DEXILANT SOLUTAB
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DEXILANT SOLUTAB (DEXILANT SOLUTAB).
Proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of gastric parietal cells.
| Metabolism | Primarily metabolized by CYP2C19 and CYP3A4 enzymes. |
| Excretion | Renal (approx. 53% as metabolites, <2% as unchanged drug), biliary/fecal (approx. 47%). |
| Half-life | Terminal elimination half-life is approximately 1-2 hours; however, the pharmacodynamic half-life (duration of acid suppression) is prolonged due to accumulation in parietal cell canaliculi. |
| Protein binding | 94-98% bound to plasma proteins (primarily albumin). |
| Volume of Distribution | Approximately 11.2 L (0.16 L/kg for a 70 kg adult), indicating distribution into total body water. |
| Bioavailability | Oral: dexlansoprazole MR (controlled-release) has an absolute bioavailability of approximately 30-40% (varies with formulation; immediate-release not applicable). |
| Onset of Action | Oral: 1-4 hours for maximal acid suppression. |
| Duration of Action | Acid suppression (>24 hours after multiple doses); clinical effect persists for 24 hours with once-daily dosing. |
| Molecular Weight | 369.36 |
30 mg orally once daily for 4-8 weeks; for non-erosive GERD, 30 mg orally once daily for 4 weeks; for erosive esophagitis, 60 mg orally once daily for up to 8 weeks; for maintenance of healed EE and relief of heartburn, 30 mg orally once daily. Administer without regard to food; dissolve tablet in water.
| Dosage form | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE |
| Renal impairment | No dose adjustment necessary for mild to moderate renal impairment (CrCl ≥30 mL/min). For severe renal impairment (CrCl <30 mL/min), maximum dose is 30 mg once daily. |
| Liver impairment | Child-Pugh Class A or B: no dose adjustment. Child-Pugh Class C: maximum dose 30 mg once daily. |
| Pediatric use | Not approved for pediatric patients under 18 years; safety and efficacy not established. |
| Geriatric use | No specific dose adjustment recommended; consider lower starting dose due to potential decreased hepatic/renal function. Maximum 30 mg once daily for patients over 65 years with severe renal impairment. |
| 1st trimester | Limited human data; animal studies show no teratogenicity at clinically relevant doses. Use only if clearly needed. |
| 2nd trimester | Limited human data; avoid use if possible due to potential for maternal gastric pH changes affecting absorption of other drugs. |
| 3rd trimester | Use near term may be associated with hypocalcemia and tetany in neonates; avoid use if possible. |
Clinical note
Comprehensive clinical and safety monograph for DEXILANT SOLUTAB (DEXILANT SOLUTAB).
| Placental transfer | Dexlansoprazole crosses the placenta in animal studies; human data not available. |
| Breastfeeding | Dexlansoprazole is excreted in human milk in small amounts; effects on nursing infant are unknown. Caution recommended; consider alternative agents during breastfeeding. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to dexlansoprazole or any component of the formulationConcomitant use with rilpivirine-containing products
| Precautions | Gastric malignancy may be present; rule out malignancy if alarm symptoms are present (e.g., weight loss, dysphagia)., Chronic use may increase risk of Clostridium difficile-associated diarrhea., May increase risk for osteoporosis-related fractures (hip, wrist, spine) with high-dose or long-term use., May cause hypomagnesemia; monitor magnesium levels if prolonged treatment or with concomitant digoxin or diuretics., May increase risk of acute interstitial nephritis., May interfere with absorption of drugs dependent on gastric pH (e.g., ketoconazole, iron salts, ampicillin esters). |
| Food/Dietary | Avoid high-fat meals as they may delay absorption. No specific food interactions, but administration with food may reduce efficacy. Best taken on an empty stomach. |
Loading safety data…
| Lactation Rating |
| L3 (Moderately Safe) |
| Teratogenic Risk | No evidence of teratogenicity in human studies; crosses placenta. Risk cannot be ruled out; use only if clearly needed. |
| Fetal Monitoring | Monitor for maternal adverse effects (e.g., fractures, infections). Fetal monitoring not routinely required. |
| Fertility Effects | No known adverse effects on fertility in animal studies; human data limited. |
| Clinical Pearls | DEXILANT SOLUTAB (dexlansoprazole) is a PPI with a dual delayed-release formulation providing prolonged acid suppression. Useful for patients with nocturnal GERD. Can be administered via oral syringe mixed with 20 mL water for patients with dysphagia. Do not crush or chew tablets. |
| Patient Advice | Take 30-60 minutes before meals, preferably breakfast. · Do not crush, chew, or cut the tablet; it is a specially formulated dual delayed-release tablet. · If using the oral syringe method, mix with 20 mL water and administer immediately. · Avoid alcohol and caffeine to reduce stomach irritation. · Report any new or worsening symptoms, such as severe diarrhea or abdominal pain. · Long-term use may increase risk of bone fractures, vitamin B12 deficiency, or Clostridium difficile infection. |