Amiprostone 8 mcg 20 capsules

Amiprostone 8 mcg 20 capsules

Composition:
ingredient: Lubiprostone 8 mcg.
Inactive ingredients: Medium-chain triglycerides.
Product Description:
Amiprostone is a locally acting chloride channel activator that increases intestinal fluid secretion, improves stool consistency, and enhances bowel motility.
It is used in adults for the treatment of chronic idiopathic constipation, opioid-induced constipation, and irritable bowel syndrome with constipation in women.
Indications for Use:
Chronic idiopathic constipation (CIC) in adults.
Opioid-induced constipation (OIC) in adults with chronic non-cancer pain.
Irritable bowel syndrome with constipation (IBS-C) in women aged 18 years and older.
Limitation of use: Effectiveness in patients receiving diphenylheptane opioids (e.g., methadone) has not been established.
Method of Administration and Dosage:
For oral use: take with food and water; swallow capsules whole.
CIC and OIC: 24 mcg twice daily.IBS-C: 8 mcg twice daily.
Hepatic Impairment:
Moderate impairment (Child-Pugh B): 16 mcg twice daily (CIC and OIC), no adjustment required for IBS-C.
Severe impairment (Child-Pugh C): 8 mcg twice daily (CIC and OIC), 8 mcg once daily (IBS-C).
Dose escalation may be considered if tolerated.
Contraindications:
Known or suspected mechanical gastrointestinal obstruction.
Precautions:
Avoid use in patients with severe diarrhea.
Discontinue treatment if severe diarrhea occurs.
Syncope and hypotension have been reported, particularly with 24 mcg twice daily.
Risk is increased in patients with diarrhea or vomiting.
Dyspnea may occur shortly after dosing.
Exclude mechanical bowel obstruction prior to initiation.
Adverse Reactions (Side Effects):
Very common/common: nausea, diarrhea, headache, abdominal pain, abdominal distension, flatulence.
Less common: vomiting, dizziness, syncope, dyspnea, fatigue, dry mouth, peripheral edema.
Pregnancy and Lactation:
Limited data are available in pregnant women. 
Use only if the potential benefit justifies the potential risk.
There are no data on the presence of lubiprostone in human milk.
Breastfed infants should be monitored for diarrhea.
Storage Conditions:
Store at a temperature not exceeding 30 °C, in a dry place.
Keep out of reach of children.
Packaging:
Carton containing 2 blisters of 10 soft gelatin capsules and a package leaflet.