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What is Protopic
TacrolimusThe Generic name of this drug
Treatment SummaryTacrolimus is a drug used to suppress the immune system in order to prevent organ rejection after transplant surgery. It can also be used to treat severe atopic dermatitis, a type of skin condition, and vitiligo, a condition where the skin loses its color. Tacrolimus works by binding to an immunophilin called FKBP-12, which switches off a protein called calcineurin and stops T-lymphocyte cells from sending signals that cause inflammation. Tacrolimus was discovered in 1984 from a Japanese soil sample containing the bacteria Streptomyces tsukubaensis.
Prografis the brand name
Protopic Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Prograf
Tacrolimus
1994
138
Approved as Treatment by the FDA
Tacrolimus, also called Prograf, is approved by the FDA for 3 uses such as Kidney Transplantation and Immunosuppressive Treatment .Kidney Transplantation
Immunosuppressive Treatment
Kidney
Effectiveness
How Protopic Affects PatientsTacrolimus works by attaching to a protein called FKBP-12, which stops the body from sending signals that cause inflammation. It is similar to another drug called cyclosporine, but has been shown to be more effective in preventing rejection of transplanted organs. Tacrolimus is also used to treat eczema, especially atopic eczema, as it suppresses inflammation like steroids but is not as strong. In addition, tacrolimus can be used directly on the face while topical steroids should not be used there since they can thin the skin. For other parts of the body though, topical steroids
How Protopic works in the bodyWe don't know exactly how tacrolimus works to treat atopic dermatitis. But, it appears to prevent cells from creating proteins that cause inflammation. Tacrolimus binds to a protein inside cells and stops them from producing molecules like interleukin-3, interleukin-4, interleukin-5, GM-CSF, and TNF-, which are all related to inflammation. Tacrolimus also stops mast cells and basophils from releasing substances that cause inflammation and it reduces the expression of a protein on Langerhans cells that helps cause inflammation.
When to interrupt dosage
The prescribed dosage of Protopic is contingent upon the confirmed affliction, including Vitiligo, Rejection; Transplant, Kidney and Pyoderma Gangrenosum. The measure of dosage is contingent upon the technique of delivery (e.g. Capsule, gelatin coated - Oral or Topical) as observed in the table underneath.Condition
Dosage
Administration
Dermatitis, Atopic
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Rheumatoid Arthritis
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Liver
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Psoriasis
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Pyoderma Gangrenosum
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Immunocompromised
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Lichen Planus, Oral
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Chronic Graft Versus Host Disease
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Lung
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Dermatitis, Atopic
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Vitiligo
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Kidney Transplantation
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Prophylaxis against heart transplant rejection
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Kidney
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Immunosuppressive Treatment
0.5 mg, , 1.0 mg, 5.0 mg, 0.001 mg/mg, 0.0003 mg/mg, 4.0 mg, 0.75 mg, 3.0 mg, 0.2 mg, 0.03 %, 0.1 %, 5.0 mg/mL, 5.0 mg/mg, 0.00003 mg/mg, 0.003 mg/mg
, Oral, Capsule, Capsule - Oral, Topical, Ointment - Topical, Ointment, Capsule, coated, extended release, Capsule, coated, extended release - Oral, Capsule, gelatin coated, Capsule, gelatin coated - Oral, Tablet, extended release, Tablet, extended release - Oral, Intravenous, Solution - Intravenous, Solution, Capsule, extended release, Capsule, extended release - Oral, Granule, Granule - Oral, Cutaneous, Ointment - Cutaneous, Injection, solution, Injection, solution - Intravenous, Granule, for suspension, Granule, for suspension - Oral, Kit, Cream, Cream - Topical, Solution - Topical
Warnings
Protopic ContraindicationsCondition
Risk Level
Notes
Severe Hypersensitivity Reactions
Do Not Combine
Tacrolimus may interact with Pulse Frequency
Common Protopic Drug Interactions
Drug Name
Risk Level
Description
Abemaciclib
Major
The serum concentration of Abemaciclib can be increased when it is combined with Tacrolimus.
Alectinib
Major
The metabolism of Alectinib can be decreased when combined with Tacrolimus.
Aminophylline
Major
The metabolism of Aminophylline can be decreased when combined with Tacrolimus.
Axitinib
Major
The serum concentration of Axitinib can be increased when it is combined with Tacrolimus.
Bacillus calmette-guerin substrain russian BCG-I live antigen
Major
The therapeutic efficacy of Bacillus calmette-guerin substrain russian BCG-I live antigen can be decreased when used in combination with Tacrolimus.
Protopic Toxicity & Overdose RiskTaking too much of this drug can lead to blurred vision, liver and kidney damage, seizures, shaking, high blood pressure, low magnesium levels, diabetes, high potassium levels, itching, difficulty sleeping, and disorientation. The lowest toxic dose in rats has been found to be between 134 and 194 mg/kg.
Protopic Novel Uses: Which Conditions Have a Clinical Trial Featuring Protopic?
147 active trials are currently being conducted to assess the potential of Protopic for Oral Lichen Planus, Pyoderma Gangrenosum and refractory Rheumatoid Arthritis management.Condition
Clinical Trials
Trial Phases
Pyoderma Gangrenosum
8 Actively Recruiting
Phase 2, Phase 4, Early Phase 1, Phase 3, Not Applicable
Rheumatoid Arthritis
58 Actively Recruiting
Not Applicable, Phase 4, Phase 3, Phase 2, Phase 1
Immunocompromised
5 Actively Recruiting
Phase 3, Not Applicable, Phase 1
Lichen Planus, Oral
0 Actively Recruiting
Vitiligo
9 Actively Recruiting
Phase 2, Phase 3, Not Applicable, Phase 1
Kidney Transplantation
0 Actively Recruiting
Kidney
0 Actively Recruiting
Immunosuppressive Treatment
0 Actively Recruiting
Liver
0 Actively Recruiting
Lung
0 Actively Recruiting
Dermatitis, Atopic
0 Actively Recruiting
Prophylaxis against heart transplant rejection
0 Actively Recruiting
Psoriasis
0 Actively Recruiting
Chronic Graft Versus Host Disease
22 Actively Recruiting
Phase 4, Phase 1, Phase 2, Not Applicable, Phase 3, Early Phase 1
Dermatitis, Atopic
0 Actively Recruiting
Protopic Reviews: What are patients saying about Protopic?
5Patient Review
4/20/2015 I had mixed results with this medication. At first, it seemed to help my eyelids, but then I developed large sores on my lips. This is a serious side effect that you should be aware of before using the medication.
5Patient Review
9/1/2014 I haven't seen any benefits from using this medication.
5Patient Review
1/5/2016 So far, this has worked great for my psoriasis. I was instructed to use it every night until my skin clears up and then twice a week for maintenance. After just two uses, the itchiness, flakiness, and redness were gone. I'm looking forward to seeing how well it works in the long term.
5Patient Review
8/20/2020 This is the only medication that has ever helped clear up my skin issue on my eyelids.
4.3Patient Review
1/25/2016 I started developing eczema around my eyes when I was fourteen. After trying a few different products, this one finally gave me the relief I needed. It burns a little bit at first, but it's definitely worth it!
4Patient Review
6/2/2015 I had eczema as a kid and it started flaring up again around my nose, mouth, and eyelids when I turned 30. I tried everything from lanolin ointment to steroid ointments without any relief for months. But after just three days of using this treatment (twice a day), my eczema was completely gone! It burns a little bit when you first put it on, but the results are more than worth it.
3.3Patient Review
1/13/2015 We tried this treatment for my son's chronic eczema at the doctor's suggestion. While it looked like it was working at first, things quickly took a turn for the worse. He started getting headaches and sore throats, and also developed stomach aches and pains. We're stopping the medication now, and hopefully there won't be any lasting effects from such a short course of treatment.
3.3Patient Review
7/22/2015 I get flare-ups on my eyelids, so bad that my eyes will almost completely swell shut. The first time I used it on my eyelids it burned and itched like fire. Gradually that went away (after a few hours) and after a day or so my the eczema was mostly gone.
2Patient Review
11/27/2014 My teenage son uses this only on flare ups and it clears it after just a few days. I only use it once a day before bed and he hasn't had any side effects. I am afraid to use it on his face though, but some of your review state that it's ok??
2Patient Review
9/30/2017 I've had eczema for over 30 years and have tried everything on the market. Protopic was the first thing that worked long-term, especially for my face. It can burn a little bit when you put it on, but that goes away after a few uses. This medication has been a lifesaver for me.
1Patient Review
10/22/2022 Do not use this cream! I have had psoriasis for 14 years and recently tried this new cream. After only four days, I broke out in painful blisters that are spreading. It's behaving similarly to a second degree burn. Avoid at all costs.
Patient Q&A Section about protopic
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.What is PROTOPIC Ointment used for?
"PROTOPIC Ointment is a prescription medicine used topically to treat eczema. It belongs to a class of medicines called topical calcineurin inhibitors and is for use in adults and children aged 2 years and older who do not have a weakened immune system."
Answered by AI
Is Protopic safe for face?
"This ointment can be applied to any area of the body, except for mucous membranes, including the face, neck, and areas where the skin bends. It shouldn't be applied with an occlusive dressing because this method hasn't been studied in patients."
Answered by AI
Is Protopic a steroid cream?
"There are many treatments for eczema, but Protopic is different because it does not contain steroids. This means that it will not cause any of the side effects of topical steroids."
Answered by AI