Amitza 8 ug/1
Lubiprostone · CAPSULE, GELATIN COATED · Direct_Rx
Amitza (lubiprostone) is an oral prescription medication that works by activating chloride channels to increase fluid secretion in the intestines. It is used to treat chronic idiopathic constipation and constipation caused by opioid medications.
Key Facts
- Brand Name
- Amitza
- Generic Name
- Lubiprostone
- NDC Code (Product)
72189-410- Manufacturer
- Direct_Rx
- Strength
- 8 ug/1
- Dosage Form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA209920
- Drug Class
- Chloride Channel Activator [EPC]
- Marketing Start
- 01/12/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1.1 Chronic Idiopathic Constipation in Adults Lubiprostone capsules are 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 capsules are 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 lubiprostone capsules in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established [see Clinical Studies (14.2)]. 1.3 Irritable Bowel Syndrome with Constipation Lubiprostone capsules are indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.
Dosage & Administration
2.1 Recommended Dosage The recommended oral dosage of lubiprostone capsules 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* Moderate Impairment (Child-Pugh Class B): No adjustment necessary Severe Impairment (Child-Pugh Class C): 8 mcg twice daily* Severe Impairment (Child-Pugh Class C): 8 mcg once 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. 2.2 Administration Instructions Take lubiprostone capsules orally with food and water. Swallow capsules whole and do not break apart or chew. Physicians and patients should periodically assess the need for continued therapy.
Contraindications
Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction [see Warnings and Precautions (5.5)].
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
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)] 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, 1,648 patients were treated with lubiprostone for 6 months and 710 patients were treated for 1 year (not mutually exclusive). Chronic Idiopathic Constipation Adverse reactions in adult dose-finding, efficacy, and long-term clinical studies: The data described below reflect exposure to lubiprostone 24 mcg twice daily in 1,113 patients with CIC over 3- or 4-week, 6-month, and 12-month treatment periods; and from 316 patients receiving placebo over short-term exposure (≤4 weeks). The placebo population (N=316) had a mean age of 48 (range 21 to 81) years; …
Frequently Asked Questions
What is Amitza used for?
Amitza (lubiprostone) is an oral prescription medication that works by activating chloride channels to increase fluid secretion in the intestines. It is used to treat chronic idiopathic constipation and constipation caused by opioid medications.
Is Amitza a controlled substance?
Amitza is not classified as a controlled substance by the DEA.
What is the generic name for Amitza?
The generic name for Amitza is Lubiprostone. There are 12 other brand versions of Lubiprostone.
What is the NDC code for Amitza 8 ug/1?
The NDC (National Drug Code) for Amitza 8 ug/1 is 72189-410, listed by Direct_Rx.