SPL Set ID: a7072c60-6dbf-4125-95e7-497c05a9e6a6
1 drug(s) with this SPL Set ID
Lopinavir and ritonavir tablets, USP are a co-formulation of lopinavir USP and ritonavir USP. Lopinavir is an inhibitor of the HIV-1 protease. As co-formulated in lopinavir and ritonavir tablets, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. Lopinavir USP is chemically designated as [1 S -[1 R *,( R *),3 R *,4 R *]]- N -[4-[[(2,6- dimethylphenoxy)acetyl]amino]-3-hydroxy-5-phenyl-1-(phenylmethyl)pentyl]tetrahydro-α-(1-methylethyl)-2-oxo-1(2 H )-pyrimidineacetamide. Its molecular formula is C 37 H 48 N 4 O 5 , and its molecular weight is 628.8 g/mol. Lopinavir USP is a white to off-white color solid. It is freely soluble in methanol, soluble in isopropyl alcohol and practically insoluble in water. Lopinavir USP has the following structural formula: Ritonavir USP is chemically designated as 2,4,7,12-Tetraazatridecan-13-oic acid, 10-hydroxy-2-methyl-5-(1-methylethyl)-1-[2-(1-methylethyl)-4-thiazolyl]-3,6-di-oxo-8,11-bis(phenylmethyl)-5-thiazolylmethylester[5 S -(5 R *,8 R *,10 R *,11 R *)]-. Its molecular formula is C 37 H 48 N 6 O 5 S 2 , and its molecular weight is 720.94 g/mol. Ritonavir USP is a white or almost white solid. It is freely soluble in methanol and in dichloromethane; very slightly soluble in acetonitrile; practically insoluble in water. Ritonavir USP has the following structural formula: Lopinavir and ritonavir tablets, USP are available for oral administration in two strengths: Yellow tablets containing 200 mg of lopinavir USP and 50 mg of ritonavir USP. Yellow tablets containing 100 mg of lopinavir USP and 25 mg of ritonavir USP. The yellow, Lopinavir and Ritonavir Tablets USP, 200 mg/50 mg contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate and sorbitan monolaurate. The following are the ingredients in the film coating: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide yellow, polyethylene glycol 400, polyethylene glycol 3350, polysorbate 80, talc, and titanium dioxide. The yellow, Lopinavir and Ritonavir Tablets USP, 100 mg/25 mg contain the following inactive ingredients: colloidal silicon dioxide, copovidone, sodium stearyl fumarate and sorbitan monolaurate. The following are the ingredients in the film coating: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide yellow, polyethylene glycol 400, polyethylene glycol 3350, polysorbate 80, talc, and titanium dioxide. lopinavir-structure ritonavir-structure