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Tacrolimus is a macrolide immunomodulalor produced by fungus Streptomyces tsukubaensis. It has been demonstrated that Tacrolimus inhibits T-lymphocyte activation by first binding to an intracellular protein, FKBP-12. A complex of Tacrolimus -FKBP-12, calcium, calmodulin and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This leads to a general decrease in the entire inflammatory cascade.
Dermus Ointment: Each gram ointment contains Tacrolimus USP 300 mcg.
Indications And Uses
Dermus ointment 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. Dermus ointment is also indicated in other skin conditions such as chronic cutaneous graft-vs-host disease, hand and foot eczema, allergic contact dermatitis, vitiligo, psoriasis, lichen planus, facial lichen, vulvar lichen sclerosus, pyoderma gangrenosum, leg ulcers in rheumatoid arthritis, steroid-induced rosacea & alopecia areata. annular erythema, chronic actinic dermatitis and recalcitrant facial erythema.
Dosage And Administration
Apply a thin layer of Dermus ointment onto the affected skin areas twice daily and rub in gentry and completely. Treatment should be continued for one week after clearing of signs and symptoms of atopic dermatitis. The safety of Dermus ointment under occlusion which may promote systemic exposure has not been evaluated. Dermus ointment should not be used with occlusive dressings.
Topically applied Dermus ointment have very few and rare type of side-effects including skin burning, pruritus. Fu-like symptoms, allergic reactions, skin erythema, skin infections, headache, etc
Cautions should be exercised while treatment with Tacrolimus ointment in patients with atopic dermatitis predisposed to superficial skin infections. The safety of Tacrolimus ointment has not been established in patients with generalized erythroderma.
Use In Pregnancy Lactation
Pregnancy: Category C; There is no adequate and well-controlled studies of topically administered Tacrolimus in pregnant women. The experience with Tacrolimus ointment when used by pregnant women is too limited to permit assessment of the safety of its use during pregnancy. Nursing Mothers: Although systemic absorption of Tacrolimus following topical applications of Tacrolimus ointment is minimal relative to systemic administration, it is known that Tacrolimus is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Tacrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Formal topical drug interaction studies with Tacrolimus ointment have not been conducted. The concomitant administration of known CYP3A4 inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are Erythromycin, Intraconazole, Ketoconazole, Fluconazole, calcium channel blockers and Cimetidine.
Dermus ointment is not for oral use. Accidental oral ingestion of Tacrolimus ointment may lead to adverse effects associated with systemic administration of Tacrolimus. If oral ingestion occurs, medical advice should be sought
Dermus ointment is contraindicated in patients with a history of hypersensitivity to Tacrolimus or any other component of the preparation.
Dermus ointment: Each tube contains 5 gm Tacrolimus ointment. Dermus 10 ointment: Each tube contains 10 gm Tacrolimus ointment.