Source: FDA, National Drug Code (US) Revision Year: 2020
JUXTAPID capsules contain lomitapide mesylate, a synthetic lipid-lowering agent for oral administration.
The chemical name of lomitapide mesylate is N-(2,2,2-trifluoroethyl)9[4-[4-[[[4'-(trifluoromethyl)[1,1'-biphenyl]-2-yl]carbonyl]amino]-1-piperidinyl]butyl]-9H-fluorene-9-carboxamide, methanesulfonate salt.
Its structural formula is:
The empirical formula for lomitapide mesylate is C39H37F6N3O2∙CH4O3S and its molecular weight is 789.8.
Lomitapide mesylate is a white to off-white powder that is slightly soluble in aqueous solutions of pH 2 to 5. Lomitapide mesylate is freely soluble in acetone, ethanol, and methanol; soluble in 2-butanol, methylene chloride, and acetonitrile; sparingly soluble in 1-octanol and 2-propanol; slightly soluble in ethyl acetate; and insoluble in heptane.
Each JUXTAPID capsule contains lomitapide mesylate equivalent to 5, 10, 20, or 30 mg lomitapide free base and the following inactive ingredients: pregelatinized starch, sodium starch glycolate, microcrystalline cellulose, lactose monohydrate, silicon dioxide and magnesium stearate. The capsule shells of all strengths contain gelatin and titanium dioxide; the 5 mg, 10 mg and 30 mg capsules also contain red iron oxide; and the 30 mg capsules also contain yellow iron oxide. The imprinting ink contains shellac, black iron oxide, and propylene glycol.
| Dosage Forms and Strengths |
|---|
|
5 mg: Orange/orange hard gelatin capsule printed with black ink “A733” and “5 mg”. 10 mg: Orange/white hard gelatin capsule printed with black ink “A733” and “10 mg”. 20 mg: White/white hard gelatin capsule printed with black ink “A733” and “20 mg”. 30 mg: Orange/yellow hard gelatin capsule printed with black ink “A733” and “30 mg”. |
| How Supplied | ||||||||
|---|---|---|---|---|---|---|---|---|
|
5 mg capsules: Orange/orange hard gelatin capsule printed with black ink “A733” and "5 mg"
10 mg capsules: Orange/white hard gelatin capsule printed with black ink “A733” and "10 mg"
20 mg capsules: White/white hard gelatin capsule printed with black ink “A733” and "20 mg"
30 mg capsules: Orange/yellow hard gelatin capsule printed with black ink “A733” and "30 mg"
|
| Drug | Countries | |
|---|---|---|
| JUXTAPID | Canada, Japan, United States |
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