Gutfix 24 Licap

Indications:

Gutfix serves as a treatment option for the following conditions:

• 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.

Pharmacology:

Lubiprostone, the active ingredient in Gutfix, functions as a locally-acting chloride-channel activator. By stimulating intestinal secretion, it enhances intestinal motility, facilitating the passage of stool and providing relief from symptoms associated with chronic idiopathic constipation.

Lubiprostone works by specifically activating ClC-2 chloride channels present in the human intestine’s apical membrane. This action triggers the efflux of chloride ions into the intestinal lumen, subsequently leading to sodium ion efflux through a paracellular pathway to maintain isoelectric neutrality. Consequently, water follows sodium into the lumen to uphold isotonic equilibrium, thereby increasing intestinal fluid secretion. This increase in fluid secretion enhances intestinal motility, aiding in the passage of stool and alleviating symptoms of chronic idiopathic constipation. Furthermore, activation of ClC-2 chloride channels may support the restoration of mucosal barrier function by reinstating tight junction protein complexes in the intestine. Studies on human cell lines using patch clamp cell techniques have shown that the beneficial biological effects of lubiprostone and its metabolites primarily occur in the luminal portion of the gastrointestinal epithelium.

Dosage & Administration:

For Irritable Bowel Syndrome with Constipation, the recommended dosage is 8 mcg twice daily orally with food and water.

In patients with hepatic impairment, no dosage adjustment is necessary for those with moderate impairment. However, for those with severe impairment, the initial recommended dose is 8 mcg once daily, which can be increased to 8 mcg twice daily if tolerated.

For Chronic Idiopathic Constipation and Opioid-induced Constipation, the recommended dosage is 24 mcg twice daily orally with food and water.

In patients with moderate hepatic impairment, the recommended starting dose is 16 mcg twice daily, while for severe hepatic impairment, the starting dose is 8 mcg twice daily.

Interactions:

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

Contraindications:

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

Side Effects:

Common side effects may include diarrhea, a sensation of fullness or pressure in the stomach, nausea, stomach pain, abdominal swelling, and dyspnea.

Pregnancy & Lactation:

Lubiprostone falls under pregnancy category C. Its excretion in human milk is not well-established. Caution is advised when administering Lubiprostone to nursing women due to its potential impact on intestinal fluid secretion and motility, necessitating monitoring for diarrhea in breastfed infants.

Precautions & Warnings:

Patients taking Gutfix may experience nausea, which may be alleviated by consuming food alongside the medication.

Lubiprostone should not be prescribed to patients with severe diarrhea or symptoms suggestive of mechanical gastrointestinal obstruction without thorough evaluation.

Overdose Effects:

Adverse reactions due to overdose may include nausea, diarrhea, vomiting, dizziness, headache, abdominal pain, flushing, retching, dyspnea, pallor, stomach discomfort, anorexia, asthenia, chest discomfort, dry mouth, hyperhidrosis, and syncope.

Therapeutic Class:

Gutfix belongs to the category of other laxative preparations.

Storage Conditions:

Store Gutfix between 15-30°C.