February 14, 2016
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Dexilant

"The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).

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Dexilant

DEXILANT
(dexlansoprazole) Delayed-release Capsules




DRUG DESCRIPTION

The active ingredient in DEXILANT (dexlansoprazole) delayed-release capsules and DEXILANT SoluTab (dexlansoprazole) delayed-release orally disintegrating tablets, 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. Dexlansoprazole has the following chemical structure:

DEXILANT (dexlansoprazole) Structural Formula Illustration

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.

Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules and orally disintegrating tablets. The capsules and tablets contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see CLINICAL PHARMACOLOGY].

DEXILANT delayed-release capsules are 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 SoluTab delayed-release orally disintegrating tablets are available as 30 mg tablets. Each tablet contains enteric-coated microgranules. The tablet consists of dexlansoprazole (active ingredient) and the following inactive ingredients: lactose monohydrate-microcrystalline cellulose spheres, magnesium carbonate, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, hypromellose, talc, titanium dioxide, mannitol, methacrylic acid copolymer, ethyl acrylate methyl methacrylate copolymer, polysorbate 80, glyceryl monostearate, triethyl citrate, anhydrous citric acid, ferric oxide, red; ferric oxide, yellow; polyethylene glycol 8000, methylacrylate methylmethacrylate methacrylic acid copolymer, microcrystalline cellulose, crospovidone, sucralose, strawberry durarome, and magnesium stearate.

What are the possible side effects of dexlansoprazole (Dexilant)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • chest pain, fast or pounding heartbeats;
  • severe stomach pain;
  • diarrhea that is watery or bloody;
  • worsening heartburn; or
  • low magnesium (dizziness, confusion, fast or uneven heart rate, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, cough or choking feeling,...

Read All Potential Side Effects and See Pictures of Dexilant »

What are the precautions when taking dexlansoprazole delayed release capsules (Dexilant)?

Before taking dexlansoprazole, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as lansoprazole, omeprazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.

Some symptoms may actually be signs of a more serious condition. Get medical help right away if you have: heartburn with lightheadedness/sweating/dizziness, chest/jaw/arm/shoulder pain (especially with shortness of breath, unusual sweating), unexplained weight loss.

Proton pump inhibitors (such as dexlansoprazole) may increase your risk...

Read All Potential Precautions of Dexilant »

Last reviewed on RxList: 2/12/2016
This monograph has been modified to include the generic and brand name in many instances.

Dexilant - User Reviews

Dexilant User Reviews

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Here is a collection of user reviews for the medication Dexilant sorted by most helpful. Patient Discussions FAQs

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