PREVACID 24 HR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PREVACID 24 HR (PREVACID 24 HR).
Proton pump inhibitor (PPI) that irreversibly inhibits the H+/K+-ATPase enzyme system (proton pump) at the secretory surface of gastric parietal cells, suppressing basal and stimulated gastric acid secretion.
| Metabolism | Primarily hepatic via CYP2C19 and CYP3A4; also metabolized by non-CYP pathways. Formed metabolites include lansoprazole sulfone and hydroxylated derivatives. |
| Excretion | Approximately 66% renal (as metabolites), 33% fecal (primarily biliary); less than 1% unchanged in urine. |
| Half-life | 1.2-1.5 hours in healthy subjects; no accumulation with once-daily dosing. |
| Protein binding | About 97% bound to plasma proteins (albumin and alpha-1-acid glycoprotein). |
| Volume of Distribution | Approximately 15-30 L (0.2-0.4 L/kg), indicating limited extravascular distribution. |
| Bioavailability | Approximately 80% after oral administration; not significantly affected by food. |
| Onset of Action | 30-60 minutes after oral administration; maximal acid suppression achieved within 2-4 hours. |
| Duration of Action | Up to 24 hours for acid suppression; single daily dose provides prolonged effect due to irreversible proton pump inhibition. |
15 mg orally once daily for 14 days.
| Dosage form | CAPSULE, DELAYED REL PELLETS |
| Renal impairment | No dose adjustment required for GFR ≥15 mL/min. For GFR <15 mL/min, dose reduction to 15 mg every other day is recommended. |
| Liver impairment | Child-Pugh Class A: No adjustment. Child-Pugh Class B: 15 mg orally once daily. Child-Pugh Class C: 15 mg orally once daily. |
| Pediatric use | Not approved for pediatric use under 18 years. For children 1-11 years: 15 mg orally once daily for up to 12 weeks; for 12-17 years: 30 mg orally once daily for up to 8 weeks. |
| Geriatric use | No specific dose adjustment. Use lowest effective dose and monitor for adverse effects, particularly Clostridium difficile infection and bone fractures. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PREVACID 24 HR (PREVACID 24 HR).
| Breastfeeding | Lansoprazole is excreted in human breast milk; the milk-to-plasma (M/P) ratio is approximately 0.2. Based on limited data, the estimated infant dose is about 2.0% of the maternal weight-adjusted dose. Caution is advised when used during breastfeeding; consider the developmental and health benefits of breastfeeding along with the mother’s clinical need. |
| Teratogenic Risk | Lansoprazole (PREVACID 24 HR) is classified as Pregnancy Category B. Animal studies have not demonstrated fetal risk, but adequate human studies in pregnant women are lacking. No teratogenic effects have been reported with lansoprazole use during pregnancy. However, due to insufficient data, it should be used only if clearly needed, particularly during the first trimester. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to lansoprazole or any component of the formulation","Co-administration with rilpivirine-containing products","History of hypersensitivity reactions to other PPIs (cross-sensitivity possible)"]
| Precautions | ["Clostridium difficile-associated diarrhea (CDAD)","Bone fracture risk (hip, wrist, spine) with long-term or high-dose use","Hypomagnesemia (with prolonged use)","Vitamin B12 deficiency (long-term therapy)","Acute interstitial nephritis","Severe cutaneous adverse reactions (e.g., SJS, TEN)","Cutaneous and systemic lupus erythematosus (new-onset or exacerbation)","Gastric fundic gland polyps (chronic use)","False-positive urine THC screening tests","Interaction with methotrexate (elevated levels)","CYP2C19 poor metabolizers (increased exposure)","Possible increased risk of gastric cancer (long-term use, controversial)"] |
Loading safety data…
| Fetal Monitoring | No specific routine fetal monitoring is required for lansoprazole use in pregnancy. However, as with any medication during pregnancy, standard prenatal care should be maintained. Monitor maternal symptoms of GERD or peptic ulcer disease as needed. |
| Fertility Effects | There are no known adverse effects of lansoprazole on human fertility. Animal studies have not shown impaired fertility at clinically relevant doses. |