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 betamethasone dipropionate Specialty [2012.08.03]
Title: Atopic Dermatitis
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 8/3/2012 12:00:00 AM
Eczema (Atopic Dermatitis) Pictures Slideshow: Causes, Symptoms and Treatment
Source: MedicineNet Skin Test For Allergy Specialty [2012.03.26]
Title: Eczema (Atopic Dermatitis) Pictures Slideshow: Causes, Symptoms and Treatment
Category: Slideshows
Created: 3/26/2012 12:00:00 AM
Last Editorial Review: 3/26/2012 12:00:00 AM
Picture of Atopic Dermatitis
Source: MedicineNet pimecrolimus Specialty [2010.12.15]
Title: Picture of Atopic Dermatitis
Category: Images
Created: 12/15/2010 6:54:00 PM
Last Editorial Review: 12/15/2010 6:54:33 PM
Picture of Atopic Dermatitis or Eczema
Source: MedicineNet pimecrolimus Specialty [2009.11.20]
Title: Picture of Atopic Dermatitis or Eczema
Category: Images
Created: 11/20/2009 11:15:00 AM
Last Editorial Review: 11/20/2009 11:15:39 AM
Identification Of Gene Associated With Eczema In Dogs
Source: Veterinary News From Medical News Today [2013.05.13]
A novel gene associated with canine atopic dermatitis has been identified by a team of researchers led by professors Kerstin Lindblad-Toh, Uppsala university and Ake Hedhammar, SLU, Sweden...
Published Studies Related to Protopic (Tacrolimus Topical)
A comparative study in efficacy and safety of 0.1% tacrolimus and 0.05%
clobetasol propionate ointment in discoid lupus erythematosus by modified
cutaneous lupus erythematosus disease area and severity index. [2012]
CONCLUSION: The present study proved the efficacy of twice-daily tacrolimus and
Single-blind, randomized controlled trial evaluating the treatment of facial seborrheic dermatitis with hydrocortisone 1% ointment compared with tacrolimus 0.1% ointment in adults. [2011.11.17]
BACKGROUND: Tacrolimus is a topical calcineurin inhibitor with immunomodulatory, anti-inflammatory, and fungicidal properties that may be beneficial in the treatment of facial seborrheic dermatitis. OBJECTIVES: We sought to compare the efficacy and safety of tacrolimus with standard corticosteroid treatment in adults with facial seborrheic dermatitis in a phase II, single-blind, randomized controlled trial... CONCLUSION: Tacrolimus 0.1% ointment required significantly fewer applications compared with hydrocortisone 1% ointment to achieve a comparable clinical response in adults with facial seborrheic dermatitis. Tacrolimus was generally well tolerated. Copyright (c) 2011 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.
A double-blind, randomized, placebo-controlled trial of topical tacrolimus 0.1% vs. clobetasol propionate 0.05% in childhood vitiligo. [2011.09]
BACKGROUND: Both clobetasol propionate 0.05% (CP 0.05%) and tacrolimus 0.1% (T 0.1%) ointments have been shown to be efficacious and safe in treating vitiligo in the paediatric population. OBJECTIVES: To assess efficacy and safety of these two therapies compared with each other and with placebo... CONCLUSIONS: Both CP 0.05% and T 0.1% ointments offer similar benefit in paediatric vitiligo, both facial and nonfacial. The facial lesions responded faster than the nonfacial ones. (c) 2011 The Authors. BJD (c) 2011 British Association of Dermatologists.
Efficacy of tacrolimus 0.1% ointment in cutaneous lupus erythematosus: a multicenter, randomized, double-blind, vehicle-controlled trial. [2011.07]
BACKGROUND: Topical calcineurin inhibitors are licensed for the treatment of atopic dermatitis; however, the efficacy of tacrolimus in cutaneous lupus erythematosus (CLE) has only been shown in single case reports. OBJECTIVE: In a multicenter, randomized, double-blind, vehicle-controlled trial, we sought to evaluate the efficacy of tacrolimus 0.1% ointment for skin lesions in CLE... CONCLUSION: Explorative subgroup analyses revealed that topical application of tacrolimus 0.1% ointment may provide at least temporary benefit, especially in acute, edematous, non-hyperkeratotic lesions of CLE patients, suggesting that calcineurin inhibitors may represent an alternative treatment for the various disease subtypes. Copyright (c) 2010 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.
Effects of topical corticosteroid and tacrolimus on ceramides and irritancy to sodium lauryl sulphate in healthy skin. [2011.05]
The skin barrier, located in the stratum corneum, is influenced mainly by the lipid and protein composition of this layer... In conclusion, treatment with betamethasone and tacrolimus has a positive effect on the ceramide/cholesterol ratio and susceptibility to irritant reaction compared with an emollient.
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%.
Reports of Suspected Protopic (Tacrolimus Topical) Side Effects
OFF Label USE (26),
Mycosis Fungoides (5),
Maternal Exposure During Pregnancy (5),
Headache (4),
Myocardial Infarction (4),
Blood Potassium Decreased (4),
Drug Ineffective (3),
Pain (3),
Fall (3),
Gastrooesophageal Reflux Disease (3), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 8 ratings/reviews, Protopic has an overall score of 5. The effectiveness score is 6.50 and the side effect score is 6.25. 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 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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| | Protopic review by 18 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | Vaginal Eczema |
| Dosage & duration: | | apply 2/day (dosage frequency: once) for the period of One day |
| Other conditions: | | none |
| Other drugs taken: | | Allegra | | |
Reported Results |
| Benefits: | | none |
| Side effects: | | IT BURNS SO BAD!!!!!! ITCHING AND BURNING LIKE MY WORST ECZEMA NIGHTMARE! LIKE A HEATING PAD HAS BEEN LEFT ON MY BARE SKIN ON HIGH HEAT FOR A LONG TIME. I paid over $100 for this and I don't think I can go through with this to see if it gets better. Not twice a day, I'm miserable right now from putting on for the first time this morning - 2 hours ago and it still is hurting, burning, itching, on fire! I'd take caution when applying this, only do a very small area and do it when you don't have to work or go to school. FML |
| Comments: | | Absolutely not following through with it. |
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Page last updated: 2013-05-13
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