Imiquimod Topical Dosage

This dosage information may not include all the information needed to use Imiquimod Topical safely and effectively. See additional information for Imiquimod Topical.

The information at Drugs.com is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Keratosis

Actinic Keratosis:
2.5% and 3.75% cream: Apply topically to the affected area (either entire face or balding scalp) once a day prior to bedtime. Up to 0.5 g (2 packets or 2 full actuations of the pump) may be applied to the treatment area at each application.

Treatment should continue for two 2-week treatment cycles separated by a 2-week no-treatment period. Neither 2-week treatment cycle should be extended due to rest periods or missed doses.

5% cream: Apply topically to defined treatment area 2 times per week prior to bedtime. The treatment area should be one contiguous area of approximately 5 cm by 5 cm on the face or scalp, but not both concurrently. No more than 1 packet should be applied to the contiguous treatment area at each application.

Treatment should continue for a full 16 weeks. The treatment period should not be extended beyond 16 weeks due to rest periods or missed doses.

2.5%, 3.75%, and 5% cream: The cream should be applied as a thin layer to the entire treatment area and rubbed in until it disappears. It should be left on for approximately 8 hours and then removed by washing with mild soap and water.

Usual Adult Dose for Condylomata Acuminata

3.75% cream: Apply a thin layer topically to external genital/perianal warts once a day prior to bedtime. Up to 0.25 g (1 packet or 1 full actuation of the pump) may be applied to the treatment area at each application. The cream should be left on for approximately 8 hours and then removed by washing with mild soap and water.

Treatment should continue until total clearance of genital/perianal warts or for up to 8 weeks. The treatment period should not be extended beyond 8 weeks due to rest periods or missed doses.

5% cream: Apply topically to external genital/perianal warts 3 times per week prior to bedtime. The cream should be applied as a thin layer to the wart area and rubbed in until it disappears. The cream should be left on for 6 to 10 hours and then removed by washing with mild soap and water.

Treatment should continue until total clearance of genital/perianal warts or for a maximum of 16 weeks.

Usual Adult Dose for Basal Cell Carcinoma

Biopsy-confirmed superficial basal cell carcinoma:
5% cream: Apply topically to target tumor 5 times per week prior to bedtime for a full 6 weeks. Sufficient cream should be applied to cover the treatment area (including a 1 cm margin of skin around the tumor) and it should be rubbed in until the cream disappears. The cream should be left on for approximately 8 hours and then removed by washing with mild soap and water.

Amount of imiquimod topical 5% cream to use:
Target tumor diameter 0.5 to less than 1 cm: 4 mm (diameter) droplet of cream (approximately 10 mg of 5% cream)

Target tumor diameter greater than or equal to 1 to less than 1.5 cm: 5 mm (diameter) droplet of cream (approximately 25 mg of 5% cream)

Target tumor diameter greater than or equal to 1.5 to 2 cm: 7 mm (diameter) droplet of cream (approximately 40 mg of 5% cream)

The target tumor should have a maximum diameter of 2 cm and be located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet). Treatment area should include a 1 cm margin of skin around the tumor.

Usual Adult Dose for Molluscum Contagiosum

(Not approved by FDA)

Study (n=15)
Apply to lesion once a day, rub in and leave on for 24 hours, for 5 days or until mollusca no longer visible. Wash with soap and water before applying next dose.

Usual Pediatric Dose for Condylomata Acuminata

12 years or older:
3.75% cream: Apply a thin layer topically to external genital/perianal warts once a day prior to bedtime. Up to 1 packet may be applied to the treatment area at each application. The cream should be left on for approximately 8 hours and then removed by washing with mild soap and water.

Treatment should continue until total clearance of genital/perianal warts or for up to 8 weeks. The treatment period should not be extended beyond 8 weeks due to rest periods or missed doses.

5% cream: Apply topically to external genital/perianal warts 3 times per week prior to bedtime. The cream should be applied as a thin layer to the wart area and rubbed in until it disappears. The cream should be left on for 6 to 10 hours and then removed by washing with mild soap and water.

Treatment should continue until total clearance of genital/perianal warts or for a maximum of 16 weeks.

Usual Pediatric Dose for Molluscum Contagiosum

2 to 12 years: Studies have failed to demonstrate effectiveness.

(Not approved by FDA)

Case Reports (n=3):
5, 7, and 8 years: Apply to lesions once or twice a day, rub in and leave on. At the end of 8 weeks of therapy, all lesions had resolved in 2 of the cases, and 75% of the lesions in the third case.

Case Report (n=13):
4 to 11 years: Apply to lesions 3 times a week at bedtime. Rub in until cream disappears. Leave on for approximately 8 hours. Then, remove the cream by washing with mild soap and water. Treatment continued for up to 16 weeks, at which point there was a 69% response rate.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

If local skin reactions from the topical application occur, a rest period of several days may be necessary.

Precautions

Intense local inflammatory reactions (including skin weeping or erosion) can occur after a few applications of imiquimod topical and may require an interruption of dosing. Administration of imiquimod topical 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, which can lead to urinary retention. Dosing should be interrupted or discontinued for severe vulvar swelling.

Influenza-like signs and symptoms may accompany or precede local inflammatory reactions. Dosing interruption and patient assessment should be considered.

Concomitant use of more than one imiquimod cream (e.g., Zyclara(R) cream with Aldara(R) cream) in the same treatment area should be avoided since the risk for and severity of local skin reactions may increase. The safety of concomitant use of more than one imiquimod product has not been established and should be avoided since the risk for and severity of systemic reactions may increase.

Sun exposure (including sunlamps) should be avoided or minimized during use of imiquimod topical due to concern for increased sunburn susceptibility. Patients should be advised to wear protective clothing during therapy. Patients with sunburn should not use imiquimod topical until fully recovered. Caution is recommended for patients with considerable sun exposure (e.g., due to occupation) and patients with inherent sensitivity to sunlight.

Safety and efficacy of repeated use of imiquimod topical for treatment of actinic keratosis in the same area have not been established. Safety and efficacy have not been established in immunosuppressed patients or in patients with xeroderma pigmentosum.

Imiquimod topical should be used with caution in patients with preexisting autoimmune conditions.

Safety of imiquimod topical 5% cream applied to areas of skin greater than 25 cm2 for actinic keratosis has not been established. Safety and efficacy of the 5% cream have not been established in patients with basal cell nevus syndrome. Safety and efficacy of the 5% cream have not been established for repeat course of treatment of superficial basal cell carcinoma (sBCC), for treatment of other types of basal cell carcinomas (including nodular and morpheaform [fibrosing or sclerosing] types), or for treatment of sBCC lesions on the face, head, or anogenital area.

Safety and efficacy of imiquimod topical 2.5% and 3.75% cream have not been established in the treatment of superficial basal cell carcinoma.

Imiquimod topical has not been evaluated for treatment of urethral, intravaginal, cervical, rectal, or intra-anal human papilloma viral (HPV) disease and is not recommended. Treatment with imiquimod topical has not been studied for prevention of transmission of HPV.

Imiquimod topical 5% cream has been evaluated in 2 randomized, vehicle-controlled, double-blind trials involving 702 pediatric patients with molluscum contagiosum (MC) (470 exposed to imiquimod topical 5% cream; median age 5 years, range 2-12 years). Patients applied imiquimod topical 5% cream or vehicle 3 times per week for up to 16 weeks. Complete clearance (no MC lesions) was assessed at Week 18. In Study 1, the complete clearance rate was 24% (52/217) in the imiquimod topical 5% cream group compared with 26% (28/106) in the vehicle group. In Study 2, the clearance rates were 24% (60/253) in the imiquimod topical 5% cream group compared with 28% (35/126) in the vehicle group. These studies failed to demonstrate efficacy.

Safety and effectiveness of imiquimod topical for external genital/perianal warts have not been established in pediatric patients less than 12 years of age. Safety and effectiveness of imiquimod topical for actinic keratoses or sBCC have not been established in pediatric patients (less than 18 years of age).

Dialysis

Data not available

Other Comments

Patients should be instructed to wash hands before and after imiquimod topical use. Before applying, the treatment area should be washed with mild soap and water and allowed to dry thoroughly (at least 10 minutes).

The treatment area should not be bandaged or otherwise occluded.

Contact with the eyes, lips, and nostrils should be avoided. Imiquimod topical is not for oral, ophthalmic, intra-anal, or intravaginal use.

Postmarketing reports of localized skin color changes (hyperpigmentation, hypopigmentation), following imiquimod cream use, may be permanent in some patients.

Unused and partially-used packets should be discarded. Partially-used packets should not be reused.

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