- Stock: In Stock
- Brand: Square Pharmaceuticals
- Product ID: Lubiprostone
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| Generic Name | Lubiprostone |
|---|---|
| Strength | 8 mcg |
| Dosage Form | Soft Gelatin Capsule |
| Manufacturer | Square Pharmaceuticals PLC |
| Therapeutic Class | Other laxative preparations |
| Pack Size | 2 x 10 (20's) |
Overview
Gutfix 8 mcg Capsule contains Lubiprostone, a locally acting chloride channel activator that enhances chloride-rich intestinal fluid secretion without altering serum sodium or potassium concentrations. Lubiprostone specifically activates ClC-2 chloride channels on the apical membrane of the human intestine, increasing intestinal motility and facilitating stool passage. It also restores mucosal barrier function by recovering tight junction protein complexes. Gutfix 8 mcg is the FDA-approved strength for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in women over 18 years of age. It is also used for Chronic Idiopathic Constipation and Opioid-Induced Constipation in adults. Relief of symptoms typically occurs within 24 hours.
Dosage and Administration
Irritable Bowel Syndrome with Constipation (IBS-C): Lubiprostone 8 mcg taken twice daily orally with food and water.
Chronic Idiopathic Constipation: The 24 mcg strength is recommended for this indication; consult the prescribing physician.
Opioid-Induced Constipation: The 24 mcg strength is recommended for this indication; consult the prescribing physician.
Patients with moderate to severe hepatic impairment should use a reduced dosage as directed by their physician. Safety and effectiveness in children and adolescents have not been established.
Interaction
Based on in vitro human microsome studies, there is a low likelihood of clinically significant drug–drug interactions with Gutfix. Cytochrome P450 isoenzymes are not involved in Lubiprostone metabolism, and no protein binding-mediated drug interactions of clinical significance are anticipated.
Contraindications
Gutfix is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction. Evaluate for the absence of bowel obstruction before initiating therapy in patients with suggestive symptoms.
Side Effects
Common side effects include nausea, vomiting, loose stools, dry mouth, stomach discomfort, headache, and dizziness. Taking Gutfix with food may reduce nausea. Gutfix should not be prescribed to patients with severe diarrhoea. Overdose may cause nausea, diarrhoea, vomiting, dizziness, headache, and abdominal pain.
Pregnancy and Lactation
Pregnancy Category C. Lubiprostone should be used during pregnancy only if the potential benefits justify the potential risk to the foetus. It is not known whether Lubiprostone is excreted in human milk; caution is advised when administering to breastfeeding women.
Precautions and Warnings
Take Gutfix with food and water to minimise nausea. Do not use in patients with severe diarrhoea. Confirm the absence of mechanical gastrointestinal obstruction before initiating therapy in patients with suggestive symptoms. Reduce dose in moderate to severe hepatic impairment. Not studied in renal impairment. Safety and efficacy in children and adolescents have not been established. Safety and efficacy in elderly patients (>65 years) with IBS-C are comparable to younger patients.
Storage Conditions
Store in a cool and dry place below 25°C, protected from light. Keep out of the reach of children.
Frequently Asked Questions
Q: What is Gutfix 8 mcg specifically used for?
Gutfix 8 mcg is specifically indicated for Irritable Bowel Syndrome with Constipation (IBS-C) in women over 18 years of age. It is the only FDA-approved treatment for IBS-C. While Lubiprostone is also used for Chronic Idiopathic Constipation and Opioid-Induced Constipation, those indications use the 24 mcg strength.
Q: How quickly does Gutfix 8 mcg work?
Gutfix (Lubiprostone) typically begins to relieve constipation symptoms within 24 hours of the first dose. For full therapeutic benefit in IBS-C, regular twice-daily dosing with food and water is recommended as prescribed by the physician.
