Source: FDA, National Drug Code (US) Revision Year: 2020
Amitiza (lubiprostone) is a chloride channel activator for oral use.
The chemical name for lubiprostone is (–)7[(2R,4aR,5R,7aR)2(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[b]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is C20H32F2O5 with a molecular weight of 390.46 and a chemical structure as follows:
Lubiprostone drug substance occurs as white, odorless crystals or crystalline powder, is very soluble in ether and ethanol, and is practically insoluble in hexane and water. Amitiza is available as an imprinted, oval, soft gelatin capsule in two strengths. Pink capsules contain 8 mcg of lubiprostone and the following inactive ingredients: ferric oxide, gelatin, medium-chain triglycerides, purified water, sorbitol, and titanium dioxide. Orange capsules contain 24 mcg of lubiprostone and the following inactive ingredients: D&C Yellow #10, FD&C Red #40, gelatin, medium-chain triglycerides, purified water, and sorbitol.
| Dosage Forms and Strengths |
|---|
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Amitiza is available as an oval, gelatin capsule containing 8 mcg or 24 mcg of lubiprostone.
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| How Supplied |
|---|
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Amitiza is available as an oval, soft gelatin capsule containing 8 mcg or 24 mcg of lubiprostone with “SPI” printed on one side. Amitiza is available as follows: 8 mcg pink capsule
24 mcg orange capsule
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| Drug | Countries | |
|---|---|---|
| AMITIZA | Brazil, Japan, Singapore, United States |
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