DEXILANT Delayed-release capsules (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Takeda Pharmaceuticals America, Inc.

Λέξεις κλειδιά

64764-171 64764-175

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1. Indications and Usage

1.1 Healing of Erosive Esophagitis DEXILANT is indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks. 1.2 Maintenance of Healed Erosive ...

2. Dosage and Administration

2.1 Recommended Dosage in Patients 12 Years of Age and Older Table 1. Recommended DEXILANT Capsules Dosage Regimen by Indication in Patients 12 Years of Age and Older: Indication Dosage of DEXILANT Capsules ...

3. Dosage Forms and Strengths

DEXILANT delayed-release capsules. 30 mg: strength is an opaque, blue and gray capsule imprinted with TAP and 30. 60 mg: strength is an opaque, blue capsule imprinted with TAP and 60.

4. Contraindications

DEXILANT is contraindicated in patients with known hypersensitivity to any component of the formulation [see Description (11)]. Hypersensitivity reactions, including anaphylaxis have been reported ...

5. Warnings and Precautions

5.1 Presence of Gastric Malignancy In adults, symptomatic response to therapy with DEXILANT does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in ...

6. Adverse Reactions

The following serious adverse reactions are described below and elsewhere in labeling: Acute Interstitial Nephritis [see Warnings and Precautions (5.2)] Clostridium difficile-Associated ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during postapproval of DEXILANT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to ...

7. Drug Interactions

Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with DEXILANT and instructions for preventing or managing them. ...

8.1. Pregnancy

Risk Summary There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk. Dexlansoprazole is the R-enantiomer of lansoprazole, and published observational studies of ...

8.2. Lactation

Risk Summary There is no information regarding the presence of dexlansoprazole in human milk, the effects on the breastfed infant, or the effects on milk production. However, lansoprazole and its metabolites ...

8.4. Pediatric Use

The safety and effectiveness of DEXILANT have been established in pediatric patients 12 years to 17 years of age for the healing of all grades of EE, the maintenance of healed EE and relief of heartburn, ...

8.5. Geriatric Use

Of the total number of patients (n=4548) in clinical studies of DEXILANT, 11% of patients were aged 65 years and over, while 2% were 75 years and over. No overall differences in safety or effectiveness ...

8.6. Hepatic Impairment

No dosage adjustment for DEXILANT is necessary for patients with mild hepatic impairment (Child-Pugh Class A). In a study of adult patients with moderate hepatic impairment (Child-Pugh Class B) who received ...

10. Overdosage

There have been no reports of significant overdose with DEXILANT. Multiple doses of DEXILANT 120 mg and a single dose of DEXILANT 300 mg did not result in death or other severe adverse events. However, ...

11. Description

The active ingredient in DEXILANT (dexlansoprazole) delayed-release capsules, a proton pump inhibitor, is (+)2[(R)-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]-1H ...

12.1. Mechanism of Action

Dexlansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H+, K+)-ATPase at the secretory surface ...

12.2. Pharmacodynamics

Antisecretory Activity The effects of DEXILANT 60 mg (n=20) or lansoprazole 30 mg (n=23) once daily for five days on 24 hour intragastric pH were assessed in healthy subjects in a multiple-dose crossover ...

12.3. Pharmacokinetics

12.3 Pharmacokinetics The dual delayed-release formulation of DEXILANT results in a dexlansoprazole plasma concentration-time profile with two distinct peaks; the first peak occurs one to two hours after ...

12.5. Pharmacogenomics

Effect of CYP2C19 Polymorphism on Systemic Exposure of Dexlansoprazole Systemic exposure of dexlansoprazole is generally higher in intermediate and poor metabolizers. In male Japanese subjects who received ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of dexlansoprazole was assessed using lansoprazole studies. In two, 24 month carcinogenicity studies, Sprague-Dawley rats were treated orally with lansoprazole at doses of 5 ...

14. Clinical Studies

14.1 Healing of Erosive Esophagitis in Adults Two multicenter, double-blind, active-controlled, randomized, eight week studies were conducted in patients with endoscopically confirmed EE. Severity of the ...

16.1. How Supplied

DEXILANT delayed-release capsules, 30 mg, are opaque, blue and gray with TAP and 30 imprinted on the capsule and supplied as: NDC Number Size 64764-171-11 Unit dose package of 100 64764-171-30 ...

16.2. Storage and Handling

Store at 20 to 25°C (68 to 77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Adverse Reactions Advise patients to report to their healthcare provider if they experience any ...