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.
|
|
PROTOPIC SUMMARY
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 as second-line
therapy for the short-term and non-continuous chronic treatment of
moderate to severe atopic dermatitis in non-immunocompromised adults and
children who have failed to respond adequately to other topical prescription
treatments for atopic dermatitis, or when those treatments are not
advisable.
PROTOPIC Ointment is not indicated for children younger than
2 years of age (see boxed WARNING, WARNINGS and PRECAUTIONS:
Pediatric
Use).
|
|
NEWS HIGHLIGHTSMedia Articles Related to Protopic (Tacrolimus Topical)
EU Approves Dupilumab (Dupixent) for Atopic Dermatitis Source: Medscape Allergy & Clinical Immunology Headlines [2017.09.28] The European Commission has granted marketing authorization to dupilumab for adults with moderate to severe atopic dermatitis, according to a company news release. International Approvals
Atopic Eczema (Atopic Dermatitis) Quiz: Test Your Skin Disorders IQ Source: MedicineNet Atopic Dermatitis Specialty [2017.09.20] Title: Atopic Eczema (Atopic Dermatitis) Quiz: Test Your Skin Disorders IQ Category: MedicineNet Quiz Created: 3/20/2012 12:50:00 PM Last Editorial Review: 9/20/2017 12:22:53 PM
Atopic Dermatitis Source: MedicineNet betamethasone dipropionate Specialty [2016.12.21] Title: Atopic Dermatitis Category: Diseases and Conditions Created: 12/31/1997 12:00:00 AM Last Editorial Review: 12/21/2016 12:00:00 AM
Eczema (Atopic Dermatitis) Causes, Symptoms, Treatment Source: MedicineNet tacrolimus ointment Specialty [2016.05.24] Title: Eczema (Atopic Dermatitis) Causes, Symptoms, Treatment Category: Slideshows Created: 3/26/2012 12:00:00 AM Last Editorial Review: 5/24/2016 12:00:00 AM
Published Studies Related to Protopic (Tacrolimus Topical)
Pimecrolimus vs. tacrolimus for the topical treatment of unresponsive oral
erosive lichen planus: a 8 week randomized double-blind controlled study. [2014] CONCLUSION: Both medications would currently appear to be a treatment of choice
Topical tacrolimus significantly promotes repigmentation in idiopathic guttate
hypomelanosis: a double-blind, randomized, placebo-controlled study. [2013] compared with placebo in the treatment of IGH... CONCLUSION: Topical 0.1% tacrolimus ointment appeared to be an effective and safe
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.
Clinical Trials Related to Protopic (Tacrolimus Topical)
Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients [Completed]
This trial was designed to address important issues that impact recipients of liver
allografts as well as clinicians, ie, renal function, reduction or discontinuation of
tacrolimus early post-transplantation, and progression rate of fibrosis in hepatitis C virus
(HCV) positive patients.
A Multicenter Study in Liver Transplant Patients Converted From Prograf� to Advagraf� During the First Post-transplantation Year [Recruiting]
A study in which two groups of patients will be analysed; patients converted from Prograf to
Advagraf within the first 3 months after transplantation and patients converted from Prograf
to Advagraf between 3 months and 1 year after transplantation.
Pharmacokinetic Studies of Tacrolimus in Transplant Patients [Completed]
The study is designed to compare the steady-state pharmacokinetics of Prograf (Brand) and
the two most disparate generic formulations (Generic Hi and Generic Lo) in a fully
replicated, 3-way cross-over study in stable kidney (n=36) and liver transplant (n=36)
subjects.
A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®) [Recruiting]
Assessment in a real situation of the conversion conditions, the efficacy and the safety of
the treatment with tacrolimus in renal transplant patients converted from the tacrolimus
twice per day form (Prograf®) to the tacrolimus once per day form (Advagraf®) with follow-up
at one year.
Analysis of two groups of patients: patients converted from Prograf® to Advagraf® early
(during the first 6 months post-transplantation) or late (between 6 and 12 months
post-transplantation).
A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation [Recruiting]
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 >>
|
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. |
|
| 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 |
|
| 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. |
|
|
Page last updated: 2017-09-28
|