Not scheduled (Non-scheduled drug)

Topical

• Cream: 1% w/w

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

▶ Atopic Dermatitis (mild to moderate) — Adults and Children ≥2 years

Particularly suitable for sensitive areas (face, neck, flexures) where topical corticosteroids are less preferred. For use in non-immunocompromised patients only.

Parameter Recommendation

Starting dose Apply thin layer of 1% cream to affected areas twice daily

Titration Not applicable

Usual maintenance dose Twice daily during flares; proactive maintenance with twice weekly application after clearance

Maximum dose Twice daily application; avoid continuous long-term daily use

Clinical Notes:

• Continue twice daily application until lesion clearance (typically 1–4 weeks)

• After clearance, step down to emollients; resume on flare recurrence

• Not intended for acute weeping or severely inflamed lesions

• Do not apply under occlusive dressings

• Treat any active bacterial, viral, or fungal infection before initiating therapy

Secondary Indications — Adults (Off-label, if any)

Indication Dose Duration Notes

Seborrheic dermatitis (facial) — OFF-LABEL Apply thin layer once or twice daily Until clearance (typically 2–4 weeks); intermittent maintenance Specialist only; evidence from small RCTs and Indian dermatology practice

Intertriginous psoriasis — OFF-LABEL Apply thin layer once daily Short-term or maintenance to minimize topical steroid exposure Specialist only; used in Indian dermatology protocols to reduce atrophy risk in skin folds

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

▶ Atopic Dermatitis (mild to moderate) — Age ≥2 years

Parameter Recommendation

Starting dose Apply thin layer of 1% cream to affected areas twice daily

Titration Not applicable

Usual maintenance dose Twice daily during flares; twice weekly for proactive maintenance after clearance

Maximum dose Twice daily application

Clinical Notes:

• Treatment duration during flares: 1–4 weeks until resolution

• Avoid application under occlusion

• Suitable for face, neck, and flexural areas

• Monitor for local irritation at each visit

Secondary Indications — Paediatric Doses (Off-label, if any)

Not applicable — no established off-label paediatric indications

⚠️ Not recommended below 2 years of age due to lack of safety data. Use below age 2 only under strict dermatologist supervision.

No adjustment required — topical application with negligible systemic absorption

• Known hypersensitivity to pimecrolimus or any formulation excipient

• Active cutaneous viral infections at treatment site (herpes simplex, varicella zoster, molluscum contagiosum)

• Immunocompromised patients (primary immunodeficiency, post-transplant immunosuppression, HIV/AIDS)

• Netherton syndrome or other conditions with significant skin barrier defect (risk of excessive absorption)

• Malignant or pre-malignant skin conditions at application site

• Avoid prolonged continuous daily use, particularly over large body surface areas

• Avoid contact with eyes, oral mucosa, and intranasal surfaces

• Active bacterial or fungal skin infection — treat infection before initiating pimecrolimus

• Photosensitivity — advise sun protection during treatment

• Local burning/stinging sensation common during initial days — typically transient

• Avoid use on skin with potential increased absorption (eroded, ulcerated)

• Do not apply under occlusive dressings

Parameter Recommendation

Overall safety Limited human data; animal studies show potential risk (Category C equivalent)

When to use Only if benefit clearly outweighs risk; specialist supervision recommended

Preferred alternatives Low-potency topical corticosteroids for short-term use; emollients

Monitoring Observe for local irritation; avoid prolonged use or large-area application

Parameter Recommendation

Compatible with breastfeeding Generally compatible if applied away from breast and nipple area

Drug levels in milk Expected negligible with correct topical application

Preferred alternatives Low-potency topical corticosteroids if extensive application needed

Precautions Ensure infant does not have skin contact with treated areas

Infant monitoring Observe for skin irritation if accidental exposure occurs

Parameter Recommendation

Starting dose Same as adults — 1% cream twice daily to affected areas

Titration Not applicable

Special considerations May experience increased local irritation due to thinner skin barrier; monitor for secondary cutaneous infections; ensure adequate sun protection

Interacting Drug/Agent Effect Management

Other topical immunomodulators (tacrolimus) Potential additive immunosuppressive effect at application site Avoid concurrent application on same area

Systemic calcineurin inhibitors (ciclosporin, tacrolimus) Theoretical additive immunosuppression if significant absorption Use with caution; generally not a concern with limited topical application

Interacting Drug/Agent Effect Management

Topical corticosteroids Potential for increased local irritation if applied concurrently Avoid simultaneous application; may be used sequentially if needed

Occlusive dressings/bandages Increased systemic absorption Avoid use under occlusion

CYP3A4 inhibitors (ketoconazole, erythromycin) — if systemic Theoretical interaction if significant absorption occurs Generally not clinically significant with limited topical use

• Application site burning or stinging (10–30%, typically transient)

• Pruritus at application site

• Erythema

• Local skin irritation or dryness

• Folliculitis

• Headache (uncommon)

Adverse Effect Action Required

Herpes simplex reactivation/eczema herpeticum Discontinue immediately; initiate antiviral therapy

Persistent lymphadenopathy Discontinue; investigate etiology

Severe or persistent local irritation Discontinue; reassess diagnosis

Suspected skin malignancy Discontinue immediately; dermatology evaluation and biopsy

Note: Long-term theoretical risk of cutaneous malignancy or lymphoma has been raised (FDA boxed warning) but no conclusive causal evidence established. Avoid unnecessary prolonged continuous use.

Phase Parameters

Baseline Confirm diagnosis of atopic dermatitis; rule out active skin infections (viral, bacterial, fungal); document extent and severity of dermatitis

After 2–4 weeks Assess clinical response; evaluate for local irritation or infection

Long-term Periodic reassessment if used for maintenance; monitor for new skin lesions, lymphadenopathy, or signs of infection; ensure treatment is intermittent rather than continuous

• Elidel (Meda/Novartis)

• Piconorm

• Pacroma

• Pimecid

• Pimclo

• Elicrom

• Not under NPPA/NLEM price control

• Prices vary across brands and retail outlets

• First-choice steroid-sparing agent for atopic dermatitis on face, eyelids, neck, and flexural areas where topical corticosteroids carry higher atrophy risk

• Proactive twice-weekly maintenance therapy after flare clearance reduces relapse frequency — counsel patients accordingly

• Local burning/stinging is common initially but typically diminishes within first week of use

• Always treat active skin infections before initiating therapy — pimecrolimus does not have antimicrobial activity

• Do not apply under occlusion or to broken/eroded skin due to potential for increased systemic absorption

• Reserve for mild-to-moderate disease; severe atopic dermatitis requires systemic therapy or more potent topical agents

pimecrolimus; calcineurin inhibitor; atopic dermatitis; topical immunomodulator; steroid-sparing; eczema; dermatology; paediatric-safe; face-safe; pregnancy-caution

RxIndia v1.0 — 04 May 2025

• CDSCO approved product inserts

• Indian Pharmacopoeia

• Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) Guidelines

• AIIMS Dermatology Department Protocols

• API Textbook of Medicine

• IAP Guidelines (Paediatric Dermatology section)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (Immunomodulator pharmacology)

• Small RCTs and observational data (for off-label indications)