Home > Products > Tacrolim
Share Print This Page

Tacrolim (Tacrolimus)
Therapeutic Group: Skin » Immunomodulator
Presentation

Tacrolim 0.03% Ointment: Each gram ointment contains Tacrolimus INN 300 mcg.

Tacrolim 0.1% Ointment: Each gram ointment contains Tacrolimus INN 1 mg.

Descriptions
Tacrolimus is a macrolide immunomodulator produced by 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.
Indications
Tacrolim 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. Tacrolim Ointment is also indicated in other skin conditions such as chronic cutaneous graft-vs-host disease, hand and foot eczema, allergic contact dermatitis, 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 & Administration
Apply a thin layer of Tacrolim ointment onto the affected skin areas twice daily and rub in gently and completely. Treatment should be continued for one week after clearing of signs and symptoms of atopic dermatitis. The safety of Tacrolim ointment under occlusion which may promote systemic exposure has not been evaluated. Tacrolim ointment should not be used with occlusive dressings.
Side Effects
Topically applied Tacrolimus ointment have very few and rare type of side-effects including skin burning, pruritus, flu-like symptoms, allergic reactions, skin erythema, skin infections, headache, etc.
Precautions
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.
Contraindications
Tacrolimus ointment is contraindicated in patients with a history of hypersensitivity to Tacrolimus or any other component of the preparation.
Use in Pregnancy & Lactation
Pregnancy: Category C- There are 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.
Drug Interaction
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, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.
Overdose
Tacrolimus 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.
Commercial Packaging
Tacrolim 0.03% Ointment: Each tube contains 5 gm Tacrolimus ointment.
Tacrolim 0.1% Ointment: Each tube contains 5 gm Tacrolimus ointment.
Products from the same therapeutic group
Skin
Anti Bacterial
Adaben Duo Gel
Adapalene BP 0.1% & Benzoyl peroxide BP 2.5% gel
Clindacin Cream
Clindamycin 2% w/w
Clindacin lotion
Topical Lotion
Clindacin Plus Gel
Clindamycin 1.2% and Tretinoin 0.025% Gel.
Retapex
Retapamulin 1% ointment
Trego
Mupirocin
Anti Fungal
Clarizol
Clotrimazole 1%
Dancel Shampoo
Ketoconazole 2% shampoo
Econate
Econazole Nitrate cream and tablet.
Nispore
Fluconazole 50 mg, 150 mg, 200mg capsule & Powder for Suspension
Oroconazol
Miconazole 2% oral gel
Topicazole
Miconazole Nitrate BP 2% Cream.
Anti Fungal Combination
Econate Plus
Econazole Nitrate and Triamcinolone Acetonide cream
Topicazole Plus
Miconazole Nitrate and Hydrocortisone Acetate
Anti Hyperpigmenting Agent
Colagel
L-Lysine hydrochloride 15% Gel
Solascren
Padimate O 8%, Avobenzone 2%, Oxybenzone 3% &Titanium dioxide 2%
Spotclen
Hydroquinone cream
TRIMELA
Fluocinolone acetonide 0.01%, Hydroquinone 4% and Tretinoin 0.05%
Anti Viral
Antipruritics
Doxiderm
Doxepin hydrochloride 5%
Itchsol cream
Pramoxine Hydrochloride and Calamine cream
Emollients
Eudrate
Urea BP 10%
Napguard
Zinc Oxide 40% w/w
Planex
Calcipotriol 0.005% Ointment
Hair Growth Inhibitor
WONICA
Eflornithine Hydrochloride Monohydrate INN Cream
Hair Growth Promoter
Xenogrow
Minoxidil topical solution 2%, 5%
Immunomodulator
Aprima
Apremilast 10 mg Tablet
Tacrolim
Tacrolimus 0.03% & 0.1%
Prevention of Keratosis
Kerasol Cream
Salicylic Acid BP
Retinoid
Apalene
Apalene 0.1% Cream
Tazoskin
Tazarotene 0.1% w/w cream.
Scabicide
Elimate Cream
Permethrin
Elimate Plus
Permethrin BP 5% and Crotamiton BP 10%
Steroid Combination
Betaderm N Ointment
Betamethasone 0.1% & Neomycin Sulphate 0.5%
Betamesal Scalp Lotion
Betamethasone 0.05 % & Salicylic Acid 2%
Fortison
Fusidic acid & Hydrocortisone cream
Nyclobate NN
Clobetasol Propionate, Neomycin Sulphate & Nystatin Cream
Steroid Plain
Betaderm Ointment
Betamethasone 0.1%
Lutisone
Fluticasone Propionate Ointment
Momeson Cream
Mometasone Furoate BP 0.1% Cream
Nyclobate
Clobetasol Propionate Cram, Ointment and Scalp Application
Ulticort
Halobetasol Propionate 0.05% Cream