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. |
| Molecular Weight | 369.36 |
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 | Limited human data; animal studies show no evidence of harm at clinically relevant doses. Generally considered safe if clinically indicated. |
| 2nd trimester | No known teratogenic risk; use if clearly needed. |
| 3rd trimester | No known fetal risk; use if clearly needed. |
Clinical note
Comprehensive clinical and safety monograph for PREVACID 24 HR (PREVACID 24 HR).
| Placental transfer | Lansoprazole crosses the placenta in rats; in humans, placental transfer is expected due to low molecular weight. Limited data suggest minimal fetal exposure. |
| Breastfeeding | Lansoprazole is excreted into human breast milk in low amounts. The estimated daily infant dose is less than 1% of the maternal weight-adjusted dose. No adverse effects have been reported in breastfed infants. Caution is advised but considered compatible with breastfeeding. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to lansoprazole or any component of the formulationConcomitant use with rilpivirine-containing products
| 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) |
| Food/Dietary | Food delays and reduces absorption; take on an empty stomach. Avoid high-fat meals immediately before or after dosing. Alcohol can exacerbate GERD symptoms; limit intake. No specific food restrictions beyond timing of dose. |
Loading safety data…
| Lactation Rating | L2 (Safer) |
| 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. |
| 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. |
| Clinical Pearls | Prevacid 24HR (lansoprazole) is a proton pump inhibitor. Onset of acid suppression is rapid, but maximal effect may take 1-4 days. For optimal efficacy, take at least 30-60 minutes before a meal (ideally breakfast). Do not crush or chew delayed-release capsules; if difficulty swallowing, open capsule and sprinkle on applesauce, yogurt, or pudding. Short-term use (≤14 days) limits risk of adverse effects; avoid concurrent use with clopidogrel due to reduced activation. Monitor for hypomagnesemia with prolonged use; consider baseline magnesium levels in patients at risk. |
| Patient Advice | Take exactly as directed: one capsule daily on an empty stomach at least 30-60 minutes before breakfast. · If a dose is missed, take it as soon as remembered unless it is almost time for next dose; do not double dose. · Do not crush, chew, or break the capsule; swallow whole or sprinkle contents on soft food. · Do not take for more than 14 days unless directed by a doctor. · Report symptoms such as severe diarrhea, rash, or muscle weakness to your healthcare provider. · Avoid alcohol and smoking as they may worsen symptoms. · Tell your doctor about all medications you take, especially clopidogrel, warfarin, or methotrexate. |