Lubiprostone 24 ug/1
Lubiprostone · CAPSULE · Zydus Pharmaceuticals USA Inc.
Lubiprostone is a capsule containing lubiprostone at 24 ug/1, taken oral. Manufactured by Zydus Pharmaceuticals USA Inc..
Key Facts
- Brand Name
- Lubiprostone
- Generic Name
- Lubiprostone
- NDC Code (Product)
70710-1642- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Strength
- 24 ug/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA214131
- Drug Class
- Chloride Channel Activator [EPC]
- Marketing Start
- 03/23/2023
Recall History
Aidapak Services, LLC
Labeling: Label Mixup; LUBIPROSTONE Capsule, 24 mcg may be potentially mislabeled as ARIPiprazole, Tablet, 2 mg, NDC 59148000613, Pedigree: AD21790_43, EXP: 5/1/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: AD21846_46, EXP: 5/1/2014; VALSARTAN, Tablet, 160 mg, NDC 00078035934, Pedigree: AD39858_1, EXP: 5/16/2014.
MALLINCKRODT PHARMACEUTICALS
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Takeda Development Center Americas, Inc.
Failed Impurities/Degradation Specifications:Elevated levels of a known impurity in the 20-month stability sample testing.
MALLINCKRODT PHARMACEUTICALS
Labeling: Label mix-up. Amitiza 8 mcg capsules are being recalled because 24 mcg capsules were found in a 8 mcg trade 60 ct. bottle. Amitiza 24 mcg capsules are being recalled because a sealed 60 ct. bottle contained only 8 mcg capsules, this incident is being considered as a labeling mix-up issue.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Lubiprostone is a chloride channel activator indicated for the treatment of: chronic idiopathic constipation (CIC) in adults. ( 1.1 ) opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. ( 1.2 ) Limitations of Use: Effectiveness of lubiprostone in the treatment of OIC in patients taking diphenylheptane opioids (e.g., methadone) has not been established. ( 1.2 , 7.1 ) irritable bowel syndrome with constipation (IBS-C) in women ≥ 18 years old. ( 1.3 ) 1.1 Chronic Idiopathic Constipation in Adults Lubiprostone is indicated for the treatment of chronic idiopathic constipation (CIC) in adults. 1.2 Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain Lubiprostone is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation. Limitations of Use: Effectiveness of lubiproston…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended Dosage ( 2.1 ) CIC and OIC: 24 mcg twice daily. IBS-C: 8 mcg twice daily. See full prescribing information for dosage adjustment by indication and degree of hepatic impairment. Administration Instructions ( 2.2 ) Swallow capsules whole and do not break apart or chew, Take capsules with food and water, Assess periodically the need for continuous therapy. 2.1 Recommended Dosage The recommended oral dosage of lubiprostone by indication and adjustments for patients with moderate (Child Pugh Class B) and severe (Child Pugh Class C) hepatic impairment are shown in Table 1. Table 1. Recommended Dosage Regimen CIC and OIC IBS-C Recommended Adult Dosage Regimen 24 mcg twice daily 8 mcg twice daily Dosage Adjustment for Hepatic Impairment [see Use in Specific Populations (8.6) ] Moderate Impairment (Child-Pugh Class B) : 16 mcg twice daily If the dose is tolerated and an adequate response has not been obtained after an appropriate interval, doses can then be escalated to full dosing with appropriate monitoring of patient response. Moderate Impairment (Child-Pugh Class B) : No adjustment necessary Severe Impairment (Child-Pugh Class C) : 8 mcg twice dai…
Contraindications
4 CONTRAINDICATIONS Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction [see Warnings and Precautions (5.5) ] . Patients with known or suspected mechanical gastrointestinal obstruction. ( 4 , 5.5 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Methadone Diphenylheptane opioids (e.g., methadone) have been shown in nonclinical studies to dose-dependently reduce the activation of ClC-2 by lubiprostone in the gastrointestinal tract. There is a possibility of a dose-dependent decrease in the efficacy of lubiprostone in patients using diphenylheptane opioids. No in vivo interaction studies have been conducted. The effectiveness of lubiprostone in the treatment of OIC in patients taking diphenylhepatane opioids (e.g., methadone) has not been established [see Indications and Usage (1.2) ] .
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described below and elsewhere in labeling: Nausea [see Warnings and Precautions (5.1) ] Diarrhea [see Warnings and Precautions (5.2) ] Syncope and Hypotension [see Warnings and Precautions (5.3) ] Dyspnea [see Warnings and Precautions (5.4) ] Most common adverse reactions (> 4%) are: CIC: nausea, diarrhea, headache, abdominal pain, abdominal distension, and flatulence. ( 6.1 ) OIC: nausea and diarrhea. ( 6.1 ) IBS-C: nausea, diarrhea, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy's Laboratories Inc. at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. During clinical development of lubiprostone for CIC, OIC, and IBS-C, 1648 patients were treated with lubiprostone for 6 months and 710 patients were treated for 1 year (not mutually exclusive). Chronic Idiopathic Constipation Adverse…
Frequently Asked Questions
What is Lubiprostone used for?
Lubiprostone contains Lubiprostone. It is a capsule taken oral. Consult your doctor for specific uses.
Is Lubiprostone a controlled substance?
Lubiprostone is not classified as a controlled substance by the DEA.
What is the generic name for Lubiprostone?
The generic name for Lubiprostone is Lubiprostone. There are 2 other brand versions of Lubiprostone.
What is the NDC code for Lubiprostone 24 ug/1?
The NDC (National Drug Code) for Lubiprostone 24 ug/1 is 70710-1642, listed by Zydus Pharmaceuticals USA Inc..