DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Protopic (Tacrolimus Topical) - Summary

 

-- advertisement --

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.

 

PROTOPIC SUMMARY

PROTOPIC®(tacrolimus)

Ointment 0.03%
Ointment 0.1%

FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE

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.

PROTOPIC NEWS HIGHLIGHTS

Media Articles Related to Protopic (Tacrolimus Topical)

Atopic Dermatitis
Source: MedicineNet Hives Specialty [2008.06.03]

more>>

Published Studies Related to Protopic (Tacrolimus Topical)

Topical tacrolimus 0.1% improves symptoms of hand dermatitis in patients treated with a prednisone taper. [2008.07]

Proactive treatment of atopic dermatitis in adults with 0.1% tacrolimus ointment. [2008.07]

Topical treatment of mild to moderate plaque psoriasis with 0.3% tacrolimus gel and 0.5% tacrolimus cream: the effect on SUM score, epidermal proliferation, keratinization, T-cell subsets and HLA-DR expression. [2008.04]

A comparative treatment study of topical tacrolimus and clobetasol in oral lichen planus. [2008.02]

Comparison of cutaneous tolerance and efficacy of calcitriol 3 mug g(-1) ointment and tacrolimus 0.3 mg g(-1) ointment in chronic plaque psoriasis involving facial or genitofemoral areas: a double-blind, randomized controlled trial. [2007.11]

more>>

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]

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]

A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation [Active, not recruiting]

Distribution of Tacrolimus in Skin, Atopic Dermatitis [Completed]

more>>

Page last updated: 2008-08-10

-- advertisement -- The American Red Cross

We comply with
HONcode standard.
Verify here.
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2008