BOX WARNING
WARNING
Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established
Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including PROTOPIC Ointment.
Therefore:
- Continuous long-term use of topical calcineurin inhibitors, including PROTOPIC Ointment, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.
- PROTOPIC Ointment is not indicated for use in children less than 2 years of age. Only 0.03% PROTOPIC Ointment is indicated for use in children 2-15 years of age.
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PROTOPIC SUMMARY
Absorption
PROTOPIC (tacrolimus) Ointment contains tacrolimus, a macrolide immunosuppressant produced by
Streptomyces tsukubaensis. It is for topical dermatologic use only.
PROTOPIC Ointment, both 0.03% and 0.1% for adults, and only 0.03% for children aged 2 to 15 years, is indicated for short-term and intermittent long-term therapy in the treatment of patients with moderate to severe atopic dermatitis in whom the use of alternative, conventional therapies are deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or are intolerant of alternative, conventional therapies.
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NEWS HIGHLIGHTSMedia Articles Related to Protopic (Tacrolimus Topical)
Atopic Dermatitis
Source: MedicineNet mupirocin Specialty [2008.06.03]
Title: Atopic Dermatitis
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 6/3/2008
Published Studies Related to Protopic (Tacrolimus Topical)
Response of vitiligo to once- vs. twice-daily topical tacrolimus: a controlled prospective, randomized, observer-blinded trial. [2009.08]
BACKGROUND: A few studies on the treatment of vitiligo with topical tacrolimus have been published and showed promising results. However, most of these trials were uncontrolled. OBJECTIVE: This study aims to assess the response of vitiligo to once- or twice-daily treatment with 0.1% tacrolimus in a controlled, randomized, observer-blinded study... CONCLUSIONS: Tacrolimus ointment appears to be an effective treatment option for facial vitiligo. A guarded prognosis is advisable for vitiliginous lesions on other localizations. Treatment must be applied twice daily for optimum response.
The pharmacokinetics of tacrolimus after first and repeated dosing with 0.03% ointment in infants with atopic dermatitis. [2009.04]
BACKGROUND: In adults and children aged > 2 years, systemic absorption of tacrolimus from tacrolimus ointment is very low. In this study, the pharmacokinetics of tacrolimus 0.03% ointment were investigated in infants aged 3-24 months... CONCLUSIONS: Tacrolimus 0.03% ointment in infants is associated with very low systemic exposure to tacrolimus. Treatment was well tolerated and led to considerable clinical improvement.
Efficacy of topical tacrolimus 0.1% in active plaque morphea: randomized, double-blind, emollient-controlled pilot study. [2009]
BACKGROUND: Tacrolimus, a calcineurin inhibitor, is an immunomodulating and anti-inflammatory drug that inhibits T-cell activation and production of cytokines. The elevated level of cytokines in morphea causes fibroblast proliferation and subsequent overproduction of collagen. Theoretically, tacrolimus could inhibit the pathophysiologic process of morphea. OBJECTIVE: To assess whether tacrolimus 0.1% ointment is an effective treatment for active plaque morphea in a double-blind, placebo (petroleum emollient)-controlled pilot study... CONCLUSION: In this first double-blind, placebo-controlled pilot study comparing tacrolimus 0.1% ointment with petrolatum in active plaque morphea, tacrolimus 0.1% ointment was shown to be an effective treatment for this condition.
Three times weekly tacrolimus ointment reduces relapse in stabilized atopic dermatitis: a new paradigm for use. [2008.12]
OBJECTIVE: Long-term, safe and effective therapeutic options for managing the chronic relapsing nature of atopic dermatitis are essential for improving patient quality of life. To minimize the risks of continued topical corticosteroid usage and potentially reduce the incidence of flares, we tested the efficacy and safety of a rotational paradigm of initial brief application of topical corticosteroid followed by long-term intermittent application of non-steroidal tacrolimus ointment to previously inflamed sites of dermatitis... CONCLUSIONS: For patients with stabilized moderate to severe atopic dermatitis, long-term intermittent application of tacrolimus ointment to normal-appearing but previously affected skin was significantly more effective than vehicle at maintaining disease stabilization, with a safety profile similar to vehicle.
Proactive disease management with 0.03% tacrolimus ointment for children with atopic dermatitis: results of a randomized, multicentre, comparative study. [2008.12]
BACKGROUND: Long-term treatment for atopic dermatitis (AD) using low-dose, intermittent, topical anti-inflammatory agents may control acute disease and prevent exacerbations. OBJECTIVES: This 12-month, European, multicentre, randomized study investigated if proactive, twice-weekly application of 0.03% tacrolimus ointment can keep AD in remission and reduce the incidence of disease exacerbation (DE) in children... CONCLUSIONS: Twice-weekly proactive application of 0.03% tacrolimus ointment over 12 months was effective for most paediatric study patients in preventing, delaying and reducing the occurrence of AD exacerbations.
Clinical Trials Related to Protopic (Tacrolimus Topical)
A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients [Active, not recruiting]
This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf®
in stable liver transplantation patients. It shall be demonstrated that FK506MR is
non-inferior to Prograf® with regards to the efficacy and safety.
Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects [Completed]
A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation [Active, not recruiting]
The patients about to undergo liver transplantation will be randomized to one of the
following two group:
Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3
months(12 weeks
A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation [Active, not recruiting]
The patients about to undergo kidney transplantation will be randomized to one of the
following two group:
Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment
period is 3 months( 12 weeks)
Distribution of Tacrolimus in Skin, Atopic Dermatitis [Completed]
This study was designed to further increase the understanding of the pharmacokinetics of
tacrolimus in the affected skin of atopic dermatitis patients following repeated topical
application of tacrolimus ointment 0. 1%.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 5 ratings/reviews, Protopic has an overall score of 6.80. The effectiveness score is 7.60 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Protopic review by 42 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | eczema |
| Dosage & duration: | | pearl size (dosage frequency: twice daily) for the period of 3 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | cleared up chronic eczema. Especially effective on elbows and legs. |
| Side effects: | | I did not experience side effects all though I was warned to avoid exposing treated area to sunlight. |
| Comments: | | I was told to use this once in the morning and once before going to bed. I had to use it on clean skin, and to make sure ointment fully absorbed. I started to see improvements within days. I was warned that I might have recurrence of eczema after a few months, but I didn't. |
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| | Protopic review by 50 year old male patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Ineffective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | vitalago |
| Dosage & duration: | | thin layer to affected area (dosage frequency: once daily) for the period of 3 months |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | The benefit that was hoped for was a repigmentation of the skins on my hands. Apparently my dermatologist had used this treatment on a number of patients and had received a good success rate. I did not see any benefits over the time I used the product (3 months) but was advised that I needed to continue treatment. |
| Side effects: | | There were no noticeable side effects that I was aware of. The product is an ointment with a rather oily feel and needs to be left on the effected areas for some period of time so I applied it at night. I did not find that it had any effect in any positive or negative way over the period I applied it. |
| Comments: | | I was asked by the prescribing doctor to apply the ointment once a day to the affected areas (the back of both of my hands). This was the entire process and I was to report back to him within a period of approximately six months. This was a rather experimental treatment. I applied the product as instructed but did not notice any repigmentation during the time I applied it (around 3 months). I subsequently was advised by the doctor that I needed to continue the application, for a total period of at least six months |
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| | Protopic review by 37 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | eczema |
| Dosage & duration: | | apply twice daily (dosage frequency: twice daily) for the period of 2 months |
| Other conditions: | | made the itch worse |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | none - the benefit was supposed to be due to the fact that it wasn't a steroid cream |
| Side effects: | | burning and itching worse than the eczema - I'd have to race to the shower and wash off remaining product - it was terrible |
| Comments: | | apply twice daily
but I'd have to wash it off w/in an hour because it burned so badly |
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Page last updated: 2009-10-20
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