Lubilax 8 mcg Capsule

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Indications of Lubilax 8 mcg

Lubilax 8 mcg is indicated in: Irritable Bowel Syndrome with Constipation (IBS-C). Chronic Idiopathic Constipation (CIC) in adults. Opioid-Induced Constipation (OIC) in adult patients with chronic, non-cancer pain.

Theropeutic Class

Other laxative preparations

Pharmacology

Lubilax 8 mcg is a locally-acting chloride-channel activator that increases intestinal secretion. In doing so, it increases intestinal motility, thus aiding the passage of stool and relieve the symptoms associated with chronic idiopathic constipation.Lubilax 8 mcg acts by specifically activating ClC-2 chloride channels, which is a normal constituent of the apical membrane of the human intestine, in a protein kinase A action independent fashion. Activation of ClC-2 chloride channels causes an efflux of chloride ions into the lumen, which in turn leads to an efflux of sodium ions through a paracellular pathway to maintain isoelectric neutrality. As a result, water follows sodium into the lumen in order to maintain isotonic equilibrium, thereby increasing intestinal fluid secretion. By increasing intestinal fluid secretion, Lubilax 8 mcg increases motility in the intestine, thereby increasing the passage of stool and alleviating symptoms associated with chronic idiopathic constipation. Activation of ClC-2 chloride channels may also stimulate the recovery of muscosal barrier function by restoring tight junction protein complexes in the intestine. Patch clamp cell studies in human cell lines have indicated that the majority of the beneficial biological activity of Lubilax 8 mcg and its metabolites is observed only on the apical (luminal) portion of the gastrointestinal epithelium.

Dosage & Administration of Lubilax 8 mcg

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 8 mcg 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.

Dosage of Lubilax 8 mcg

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 8 mcg 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.

Interaction of Lubilax 8 mcg

There is a possibility of a dose-dependent decrease in the efficacy of Lubilax 8 mcg in patients using diphenylheptane opioids.

Contraindications

Lubilax 8 mcg is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

Side Effects of Lubilax 8 mcg

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

Pregnancy & Lactation

Pregnancy category C. It is not known whether Lubilax 8 mcg is excreted in human milk. Because Lubilax 8 mcg increases fluid secretion in the intestine and intestinal motility, human milk-fed infants should be monitored for diarrhea. Caution should be exercised when Lubilax 8 mcg is administered to a nursing woman.

Precautions & Warnings

Nausea: Patients taking Lubilax 8 mcg may experience nausea. Concomitant administration of food with Lubilax 8 mcg 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 Lubilax 8 mcg.

Overdose Effects of Lubilax 8 mcg

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.

Storage Conditions

Store between 15-30° C.

Drug Classes

Other laxative preparations

Mode Of Action

Lubilax 8 mcg is a locally-acting chloride-channel activator that increases intestinal secretion. In doing so, it increases intestinal motility, thus aiding the passage of stool and relieve the symptoms associated with chronic idiopathic constipation.Lubilax 8 mcg acts by specifically activating ClC-2 chloride channels, which is a normal constituent of the apical membrane of the human intestine, in a protein kinase A action independent fashion. Activation of ClC-2 chloride channels causes an efflux of chloride ions into the lumen, which in turn leads to an efflux of sodium ions through a paracellular pathway to maintain isoelectric neutrality. As a result, water follows sodium into the lumen in order to maintain isotonic equilibrium, thereby increasing intestinal fluid secretion. By increasing intestinal fluid secretion, Lubilax 8 mcg increases motility in the intestine, thereby increasing the passage of stool and alleviating symptoms associated with chronic idiopathic constipation. Activation of ClC-2 chloride channels may also stimulate the recovery of muscosal barrier function by restoring tight junction protein complexes in the intestine. Patch clamp cell studies in human cell lines have indicated that the majority of the beneficial biological activity of Lubilax 8 mcg and its metabolites is observed only on the apical (luminal) portion of the gastrointestinal epithelium.

Pregnancy

Pregnancy category C. It is not known whether Lubilax 8 mcg is excreted in human milk. Because Lubilax 8 mcg increases fluid secretion in the intestine and intestinal motility, human milk-fed infants should be monitored for diarrhea. Caution should be exercised when Lubilax 8 mcg is administered to a nursing woman.
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