Dexilant

Dexilant

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Healing of Erosive Esophagitis

DEXILANT is indicated for healing of all grades of erosive esophagitis (EE) for up to 8 weeks.

1.2 Maintenance of Healed Erosive Esophagitis

DEXILANT is indicated to maintain healing of EE and relief of heartburn for up to 6 months.

1.3 Symptomatic Non-Erosive Gastroesophageal Reflux Disease

DEXILANT is indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks.

History

There is currently no drug history available for this drug.

Other Information

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-benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R-enantiomer of lansoprazole (a racemic mixture of the R- and S-enantiomers). Its empirical formula is: C16H14F3N3O2S, with a molecular weight of 369.36. The structural formula is:

Chemical Structure

Dexlansoprazole is a white to nearly white crystalline powder which melts with decomposition at 140°C. Dexlansoprazole is freely soluble in dimethylformamide, methanol, dichloromethane, ethanol, and ethyl acetate; and soluble in acetonitrile; slightly soluble in ether; and very slightly soluble in water; and practically insoluble in hexane.

Dexlansoprazole is stable when exposed to light. Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions.

DEXILANT is supplied as a dual delayed-release formulation in capsules for oral administration. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3)].

DEXILANT is available in two dosage strengths: 30 mg and 60 mg, per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: sugar spheres, magnesium carbonate, sucrose, low-substituted hydroxypropyl cellulose, titanium dioxide, hydroxypropyl cellulose, hypromellose 2910, talc, methacrylic acid copolymers, polyethylene glycol 8000, triethyl citrate, polysorbate 80, and colloidal silicon dioxide. The components of the capsule shell include the following inactive ingredients: hypromellose, carrageenan and potassium chloride. Based on the capsule shell color, blue contains FD&C Blue No. 2 aluminum lake; gray contains black ferric oxide; and both contain titanium dioxide.

Dexilant Manufacturers


  • Physicians Total Care, Inc.
    Dexilant (Dexlansoprazole) Capsule, Delayed Release [Physicians Total Care, Inc.]
  • Takeda Pharmaceuticals America, Inc.
    Dexilant (Dexlansoprazole) Capsule, Delayed Release [Takeda Pharmaceuticals America, Inc.]
  • Cardinal Health
    Dexilant (Dexlansoprazole) Capsule, Delayed Release [Cardinal Health]

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