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PROTOPIC (TACROLIMUS)
- Intractable eczema
- Atopic dermatitis
0.03 % topical ointment
- Apply a thin layer to the affected area(s) by topical route 2 times per day ; rub in gently and completely
0.1 % topical ointment
- Apply a thin layer to the affected area(s) by topical route 2 times per day ; rub in gently and completely
0.03 % topical ointment
- Apply a thin layer to the affected area(s) by topical route 2 times per day ; rub in gently and completely
0.1 % topical ointment
- Apply a thin layer to the affected area(s) by topical route 2 times per day ; rub in gently and completely
Atopic dermatitis
- Apply a thin layer to the affected area(s) by topical route 2 times per day ; rub in gently and completely
Intractable eczema
- Apply a thin layer to the affected area(s) by topical route 2 times per day ; rub in gently and completely
- None
Contraindicated
- None
Severe
Moderate
- None
- None
Contraindicated
- Eczema herpeticum
- Graft versus host disease
- Herpes simplex infection
- Herpes zoster
- Immunosuppression
- Infectious mononucleosis
- Lamellar ichthyosis
- Netherton's syndrome
Severe
Moderate
- Lymphadenopathy
- Malignancy
- Malignant lymphoma
PROTOPIC (TACROLIMUS)
- Intractable eczema
- Atopic dermatitis
- Flushing
- Skin rash
- Wheezing
- Fever
- Flu-like symptoms
- Headache disorder
- Paresthesia
- Pruritus of skin
- Treatment site sequelae
More Frequent
Severe
Less Severe
- None
- Acne vulgaris
- Alcohol intolerance
- Back pain
- Bullous dermatitis
- Dyspepsia
- Dyspnea
- Eye tearing
- Eyelid erythema
- Folliculitis
- Myalgias
- Ocular itching
- Ocular redness
- Sinusitis
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Malignancy
Less Severe
- Localized edema
Contraindicated
None
Severe Precaution
Tacrolimus 0.03% (Top)
Off-label use for mild to severe atopic dermatitis as steroid sparing agent. Possible risk of infection, unknown risk of malignancy.
Possible risk of infection, unknown risk of malignancy. 0.1% strength not approved age< 18 years.
- 1 Day – 2 Years
- Off-label use for mild to severe atopic dermatitis as steroid sparing agent. Possible risk of infection, unknown risk of malignancy.
- 1 Day – 18 Years
- Off-label use for mild to severe atopic dermatitis as steroid sparing agent. Possible risk of infection, unknown risk of malignancy.
Tacrolimus 0.1% (Top)
Off-label use for mild to severe atopic dermatitis as steroid sparing agent. Possible risk of infection, unknown risk of malignancy.
Possible risk of infection, unknown risk of malignancy. 0.1% strength not approved age< 18 years.
- 1 Day – 2 Years
- Possible risk of infection, unknown risk of malignancy. 0.1% strength not approved age< 18 years.
- 1 Day – 18 Years
- Possible risk of infection, unknown risk of malignancy. 0.1% strength not approved age< 18 years.
Management or Monitoring Precaution
None
Tacrolimus (topical)
- Severity Level:
C
- Additional Notes: Insufficient human and animal data with topical form; minimally absorbed
Contraindicated
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Precaution Exists
Tacrolimus(topical)
Minimal systemic absorption expected
| General | Excretion Potential | Effect on Infant | Notes |
| Evaluate use carefully | Unknown | Not known; no or inclusive data | Minimal systemic absorption expected |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- Patients have benefited from tacrolimus when it is used correctly. Long-term safety for this drug is not known at this time. There have been rare reports of cancers (e.g., skin cancer, lymphoma) in patients using tacrolimus.<br /><br />It is not known whether tacrolimus caused these cancers when used on the skin. Further studies to determine the long-term safety of this product are ongoing. In the unlikely event that unusual lumps, swollen glands, or growths (especially on the skin) occur, contact your doctor right away.<br /><br /> The US Food and Drug Administration recommends the following: This drug should be used only if other drugs have failed or if other medications are not considered appropriate by your doctor. Tacrolimus should be used on the skin for short treatment periods only. If needed, treatment may be repeated with breaks in between.<br /><br />Use the smallest amount that will treat your condition properly, and apply only on the affected skin. Also, this medication should not be used in children younger than 2 years. As with all medications, discuss the risks, benefits, and proper use of this medication with your doctor.
| Atopic dermatitis | |
| L20 | Atopic dermatitis |
| L20.0 | Besnier's prurigo |
| L20.8 | Other atopic dermatitis |
| L20.81 | Atopic neurodermatitis |
| L20.82 | Flexural eczema |
| L20.84 | Intrinsic (allergic) eczema |
| L20.89 | Other atopic dermatitis |
| L20.9 | Atopic dermatitis, unspecified |
| Intractable eczema | |
| L20.82 | Flexural eczema |
| L20.84 | Intrinsic (allergic) eczema |
| 0-9 | A-Z |
|---|---|
| L20 | Atopic dermatitis |
| L20.0 | Besnier's prurigo |
| L20.8 | Other atopic dermatitis |
| L20.81 | Atopic neurodermatitis |
| L20.82 | Flexural eczema |
| L20.82 | Flexural eczema |
| L20.84 | Intrinsic (allergic) eczema |
| L20.84 | Intrinsic (allergic) eczema |
| L20.89 | Other atopic dermatitis |
| L20.9 | Atopic dermatitis, unspecified |
Formulary Reference Tool