Dexilant
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
DEXILANT is indicated for healing of all grades of erosive esophagitis (EE) for up to 8 weeks.
DEXILANT is indicated to maintain healing of EE and relief of heartburn for up to 6 months.
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:
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.
Sources
Dexilant Manufacturers
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Physicians Total Care, Inc.
![Dexilant (Dexlansoprazole) Capsule, Delayed Release [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Dexilant | Physicians Total Care, Inc.
2.1 Recommended DoseDEXILANT 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 Indication Recommended Dose Frequency Healing of EE 60 mg Once daily for up to 8 weeks Maintenance of Healed EE and relief of heartburn 30 mg Once daily Symptomatic Non-Erosive GERD 30 mg Once daily for 4 weeks 2.2 Hepatic ImpairmentNo 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 (12.3)].
2.3 Important Administration InformationDEXILANT can be taken without regard to food.
DEXILANT should be swallowed whole.
Alternatively, DEXILANT capsules can be administered as follows: –Open capsule; –Sprinkle intact granules on one tablespoon of applesauce; – Swallow immediately. Granules should not be chewed. -
Takeda Pharmaceuticals America, Inc.
Dexilant | Takeda Pharmaceuticals America, Inc.
2.1 Recommended DoseDEXILANT 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.
* Controlled studies did not extend beyond 6 months.Table 1. DEXILANT Dosing Recommendations
Indication
Recommended Dose
Frequency
Healing of EE
60 mg
Once daily for up to 8 weeks
Maintenance of Healed EE and relief of heartburn
30 mg
Once daily*
Symptomatic Non-Erosive GERD
30 mg
Once daily for 4 weeks
2.2 Hepatic ImpairmentNo 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 (12.3)].
2.3 Important Administration Information • DEXILANT can be taken without regard to food. • DEXILANT should be swallowed whole. • DEXILANT should not be chewed.For patients who have difficulty swallowing capsules, follow the instructions below for administration:
Administration with Applesauce
• Place one tablespoon of applesauce into a clean container. • Open capsule. • Sprinkle intact granules on applesauce. • Swallow applesauce and granules immediately. Do not chew granules. Do not save the applesauce and granules for later use.Administration with Water in an Oral Syringe
• Open the capsule and empty the granules into a clean container with 20 mL of water. • Withdraw the entire mixture into a syringe. • Gently swirl the syringe in order to keep granules from settling. • Administer the mixture immediately into the mouth. Do not save the water and granule mixture for later use. • Refill the syringe with 10 mL of water, swirl gently, and administer. • Refill the syringe again with 10 mL of water, swirl gently, and administer.Administration with Water via a Nasogastric Tube (≥16 French)
• Open the capsule and empty the granules into a clean container with 20 mL of water. • Withdraw the entire mixture into a catheter-tip syringe. • Swirl the syringe gently in order to keep the granules from settling, and immediately inject the mixture through the nasogastric tube into the stomach. Do not save the water and granule mixture for later use. • Refill the syringe with 10 mL of water, swirl gently, and flush the tube. • Refill the syringe again with 10 mL of water, swirl gently, and administer. -
Cardinal Health
Dexilant | Cardinal Health
2.1 Recommended DoseDEXILANT 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.
* Controlled studies did not extend beyond 6 months.Table 1. DEXILANT Dosing Recommendations
Indication
Recommended Dose
Frequency
Healing of EE
60 mg
Once daily for up to 8 weeks
Maintenance of Healed EE and relief of heartburn
30 mg
Once daily*
Symptomatic Non-Erosive GERD
30 mg
Once daily for 4 weeks
2.2 Hepatic ImpairmentNo 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 (12.3)].
2.3 Important Administration Information • DEXILANT can be taken without regard to food. • DEXILANT should be swallowed whole. • DEXILANT should not be chewed.For patients who have difficulty swallowing capsules, follow the instructions below for administration:
Administration with Applesauce
• Place one tablespoon of applesauce into a clean container. • Open capsule. • Sprinkle intact granules on applesauce. • Swallow applesauce and granules immediately. Do not chew granules. Do not save the applesauce and granules for later use.Administration with Water in an Oral Syringe
• Open the capsule and empty the granules into a clean container with 20 mL of water. • Withdraw the entire mixture into a syringe. • Gently swirl the syringe in order to keep granules from settling. • Administer the mixture immediately into the mouth. Do not save the water and granule mixture for later use. • Refill the syringe with 10 mL of water, swirl gently, and administer. • Refill the syringe again with 10 mL of water, swirl gently, and administer.Administration with Water via a Nasogastric Tube (≥16 French)
• Open the capsule and empty the granules into a clean container with 20 mL of water. • Withdraw the entire mixture into a catheter-tip syringe. • Swirl the syringe gently in order to keep the granules from settling, and immediately inject the mixture through the nasogastric tube into the stomach. Do not save the water and granule mixture for later use. • Refill the syringe with 10 mL of water, swirl gently, and flush the tube. • Refill the syringe again with 10 mL of water, swirl gently, and administer.
![Dexilant (Dexlansoprazole) Capsule, Delayed Release [Takeda Pharmaceuticals America, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9819f033-3bbe-442e-8e92-45fec77b237d&name=image-03.jpg)
![Dexilant (Dexlansoprazole) Capsule, Delayed Release [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8a957692-7f20-4752-b29a-53cff9325dd2&name=image-03.jpg)
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