Lubistone Capsule 8mcg

PRESENTATION

Lubistone 8 Capsule: each capsule contains Lubiprostone INN 8mcg

Lubistone 24 Capsule: each capsule contains Lubiprostone INN 24mcg

DESCRIPTION

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.

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.

INDICATIONS

• Chronic Idiopathic Constipation

• Opioid-induced Constipation (OIC) in adults with chronic non-cancer pain.

• Irritable Bowel Syndrome with Constipation (IBS-C).

DOSAGE & ADMINISTRATION

Irritable Bowel Syndrome with Constipation:

The recommended dose is 8 mcg twice daily orally with food and water.

Dosage in patients with hepatic impairment: Dosage adjustment is not required for patients with moderately impaired hepatic

function. For patients with severely impaired hepatic function, the recommended starting dose is 8 mcg once daily. If tolerated

then dose can be increased to 8mcg twice

Chronic Idiopathic Constipation and Opioid-induced Constipation:

The recommended dose is 24 mcg twice daily orally with food and water.

Dosage in patients with hepatic impairment: For patients with moderately impaired hepatic function, the recommended starting dose

is 16 mcg twice daily. For patients with severely impaired hepatic function, the recommended starting dose is 8 mcg twice daily.

SIDE EFFECTS

Diarrhea, full or bloated feeling or pressure in the stomach, nausea, stomach pain, swelling of abdominal or stomach area, Dyspnea

PRECAUTIONS

Nausea: Patients taking Lubiprostone may experience nausea. Concomitant administration of food with Lubiprostone may reduce

symptoms of nausea.

Diarrhea: Lubistone should not be prescribed to patients that have severe diarrhea.

Bowel Obstruction: In patients with symptoms suggestive of mechanical gastrointestinal obstruction, perform a thorough evaluation

to confirm the absence of an obstruction prior to initiating therapy with Lubiprostone.

USE IN PREGNANCY & LACTATION

Pregnancy Category C.

It is not known whether lubiprostone is excreted in human milk. Because lubiprostone increases fluid secretion in the intestine

and intestinal motility, human milk-fed infants should be monitored for diarrhea. Caution should be exercised when Lubiprostone is

administered to a nursing woman.

DRUG INTERACTION

There is a possibility of a dose-dependent decrease in the efficacy of Lubiprostone in patients using diphenylheptane opioids.

OVER DOSE

Adverse reactions due to overdose may include: nausea, diarrhea, vomiting, dizziness, headache, abdominal pain, flushing/hot

flash, retching, dyspnea, pallor, stomach discomfort, anorexia, asthenia , chest discomfort, dry mouth, hyperhidrosis , and

syncope.

COMMERCIAL PACK

Lubistone 8 capsule: Each box contains 2 blister strips of 10 capsules.

Lubistone 24 capsule: Each box contains 2 blister strips of 10 capsules.