DELANZO
Dexlansoprazole 30 mg & 60 mg
Dosage Form: CapsulePack Size: 3 X 10's
Composition:
DELANZO 30 Capsule: Each capsule contains Dexlansoprazole INN 30mg as enteric coated pellets,
DELANZO 60 Capsule: Each capsule contains Dexlansoprazole INN 60mg as enteric coated pellets
DELANZO (Dexlansoprazole) delayed release capsule has been characterized as a gastric Proton Pump Inhibitor (PP) that blocks the final step of gastric acid production, It is the R-enantiomer of Lansoprazole ja racemic mixture of the R- and S-enantiomers). Dexlansoprazole capsule contains enteric coated pellets with different pH-dependent dissolution profiles.
The formulation of DELANZO (Dexlansoprazole) utilizes Dual Delayed Release (DDR) technology which results in plasma concentration-time profile with two distinct peaks; 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 daily doses of DELANZO 30 mg or 60 mg.
Indications:
DELANZO 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:
DELANZO (Dexlansoprazole) capsule is administered orally. The recommended doses of Dexlansoprazole for adults are as follows:
| Indication | Dose |
| Healing of Erosive Esophagitis | 60 mg once daily for up to 8 weeks |
| Maintenance of healed Erosive Esophagitis and relief of heartburn | 30 mg once daily for up to 6 months |
| Symptomatic Non-Erosive GERD | 30 mg once daily for up to 4 weeks |
Contraindications:
Dexlansoprazole is contraindicated in patients with known hypersensitivity to any component of the formulation.
Warning & Precautions:
Patients taking concomitant Warfarin may require monitoring for increased International Normalized Ratio (INF) and Prothrombin Time, Increased INR and Prothrombin Time may lead to abnormal bleeding and even death.
Overdose:
There have been no reports of significant overdose of Dexlanzoprazole, Multiple doses of Dexlansoprazole 120 mg and a single dose of Dexlansoprazole 300 mg did not result in any severe adverse events.
Storage Conditions:
Store below 30 C & in dry places. Protect from light. Keep out of the reach of children
Commercial Pack:
DELANZO 30 Capsule: Each box contains 30 capsules in 5 x 10's Alu-Alu blister strips
DELANZO 60 Capsule: Each box contains 30 capsules in 3 x 10's Allu-Alu blister strips