SPL Set ID: 9f64692d-2a18-ffcb-c572-0f218a71ca67

1 drug(s) with this SPL Set ID

Open DailyMed details

Sirolimus SIROLIMUS
60 mg/60 ml Liquid
APOTEX CORP FDA Rx Only

Sirolimus is an mTOR inhibitor immunosuppressive agent. Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. The chemical name of sirolimus (also known as rapamycin) is (2S, 10R, 11R, 14S, 16S, 18E, 20E, 22E, 23S, 25R, 27R, 28R, 30E, 31R, 34S)- 2, 3, 4, 5, 10, 11, 12, 13, 14, 15, 16, 23, 24, 25, 27, 28-hexadecahydro-10, 28-dihydroxy-34-[(1R)-2-[(1S,3R,4R)-4-hydroxy-3-methoxycyclohexyl]-1-methylethyl]- 16, 27-dimethoxy-11, 17, 23, 25, 29,31-hexamethyl-10,14-epoxy-34H-pyrido[2,1-c][1,4]-oxaazacyclohentriacontine-1, 8, 9, 26,32 (6H, 31H, 33H)-pentone. Its molecular formula is C 51 H 79 NO 13 and its molecular weight is 914.17 g/mol. The structural formula of sirolimus is illustrated as follows. Sirolimus is a white to off-white powder and is insoluble in water, but freely soluble in ether, chloroform, acetone, methanol, dimethylformamide, isopropanol and ethyl acetate. Sirolimus is available for administration as an oral solution containing 1 mg/mL sirolimus. The inactive ingredients in sirolimus oral solution are Phosal 50 PG ® (ascorbyl palmitate, ethanol, lysophosphatidylcholine, phosphatidylcholine, propylene glycol, sunflower mono- diglycerides, and water) and polysorbate 80. Sirolimus oral solution contains 1.5% to 2.5% ethanol. Chemical Structure

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