Sanbur (Dexlansoprazole) - Product Summary

1. Indications

• Healing of Erosive Esophagitis (EE): Indicated for healing all grades of EE for up to 8 weeks.

• Maintenance of Healed EE: Maintains EE healing and relieves heartburn for up to 6 months.

• Symptomatic Non-Erosive GERD: Treats heartburn associated with non-erosive Gastroesophageal Reflux Disease for up to 4 weeks.

Note: Take strictly as prescribed by a registered physician.

2. Pharmacology

Dexlansoprazole is a Proton Pump Inhibitor (PPI) that reduces gastric acid production by inhibiting the (H+/K+)-ATPase enzyme in gastric parietal cells. Formulated with Dual Delayed Release (DDR) technology, it features two distinct peak concentration times in the blood: 1 to 2 hours after administration, followed by a second peak at 4 to 5 hours. It is metabolized in the liver and excreted in urine.

3. Dosage & Administration

Dosage Guidelines

• Healing of Erosive Esophagitis: 60 mg once daily (up to 8 weeks).

• Maintenance of Healed EE: 30 mg once daily (up to 6 months for adults; up to 16 weeks for ages 12 to 17).

• Symptomatic GERD: 30 mg once daily (for 4 weeks).

Administration

• Can be taken with or without food. Swallow capsules or tablets whole.

• Alternative method: Open the capsule, sprinkle the intact granules onto a tablespoon of soft food, and swallow immediately without chewing.

• Missed Dose: Take as soon as remembered. If close to the next scheduled dose, skip the missed dose. Do not take a double dose.

4. Safety & Precautions

5. Use in Special Populations

• Pediatrics (under 12 years): Safety and efficacy not established.

• Pregnancy & Lactation: Pregnancy Category B. Adequate controlled studies in pregnant/lactating women are not available.

• Geriatric & Renal Impairment: No dose adjustment necessary.

• Hepatic Impairment: No dose adjustment for mild impairment. Maximum dose of 30 mg daily for moderate hepatic impairment.

6. Overdose & Storage

• Overdose: No significant adverse events reported with multiple doses up to 120 mg or a single dose up to 300 mg.

• Storage: Store below 30°C in a dry place, protected from light. Keep out of reach of children.