VIOTOPIC 0.03% OINTMENT 30G

Indications

Approved Uses

Atopic dermatitis (eczema): second-line short-term and intermittent long-term therapy for moderate-to-severe disease in patients not adequately responsive to or intolerant of conventional therapies (e.g., topical corticosteroids); 0.03% is approved for adults and for children ≥2 years (where locally authorized).

Off-Label Uses

Off-label uses include vitiligo, facial/intertriginous psoriasis, seborrheic dermatitis, lichen planus, and other steroid-sensitive dermatoses (evidence varies by condition).

Dosage & Administration

Dosing by Condition

Atopic dermatitis: Apply a thin layer to affected areas twice daily until lesions clear, then stop; for proactive maintenance in patients with frequent relapses, apply to previously affected areas twice weekly (e.g., 2-3 days apart).

Initial Dose

Apply a thin layer to the affected areas twice daily.

Maintenance Dose

Apply once daily, twice weekly (e.g., Monday and Thursday) to areas commonly affected to prevent flares.

Maximum Dose

No defined maximum dose in grams for topical tacrolimus 0.03% ointment; apply a thin layer to affected areas only, and avoid continuous long-term use (use short-term/intermittent therapy).

Children's Dosage

0.03% strength: approved for children aged 2-15 years - apply thin layer twice daily to affected areas; discontinue after 3 weeks if no improvement

How to Take

Apply a thin layer to clean, dry affected skin twice daily; rub in gently. Wash hands after application unless hands are treated. Avoid contact with eyes and mucous membranes (mouth/nose). Do not use occlusive dressings/bandages. Minimize sun/UV exposure on treated areas.

Side Effects

Common Side Effects

Application-site burning/stinging, pruritus, erythema/irritation; folliculitis and acne; increased risk of local skin infections (e.g., herpes simplex) can occur.

Side Effect Frequency

Very common (>10%): application-site burning, pruritus. Common (1-10%): application-site erythema/irritation/pain, skin infections (including folliculitis), headache, alcohol intolerance (facial flushing). Uncommon/rare: lymphadenopathy and other systemic-type effects (typically with extensive use/compromised skin).

Safety & Warnings

Contraindications

Contraindication: hypersensitivity to tacrolimus or any component of the formulation.

Warnings & Precautions

Warnings/precautions: use for short-term and intermittent treatment only; avoid continuous long-term use; apply only to affected areas; avoid use on malignant or pre-malignant lesions; minimize/avoid natural or artificial UV exposure on treated areas; avoid occlusive dressings unless directed; avoid eyes/mucous membranes; caution in immunocompromised patients and in skin barrier defects (e.g., Netherton’s syndrome/generalized erythroderma) due to increased absorption; do not apply to active infections-treat infection first; monitor/assess lymphadenopathy and discontinue if persistent/unexplained.

Age Restriction

Not approved for use in children under 2 years of age.

Drug Interactions

Food Interaction

No clinically relevant food interactions (topical product).

Special Populations

Children

0.03% strength: approved for children aged 2-15 years - apply thin layer twice daily to affected areas; discontinue after 3 weeks if no improvement

Storage & Patient Advice

Patient Counseling

Apply a thin layer to affected skin twice daily (or as prescribed) and rub in gently; stop when lesions clear and use intermittently for flares/maintenance as directed. Avoid eyes, mouth, and inside the nose; wash hands after application unless treating hands. Do not cover with occlusive dressings/tight wraps. Burning/stinging/itching at the site is common early and usually improves within days to a week. Minimize sun/UV exposure on treated areas (avoid tanning beds); use protective clothing and sunscreen. Do not apply to infected skin; seek medical advice for signs of skin infection, new lumps/swollen lymph nodes, or unusual skin changes. Keep out of reach of children and store below 25°C.

Monitoring Requirements

No routine laboratory monitoring is required for topical use; clinically monitor for application-site reactions, secondary skin infection (especially herpes), lymphadenopathy, and lack of response; reassess if prolonged continuous use is needed.

Pharmacology

Mechanism of Action

Tacrolimus binds FKBP-12 and the complex inhibits calcineurin, reducing T-cell activation and decreasing transcription of pro-inflammatory cytokines (e.g., IL-2 and others).

Onset of Action

Pruritus often improves within the first week; visible skin lesion improvement typically occurs over 1-3 weeks (sometimes up to ~4 weeks).

Duration of Effect

Benefit persists while used (BID during flares or twice-weekly for maintenance); symptoms commonly recur after discontinuation, with timing varying by patient.

Bioavailability

Minimal systemic absorption after topical use; blood levels are usually undetectable/very low, and absorption increases with impaired skin barrier (inflamed/eroded skin, large surface area, occlusion).

Excretion

If systemically absorbed, tacrolimus is eliminated mainly via biliary/fecal excretion; renal excretion of unchanged drug is negligible (<1%).

Product Information

Available Dosage Forms

Ointment (topical) only for this product (VIOTOPIC 0.03% ointment, 30 g tube).

Composition per Dose

Each gram of ointment: 0.3 mg tacrolimus (as monohydrate) in a white petrolatum-based ointment base

OTC Alternatives

No direct OTC alternative to topical tacrolimus; for mild eczema, OTC low-potency topical corticosteroid (e.g., hydrocortisone 1%) plus regular emollients can be used when appropriate.

Skin Condition

Eczema

Steroid Potency

Not a corticosteroid

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.