4
  • No data
  • 2n- 5.1n- 6
  • 2n- 5.2n- 6
  • 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 drug and may not reflect the rates observed in practice.
  • 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 (u22651 %) include fatigue, fever, and headache (, )
  • To report SUSPECTED ADVERSE REACTIONS, contact Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or .
  • No data
  • Topical
  • 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.
  • Imiquimod Cream 5% is an immune response modifier for topical administration. Each gram contains 50 mg of imiquimod in an off-white oil-in-water vanishing cream base consisting of purified water, oleic acid, white petrolatum, polysorbate 60, glycerin, stearyl alcohol, benzyl alcohol, cetyl alcohol, sorbitan monostearate, xanthan gum, methylparaben, propylparaben.
  • Chemically, imiquimod is 1-(2-methylpropyl)-1-imidazo[4,5-c]quinolin-4-amine. Imiquimod has a molecular formula of CHN and a molecular weight of 240.3. Its structural formula is:
  • No data
  • In an oral (gavage) rat carcinogenicity study, imiquimod was administered to Wistar rats on a 2x/week (up to 6 mg/kg/day) or daily (3 mg/kg/day) dosing schedule for 24 months. No treatment related tumors were noted in the oral rat carcinogenicity study up to the highest doses tested in this study of 6 mg/kg administered 2x/week in female rats (87x MRHD based on weekly AUC comparisons), 4 mg/kg administered 2x/week in male rats (75x MRHD based on weekly AUC comparisons) or 3 mg/kg administered 7x/week to male and female rats (153x MRHD based on weekly AUC comparisons).
  • In a dermal mouse carcinogenicity study, imiquimod cream (up to 5 mg/kg/application imiquimod or 0.3% imiquimod cream) was applied to the backs of mice 3x/week for 24 months. A statistically significant increase in the incidence of liver adenomas and carcinomas was noted in high dose male mice compared to control male mice (251x MRHD based on weekly AUC comparisons). An increased number of skin papillomas was observed in vehicle cream control group animals at the treated site only. The quantitative composition of the vehicle cream used in the dermal mouse carcinogenicity study is the same as the vehicle cream used for Imiquimod Cream, minus the active moiety (imiquimod).
  • In a 52-week dermal photoco-carcinogenicity study, the median time to onset of skin tumor formation was decreased in hairless mice following chronic topical dosing (3x/week; 40 weeks of treatment followed by 12 weeks of observation) with concurrent exposure to UV radiation (5 days per week) with the Imiquimod Cream vehicle alone. No additional effect on tumor development beyond the vehicle effect was noted with the addition of the active ingredient, imiquimod, to the vehicle cream.
  • Imiquimod revealed no evidence of mutagenic or clastogenic potential based on the results of five genotoxicity tests (Ames assay, mouse lymphoma L5178Y assay, Chinese hamster ovary cell chromosome aberration assay, human lymphocyte chromosome aberration assay and SHE cell transformation assay) and three genotoxicity tests (rat and hamster bone marrow cytogenetics assay and a mouse dominant lethal test).
  • Daily oral administration of imiquimod to rats, throughout mating, gestation, parturition and lactation, demonstrated no effects on growth, fertility or reproduction, at doses up to 87x MRHD based on AUC comparisons.
  • No data
  • Imiquimod Cream 5%, is supplied in single-use packets which contain 250 mg of the cream.
  • Available as: box of 24 packets NDC 0168-0432-24.
  • Store at 4u00b0 to 25u00b0C (39u00b0 to 77u00b0F). Avoid freezing.
  • Arrayn- Keep out of reach of children.
  • See FDA-Approved Patient Labeling
  • Arrayn- Rn
  • PATIENT INFORMATION
  • IMIQUIMOD CREAM 5%
  • IMPORTANT: Not for mouth, eye, vaginal use
  • Read the Patient Information that comes with Imiquimod Cream before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment. If you do not understand the information, or have any questions about Imiquimod Cream, talk with your healthcare provider or pharmacist.
  • What is Imiquimod Cream?
  • Imiquimod Cream is a skin use only (topical) medicine used to treat:
  • u2022 external genital and perianal warts in people 12 years and older.
  • u2022 actinic keratosis in adults with normal immune systems. Actinic keratosis is caused by too much sun exposure.
  • Imiquimod Cream is used in different ways for the three different skin conditions it is used to treat. It is very important that you follow the instructions for your skin condition. Talk to your healthcare provider if you have questions.
  • Imiquimod Cream does not work for everyone. Imiquimod Cream will not cure your genital or perianal warts. New warts may develop during treatment with Imiquimod Cream. It is not known if Imiquimod Cream can stop you from spreading genital or perianal warts to other people. For your own health and the health of others, it is important to practice safer sex. Talk to your healthcare provider about safer sex practices.
  • Who should not use Imiquimod Cream?
  • u2022 Imiquimod Cream has not been studied in children under 12 years old for external genital and perianal warts.
  • Before using Imiquimod Cream, tell your healthcare provider:
  • u2022 n
  • u2022 Especially tell your healthcare provider if you have had other treatments for genital orperianal warts, or actinic keratosis. Imiquimod Cream should not be used until your skin has healed fromother treatments.
  • How should I use Imiquimod Cream?
  • u2022 Use Imiquimod Cream exactly as prescribed by your healthcare provider. Do not use Imiquimod Creamunless your healthcare provider has taught you the right way to use it. Talk to your healthcare provider ifyou have any questions.
  • u2022 Imiquimod Cream is used for several skin conditions. Your healthcare provider will tell you where to apply Imiquimod Cream and how oftenand for how long to apply it for your condition. Do not use Imiquimod Cream longer than prescribed. Usingtoo much Imiquimod Cream, or using it too often, or for too long can increase your chances for having asevere skin reaction or other side effect. Talk to your healthcare provider if Imiquimod Cream does notwork for you.
  • For external genital and perianal warts
  • u2022 Monday, Wednesday and Friday, or
  • u2022 Tuesday, Thursday and Saturday
  • For these conditions, Imiquimod Cream is usually left on the skin for 6 to 10 hours. Treatment should continue until the warts are completely gone, or up to 16 weeks.
  • For actinic keratosis
  • u2022 Monday and Thursday, or
  • u2022 Tuesday and Friday
  • For this condition, Imiquimod Cream is usually left on the skin for about 8 hours. Treatment should continue for the full 16 weeks even if all actinic keratosis appear to be gone, unless you are told otherwise by your healthcare provider. The area you treat with Imiquimod Cream should be no larger than approximately the size of your forehead or one cheek (for example 2 inches by 2 inches), unless otherwise directed by your healthcare provider.
  • Applying Imiquimod Cream
  • Imiquimod Cream should be applied just before your bedtime.
  • u2022 Wash the area to be treated with mild soap and water. Allow the area to dry.
  • u2022 Wash your hands.
  • u2022 Open a new packet of Imiquimod Cream just before use.
  • u2022 Apply a thin layer of Imiquimod Cream to the affected area or areas to be treated. Do not use more Imiquimod Cream than is needed to cover the treatment area.
  • u2022 Rub the cream in all the way to the affected area or areas.
  • u2022 Do not cover the treated site with an airtight bandage. Cotton gauze dressings can be used. Cotton underwear can be worn after applying Imiquimod Cream to the genital or perianal area.
  • u2022 Safely throw away the open packet of Imiquimod Cream so that children and pets cannot get it. The open packet should be thrown away even if all the Imiquimod Cream was not completely used.
  • u2022 After applying Imiquimod Cream, n
  • u2022 Leave the cream on the affected area or areas for the time prescribed by your healthcare provider. The length of time that Imiquimod Cream is left on the skin is not the same for the different skin conditions that Imiquimod Cream is used to treat. Do not bathe or get the treated area wet before the right time has passed. Do not leave Imiquimod Cream on your skin longer than prescribed.
  • u2022 After the right amount of time has passed, wash the treated area with mild soap and water.
  • u2022 If you forget to apply Imiquimod Cream, apply the missed dose of cream as soon as you remember and then continue on your regular schedule.
  • u2022 If you get Imiquimod Cream in your mouth or in your eyes rinse well with water right away.
  • What should I avoid while using Imiquimod Cream?
  • u2022 Do not cover the treated area with bandages or other closed dressings. Cotton gauze dressing are okay to use, if needed. Cotton underwear can be worn after treating the genital or perianal area.
  • u2022 Do not apply Imiquimod Cream in or near the eyes, lips or nostrils, or in the vagina or anus.
  • u2022 Do not use sunlamps or tanning beds, and avoid sunlight as much as possible during treatment with Imiquimod Cream. Use sunscreen and wear protective clothing if you go outside during daylight.
  • u2022 Do not have sexual contact including genital, anal, or oral sex when Imiquimod Cream is on your genital or perianal skin. Imiquimod Cream may weaken condoms and vaginal diaphragms. This means they may not work as well to prevent pregnancy. For your own health and the health of others, it is important to practice safer sex. Talk to your healthcare provider about safer sex practices.
  • What are the possible side effects of Imiquimod Cream?
  • The most common side effects with Imiquimod Cream
  • u2022 redness
  • u2022 scabbing and crusting
  • u2022 swelling
  • u2022 itching
  • u2022 a sore, blister, or ulcer
  • u2022 burning
  • u2022 skin that becomes hard or thickened
  • u2022 changes in skin color that do not always go away
  • u2022 skin peeling
  • Actinic Keratosis
  • During treatment and until the skin has healed, your skin in the treatment area is likely to appear noticeably different from normal skin. n- u00a0n- u00a0n- u00a0n- u00a0n- u00a0
  • External Genital and Perianal Warts
  • Patients should be aware that new warts may develop during treatment, as Imiquimod Cream is not a cure. Many people see reddening or swelling on or around the application site during the course of treatment. If you have questions regarding treatment or local skin reactions, please talk with your healthcare provider.
  • You have a higher chance for severe skin reactions if you use too much Imiquimod Cream or use it the wrong way. Sometimes, Imiquimod Cream must be stopped for a while to allow your skin to heal. Talk to your healthcare provider if you have questions about your treatment or skin reactions.
  • Other side effects of Imiquimod Cream include headache, back pain, muscle aches, tiredness, flu-like symptoms, swollen lymph nodes, diarrhea, and fungal infections.
  • If the reactions seem excessive, if either skin breaks down or sores develop during the first week of treatment, if flu-like symptoms develop or if you begin to not feel well at anytime, contact your healthcare provider.
  • These are not all the side effects of Imiquimod Cream. For more information, ask your healthcare provider or pharmacist.
  • How do I store Imiquimod Cream?
  • u2022 Store Imiquimod Cream between 39u00baF to 77u00baF (4u00baC to 25u00baC). Do not freeze.
  • u2022 Safely throw away Imiquimod Cream that is out of date or that you do not need.
  • u2022 n
  • General Information about Imiquimod Cream
  • Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Imiquimod Cream for a condition for which it was not prescribed. Do not give Imiquimod Cream to other people, even if they have the same symptoms you have.
  • This leaflet summarizes the most important information about Imiquimod Cream. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Imiquimod Cream that is written for the healthcare provider. If you have other questions about Imiquimod Cream, call 1-800-645-9833.
  • What are the ingredients in Imiquimod Cream?
  • Active Ingredient:
  • Inactive Ingredients:
  • IF2432ER07/15
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 CONTAINER 0.25g foilpac
  • Fougeran n- Rx onlyn- NET WT. 0.25 gn- NDC 0168-0432-27n- IMIQUIMODn- CREAM 5%n- Contains 1 Applicationn- Discard Unused Portionn- For Dermatologic Use Only.n- Not for Ophthalmic, Oraln- or Intravaginal Use.
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Carrier for 24 single-use foilpacsn
  • NDC
  • NET WT. PER foilpac 0.25 gn- NET WT. PER BOX 6 g
  • Fougeran
  • IMIQUIMOD CREAM 5%
  • 24 single-use foilpacsn
  • Rx only

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