Label: LUBIPROSTONE capsule
- NDC Code(s): 76420-777-01, 76420-777-30, 76420-777-60, 76420-777-90, view more
- Packager: Asclemed USA, Inc.
- This is a repackaged label.
- Source NDC Code(s): 70710-1641, 70710-1642
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 6, 2025
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use LUBIPROSTONE CAPSULES safely and effectively. See full prescribing information for LUBIPROSTONE CAPSULES. LUBIPROSTONE capsules ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGE1.1 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 ...
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2 DOSAGE AND ADMINISTRATION2.1 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 ...
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3 DOSAGE FORMS AND STRENGTHSLubiprostone capsules are available as an oval, soft gelatin capsule containing 8 mcg or 24 mcg of lubiprostone. 8 mcg capsules are light pink to pink colored and are imprinted with "8" in black ...
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4 CONTRAINDICATIONSLubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction - [see Warnings and Precautions ( 5.5)] .
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5 WARNINGS AND PRECAUTIONS5.1 Nausea - Patients taking lubiprostone may experience nausea. Concomitant administration of food with lubiprostone may reduce symptoms of nausea - [see Adverse Reactions ( 6.1) ...
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6 ADVERSE REACTIONSThe following adverse reactions are described below and elsewhere in labeling: Nausea - [see Warnings and Precautions ( 5.1)] Diarrhea - [see Warnings and Precautions ...
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7 DRUG INTERACTIONS7.1 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 ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - Following oral administration, concentrations of lubiprostone in plasma are below the level of quantitation; however, one of the metabolites, M3, has measurable ...
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10 OVERDOSAGEThere have been six reports of overdosage with lubiprostone during clinical development. Of these six cases, only two subjects reported adverse events: one reported vomiting, diarrhea and stomach ...
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11 DESCRIPTIONLubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (–)-7-[(2 - R,4a - R,5 - R,7a ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Lubiprostone is a locally acting chloride channel activator that enhances a chloride-rich intestinal fluid secretion without altering sodium and potassium ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - Two 2-year oral (gavage) carcinogenicity studies (one in Crl:B6C3F1 mice and one in Sprague-Dawley rats) were ...
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14 CLINICAL STUDIES14.1 Chronic Idiopathic Constipation in Adults - Two double-blinded, placebo-controlled studies of identical design were conducted in patients with CIC. CIC was defined as, on average, less than ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGLubiprostone Capsules, 8 mcg are opaque, oval shaped, light pink to pink colored soft gelatin capsules imprinted with "8" in black ink, containing clear colorless to pale yellow oily liquid and ...
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17 PATIENT COUNSELING INFORMATIONAdministration Instructions - Instruct patients to take lubiprostone orally with food and water to reduce the occurrence of nausea - [see Warnings and Precautions ( 5.1) ...
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SPL UNCLASSIFIED SECTIONRelabeled and Repackaged by: Enovachem PHARMACEUTICALS - Torrance, CA 90501
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-8 mcg
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-24 mcg
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INGREDIENTS AND APPEARANCEProduct Information