Product Overview
[Generic Name]
Lubiprostone Soft Capsules
[Drug Name]
Changfan Lubiprostone Soft Capsules
[Main Ingredients]
The active ingredient of this product is lubiprostone. Chemical name: 7-[(2R,4aR,5R,7aR)-2-(1,1-difluoropentyl)-2-hydroxy-6-oxooctahydrocyclopentanopyran-5-yl]-n-heptanoic acid.
[Indications]
This product is indicated for the treatment of chronic idiopathic constipation in adults.
[Dosage and Administration]
Oral administration. Take with food and water. Swallow the capsule whole; do not split or chew. Physicians and patients should regularly assess the need for continued treatment. Chronic idiopathic constipation: The recommended dose is 24 μg twice daily. Dosage adjustment for patients with hepatic impairment: Moderate hepatic impairment (Child-Pugh B): 16 μg twice daily*; Severe hepatic impairment (Child-Pugh C): 8 μg twice daily* If the dose is tolerated and an adequate response is not achieved after appropriate intervals, the dose can be increased gradually to the full dose with appropriate monitoring of the patient's response.
[Appearance]
This product is a colorless, clear, oily liquid.
[Adverse Reactions]
Nausea, diarrhea, syncope, hypotension, and dyspnea.
[Precautions]
Nausea: Patients taking this product may experience nausea. Taking this product with food may alleviate nausea symptoms [see [Adverse Reactions]]. Diarrhea: Patients with severe diarrhea should avoid this product. Patients should be aware that abdominal effusions may occur during treatment. If severe diarrhea occurs, patients should be instructed to discontinue this product and inform their physician (see [Adverse Reactions]). Syncope and hypotension: Syncope and hypotension have been reported with this product since its marketing, and a few of these adverse reactions have led to hospitalization. Most cases occurred in patients taking 24 μg twice daily, with some cases occurring within one hour of the first or subsequent doses. Some patients experienced diarrhea or vomiting before the onset of adverse reactions. Syncope and hypotension usually resolve after discontinuation of the drug or before the next dose, but recurrence has been reported with subsequent dosing. Some case reports have included concomitant use of known blood pressure-lowering medications, which may increase the risk of syncope or hypotension. Patients should be aware of the risk of syncope and hypotension during treatment, and other adverse reactions may increase this risk, such as diarrhea or vomiting. Dyspnea: In clinical trials, the incidence of dyspnea in the CIC, OIC, and IBS-C groups treated with this product was 3%, 1%, and <1%, respectively, compared to 0%, 1%, and <1%, respectively, in the placebo-treated group. Post-marketing reports of dyspnea have been reported with the use of this product at 24 μg twice daily. Some patients discontinued treatment due to dyspnea. These events were typically described as chest tightness and difficulty breathing, typically with acute onset within 30 to 60 minutes of the first dose. Symptoms typically resolved within a few hours of taking the drug, but recurrence has been reported with subsequent doses. Patients should inform their physician if they experience dyspnea. Intestinal Obstruction: In patients with symptoms suggestive of mechanical gastrointestinal obstruction, a thorough evaluation should be performed to confirm the absence of obstruction before initiating treatment with this drug.
[Interactions]
Methadone: Nonclinical studies have shown that diphenylheptane opioids (e.g., methadone) can dose-dependently reduce CIC-2 activation by lubiprostone in the gastrointestinal tract. There is a potential for a dose-dependent reduction in the efficacy of this drug in patients taking diphenylheptane opioids. In vivo drug interaction studies have not been conducted with this drug. The effectiveness of this drug in treating patients with OIC taking diphenylheptane opioids (e.g., methadone) has not been established.
[Strength]
24 μg*10 tablets
[Approval Number]
National Medical Products Approval No. H20233802
[Manufacturer]
Nanjing Zhengda Tianqing Pharmaceutical Co., Ltd.
