Kapidex Delayed Release Capsules

DRUG DESCRIPTION

The active ingredient in KAPIDEX (dexlansoprazole delayed release capsules) (dexlansoprazole) delayed release capsules 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:

KAPIDEX (dexlansoprazole)  Structural Formula Illustration

Dexlansoprazole is a white to nearly white crystalline powder which melts with decomposition at 140C. 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.

KAPIDEX (dexlansoprazole delayed release capsules) 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].

KAPIDEX (dexlansoprazole delayed release capsules) 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 copolymer, 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 and aluminum lake; gray contains ferric oxide and aluminum lake; and both contain titanium dioxide.

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

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; or
  • worsening heartburn.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, gas;
  • diarrhea; or
  • stuffy nose, sneezing, or other cold...

Read All Potential Side Effects and See Pictures of Kapidex Delayed Release Capsules


Kapidex Delayed Release Capsules Patient Information Including Side Effects

Brand Names: Kapidex

Generic Name: dexlansoprazole (Pronunciation: DEX lan SOE pra zol)

  • What is dexlansoprazole (Kapidex Delayed Release Capsules)?
  • What are the possible side effects of dexlansoprazole (Kapidex Delayed Release Capsules)?
  • What is the most important information I should know about dexlansoprazole (Kapidex Delayed Release Capsules)?
  • What should I discuss with my healthcare provider before taking dexlansoprazole (Kapidex Delayed Release Capsules)?
  • How should I take dexlansoprazole (Kapidex Delayed Release Capsules)?
  • What happens if I miss a dose (Kapidex Delayed Release Capsules)?
  • What happens if I overdose (Kapidex Delayed Release Capsules)?
  • What should I avoid while taking dexlansoprazole (Kapidex Delayed Release Capsules)?
  • What other drugs will affect dexlansoprazole (Kapidex Delayed Release Capsules)?
  • Where can I get more information?

What is dexlansoprazole (Kapidex Delayed Release Capsules)?

Dexlansoprazole decreases the amount of acid produced in the stomach.

Dexlansoprazole is used to treat heartburn caused by gastroesophageal reflux disease (GERD), and to heal erosive esophagitis (damage to the esophagus from stomach acid).

Dexlansoprazole may also be used for other purposes not listed in this medication guide.

What are the possible side effects of dexlansoprazole (Kapidex Delayed Release Capsules)?

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; or
  • worsening heartburn.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, gas;
  • diarrhea; or
  • stuffy nose, sneezing, or other cold symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dexlansoprazole (Kapidex Delayed Release Capsules)?

Before taking this medication, tell your doctor if you are allergic to any drugs, or if you have liver disease. You may need a dose adjustment or special tests to safely take dexlansoprazole.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before your treatment is completed.

When treating heartburn, dexlansoprazole is usually given for 4 weeks. To best heal erosive esophagitis, you may need to take dexlansoprazole for several months. Follow your doctor's instructions.

Heartburn can be confused with early symptoms of heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, dizziness, pain spreading to the arm or shoulder, sweating, nausea or vomiting, and a general ill feeling.

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