PROTOPIC ® Tacrolimus

PROTOPIC® is a Tacrolimus monohydrate drug

THERAPEUTIC GROUP: Other dermatological preparations

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications PROTOPIC ® Tacrolimus

PROTOPIC® is a drug particularly indicated for the treatment of atopic dermatitis, both moderate and severe in patients not responding to corticosteroid therapy or for which the above treatment is contraindicated

Mechanism of action PROTOPIC ® Tacrolimus

PROTOPIC® is a medicinal product based on Tacrolimus, an active ingredient usually used with other doses and with other methods of administration in organ transplants given the important immunosuppressive activity.

Different molecular studies demonstrate the ability of Tacrolimus to bind specific protein factors defined as immunophylline, inhibiting the signal transduction mechanisms that lead to the synthesis of inflammatory cytokines such as interleukins, tumor necrosis factors, interferon and growth factors in T cells.

All this takes the form of a particularly active control of the inflammatory process, controlling both recruitment and activation of inflammatory cells.

Probably the same mechanism of action would be at the base of the therapeutic properties of PROTOPIC® in the course of atopic dermatitis, given however the important role of the immune system in the genesis of this manifestation.

The aforementioned mechanisms of action would also be accompanied by the excellent pharmacokinetic properties of Tacrolimus applied topically, so as to significantly limit the systemic absorption of the product and the consequent appearance of adverse reactions.

Studies carried out and clinical efficacy

THE TACROLIMUS IN THE CHERATOCONGIUNTIVITE

Cornea. 2013 Jun 13. [Epub ahead of print]

Interesting Greek study that demonstrates how the treatment with Tacrolimus at 0.03% can be effective and safe in the course of keratoconjunctivitis, guaranteeing a rapid improvement in symptoms.

TACROLIMUS EFFECTIVE AS A PROTECTIVE IN PATIENTS WITH ATOPIC DERMATITIS

J Dtsch Dermatol Ges. 2013 May; 11 (5): 437-43.

Recent study that demonstrates how Tacrolimus-based ointments can guarantee not only an important anti-inflammatory effect but also significantly improve the skin lipid barrier in patients suffering from atopic dermatitis.

TACROLIMUS NANOPARTICLES

Int J Pharm. 2012 Sep 15; 434 (1-2): 70-9. doi: 10.1016 / j.ijpharm.2012.04.051. Epub 2012 Apr 27.

Interesting study that tests clinical efficacy as well as the typical pharmacokinetic properties of Tacrolimus-based nano particles in patients with atopic dermatitis, demonstrating the best penetrability of the active ingredient in the face of modest side effects, comparable to those of the ointment.

Method of use and dosage

Protopic

Ointment at 0.03% - 0.1% of Tacrolimus monohydrate

Topical Tacrolimus therapy should be set and supervised by a physician experienced in the treatment of atopic dermatitis, always considering intermittent and short-term treatment.

In adults it is generally recommended to use PROTOPIC® at 0.1% twice a day in the initial stages of the disease, taking care to redefine dosages and timing of intake in the subsequent maintenance phases, up to the remission of the complained symptomatology.

Warnings PROTOPIC ® Tacrolimus

The use of PROTOPIC® must necessarily be preceded by a careful medical examination in order to assess the general health conditions of the patient, the prescriptive appropriateness and oriented to inform the patient in relation to the correct sanitary regulations to be respected during the treatment.

In fact, the patient on PROTOPIC® therapy should:

clean hands after each application;
avoid contact of the drug with eyes and mucous membranes;
avoid exposure of the treated region to ultraviolet radiation;
avoid applying emollients or other products through the skin.

The doctor should also prescribe PROTOPIC® with particular caution in patients suffering from immune system disorders, severe liver diseases and above all neoplastic diseases.

PREGNANCY AND BREASTFEEDING

The aforementioned contraindications to the use of PROTOPIC® also extend to pregnancy and the subsequent period of breastfeeding, given the absence of studies able to best characterize the safety profile of this drug for the health of the fetus and infant .

Interactions

The patient on PROTOPIC® therapy should avoid the use of other drugs or emollients via the skin and potential inhibitors or inducers of the cytochromial system, I know the hepatic metabolism of the possible quota of Tacrolimus absorbed.