PROTOPIC Ressources

Application Information

This drug has been submitted to the FDA under the reference 050777/001.

Names and composition

"PROTOPIC" is the commercial name of a drug composed of TACROLIMUS.
It belongs to the class Immunomodulators and is used in Eczema, pruritus, dry skin conditions (Skin)

Answered questions

Can you help me i want to know if protopic ointment is a cortisteroid?
Asked by Eboni Vancooten 4 months ago.

Protopic is not a corticosteroid - it is an immuno suppressant. It is why you don't have to stop using it after a few weeks. It could be the next wave of drugs to combat eczema and dermatitis, but there could be some troubles with it as well. The FDA released an advisory a few years ago on the immuno suppressant topical ointments like Protopic and Elidel saying they may increase risk of cancer if used in high doses but it is still under investigation. You may want to ask your doctor about his feelings on this. Answered by Gary Tinsley 4 months ago.


I have been using (protopic) ointment. i heard that its give skin cancer?
i heard that protopic ointment can cause skin cancer should i continue to use it? i dont want to put myself at risk Asked by Kathrine Padro 4 months ago.

The Black box warning placed on Protopic was done as a precaution. There have been no cases of cancer reported that were definitely caused by the use of Protopic. Curr Allergy Asthma Rep. 2006 Jul;6(4):270-4. Safety of topical calcineurin inhibitors in atopic dermatitis: evaluation of the evidence.Spergel JM, Leung DY. Topical calcineurin inhibitors (pimecrolimus, Elidel, East Hanover, NJ; and tacrolimus, Protopic, Tokyo, Japan) have been approved for the use in atopic dermatitis since the year 2000. These compounds represent a relatively safe class of topical anti-inflammatory, nonsteroidal therapy. However, in January of 2006, the US Food and Drug Administration issued a black box warning on these compounds about possible concerns of increased long-term malignancy risk due to systemic immunosuppression. To date, studies from clinical trials, systemic absorption, and post-marketing surveillance show no evidence for this systemic immunosuppression or increased risk for any malignancy. PMID: 16822378 Answered by Chia Horwood 4 months ago.

I havent heard that and my Aunt is a nurse and she said that it is ok to use Answered by Hee Foggs 4 months ago.


Will I have cancer now that ive used Protopic for a few years.?
Ive been using it because I have eczema Asked by Doreen Naud 4 months ago.

The Black box warning placed on Protopic was done as a precaution. There have been no cases of cancer reported that were definitely caused by the use of Protopic. Curr Allergy Asthma Rep. 2006 Jul;6(4):270-4. Safety of topical calcineurin inhibitors in atopic dermatitis: evaluation of the evidence.Spergel JM, Leung DY. Topical calcineurin inhibitors (pimecrolimus, Elidel, East Hanover, NJ; and tacrolimus, Protopic, Tokyo, Japan) have been approved for the use in atopic dermatitis since the year 2000. These compounds represent a relatively safe class of topical anti-inflammatory, nonsteroidal therapy. However, in January of 2006, the US Food and Drug Administration issued a black box warning on these compounds about possible concerns of increased long-term malignancy risk due to systemic immunosuppression. To date, studies from clinical trials, systemic absorption, and post-marketing surveillance show no evidence for this systemic immunosuppression or increased risk for any malignancy. PMID: 16822378 Answered by Julene Delpino 4 months ago.

no you do not have a 100% chance of having cancer because of this. If you are that worried about it have your mom take you to the doctors to get checked but i am sure everything will be okay. Answered by Cris Leppink 4 months ago.


Dermatologists or anyone who knows about Protopic!!?
I had little light spots on my arm and my dermatologist put me on hydrocortisone and then put me on protopic. He said he doesnt know if the skin doesnt tan evenly or its a allergic reaction. What is it used for? what do i have? Asked by Ocie Aponta 4 months ago.

I used protopic one time, and it was the worst thing I ever did. I applied it on my neck, and it became insanely itchy, uncomfortable for hours. I have the box infront of me, I don't remember what it's used for, but here it advertises "www.eczemacanada.ca" so it probably is for eczema. Try a bit on yourself first and see the reaction - I don't want you to go through what I had to go through. Answered by Beverlee Frear 4 months ago.


Does anyone here have experience with Protopic ointment for eczema and other skin conditions?
It was prescribed for me after my diabetes reacted horribly to Desonide lotion. Asked by Madelaine Ofsak 4 months ago.

I can actually picture the desonide reacting with your diabetes. If you manage to get some absorbed into your skin it actually increases blood sugar levels because it is a corticosteroid. You might have applied it while you have wet skin or into open skin or you rubbed a cream on top of it to increase absorption. Now protopic (tacrolimus) on the other hand is not a hormone and acts in a cellular level. It blocks helper T1 cells preventing inflammation (ie itch and redness) from occuring. There are rumours that it can cause cancer and no research proves this but the theory is there. Corticosteroids (desonide) as well as Immunomodulators (ie protopic) surpress the immune system. If it's surpressed too long then damaged cells do not become repaired. If damaged cells are not eliminated through the immune system, they can become cancerous. The risk is there but it's low, thats why you should always take a break from using them from time to time to allow your cells to recover. Now concerning protopic, it's not as good as corticosteroids but its safer. It's also considered as long time treatment and you have to apply it right when it STARTS to itch and not full blown. If you have any questions feel free to email me Answered by Torri Haacke 4 months ago.

My little boy had eczema on his cheeks. I was not sure what method to use but I didn't want to make my boy go through any surgery treatments at this young age. Some suggested a plastic surgeon since it was in a very visible location but our family doctor recommend this natural guide. Best Eczema Treatment? Answered by Rickie Muhlbach 4 months ago.

oh u poor thing. I have eczema myself too on my hands along with my brother and sister. My dad or mum doesnt have it either. Mine broke out after i was very sick or was it a hoilday??im not too sure but anyway. My brother doesnt have eczema as long as he mositurizes. Me and my sister use 'Celestone M Cream' We live in Australia It works for us but im not sure if you can put it on ur face. Were meant to use it 3 times a day but i offen forget and only use it once in a while because my eczema isnt that bad anymore. We only use it lightly coz its strong. Ive heard sometimes people grow out of eczema. My hands are getting better. Ive had it since i was 6. Im 15 now. Plz dont hide away coz of ur eczema dont worry about the people normally they just want to understand. I know this lady that has a birthmark on her face and she still works and goes out etc. so dont worry okay? I now its embarrssing. I wanted to hide it too but im starting to appect it...most of my friends now about it and their okay with it. Answered by Mac Scates 4 months ago.

If your reacting badly to prescribed medicine, I'd try some healing salve. It's herbal and may not react as badly if at all. there are plenty of sites to find it to buy or it is easily made at home if you get the ingredients. Hope it helps. Answered by Melva Christofferse 4 months ago.


How effective is Protopic for lichen nitidus?
Asked by Emelina Gaskins 4 months ago.

Google Protopic and see if the site tells you whether it's prescribed for that. Better yet, Google lichen nitidus and see what medicines are recommended. Answered by Suzette Burtless 4 months ago.


My dermatologist has prescribed Protopic to try and clear my steroid induced rosacea, is it effective?
Asked by Naoma Hesselink 4 months ago.

Well, first protopic is not for rosacea, is for Seborrheic dermatitis, that look like rosacea. You should take metronidazole (Metrocream, Metrogel, Noritate). Another prescription medication is azelaic acid (Azelex, Finacea), which reduces redness and inflammation. Talk to your doctor about it. good luck Answered by Arlene Mateos 4 months ago.

Steroids can most definitely induce rosacea. You should only use steroids on the face for the minimum period possible and the mildest form available to treat what is wrong. You Dr. can prescribe some treatments that have been shown to be useful in treating steroid induced rosacea. "tacrolimus 0.075% ointment may be effective for patients with steroid-induced rosacea, when combined with avoidance of topical steroid use, as well as avoidance of other agents known to aggravate rosacea (caffeine, spicy foods, alcohol, hot fluids, and fluoride)." Links Below: over the counter steroids can cause steroid induced rosacea treating steroid induced rosacea the rosacea cortisone/steroid story continues Answered by Edelmira Ortaga 4 months ago.


Protopic ointment for psoriasis
does protopic ointment help reduce psoriasis?? if it does, is it really effective? have anyone tried this before Asked by Piper Brom 4 months ago.

i have used protopic ointment before but for eczema and it didnt help at all,whenever i applied it to my eczema and went outside the sun would cause my eczema to itch even more....also the ointment is very oily and greasy which bothered me a lot. Answered by Rey Geres 4 months ago.


Is it safe to use Protopic twice a day for several months?
Asked by Warren Hevesy 4 months ago.

My daughter uses Protopic for dermatitis on her hands. The usual regimine is to use it for a few weeks, when symptoms are gone to stop. There is some case studies of prolonged use causing skin cancer, so ask your doctor exactly how long he expects you to be on it. Answered by Maurita Rabeck 4 months ago.


Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
050777/001 PROTOPIC TACROLIMUS OINTMENT/TOPICAL 0.03%
050777/002 PROTOPIC TACROLIMUS OINTMENT/TOPICAL 0.1%

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
050708/001 PROGRAF TACROLIMUS CAPSULE/ORAL EQ 1MG BASE
050708/002 PROGRAF TACROLIMUS CAPSULE/ORAL EQ 5MG BASE
050708/003 PROGRAF TACROLIMUS CAPSULE/ORAL EQ 0.5MG BASE
050709/001 PROGRAF TACROLIMUS INJECTABLE/INJECTION EQ 5MG BASE per ML
050777/001 PROTOPIC TACROLIMUS OINTMENT/TOPICAL 0.03%
050777/002 PROTOPIC TACROLIMUS OINTMENT/TOPICAL 0.1%
065461/001 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 0.5MG BASE
065461/002 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 1MG BASE
065461/003 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 5MG BASE
090402/001 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 5MG BASE
090509/001 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 0.5MG BASE
090509/002 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 1MG BASE
090509/003 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 5MG BASE
090596/001 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 0.5MG BASE
090596/002 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 1MG BASE
090596/003 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 5MG BASE
090687/001 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 0.5MG BASE
090687/002 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 1MG BASE
090687/003 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 5MG BASE
090802/001 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 0.5MG BASE
090802/002 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 1MG BASE
090802/003 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 5MG BASE
091195/001 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 0.5MG BASE
091195/002 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 1MG BASE
091195/003 TACROLIMUS TACROLIMUS CAPSULE/ORAL EQ 5MG BASE
200744/001 TACROLIMUS TACROLIMUS OINTMENT/TOPICAL 0.03%
200744/002 TACROLIMUS TACROLIMUS OINTMENT/TOPICAL 0.1%
204096/001 ASTAGRAF XL TACROLIMUS CAPSULE, EXTENDED RELEASE/ORAL EQ 0.5MG BASE
204096/002 ASTAGRAF XL TACROLIMUS CAPSULE, EXTENDED RELEASE/ORAL EQ 1MG BASE
204096/003 ASTAGRAF XL TACROLIMUS CAPSULE, EXTENDED RELEASE/ORAL EQ 5MG BASE
206406/001 ENVARSUS XR TACROLIMUS TABLET, EXTENDED RELEASE/ORAL EQ 0.75MG BASE
206406/002 ENVARSUS XR TACROLIMUS TABLET, EXTENDED RELEASE/ORAL EQ 1MG BASE
206406/003 ENVARSUS XR TACROLIMUS TABLET, EXTENDED RELEASE/ORAL EQ 4MG BASE

Manufacturers

Manufacturer name
Leo Pharma

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