VIOTOPIC 0.1% OINTMENT 30G

Indications

Off-Label Uses

Common off-label dermatologic uses include vitiligo, facial/flexural psoriasis, seborrheic dermatitis, lichen planus, cutaneous lupus erythematosus, lichen sclerosus, and rosacea (selected cases).

Dosage & Administration

Initial Dose

Apply a thin layer to the affected areas twice daily.

Maintenance Dose

Apply twice daily until lesion clearance; may reduce to once daily or use intermittently (twice weekly) for maintenance

Maximum Dose

No defined maximum dose; apply a thin layer to affected areas twice daily using the minimum amount for the shortest duration; avoid use on large body surface areas and avoid occlusion.

Children's Dosage

The 0.1% strength is not recommended for children under 16 years. The 0.03% strength is approved for children aged 2 to 15 years.

Side Effects

Common Side Effects

Application-site burning/stinging, pruritus, erythema; folliculitis/acne; local skin infections (e.g., herpes simplex); facial flushing with alcohol (alcohol intolerance).

Safety & Warnings

Warnings & Precautions

Use minimum amount for shortest duration; avoid continuous long-term use; avoid sun/UV exposure on treated areas; do not apply to malignant/premalignant lesions; avoid occlusive dressings; avoid use on infected skin and in immunocompromised patients; caution in skin-barrier defects (e.g., Netherton syndrome/generalized erythroderma) due to increased absorption; avoid eyes/mucous membranes and wash hands after application.

Age Restriction

Not approved for children <2 years; tacrolimus 0.1% ointment is generally indicated for ≥16 years (0.03% is used for ages 2-15).

Driving Warning

Safe

Drug Interactions

Food Interaction

No clinically relevant food interactions for topical tacrolimus.

Special Populations

Children

The 0.1% strength is not recommended for children under 16 years. The 0.03% strength is approved for children aged 2 to 15 years.

Elderly

Standard adult dosing; no specific dose adjustment required

Liver Impairment

No routine dose adjustment for topical use; use with caution in severe hepatic impairment if extensive application or impaired skin barrier could increase systemic exposure.

Storage & Patient Advice

Patient Counseling

Apply a thin layer to affected skin twice daily (or as prescribed) and rub in gently; use the minimum amount for the shortest duration needed and stop when clear. Avoid contact with eyes, mouth, and inside the nose; wash hands after application unless treating hands. A transient burning/stinging/itching is common at the start and usually improves within days. Do not apply to infected skin; seek treatment if signs of infection occur. Do not cover with occlusive dressings/tight bandages. Minimize sun/UV exposure (including tanning beds/UV therapy); use protective clothing/sunscreen on treated areas. Alcohol may cause facial flushing, especially when applied to the face. Seek medical advice if swollen lymph nodes, unusual skin lesions, or persistent/worsening irritation occur. Keep out of reach of children.

Monitoring Requirements

No routine laboratory monitoring is required for topical use; reassess if no improvement within ~6 weeks or if worsening occurs, and monitor clinically for local infection, lymphadenopathy, or suspicious skin lesions with prolonged/intermittent long-term use.

Pharmacology

Mechanism of Action

Tacrolimus binds FKBP-12 and inhibits calcineurin, reducing T-cell activation and decreasing transcription of pro-inflammatory cytokines (e.g., IL-2 and others), producing local immunomodulation in skin.

Onset of Action

Improvement is often seen within about 1 week, with clearer benefit over 1-2 weeks (and may continue improving over several weeks).

Duration of Effect

Benefit persists while used; atopic dermatitis commonly relapses after discontinuation, and proactive twice-weekly maintenance can prolong remission and reduce flares.

Bioavailability

Minimal systemic absorption; typically <0.5% in adults with intact skin, but can be higher with extensive disease, inflamed/broken skin, occlusion, or in children.

Excretion

If systemically absorbed, elimination is primarily via biliary/fecal excretion; renal excretion is minimal.

Product Information

Composition per Dose

Each gram of ointment: 1 mg tacrolimus (0.1%) in a white petrolatum-based ointment vehicle

Skin Condition

Eczema

Steroid Potency

N/A - not a corticosteroid

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