Label: LUBIPROSTONE capsule

  • 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 INFORMATION
    These highlights do not include all the information needed to use LUBIPROSTONE CAPSULES safely and effectively. See full prescribing information for LUBIPROSTONE CAPSULES. LUBIPROSTONE capsules ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND 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 ...
  • 2 DOSAGE AND ADMINISTRATION
    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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Lubiprostone 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 ...
  • 4 CONTRAINDICATIONS
    Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction - [see Warnings and Precautions ( 5.5)] .
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Nausea - Patients taking lubiprostone may experience nausea. Concomitant administration of food with lubiprostone may reduce symptoms of nausea - [see Adverse Reactions ( 6.1) ...
  • 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 ...
  • 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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 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 ...
  • 10 OVERDOSAGE
    There 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 ...
  • 11 DESCRIPTION
    Lubiprostone is a chloride channel activator for oral use. The chemical name for lubiprostone is (–)-7-[(2 - R,4a - R,5 - R,7a ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Lubiprostone is a locally acting chloride channel activator that enhances a chloride-rich intestinal fluid secretion without altering sodium and potassium ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 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 ...
  • 14 CLINICAL STUDIES
    14.1 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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Lubiprostone 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 ...
  • 17 PATIENT COUNSELING INFORMATION
    Administration Instructions - Instruct patients to take lubiprostone orally with food and water to reduce the occurrence of nausea - [see Warnings and Precautions ( 5.1) ...
  • SPL UNCLASSIFIED SECTION
    Relabeled and Repackaged by: Enovachem PHARMACEUTICALS - Torrance, CA 90501
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-8 mcg
    label-8
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-24 mcg
    label-24
  • INGREDIENTS AND APPEARANCE
    Product Information