Amitiza

Amitiza

Amitiza Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Chronic Idiopathic Constipation

Amitiza® is indicated for the treatment of chronic idiopathic constipation in adults.

1.2 Irritable Bowel Syndrome with Constipation

Amitiza is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women ≥ 18 years old.

History

There is currently no drug history available for this drug.

Other Information

Amitiza (lubiprostone) is chemically designated as (–)-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:

Chemical Structure

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: medium-chain triglycerides, gelatin, sorbitol, ferric oxide, titanium dioxide, and purified water. Orange capsules contain 24 mcg of lubiprostone and the following inactive ingredients: medium-chain triglycerides, gelatin, sorbitol, FD&C Red #40, D&C Yellow #10, and purified water.

Amitiza Manufacturers


  • Stat Rx Usa Llc
    Amitiza (Lubiprostone) Capsule, Gelatin Coated [Stat Rx Usa Llc]
  • Physicians Total Care, Inc.
    Amitiza (Lubiprostone) Capsule, Gelatin Coated [Physicians Total Care, Inc.]
  • Lake Erie Medical Dba Quality Care Products Llc
    Amitiza (Lubiprostone) Capsule, Gelatin Coated [Lake Erie Medical Dba Quality Care Products Llc]
  • Takeda Pharmaceuticals America, Inc.
    Amitiza (Lubiprostone) Capsule, Gelatin Coated [Takeda Pharmaceuticals America, Inc.]
  • Carilion Materials Management
    Amitiza (Lubiprostone) Capsule, Gelatin Coated [Carilion Materials Management]

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