ALDARA 5% Cream

What is ALDARA 5%

ALDARA 5% is a topical immunomodulatory medication containing 5% imiquimod. Packaged in 250 mg sachets (twelve per box), it is a prescription cream used for:

• External genital and perianal warts (condylomata acuminata) in individuals aged 12 years and above :contentReference[oaicite:1]{index=1}.
• Actinic keratosis on the face or scalp in immunocompetent adults :contentReference[oaicite:2]{index=2}.
• Superficial basal cell carcinoma (sBCC) on trunk or extremities when surgery is unsuitable :contentReference[oaicite:3]{index=3}.

It is an immune response modifier, applied topically to stimulate local immunity. It's not directly antiviral or cytotoxic; rather, it harnesses the body's immune response :contentReference[oaicite:4]{index=4}. :contentReference[oaicite:5]{index=5}

How to use ALDARA 5%

• Clean application area: Gently wash with mild soap, pat dry, and apply before bedtime. Do not apply on inflamed or non-intact skin :contentReference[oaicite:6]{index=6}.
• Dosage based on indication:
  • Warts: Apply once daily, 3× per week (e.g., Mon/Wed/Fri), leave on 6–10 hours, for up to 16 weeks :contentReference[oaicite:7]{index=7}.
  • Actinic keratosis: Once daily, 2× per week (e.g., Mon/Thu), leave on ~8 hours, for 16 weeks :contentReference[oaicite:8]{index=8}.
  • sBCC: Apply once daily, 5× per week for 6 weeks, on lesion plus a 1-cm margin :contentReference[oaicite:9]{index=9}.
• Post-application: Wash off with mild soap after the time elapses. Avoid occlusive dressings :contentReference[oaicite:10]{index=10}.
• Protect skin: Avoid sun exposure; use sunscreen, hats, and avoid tanning beds during treatment :contentReference[oaicite:11]{index=11}.
• Missed dose: If forgotten, skip it—do not double. Continue according to the prescribed schedule :contentReference[oaicite:12]{index=12}.

Mode of Action ALDARA 5%

Imiquimod is a toll-like receptor 7 (TLR7) agonist. Here's how it works:

• Immune activation: Stimulates TLR7 on dendritic cells and macrophages to produce cytokines—IFN‑α, TNF‑α, IL‑6, IL‑12—that initiate a local immune response :contentReference[oaicite:13]{index=13}.
• Langerhans cell migration: These antigen-presenting cells migrate to lymph nodes to support adaptive immunity :contentReference[oaicite:14]{index=14}.
• Antitumoral and antiviral effects: Cytokines create an environment toxic to abnormal or virus-infected cells, leading to lesion clearance :contentReference[oaicite:15]{index=15}.
• Local usage: Designed to act on skin lesions with little to no systemic absorption—serum half-life ~30 hours only if absorbed topically :contentReference[oaicite:16]{index=16}.

ALDARA 5% Interactions ALDARA 5%

There are minimal drug interactions due to low systemic absorption. Key considerations include:

• Drug interactions: No known significant interactions with oral medications :contentReference[oaicite:17]{index=17}.
• Topical agents: Concurrent use of other topical treatments (e.g., corticosteroids, retinoids, fluorouracil) may alter efficacy or increase irritation—discuss with your provider.
• Skin conditions: Avoid use over eczema or sunburned skin due to potential for excessive inflammation :contentReference[oaicite:18]{index=18}.
• Autoimmune diseases: May exacerbate conditions such as psoriasis or graft-versus-host disease—use with caution :contentReference[oaicite:19]{index=19}.

Dosage of ALDARA 5%

Specific dosing depends on the condition being treated:

• External genital/perianal warts: Apply once daily, 3× per week for up to 16 weeks, each for 6–10 hours :contentReference[oaicite:20]{index=20}.
• Actinic keratosis: Apply once daily, 2× per week for 16 weeks, 8-hour applications :contentReference[oaicite:21]{index=21}.
• Superficial BCC: Apply once daily, 5× per week for 6 weeks; target lesion + 1 cm margin :contentReference[oaicite:22]{index=22}.
• Pediatric use: ≥12 years for warts; safety for other uses not established :contentReference[oaicite:23]{index=23}.
• Discontinuation: Stop after cycles are complete or if severe reactions occur; consult your doctor before restarting.

Possible side effects of ALDARA 5%

Local skin reactions are common and often anticipated; systemic effects are rarer but possible:

• Local reactions (common): Erythema, edema, scabbing, crusting, ulceration, burning, pain, itching, scaling, erosion, exudate :contentReference[oaicite:24]{index=24}.
• Flu-like symptoms: Headache, fever, fatigue, chills, muscle aches, nausea, diarrhea :contentReference[oaicite:25]{index=25}.
• Serious local reactions: Severe ulceration, erosion, or weeping—may require treatment interruption :contentReference[oaicite:26]{index=26}.
• Allergic reactions: Rare anaphylaxis or hives—discontinue and seek emergency care if event occurs :contentReference[oaicite:27]{index=27}.
• Systemic complications (rare): Capillary leak syndrome, exacerbation of autoimmune conditions, lymph node swelling :contentReference[oaicite:28]{index=28}.
• Pediatric effects: Application in children may reduce white blood cell and neutrophil counts; use caution :contentReference[oaicite:29]{index=29}.

ALDARA 5% Contraindications ALDARA 5%

• Hypersensitivity: Allergy to imiquimod or formulation excipients :contentReference[oaicite:30]{index=30}.
• Broken skin: Avoid use on open wounds, ulcers, eczema, or sunburned areas :contentReference[oaicite:31]{index=31}.
• Autoimmune conditions: Use with caution in psoriasis or active graft-versus-host disease :contentReference[oaicite:32]{index=32}.
• Pregnancy: FDA class C—use only if benefits outweigh risks :contentReference[oaicite:33]{index=33}.
• Breastfeeding: Unknown if imiquimod passes into breast milk—avoid contact with infant skin :contentReference[oaicite:34]{index=34}.
• Immunocompromised: Efficacy and safety not established in immunosuppressed individuals :contentReference[oaicite:35]{index=35}.

Storage of ALDARA 5%

• Temperature: Store at room temperature (20–25 °C). Do not freeze or refrigerate :contentReference[oaicite:36]{index=36}.
• Packaging: Keep sachets sealed until use in original box to protect from moisture and light.
• Expiration: Discard unused sachets after the expiry date.
• Safety: Keep out of reach of children. Avoid eye contact; wash hands thoroughly post-application :contentReference[oaicite:37]{index=37}.
• Disposal: Do not flush. Use take-back programs or follow local regulations :contentReference[oaicite:38]{index=38}.