A1,
A2,
B,
C1,
C2,
D,
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F,
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P2,
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Rapamune Online, Description, Chemistry, Ingredients - Sirolimus
Rapamune Online, Description, Chemistry, Ingredients - Sirolimus
DESCRIPTION
WARNING:
Increased susceptibility to infection and the possible development of
lymphoma may result from immunosuppression. Only physicians experienced
in immunosuppressive therapy and management of renal transplant patients
should use Rapamune®. Patients receiving the drug should be managed in
facilities equipped and staffed with adequate laboratory and supportive
medical resources. The physician responsible for maintenance therapy should
have complete information requisite for the follow-up of the patient.
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Rapamune® (sirolimus) is an immunosuppressive agent. Sirolimus is a macrocyclic
lactone produced by Streptomyces hygroscopicus . The chemical name of
sirolimus (also known as rapamycin) is (3 S ,6 R ,7 E ,9
R ,10 R ,12 R ,14 S ,15 E ,17 E ,
19 E ,21 S ,23 S ,26 R ,27 R ,34a S )-9,
10,12,13,14,21,22, 23,24,25,26,27,32,33,34,34a- hexadecahydro-9,27-dihydroxy-3-[(1
R )-2-[(1 S ,3 R ,4 R )-4 -hydroxy-3-methoxycyclohexyl]
-1-methylethyl]-10,21-dimethoxy- 6,8,12,14,20,26-hexamethyl-23, 27-epoxy-3 H
-pyrido[2,1- c ][1,4] oxaazacyclohentri-acontine-1,5,11,28,29 (4
H ,6 H ,31 H )- pentone. Its molecular formula is C 51
H 79 NO 13 and its molecular weight is 914.2.
Sirolimus is a white to off-white powder and is insoluble in water, but freely
soluble in benzyl alcohol, chloroform, acetone, and acetonitrile.
Rapamune® is available for administration as an oral solution containing 1
mg/mL sirolimus and as a white, triangular-shaped tablet containing 1 mg sirolimus.
The inactive ingredients in Rapamune® Oral Solution are Phosal 50 PG® (phosphatidylcholine,
propylene glycol, mono- and di-glycerides, ethanol, soy fatty acids, and ascorbyl
palmitate) and polysorbate 80. Rapamune Oral Solution contains 1.5%-2.5% ethanol.
The inactive ingredients in Rapamune® Tablets include sucrose, lactose, polyethylene
glycol 8000, calcium sulfate, microcrystalline cellulose, pharmaceutical glaze,
talc, titanium dioxide, magnesium stearate, povidone, poloxamer 188, polyethylene
glycol 20,000, glyceryl monooleate, carnauba wax, and other ingredients.
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