Tacrel Forte Ointment (tacrolimus 0.1%)

Tacrel Forte general information

What is Tacrel Forte used for?

Tacrel Forte Ointment 0.1% is used to treat moderate to severe atopic dermatitis in adults and children who have not responded well to other topical treatments including emollients, topical and oral steroids, antibiotics and phototherapy, or who cannot tolerate other treatments due to side effects.  Atopic dermatitis, which is a form of eczema, is one of a group of atopic conditions that have an inherited predisposition and includes asthma and hay fever.  It is characterised by inflammation of the skin due to overreaction of the immune system, with scaly patches of itchiness, redness and dryness that appear usually on the face, hands, wrists and back of the knees but can affect skin on other areas of the body.  Atopic dermatitis can settle for periods after treatment, giving the skin a chance to clear and heal, but it can then flare up again; Tacrel Forte Ointment is also use to prevent flares and prolong flare-free intervals in cases where the exacerbations occur frequently, more than 4 times a year. 

How does Tacrel Forte work?

Tacrel Forte Ointment 0.1% contains tacrolimus, which is an immunomodifying drug belonging to the macrolide lactones group of drugs and has similar activity to cyclosporine, an immunosuppressive that is given orally to prevent transplant rejection.  Tacrolimus in Tacrel Forte Ointment acts directly on the T-cells of the immune system in the skin inhibiting the production by T-cells of specific interleukins like IL-2, which cause inflammation.  Normally T-cells are activated via an intracellular calcium dependent signal transduction mechanism that is stimulated by increase in intracellular calcium.  This in turn activates the mediator called calcineurin, which regulates the transcription of specific genes for IL-2.  Tacrolimus in Tacrel Forte Ointment binds to a receptor inside the cell called FKBP12 and this complex inhibits the action of calcineurin and thereby reduces the transcription of genes for IL-2 and the consequent activation of T-cells, including T-cell replication and production of IL-2 and other interleukins and cytokines¹.  Tacrel Forte Ointment helps damp down the immune system at the site of the inflammatory skin reaction, relieving symptoms of dermatitis and eczema.

What does Tacrel Forte contain?

Tacrel Forte Ointment contains the active ingredient tacrolimus (0.1% w/w), an immunomodifying agent used to treat severe atopic dermatitis.

Treating atopic dermatitis with Tacrel Forte

Tacrel Forte Ointment 0.1% contains tacrolimus an immunomodifying drug used to treat moderate to severe atopic dermatitis, in adults and children who have not responded well to other topical treatments including emollients, topical and oral steroids, antibiotics and phototherapy, or who cannot tolerate other treatments due to side effects.  Atopic dermatitis, which is a form of eczema, is one of a group of atopic conditions that have an inherited predisposition and includes asthma and hay fever.  It is characterised by inflammation of the skin due to overreaction of the immune system, with scaly patches of itchiness, redness and dryness that appear usually on the face, hands, wrists and back of the knees but can affect skin on other areas of the body. After treatment the inflammation can settle but then flare up again as the skin is sensitive to triggers like dry air with low humidity, seasonal allergies, exposure to harsh soaps and detergents, and cold weather.  Tacrel Forte Ointment 0.1% is also used to prevent exacerbations and flares.  Tacrolimus in Tacrel Forte Ointment acts directly on the T-cells of the immune system in the skin by inhibiting the production by T-cells of specific interleukins like IL-2, which cause inflammation via inhibition of the of calcineurin in the skin that normally regulates T-cell activation. 

What are the side effects of Tacrel Forte?

The most commonly reported side effects when taking Tacrel Forte Ointment include: skin irritation, pruritus (itching), redness and burning at the site of application, local skin infection and infection of the hair follicle, skin tingling, increased sensitivity of the skin to hot, cold, touch and pain, facial flushing after consumption of alcohol.

When should Tacrel Forte not be used?

You should not use Tacrel Forte Ointment if you:

• are allergic to tacrolimus or any other macrolide or any ingredients in Tacrel Forte
• are pregnant or are breastfeeding
• have liver failure
• have infected lesions on the skin or a viral skin infection such as shingles, cold sores or warts
• have a condition with disrupted skin barrier function, such as Netherton syndrome, lamellar ichthyosis (extensive scaling of the skin due to a thickening of the outer layer of the skin), or if you suffer from generalised erythroderma (inflammatory reddening and scaling of the entire skin) as these skin conditions may increase systemic absorption of tacrolimus
• spend a lot of time exposed to sunlight, without protection, as the skin may have increased sensitivity to UV light
• have swollen lymph nodes when you start treatment
• have a skin malignancy or are immunocompromised (weakened immune system)

How should Tacrel Forte be used?

You should apply your Tacrel Forte Ointment as a thin layer to your skin twice daily and rubbing gently into the skin until it is fully absorbed.  You should see an improvement within a week but you should continue to apply your Tacrel Forte Ointment until your skin has cleared and for as long as recommended by your doctor, which may be for several weeks or months if the dermatitis flares up again.  For maintenance treatment you should apply your Tacrel Forte Ointment once or twice weekly, depending on your doctor’s recommendation.  Always wash your hands after applying your Tacrel Forte Ointment and avoid contact with eyes and mucous membranes.  You should not use occlusive dressings over the area of dermatitis after applying your Tacrel Forte Ointment.

How long should you use Tacrel Forte?

You should continue to apply your Tacrel Forte Ointment until your skin has cleared and for as long as recommended by your doctor, which may be for several weeks or months if the dermatitis flares up again. 

Missed dose of Tacrel Forte

If you miss a dose of Tacrel Forte apply it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.

How should Tacrel Forte be stored?

You should store your Tacrel Forte below 25°C in a cool dry place. 

References

1. Ashcroft DM, Dimmock P, Garside R, Stein K, Williams HC.  Efficacy and tolerability of topical pimecrolimus and tacrolimus in the treatment of atopic dermatitis: meta-analysis of randomised controlled trials. BMJ 2005;330:516.