Rx Item-Amitiza lubiprostone 8mcg Cap 60 By Takeda Pharma

Clinical Information
Gen. Code and Des.
63946 lubiprostone ORAL CAPSULE 8 MCG
GCN and Des.
99658 lubiprostone ORAL CAPSULE 8 MCG
Strength
8MCG
Dose Form
CAPSULE
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
56120000 CATHARTICS AND LAXATIVES
Active Ingredients
11200 lubiprostone 136790766
Inactive Ingredients
2549 gelatin 9000708
2599 sorbitol 50704







AMITIZA lubiprostone capsule, gelatin coated
STAT RX USA LLC
DESCRIPTION
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 C20 H32 F2 O5 with molecular weight of 390.46 CLINICAL PHARMACOLOGY
Mechanism of Action
Lubiprostone is locally acting chloride channel activator that enhances chloride-rich intestinal fluid secretion without altering sodium and potassium concentrations in the serum. Lubiprostone acts by specifically activating ClC-2, which is normal constituent of the apical membrane of the human intestine, in 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 ex vivo studies of ischemic porcine intestine

INDICATIONS AND USAGE
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.
2 DOSAGE AND ADMINISTRATION
Amitiza should be taken twice daily orally with food and water. Physicians and patients should periodically assess the need for continued therapy.
2.1 Chronic Idiopathic Constipation
24 mcg twice daily orally with food and water.
2.2 Irritable Bowel Syndrome with Constipation
8 mcg twice daily orally with food and water.
3 DOSAGE FORMS AND STRENGTHS
Amitiza is available as an oval, gelatin capsule containing mcg or 24 mcg of lubiprostone.
8-mcg capsules are pink and are printed with ?SPI? on one side
24-mcg capsules are orange and are printed with ?SPI? on one side

Rx Item-Amitiza 8mcg Cap 60 By Takeda Ph
RX629129 629129 NDC No.64764-0080-60 64764-080-60 64764008060 6476408060 UPC/GTIN No.3-64764-08060-3 364764-080603 364764080603 MPN No. 8060

AmericanPharmaWholesale.com
RX629129 629129 NDC No.64764-0080-60 64764-080-60 64764008060 6476408060 UPC/GTIN No.3-64764-08060-3 364764-080603 364764080603 MPN No. 8060

LUBIPROSTONE ORAL CAPSULE
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