Capsules, delayed-release: 30 mg and 60 mg.
Tablets, orally-disintegrating*: 30 mg
*Two ORD tablets are not equivalent to one 60 mg capsule.
For the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks: 30 mg once daily.
To maintain healing of erosive esophagitis and relief of heartburn for up to 6 months: 30 mg once daily.
To heal all grades of erosive esophagitis for up to 8 weeks: 60 mg once daily.
Pharmacology/Pharmacokinetics:
Dexlansoprazole inhibits the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. This enzyme system is involved in the movement and production of gastric acid. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, dexlansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect id dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. Dexilant form of dexlansoprazole has a dual delayed release effect with two distinct peaks in the plasma. The first peak occurs 1 to 2 hours after an oral dose and the second peak occurs at about 4 to 5 hours post dose. Dexlansoprazole is extensively metabolized in the liver by CYP2C19 and CYP3A4.
Drug Interactions:
Because dexlansoprazole causes a profound and long-lasting inhibition of gastric acid secretion it may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, ampicillin esters, iron salts, digoxin). Dexlansoprazole may increase whole blood levels of tacrolimus.
Contraindications/Precautions:
Contraindicated in patients with know hypersensitivity to dexlansoprazole. Systemic response to therapy with dexlansoprazole does not preclude the presence of gastric malignancy. Long-term use of proton-pump inhibitors has been associated with an increase in risk of osteoporosis-related fractures of the hip, wrist, or spine and of the development of hypomagnesemia. Appropriate precautions and monitoring should apply. Pregnancy Category B.
Adverse Effects:
Common adverse effects include diarrhea, nausea, upper respiratory tract infection, vomiting, abdominal pain, and flatulence.
May be taken without regard to meals.
The capsules should be swallowed whole or the contents sprinkled onto soft food and swallowed without chewing.
ODT should be placed on the tongue and dissolved or swallowed whole with water.
Store in a cool, dry place away from sunlight and children.
Contact a physician if the above side effects are severe or persistent.
Seek medical attention if palpitations, dizziness, seizures, or tetany occur as these are signs of hypomagnesemia.
If a dose is missed, take it as soon as possible. If it is closer to the time of your next dose than the dose you missed, skip the missed dose and return to your dosing schedule. Do not double doses.