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Dexilant

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Overview

What is Dexilant?

The active ingredient in DEXILANT (dexlansoprazole) delayed-release capsules, a proton pump inhibitor, is (+)-2-[()-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]--benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the -enantiomer of lansoprazole (a racemic mixture of the - and -enantiomers). Its empirical formula is: CHFNOS, with a molecular weight of 369.36. Dexlansoprazole has the following 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.

Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles .

DEXILANT delayed-release capsules are available in two dosage strengths: 30 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.



What does Dexilant look like?



What are the available doses of Dexilant?

DEXILANT delayed-release capsules

What should I talk to my health care provider before I take Dexilant?

How should I use Dexilant?

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.

See full prescribing information for complete dosing information for DEXILANT by indication and age group and dosage adjustment in patients with hepatic impairment. (, )


What interacts with Dexilant?

Sorry No Records found


What are the warnings of Dexilant?

Sorry No Records found


What are the precautions of Dexilant?

Sorry No Records found


What are the side effects of Dexilant?

Sorry No records found


What should I look out for while using Dexilant?

Patients with known hypersensitivity to any component of the formulation. ()

Patients receiving rilpivirine-containing products. (, )


What might happen if I take too much Dexilant?

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, serious adverse events of hypertension have been reported in association with twice daily doses of DEXILANT 60 mg. Non-serious adverse reactions observed with twice daily doses of DEXILANT 60 mg include hot flashes, contusion, oropharyngeal pain, and weight loss. Dexlansoprazole is not expected to be removed from the circulation by hemodialysis.

In the event of over-exposure, treatment should be symptomatic and supportive.

If over-exposure occurs, call your poison control center at 1-800-222-1222 for current information on the management of poisoning or over-exposure.


How should I store and handle Dexilant?

StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled RoomTemperature].StorageStore at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled RoomTemperature].DEXILANT delayed-release capsules, 30 mg, are opaque, blue and gray with "TAP" and "30" imprinted on the capsule and supplied as:DEXILANT delayed-release capsules, 60 mg, are opaque, blue with "TAP" and "60" imprinted on the capsule and supplied as:DEXILANT delayed-release capsules, 30 mg, are opaque, blue and gray with "TAP" and "30" imprinted on the capsule and supplied as:DEXILANT delayed-release capsules, 60 mg, are opaque, blue with "TAP" and "60" imprinted on the capsule and supplied as:


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

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 of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, dexlansoprazole has been characterized as a gastric proton-pump inhibitor, in that it blocks the final step of acid production.

Non-Clinical Toxicology
Patients with known hypersensitivity to any component of the formulation. ()

Patients receiving rilpivirine-containing products. (, )

In adults, symptomatic response to therapy with DEXILANT does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.

The following serious adverse reactions are described below and elsewhere in labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

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