Generic
Tacrolimus 0.1%, 0.03% Topical
16 brands available in the market
At a glance
Tacrolimus 0.1% & 0.03% Topical Ointment is used for moderate to severe atopic dermatitis (eczema) and other skin conditions, particularly when conventional therapies are inadvisable or inadequate.
Description
Tacrolimus is a macrolide immunomodulator that binds to FKBP-12, inhibiting calcineurin phosphatase activity. This reduces the inflammatory cascade by inhibiting T-lymphocyte activation, relieving skin inflammation, itching, and rashes.
Indications
- Moderate to severe atopic dermatitis (eczema)
- Allergic contact dermatitis
- Psoriasis
- Vitiligo
- Lichen planus
- Seborrheic dermatitis
- Pemphigus vulgaris
- Chronic cutaneous graft-versus-host disease
Therapeutic class
Drugs Affecting the Immune Response
Pharmacological class
Topical Immunomodulator
Pharmacology
Tacrolimus binds to FKBP-12, inhibiting calcineurin phosphatase activity, preventing NF-AT dephosphorylation and translocation, and reducing cytokine production. It inhibits T-lymphocyte activation, reducing the inflammatory cascade and relieving skin inflammation and itching.
Mechanism of action
Reduces skin inflammation by inhibiting T-lymphocyte activation.
Dosage
Adult Dose (Topical):
- Apply a thin layer of 0.03% or 0.1% ointment to affected areas twice daily
- Rub in gently and completely
- For short-term and intermittent use only
Pediatric Dose (Topical):
- ≥2 years: 0.03% ointment twice daily
- ≥16 years: 0.1% ointment may be used
Administration
- For external use only
- Clean and dry the affected area
- Apply a thin layer and massage gently
- Do not use with occlusive dressings
Missed dose
If you miss a dose, apply it as soon as you remember; if almost time for the next dose, skip it; do not double the dose.
Side effects
Common Side Effects:
- Application site burning, irritation, itching, and redness
- Skin erythema
- Flu-like symptoms
- Headache
Precautions & warnings
- Caution in patients with skin infections
- Safety not established in generalized erythroderma
- Avoid continuous long-term use
- Caution in pregnancy and lactation
Contraindications
- History of hypersensitivity to tacrolimus or any other component
Drug interactions
- CYP3A4 inhibitors (erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers, cimetidine): Caution in widespread/erythrodermic disease
Food interactions
Alcohol consumption is not relevant (topical application).
Use in pregnancy
Use in Pregnancy: May be unsafe; animal studies show harmful effects; use only if clearly needed; consult your doctor.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Probably safe; limited data suggests no significant risk; consult your doctor.
Pediatric use
Ages 2-15: 0.03% ointment; Ages 16+: 0.1% ointment may be used
Geriatric use
Adverse event profile in elderly is consistent with other adults
Renal / hepatic impairment
Renal Impairment: Not applicable (topical application)
Hepatic Impairment: Not applicable (topical application)
Overdose effects
Accidental oral ingestion may cause systemic tacrolimus side effects; seek medical advice.
Storage conditions
Store below 30°C; keep away from light; keep out of reach of children.
Chemical structure
Tacrolimus 0.1% & 0.03%