Information about Delastom
Composition:

Each delayed-release capsule contains:

enteric-coatedgranules consisting of dexlansoprazole 30 mg or 60 mg.

Pharmacological Properties:

Delastomis a proton pump inhibitor (PPI) that suppresses gastric acid secretion by specific inhibition of the (H+, K+)-ATPase in the gastricparietal cell.

Byacting specifically on the proton pump, dexlansoprazole blocks the final stepof acid production.

Theeffects of  Delastom 60 mg once daily forfive days on 24-hours intragastric pH resulted in pH > 4.

In patients treated for more than 6 months, mean serum gastrin levels increased during the first 3 months of treatment and were stable for the remainder oftreatment.

After oral administration of Delastom, mean C max and AUC values increased approximately dose proportionally.

Dexlansoprazoleis extensively metabolized in the liver by oxidation, reduction, and subsequent formation of sulfate, glucuronide and glutathione conjugates to inactive metabolites.

Following the administration of  Delastom,approximately 50.7% is excreted in urine and 47.6% in the feces.

Delastom can be taken without regard to food.

Indications:

Delastom is indicated for:

Treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD). 

Healing of all grades of erosive esophagitis (EE).

Maintain healing of erosive esophagitis (EE) and relief of heartburn.

Contraindications:

Delastomis contraindicated in patients with known hypersensitivity to any component of the formulation.

Warnings and Precautions:

Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.

Bone Fracture: Long-term andmultiple daily dose (PPI) therapy may be associated with an increased risk forosteoporosis-related fractures of the hip, wrist or spine.

Gastric malignancy: Symptom aticresponse with Delastom does not preclude the presence of gastric malignancy.

Side Effects:

Most commonly reported side effects (≥2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting and flatulence.

Otherrare side effects at an incidence of less than 2% are: anemia, lymphadenopathy,angina, arrhythmia, bradycardia, chest pain, edema, myocardial infarction,palpitation, tachycardia, ear pain, tinnitus, vertigo, goiter, eye irritation,eye swelling, abdominal discomfort, asthenia, chest pain, pyrexia,hypercalcemia, hypokalemia, psychomotor hyperactivity, tremor, menstrual disorder, libido changes, dysuria, anxiety, depression, tissue disorders.

Drug Interactions:

Atazanavir : Co-administration of Delastom and atazanavir may substantially decrease the systemic concentrations.

Drugs with pH-dependent absorption (e.g., ampicillin esters, digoxin, iron salts, ketoconazole): Delastommay interfere with the absorption ofdrugs for which gastric pH is important for bioavailability.

Warfarin: Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time.

Tacrolimus: Concomitant tacrolimus use may increase tacrolimus whole blood concentrations.

Dosage and Administration:

Healing of erosive esophagitis(EE): 60 mg once daily for up to 8 weeks.

Maintenance of healed erosive esophagitis (EE): 30 mg once daily for up to 6 months.

Symptomatic non-erosive GERD: 30mg once daily for 4 weeks.

Hepatic Impairment: 30 mg shouldbe considered maximum daily dose for patients with moderate hepatic impairment(Child-Pugh Class B).

Nostudies were conducted in patients with severe hepatic impairment

(Child-PughClass C).

Delastom can be taken without regard to food.

Delastom should be swallowed whole.Alternatively, capsules can be opened, sprinkled on one tablespoon of applesauce, and swallowed immediately.

Use in Specific Populations:

Pregnancy and Lactation:

Pregnancy Category B. Delastom should be used during pregnancy only if clearly needed.

Adecision should be made whether to discontinue nursing or to discontinue thedrug, taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of Delastom in pediatric patients (less than 18 years ofage) have not been established.

Geriatric Use: No overall differences in safety or effectiveness were observed between these patients andyounger patients, and no significant differences in responses between them.

Renal and Hepatic impairment: No dosage adjustment of Delastom is necessary in patients with renal or hepaticimpairment.

Overdosage:

Therehave been no reports of significant overdose of Delastom 120 mg and a singledose of Delastom 300 mg did not result in death or other severe adverseevents.

Non-seriousadverse reactions observed with twice daily doses of Delastom 60 mg include hotflashes, contusion, oropharyngeal pain, and weight loss. Dexlansoprazole is notexpected to be removed from the circulation by hemodialysis.

If an overdose occurs, treatment should be symptomatic and supportive.

Storage:

Delastom should be stored at temperature 25°C, and should be kept out of reach of children.

Packings:

Packs of 24 delayed-release capsules, 30 mg dexlansoprazole .

Packs of 20 delayed-release capsules, 60 mg dexlansoprazole .