Aldara


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imiquimod

(i-mi-kwi-mod) ,

Aldara

(trade name),

Vyloma

(trade name),

Zyclara

(trade name)

Classification

Therapeutic: antivirals
Pharmacologic: immune response modifiers
Pregnancy Category: C

Indications

External genital or perianal warts/condylomata (condyloma acuminatum).Typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp.Biopsy-confirmed, primary superficial basal cell carcinoma (Aldara only).

Action

May induce the formation of interferons that have antiproliferative and antiviral properties.

Therapeutic effects

Regression of external genital or perianal warts/condylomata, actinic keratoses, or basal cell carcinoma lesions.

Pharmacokinetics

Absorption: Minimal absorption.
Distribution: Action is primarily local.
Metabolism and Excretion: <0.9% excreted in urine and feces.
Half-life: Unknown.

Time/action profile (regression of lesions)

ROUTEONSETPEAKDURATION
Topicaldays–wk10–16 wkunknown

Contraindications/Precautions

Contraindicated in: None known.
Use Cautiously in: Previous treatment/surgery in affected area (area should be healed prior to use);Pre-existing inflammatory skin lesions (may be exacerbated);Immunocompromised patients (safety not established); Obstetric / Lactation / Pediatric: Pregnancy, lactation, or children <12 yr (safety not established).

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • fatigue
  • headache

Gastrointestinal

  • diarrhea
  • nausea

Genitourinary

  • dysuria
  • vulvar swelling

Local

  • irritation (most frequent)
  • pain (most frequent)
  • pruritus (most frequent)
  • burning (most frequent)
  • swelling (most frequent)
  • fungal infections (women)

Interactions

Drug-Drug interaction

None known.

Route/Dosage

External Genital Warts

Topical (Adults and children ≥12 yr) Aldara—Apply thin layer to warts at bedtime every other day (3 times weekly); leave on for 6–10 hr, then rinse off with mild soap and water. Use until lesions are completely cleared or up to 16 wk. Zyclara—Apply thin layer of 3.75% cream to warts at bedtime every day; leave on for 8 hr, then rinse off with mild soap and water. Use until lesions are completely cleared or up to 8 wk.

Actinic Keratoses

Topical (Adults) Aldara—Apply thin layer to clean, dry affected area twice weekly; leave on for 8 hr, then rinse off with mild soap and water. Continue for 16 wk. Zyclara—Apply thin layer of 2.5% or 3.75% cream to clean, dry affected area once daily before bedtime; leave on for 8 hr, then rinse off with mild soap and water. Continue for 2 wk, followed by 2 wk without treatment, then begin applying cream again for another 2 wk.

Superficial Basal Cell Carcinoma

Topical (Adults) Apply thin layer to clean, dry affected area 5 times per week; leave on for 8 hr, then rinse off with mild soap and water. Continue for 6 wk.

Availability (generic available)

Cream: 2.5% in single-use packets and pump bottles (Zyclara), 3.75% in single-use packets and pump bottles (Zyclara), 5% in single-use packets (Aldara)

Nursing implications

Nursing assessment

  • Assess affected area(s) prior to and periodically during therapy.

Potential Nursing Diagnoses

Risk for infection (Indications)
Risk for infection (Patient/Family Teaching)

Implementation

  • Do not confuse Aldara (imiquimod) with Alora (estradiol).
  • Topical: Apply a thin film to clean and dry skin as directed prior to bedtime. Rub in well and leave on skin for time period specified. Remove by washing with mild soap and water. Discard unused cream from single-dose packet. A rest period of several days may be taken if required for patient comfort or severity of skin reaction. Resume therapy when reaction subsides.
    • Do not use occlusive dressings. If covering is needed, use cotton gauze or cotton underclothes.

Patient/Family Teaching

  • Instruct patient on proper application technique. Emphasize the importance of washing hands before and after application and avoiding contact with eyes. Advise patient not to use more cream than was prescribed. Missed doses should be applied as soon as possible; then return to regular schedule.
  • Advise patient to delay next dose for several days when experiencing discomfort or severe reactions. Notify health care professional if severe reactions occur.
  • Advise patient to avoid sharing this medication with others.
  • Instruct patient to avoid contact with affected areas while the cream is on the skin. Wash cream off of genital areas before engaging in sexual activities. Inform patient that oils in the cream weaken latex contraceptive devices, such as cervical caps, condoms, and diaphragms.
  • Advise patient to avoid use of other topical medications on same treatment area unless recommended by health care professional.

Evaluation/Desired Outcomes

  • Healing of genital or perianal warts. Treatment is continued until wart is healed or up to 16 wk.
  • Healing of actinic keratosis. Treatment is continued for 16 wk.
  • Resolution of superficial basal cell carcinoma lesions. Treatment is continued for 6 wk.

Aldara®

A proprietary topical immune response modifier, which is used to manage actinic keratosis, superficial basal cell carcinomas, and external genital warts.
Adverse effects Rash at application site, upper respiratory tract infection, squamous carcinoma of skin.
References in periodicals archive ?
Sales of Aldara (treatment of actinic keratosis) amounted to SEK 219 million (248).
Aldara Cream is a skin-use only (topical) prescription medicine used to treat external genital and perianal warts in people 12 years and older.
3 Aldara Sales Will Decline Sharply Owing to the Launch of Generics
Aldara (actinic keratosis treatment) totaled SEK 122 million (125), a 2% decrease on the previous year, primarily due to inventory reductions at the wholesale level in Germany.
The product is the generic equivalent of Aldara Cream, 5%, a topical treatment for actinic keratoses on the face or scalp, superficial basal cell carcinoma, and external genital and perianal warts in patients 12 years old or older.
Aldara (actinic keratosis treatment) totaled SEK 111 million (95), a 17% increase on the previous year.
Aldara had sales of approximately $370 million for the 12 months ended February 2010, as measured by Wolters Kluwer Health.
Zyclara shares the same active ingredient as Aldara (imiquimod) Cream, 5% and while both topicals are FDA-approved for the treatment of AK, there are notable differences between the two.
ALDARA is the brand name for imiquimod cream, 5%, which is an immune-response modifier.
Fougera's Imiquimod Cream 5% is rated AB, generically equivalent to Aldara by Graceway Pharmaceuticals and substitutable for all indications.
It is currently working on the Phase IV expansion of the Madinat Jumeirah resort in Dubai and the Aldara Hospital and Medical Center in Riyadh.
The firm will be working with the Aldara Medical Corporation to deliver Phase II of the Aldara Hospital and Medical Centre in Riyadh.