Dexigent 30 mg Capsule

Indication:

Dexigent 30 mg Capsule is indicated for the treatment of-

• Healing of Erosive Esophagitis (EE): Healing of all grades of erosive esophagitis for up to 8 weeks.
• Maintenance of Healed Erosive Esophagitis: Maintenance of healing and reduction of relapse of erosive esophagitis, as well as relief of associated heartburn, for up to 6 months.
• Symptomatic Non-Erosive Gastro-Esophageal Reflux Disease (GERD): Treatment of heartburn and other symptoms associated with symptomatic, non-erosive GERD for 4 weeks.
• Long-Term Acid Suppression: Extended management of hyperacidic states requiring a sustained 24-hour therapeutic window.

Dogase & Adminstration:

Adult Dosage (Ages 18 and older)

• Healing of Erosive Esophagitis: 60 mg once daily for up to 8 weeks.
• Maintenance of Healed Erosive Esophagitis: 30 mg once daily for up to 6 months.
• Symptomatic Non-Erosive GERD: 30 mg once daily for 4 weeks.
• Hepatic Impairment Dosing: For patients with moderate hepatic impairment (Child-Pugh Class B), a maximum dose of 30 mg per day should be considered. It is not recommended for severe hepatic impairment.

Child Dosage :

Pediatric considerations are guided by safety validation records and age/weight limits to avoid toxic accumulation.

• Neonate (0–28 days): Not indicated. The neonatal liver lacks mature metabolic enzyme pathways to clear the drug, making it unsafe.
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• Infants (1 month to 11 months): Safety and efficacy have not been clinically established; avoid use due to risks of accumulation.
• Children (1 year to 11 years): Standard guidelines advise against routine use unless under direct specialist supervision, as clinical safety validation trails behind older demographics.
• Adolescents (12 to 17 years):
  • Healing of Erosive Esophagitis: 60 mg once daily for up to 8 weeks.
  • Maintenance of Healed Erosive Esophagitis: 30 mg once daily.
  • Symptomatic Non-Erosive GERD: 30 mg once daily for 4 weeks.

Administration Tip: Dexlansoprazole capsules must be swallowed whole. Alternatively, for patients with swallowing difficulties, the capsules can be opened, and the intact granules can be sprinkled onto a tablespoon of applesauce or mixed into a small amount of water or juice and swallowed immediately without chewing.

”রেজিস্ট্রার চিকিৎসকের পরামর্শ অনুযায়ী ঔষধ সেবন করুন”

Pharmacology:

• Mechanism of Action (MOA): Dexlansoprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase enzyme system at the secretory surface of the gastric parietal cell. By binding irreversibly to this proton pump, it blocks the final step of acid production.
• Dual Delayed-Release (DDR) Technology: Unlike conventional PPIs, Dexlansoprazole utilizes an innovative Dual Delayed-Release formulation. The capsule contains two distinct types of enteric-coated granules designed to release the drug at different times based on pH levels:
  • First Release: Approximately 25% of the dose is released in the proximal small intestine (at a pH of ~5.5) within 1 to 2 hours of administration.
  • Second Release: The remaining 75% of the dose is released in the distal small intestine (at a pH of ~6.75) roughly 4 to 5 hours later.
  • Clinical Impact: This dual-peak pharmacokinetic profile extends the plasma concentration-time curve, providing prolonged acid suppression and maintaining a gastric pH above 4 for up to 24 hours with a single daily dose.
• Pharmacokinetics:
  • Absorption: Rapidly absorbed after release. While food delays absorption, it does not significantly impact overall systemic exposure; however, taking it prior to meals optimizes its clinical efficacy.
  • Distribution: Plasma protein binding is approximately 96% to 99%.
  • Metabolism: Extensively metabolized in the liver via oxidation, reduction, and subsequent formation of sulfate, glucuronide, and glutathione conjugates. Metabolism is primarily mediated by the CYP2C19 enzyme (to form inactive 5-hydroxy dexlansoprazole) and the CYP3A4 enzyme (to form dexlansoprazole sulfone).
  • Elimination: Excreted via urine (~50.7%) and feces (~47.6%). The elimination half-life is approximately 1 to 2 hours, though the biological effect lasts significantly longer due to irreversible enzyme inhibition.

Side Effects:

• Common: Diarrhea, abdominal pain, nausea, vomiting, flatulence, upper respiratory tract infections, and headache.
• Long-Term/Rare Risks: Severe hypomagnesemia, increased risk of osteoporosis-related fractures (hip, wrist, spine), acute interstitial nephritis, and Vitamin B12 deficiency with prolonged use.

Drug Interaction:

• pH-Dependent Absorption Drugs: Dexlansoprazole reduces gastric acidity, which can lower the absorption of drugs like Ketoconazole, Itraconazole, Erlotinib, Iron salts, and Mycophenolate Mofetil.
• HIV Protease Inhibitors: Co-administration with Atazanavir or Nelfinavir is contraindicated due to severe reductions in their therapeutic concentrations.
• Methotrexate: Concomitant use may elevate and prolong serum levels of Methotrexate, leading to toxicity.
• Warfarin: Co-administration may increase INR and prothrombin time; monitor closely.

Pregnancy & Lactation:

• Pregnancy: Category B. There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and prescribed by a physician.
• Lactation: It is unknown whether dexlansoprazole is excreted in human breast milk. A choice should be made between discontinuing nursing or discontinuing the drug, balancing its importance to the mother.

Over Dosage:

There have been no reports of significant toxicity from acute Dexlansoprazole overdose. Doses up to 120 mg have been well-tolerated. It is not significantly removed via hemodialysis. Treatment should focus on supportive care and symptomatic management.

Therapeutic Class:

 Proton Pump Inhibitor (PPI) / Antacid and Antiulcerant.

Storage Conditions:

Store below at 30°C  temperature in a dry place. Away from light and out of reach of children. Do not use the medication after its expiration date.