Adult Dosing

Chronic idiopathic constipation and opioid-induced constipation

• 24 mcg PO bid taken with food and water

Irritable bowel syndrome with constipation (IBS-C)

• Women (18 yrs): 8 mcg PO bid taken with food and water

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been studied

[Outline]

• Adult Dosing
• Pediatric Dosing

• Chronic idiopathic constipation
• Opioid-induced constipation in patients with chronic, non-cancer pain
• Irritable bowel syndrome with constipation

Note:

• Effectiveness of the therapy in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (eg, methadone) has not been established

• Hypersensitivity to any of the ingredients of the product
• Hx of GI obstruction
• Hx of severe diarrhea
• Pregnancy not recommended

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustment not defined

Hepatic Dose Adjustment

Chronic idiopathic constipation and opioid-induced constipation

• Child-Pugh Class A: No dose adjustment required
• Child-Pugh Class B: Initial dose: 16 mcg bid; dose may be increased if the recommended dose is tolerated and present adequate response
• Child-Pugh Class C: Initial dose: 8 mcg bid; dose may be increased if the recommended dose is tolerated and show inadequate response

Irritable bowel syndrome with constipation

• Child-Pugh Class A: No dose adjustment required
• Child-Pugh Class B: No dose adjustment required
• Child-Pugh Class C: Initial dose: 8 mcg bid; dose may be increased if the recommended dose is tolerated and show inadequate response

• Evaluate patients with symptoms suggestive of mechanical gastrointestinal obstruction prior to initiating treatment with lubiprostone
• Therapy may cause nausea, therefore administer with food to reduce nausea
• Avoid use in diarrhea or severe diarrhea
• Events of dyspnea within an hour of first dose have been reported with the therapy. This may resolve within 3 hours, but may recur with repeat dosing.
• Prior to initiating treatment evaluate patients with symptoms suggestive of mechanical gastrointestinal obstruction

Cautions: Use cautiously in

• Diarrhea
• Lactation

Pregnancy Category:C

Breastfeeding: Safety unknown; use not recommended due to potential to cause serious adverse reactions in nursing infants.

• CNS: Dizziness, headache, fatigue
• CV: Peripheral edema
• RESP: Dyspnea, URI, dyspnea
• GI: Severe diarrhea, nausea, vomiting, abdominal pain, abdominal distention, dyspepsia, dry mouth, reflux, flatulence, loose stools
• EENT: Sinusitis, nasopharyngitis
• MUSC: Arthralgia, back pain
• GU: UTI
• MISC: Allergic reactions

• Chloride channel activator; activates chloride channels in intestinal epithelium resulting in increased intestinal fluid secretion
• Minimally systemic absorption
• Metabolized in the GI tract; CYP450: None
• Renally excreted: 60%; feces: 30%
• Half-life; M3 metabolite: 0.9-1.4 hrs

US Trade Name(s)

• Amitiza

US Availability

Amitiza

• CAPS: 8, 24 mcg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Gastrointestinal

Functional Bowel Disorder Agents

Chloride Channel Activators

Pricing data from www.DrugStore.com in U.S.A.

• Amitiza 8 MCG CAPS [Bottle] (TAKEDA PHARMACEUTICALS)
  60 mcg = $258.98
  180 mcg = $717.98
• Amitiza 24 MCG CAPS [Bottle] (TAKEDA PHARMACEUTICALS)
  30 mcg = $130.8
  90 mcg = $370.78

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Amitiza 0.008 MG Oral Capsule

Ingredient(s): Lubiprostone

Imprint: SPI

Color(s): Pink

Shape: Oval

Size (mm): 9.00

Score: 1

Inactive Ingredient(s): medium-chain triglycerides / gelatin / sorbitol / ferric oxide red / titanium dioxide / water

Drug Label Author:
Takeda Pharmaceuticals America, Inc.

DEA Schedule:
Non-Scheduled

Drug Name: Amitiza 0.024 MG Oral Capsule

Ingredient(s): Lubiprostone

Imprint: SPI

Color(s): Orange

Shape: Oval

Size (mm): 9.00

Score: 1

Inactive Ingredient(s): medium-chain triglycerides / gelatin / sorbitol / fd&c red no. 40 / d&c yellow no. 10 / water

Drug Label Author:
Takeda Pharmaceuticals America, Inc.

DEA Schedule:
Non-Scheduled