Generic Name

Pimecrolimus

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Classification

FDA Approved Indications

• Atopic dermatitis (moderate to severe) in pediatric patients 2 years and older and adults

Mechanism of Action

Pimecrolimus inhibits calcineurin, thereby decreasing T-cell activation and the release of inflammatory cytokines, leading to reduced inflammation.

Dosage and Administration

Adult: Apply a thin layer to affected areas twice daily.

Pediatric: Apply a thin layer to affected areas twice daily starting at age 2, as prescribed.

Geriatric: No specific dose adjustments; use with caution and monitor.

Renal Impairment: No specific adjustment needed.

Hepatic Impairment: No specific adjustment needed.

Pharmacokinetics

Absorption: Minimal systemic absorption when used topically.

Distribution: Widely distributed in tissues, negligible in plasma.

Metabolism: Metabolized hepatically via CYP3A4 enzymes.

Excretion: Excreted primarily in feces; minimal renal excretion.

Half Life: Approximately 3 hours in systemic circulation.

Contraindications

• Known hypersensitivity to pimecrolimus or any component.

Precautions

• Avoid in skin infections or open wounds.
• Use with caution in children under 2 years.
• Long-term safety data is limited; monitor for local adverse effects.

Adverse Reactions - Common

• Application site burning or sensation (Common)
• Erythema (Common)

Adverse Reactions - Serious

• Herpes virus infection (HSV, VZV) in treated areas (Less common)
• Lymphadenopathy, hypersensitivity reactions (Rare)

Drug-Drug Interactions

• None well-established; avoid concomitant use with other topical immunosuppressants

Drug-Food Interactions

• None

Drug-Herb Interactions

• Limited data; use caution with herbal products affecting immune function

Nursing Implications

Patient/Family Teaching

• Apply as directed, avoid occlusive dressings unless instructed.
• Report signs of infection or severe irritation.
• Avoid emotional stress to reduce flare-ups.
• Use caution around eyes, mouth, and genital areas.

Special Considerations

Black Box Warnings:

• Possible increased risk of lymphoma and skin cancer with prolonged use.

Genetic Factors: Limited data available.

Lab Test Interference: None known.

Overdose Management

Signs/Symptoms: Local skin irritation, systemic absorption in overdose may cause immunosuppression.

Treatment: Discontinue use, supportive care, and symptomatic treatment.

Storage and Handling

Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F).

Stability: Stable; keep in original container, protect from excessive heat or moisture.