Presentation

Delanix 30 capsule: Each capsule contains Dexlansoprazole INN 30 mg as enteric coated pellets.

Delanix 60 capsule: Each capsule contains Dexlansoprazole INN 60 mg as enteric coated pellets.

Description

Delanix (Dexlansoprazole) delayed release capsule has been characterized as a gastric Proton Pump Inhibitor (PPI) that blocks the final step of gastric acid production. It is the R-enantiomer of Lansoprazole (a racemic mixture of the R- and S-enantiomers). Dexlansoprazole capsule contains a mixture of two type enteric coated pellets with different pH-dependent dissolution profiles. The formulation of Delanix (Dexlansoprazole) utilizes Dual Delayed Release (DDR) technology which results in plasma concentration-time profile with two distinct peak; the first peak occurs within 1 to 2 hours after administration, followed by a second peak within 4 to 5 hours. No accumulation of Dexlansoprazole occurs after multiple once daily doses of Delanix 30 mg or 60 mg.

Indications

Delanix (Dexlansoprazole) is a Proton Pump Inhibitor (PPI) used to treat-

1. Healing of all grades of Erosive Esophagitis. 2. Maintenance of healed Erosive Esophagitis. 3. Heartburn associated with Non-Erosive Gastroesophageal reflux disease (GERD)

Dosage & Administration

Delanix (Dexlansoprazole) capsule is administered orally. The recommended doses of Dexlansoprazole for adults are as follows: Indications Dose Duration: Healing of Erosive 60 mg once daily Up to 8 weeks Esophagitis. Maintenance of healed 30 mg once daily Up to 6 months Erosive Esophagitis and relief of heartburn. Symptomatic Non-Erosive 30 mg once daily 4 weeks.

Side Effects

Adverse events are rarely seen; such as diarrhea, abdominal pain, nausea, vomiting, flatulence etc.

Precautions

Patients taking concomitant Warfarin may require monitoring for increased International Normalized Ratio (INR) and Prothrombin Time. Increased INR and Prothrombin Time may lead to abnormal bleeding and even death.

Drug Interaction

Dexlansoprazole may interfere with the absorption of drugs for which gastric pH is important for bioavailability (e.g., Ampicillin esters, Digoxin, Iron salts, Ketoconazole).

Over Dose

There have been no reports of significant overdose of Dexlansoprazole. Multiple doses of Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in any severe adverse events.

Storage

Do not store above 30 0C. Keep away from light and out of the reach of children.

Commercial Pack

Delanix 30 capsule: Each box contains 5 alu-alu blister strips of 6 capsules. Delanix 60 capsule: Each box contains 7 alu-alu blister strips of 4 capsules.