Tacrolimusdrug info

tacrolimus 1 MG Oral Capsule

What it is used for

Tacrolimus capsules are calcineurin-inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in adult patients receiving allogeneic liver, kidney or heart transplants and pediatric patients receiving allogeneic liver transplants in combination with other immunosuppressants.

1.1 Prophylaxis of

Organ Rejection in Kidney, Liver or Heart Transplant Tacrolimus capsules are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant, liver transplants and heart transplant, and pediatric patients receiving allogeneic liver transplants in combination with other immunosuppressants. Additional pediatric use information is approved for Astellas Pharma US, Inc.’s Prograf (tacrolimus) products. However, due to Astellas Pharma US, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective September 28, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Description

Tacrolimus USP, previously known as FK506, is the active ingredient in Tacrolimus capsules, USP. Tacrolimus is a calcineurin-inhibitor immunosuppressant produced by Streptomyces tsukubaensis. Chemically, tacrolimus USP is designated as 15,19-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclotricosine-1,7,20,21(4H,23H)-tetrone 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-3-[2-(4-hy-droxy-3-methoxy cyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18-tetramethyl-8- (2-propenyl)-, mono-hydrate, [3S [3R*,E(1S*,3S*,4S*)], 4S*,5R*,8S*,9E,12R*,-14R*,15S*,16R*,18S*,19S*,26aR*]]-; (-)- (3S,4R,5S,8R, 9E,12S,14S,15R,16S,18R,19R,26aS)-8-Allyl-5,6,8,11,12,13,14,15,16,17,18,19,24, 25,26,26ahexadecahydro- 5,19-dihydroxy-3-[(E)-2-[(1R,3R,4R)-4- hydroxy-3-methoxycyclohexyl]-1-methylvinyl]-14,16- dimethoxy-4,10,12,18-tetramethyl-15,19-epoxy-3Hpyrido[ 2,1-c][1,4] oxaazacyclotricosine-1,7,20,21(4H,23H)- te-trone, monohydrate. The chemical structure of tacrolimus is: Tacrolimus USP has an empirical formula of C 44 H 69 NO 12

H 2 O and a formula weight of 822.03. Tacrolimus USP appears as white to off-white powder. It is soluble in methanol, ethanol, acetone, ethyl acetate and chloroform. Insoluble in water. Tacrolimus USP is available for oral administration as capsules (tacrolimus capsules USP) containing the equivalent of 0.5 mg, 1 mg or 5 mg of anhydrous tacrolimus USP. Inactive ingredients include lactose anhydrous NF, croscarmellose sodium NF, hypromellose USP, magnesium stearate NF. The 0.5 mg capsule shell contains ferric oxide yellow, gelatin NF and titanium dioxide USP, the 1 mg capsule shell contains gelatin NF and titanium dioxide USP, and the 5 mg capsule shell contains ferric oxide red, gelatin NF, and titanium dioxide USP. Contains no ingredient made from a gluten-containing grain (wheat, barley, or rye). The components of red ink used in Tacrolimus capsules USP, 0.5 mg and 1 mg are Shellac, Propylene glycol, Sodium hydroxide, Titanium dioxide, Povidone and FD&C Red Aluminium Lake. The components of white ink used in Tacrolimus capsules USP, 5 mg are Shellac, Propylene glycol, Ammonia solution, Titanium dioxide and Potassium Hydroxide. Tacrolimus capsules meet USP Organic Impurities, Procedure 2. FDA approved dissolution test specifications differ from USP.

This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.

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