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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use DEXILANT safely and effectively. See full prescribing information for DEXILANT.
DEXILANT (dexlansoprazole) delayed release capsules
Initial U.S. Approval: 1995 (lansoprazole)
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INDICATIONS AND USAGE
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DEXILANT is a proton pump inhibitor (PPI) indicated for:
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Healing of all grades of erosive esophagitis (EE). (1.1)
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Maintaining healing of EE. (1.2)
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Treating heartburn associated with non-erosive gastroesophageal reflux disease (GERD). (1.3)
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DOSAGE AND ADMINISTRATION
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Healing of EE: 60 mg once daily for up to 8 weeks. (2.1)
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Maintenance of healed EE: 30 mg once daily for up to 6 months. (2.1)
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Symptomatic non-erosive GERD: 30 mg once daily for 4 weeks. (2.1)
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Hepatic impairment: Consider 30 mg maximum daily dose for patients with moderate hepatic impairment (Child-Pugh Class B). No studies were conducted in patients with severe hepatic impairment (Child-Pugh Class C). (2.2, 8.7)
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DEXILANT can be taken without regard to food. (2.3)
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DEXILANT should be swallowed whole. Alternatively, capsules can be opened, sprinkled on one tablespoon of applesauce, and swallowed immediately. (2.3)
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DOSAGE FORMS AND STRENGTHS
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Capsules: 30 mg and 60 mg. (3)
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CONTRAINDICATIONS
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Patients with known hypersensitivity to any component of the formulation. (4)
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WARNINGS AND PRECAUTIONS
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Gastric malignancy: Symptomatic response with DEXILANT does not preclude the presence of gastric malignancy. (5.1)
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ADVERSE REACTIONS
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Most commonly reported adverse reactions (≥2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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DRUG INTERACTIONS
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Atazanavir: Do not co-administer with DEXILANT because atazanavir systemic concentrations may be substantially decreased. (7.1)
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Drugs with pH-dependent absorption (e.g., ampicillin esters, digoxin, iron salts, ketoconazole): DEXILANT may interfere with absorption of drugs for which gastric pH is important for bioavailability. (7.1)
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Warfarin: Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time. (7.2)
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Concomitant tacrolimus use may increase tacrolimus whole blood concentrations (7.3)
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USE IN SPECIFIC POPULATIONS
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Nursing mothers: Discontinue drug or nursing, taking into consideration importance of drug to mother. (8.4)
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Pediatric use: Safety and effectiveness not established in pediatric patients. (8.4)
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See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling |
Revised: 03/2010 |
Back to Highlights and Tabs
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FULL PRESCRIBING INFORMATION: CONTENTS* |
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1INDICATIONS AND USAGE
1.1Healing of Erosive Esophagitis
1.2Maintenance of Healed Erosive Esophagitis
1.3Symptomatic Non-Erosive Gastroesophageal Reflux Disease
2DOSAGE AND ADMINISTRATION
2.1Recommended Dose
2.2Special Populations
2.3Important Administration Information
3DOSAGE FORMS AND STRENGTHS
4CONTRAINDICATIONS
5WARNINGS AND PRECAUTIONS
5.1Gastric Malignancy
6ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7DRUG INTERACTIONS
7.1Drugs with pH-Dependent Absorption Pharmacokinetics
7.2Warfarin
7.3 Tacrolimus
8USE IN SPECIFIC POPULATIONS
8.1Pregnancy
8.3Nursing Mothers
8.4Pediatric Use
8.5Geriatric Use
8.6Renal Impairment
8.7Hepatic Impairment
10OVERDOSAGE
11DESCRIPTION
12CLINICAL PHARMACOLOGY
12.1Mechanism of Action
12.2Pharmacodynamics
12.3Pharmacokinetics
12.4 Effect of Food on Pharmacokinetics and Pharmacodynamics
12.5Special Populations
12.6Drug-Drug Interactions
13NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14CLINICAL STUDIES
14.1Healing of Erosive Esophagitis
14.2Maintenance of Healed Erosive Esophagitis
14.3Symptomatic Non-Erosive GERD
16HOW SUPPLIED/STORAGE AND HANDLING
17PATIENT COUNSELING INFORMATION
17.1 Information for Patients
17.2FDA-Approved Patient Labeling
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FULL PRESCRIBING INFORMATION
1INDICATIONS AND USAGE
1.1Healing of Erosive Esophagitis
DEXILANT is indicated for healing of all grades of erosive esophagitis (EE) for up to 8 weeks.
1.2Maintenance of Healed Erosive Esophagitis
DEXILANT is indicated to maintain healing of EE for up to 6 months.
1.3Symptomatic Non-Erosive Gastroesophageal Reflux Disease
DEXILANT is indicated for the treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks.
2DOSAGE AND ADMINISTRATION
2.1Recommended Dose
DEXILANT is available as capsules in 30 mg and 60 mg strengths for adult use. Directions for use in each indication are summarized in Table 1.
Table 1: DEXILANT Dosing Recommendations
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Indication |
Recommended Dose |
Frequency |
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Healing of EE |
60 mg |
Once daily for up to 8 weeks |
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Maintenance of Healed EE |
30 mg |
Once daily* |
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Symptomatic Non-Erosive GERD |
30 mg |
Once daily for 4 weeks |
2.2Special Populations
No adjustment for DEXILANT is necessary for patients with mild hepatic impairment (Child-Pugh Class A). Consider a maximum daily dose of 30 mg for patients with moderate hepatic impairment (Child-Pugh Class B). No studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.5)].
No dosage adjustment is necessary for elderly patients or for patients with renal impairment [see Clinical Pharmacology (12.5)].
2.3Important Administration Information
DEXILANT can be taken without regard to food.
DEXILANT should be swallowed whole.
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Alternatively, DEXILANT capsules can be opened and administered as follows:
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Open capsule;
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Sprinkle intact granules on one tablespoon of applesauce;
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| 以下是“全球医药”详细资料 |
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