Dexger

Approved Indications:

• Erosive Esophagitis (EE): Treatment of healing and maintenance of healed EE in adults and adolescents (12 years and older).
• Gastroesophageal Reflux Disease (GERD): Relief of heartburn and other symptoms associated with GERD.
• Maintenance Therapy: Prevention of relapse of healed EE.
• Frequent Heartburn: Treatment of frequent heartburn occurring two or more days per week in adults.
• Helicobacter pylori Eradication: Used as part of combination therapy with antibiotics to eradicate H. pylori infection and reduce the risk of duodenal ulcer recurrence.

Off-label or Clinically Accepted Uses:

• Prevention and treatment of gastric ulcers associated with chronic NSAID use.
• Zollinger-Ellison syndrome and other pathological hypersecretory conditions (at higher doses, under specialist supervision).

Adults:

• Erosive Esophagitis Treatment: 60 mg orally once daily for up to 8 weeks.
• Maintenance of Healed Erosive Esophagitis: 30 mg orally once daily.
• Symptomatic GERD: 30 mg orally once daily for up to 4 weeks.
• Frequent Heartburn: 30 mg orally once daily for 14 days; may repeat treatment every 4 months if symptoms recur.
• H. pylori Eradication (Triple Therapy): 30 mg twice daily with appropriate antibiotics for 10–14 days.

Pediatrics:

• Approved for patients 12 years and older, dosing as per adult recommendations.

Elderly:

• No dose adjustment needed based on age.

Renal Impairment:

• No dosage adjustment required for mild to moderate impairment.
• Limited data in severe renal impairment; monitor clinical response.

Hepatic Impairment:

• No adjustment needed in mild to moderate impairment.
• Use caution in severe hepatic impairment; clinical monitoring advised.

Administration Notes:

• Oral use only.
• Capsules may be swallowed whole or opened and sprinkled onto a spoonful of applesauce; do not crush or chew granules.
• Can be taken with or without food.

Dexlansoprazole is a proton pump inhibitor that specifically targets the gastric H+/K+ ATPase enzyme located on the secretory surface of parietal cells in the stomach lining. By irreversibly binding to this proton pump, dexlansoprazole blocks the final step of gastric acid production, thereby suppressing both basal and stimulated gastric acid secretion. Its unique dual delayed-release formulation allows for two separate releases of medication at different times, providing prolonged acid suppression over 24 hours, which enhances healing of erosive esophagitis and symptom control in GERD.

• Absorption: Well absorbed with an approximate bioavailability of 60%. The dual delayed-release system causes two distinct peaks in plasma concentration at roughly 1–2 hours and 4–5 hours post-dose.
• Distribution: Approximately 96% bound to plasma proteins.
• Metabolism: Metabolized primarily by hepatic cytochrome P450 enzymes CYP2C19 and CYP3A4 into inactive metabolites.
• Half-life: Terminal half-life ranges from 1 to 2 hours; pharmacodynamic effect lasts longer due to irreversible enzyme inhibition.
• Excretion: Eliminated mainly through renal (about 51%) and fecal (about 45%) pathways as metabolites.

• Pregnancy: Classified as FDA Pregnancy Category B. Animal studies have not demonstrated harm to the fetus, but controlled human studies are lacking. Use only if clearly needed after evaluating risks and benefits.
• Lactation: Dexlansoprazole is excreted in breast milk in small amounts. Caution is advised when administered to breastfeeding women; infants should be monitored for adverse effects.

• Primary Class: Proton Pump Inhibitor (PPI)
• Subclass: Benzimidazole derivative acid suppressant

• Hypersensitivity to dexlansoprazole, lansoprazole, other proton pump inhibitors, or any ingredient in the formulation.
• Concurrent use with rilpivirine-containing products due to reduced antiviral efficacy.
• Severe hepatic impairment (relative contraindication; use caution).

• Use with caution in patients with severe hepatic impairment.
• Long-term use may increase risk of bone fractures, hypomagnesemia, vitamin B12 deficiency, and Clostridium difficile infection.
• Monitor magnesium levels during prolonged treatment, especially in patients on diuretics or with conditions predisposing to hypomagnesemia.
• Persistent symptoms warrant evaluation to exclude gastric malignancy.
• Rare cases of acute interstitial nephritis have been reported; discontinue drug if suspected.
• Observe for serious skin reactions.

Common:

• Headache
• Diarrhea
• Nausea
• Abdominal pain
• Flatulence
• Constipation

Rare/Serious:

• Hypersensitivity reactions (rash, pruritus, anaphylaxis)
• Acute interstitial nephritis
• Clostridium difficile-associated diarrhea
• Hypomagnesemia (usually with prolonged use)
• Vitamin B12 deficiency with long-term therapy

• May inhibit CYP2C19 and CYP3A4; potential interaction with drugs metabolized by these enzymes.
• Contraindicated with rilpivirine (antiretroviral).
• May increase plasma levels and effects of warfarin; monitor INR.
• Possible increased methotrexate toxicity.
• Digoxin levels may increase; monitor accordingly.
• Minimal clinically significant interaction with clopidogrel.

• Dexlansoprazole is recommended for patients needing extended acid suppression due to its dual delayed-release formulation.
• Monitoring for magnesium deficiency and bone health is advised during long-term use.
• Updated guidelines emphasize cautious use to minimize risks of infections and nutrient deficiencies.
• Continues to be included in H. pylori eradication regimens in combination with antibiotics.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep capsules in original packaging until use.
• Do not freeze.
• Keep out of reach of children.