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Amitiza

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Overview

What is Amitiza?

Amitiza (lubiprostone) is chemically designated as (–)-7-[(2,4a,5,7a)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopenta[]pyran-5-yl]heptanoic acid. The molecular formula of lubiprostone is CHFO 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: 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.



What does Amitiza look like?



What are the available doses of Amitiza?

Amitiza is available as an oval, gelatin capsule containing 8 mcg or 24 mcg of lubiprostone.

What should I talk to my health care provider before I take Amitiza?

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How should I use Amitiza?

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Amitiza should be taken twice daily orally with food and water. Physicians and patients should periodically assess the need for continued therapy.


What interacts with Amitiza?

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What are the warnings of Amitiza?

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What are the precautions of Amitiza?

Sorry No Records found


What are the side effects of Amitiza?

Sorry No records found


What should I look out for while using Amitiza?

Amitiza is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.


What might happen if I take too much Amitiza?

There have been two confirmed reports of overdosage with Amitiza. The first report involved a 3-year-old child who accidentally ingested 7 or 8 capsules of 24 mcg of Amitiza and fully recovered. The second report was a study patient who self-administered a total of 96 mcg of Amitiza per day for 8 days. The patient experienced no adverse reactions during this time. Additionally, in a Phase 1 cardiac repolarization study, 38 of 51 patients given a single oral dose of 144 mcg of Amitiza (6 times the highest recommended dose) experienced an adverse event that was at least possibly related to the study drug. Adverse reactions that occurred in at least 1% of these patients included the following: nausea (45%), diarrhea (35%), vomiting (27%), dizziness (14%), headache (12%), abdominal pain (8%), flushing/hot flash (8%), retching (8%), dyspnea (4%), pallor (4%), stomach discomfort (4%), anorexia (2%), asthenia (2%), chest discomfort (2%), dry mouth (2%), hyperhidrosis (2%), and syncope (2%).


How should I store and handle Amitiza?

Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].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 capsuleStore at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).PROTECT FROM EXTREME TEMPERATURES.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 capsuleStore at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).PROTECT FROM EXTREME TEMPERATURES.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 capsuleStore at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).PROTECT FROM EXTREME TEMPERATURES.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 capsuleStore at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).PROTECT FROM EXTREME TEMPERATURES.


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Lubiprostone is a locally acting chloride channel activator that enhances a chloride-rich intestinal fluid secretion without altering sodium and potassium concentrations in the serum. Lubiprostone acts by specifically activating ClC-2, which is a normal constituent of the apical membrane of the human intestine, in a protein kinase A–independent fashion. By increasing intestinal fluid secretion, lubiprostone increases motility in the intestine, thereby facilitating the passage of stool and alleviating symptoms associated with chronic idiopathic constipation. Patch clamp cell studies in human cell lines have indicated that the majority of the beneficial biological activity of lubiprostone and its metabolites is observed only on the apical (luminal) portion of the gastrointestinal epithelium. Additionally, activation of ClC-2 by lubiprostone has been shown to stimulate recovery of mucosal barrier function via the restoration of tight junction protein complexes in studies of ischemic porcine intestine.

Non-Clinical Toxicology
Amitiza is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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