DELANZ Capsule

Indication:

- Healing of Erosive Esophagitis

Dexlansoprazole is indicated for healing of all grades of erosive esophagitis (EE) for up to eight weeks.

- Maintenance of Healed Erosive Esophagitis

Dexlansoprazole is indicated to maintain healing of EE and relief of heartburn for up to six months . Symptomatic Non-Erosive Gastroesophageal Reflux Disease.

Dexlansoprazole is indicated for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.

Dosage and administration:

Recommended dose

Dexlansoprazole is available as capsules in 30mg and 60mg strengths for adults use. Directions for use in each indication are summerized below:

- healing of EE: 60mg once daily for up to 8 weeks.

- Maintenance of Healed EE and relief of heartburn: 30mg once daily (controlled studies did not extend beyond 6 months.

- Symptomatic Non Erosive GERD: 30mg Once daily for 4 weeks.

Hepatic Impairment:

No adjustment for dexlansoprazole 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)

Important Administration Information:

• Dexlansoprazole can be taken without regard to food.

• Dexlansoprazole should be swallowed whole.

• Dexlansoprazole should not be chewed.

Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity and anaphylaxis have been reported with dexlansoprazole use. Acute interstitial nephritis has been reported with other proton pump inhibitors (PPIs), including lansoprazole.

Diarrhea

Abdominal pain

Nausea

Upper Respiratory

Tract Infection

Vomiting

Flatulence

Drugs with pH-Dependent Absorption Kinetics

Due to its effects on gastric acid secretion, dexlansoprazole can reduce the absorption of drugs where gastric pH is an important determinant of their bioavailability. Like with other drugs that decrease the intragastric acidity, the absorption of drugs such as ampicillin esters, ketoconazole, atazanavir, iron salts, erlotinib, and mycophenolate mofetil (MMF) can decrease, while the absorption of drugs such as digoxin can increase during treatment with dexlansoprazole.

Warfarin

Co-administration of dexlansoprazole 90 mg and warfarin 25 mg did not affect the pharmacokinetics of warfarin or INR However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with dexlansoprazole and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.

Tacrolimus

Concomitant administration of dexlansoprazole and tacrolimus may increase whole blood levels of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.

Clopidogrel

Concomitant administration of dexlansoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition. No dose adjustment of clopidogrel is necessary when administered with an approved dose of dexlansoprazole.

Methotrexate

Case reports: published population pharmacokinetic studies, and retrospective analysis suggest that concomitant administration of PPIs and methotrexate (primarily at high dose) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate.

However, no formal drug interaction studies of high-dose methotrexate with PPIs have been conducted.

Teratogenic Effects

Pregnancy Category B. There are no adequate and well-controlled studies with dexlansoprazole in pregnant women. There were no adverse fetal effects in animal reproduction studies of dexlansoprazole in rabbits. Because animal reproduction studies are not always predictive of human response-dexlansoprazole should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether dexlansoprazole is excreted in human milk. However, lansoprazole and its metabolites are present in rat milk following the administration of lansoprazole. As many drugs are excreted in human milk, and because of the potential for tumorigenicity shown for lansoprazole in rat carcinogenicity a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of dexlansoprazole in pediatric patients (less than 18 years of age) have not been established.

Dexlansoprazole is PPI that suppresses gastric acid secretion by specific inhibition of the (H+, K+)-ATPase in the gastric parietal cell. By acting specifically on the proton pump, dexlansoprazole blocks the final step of acid production.