PREVACID IV
Clinical safety rating: caution
Comprehensive clinical and safety monograph for PREVACID IV (PREVACID IV).
Lansoprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by specific inhibition of the (H+, K+)-ATPase enzyme system at the secretory surface of gastric parietal cells. This action is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion.
| Metabolism | Lansoprazole is extensively metabolized in the liver, primarily by CYP2C19 and CYP3A4, with minor contributions from CYP1A1 and CYP1A2. The metabolites are inactive and eliminated in urine and feces. |
| Excretion | Primarily hepatic metabolism via CYP2C19 and CYP3A4; approximately 75% excreted in urine as metabolites, with less than 1% as unchanged drug; about 20% eliminated in feces via bile. |
| Half-life | Terminal elimination half-life is approximately 1.5–2 hours in healthy individuals; however, the pharmacodynamic half-life (duration of acid suppression) is longer (up to 24 hours) due to accumulation in parietal cell canaliculi. |
| Protein binding | Approximately 97% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is about 0.15–0.30 L/kg, indicating distribution primarily into extracellular fluid and tissues; the low Vd reflects limited extravascular distribution except into parietal cells. |
| Bioavailability | Bioavailability is 100% for intravenous administration; no oral bioavailability data are provided as PREVACID IV is for IV use only. |
| Onset of Action | IV: Onset of acid suppression occurs within 30–60 minutes after intravenous administration, with peak effect at about 1.5–2 hours. |
| Duration of Action | Duration of acid suppression persists for up to 24 hours, allowing once-daily dosing despite the short plasma half-life; clinical efficacy in acid-related disorders is maintained throughout the dosing interval. |
| Molecular Weight | 369.36 |
30 mg intravenous infusion over 30 minutes once daily for up to 7 days; may switch to oral therapy when patient can tolerate oral intake.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for renal impairment; not removed by hemodialysis. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). For severe hepatic impairment (Child-Pugh C), consider dose reduction; no specific recommendation available; use with caution. |
| Pediatric use | 1 mg/kg (max 30 mg) intravenous infusion over 30 minutes once daily for 1-7 days; indicated for children 1-17 years with GERD and erosive esophagitis. |
| Geriatric use | No specific dose adjustment; however, elderly patients may have reduced renal function; monitor for adverse effects. Dosing same as for younger adults. |
| 1st trimester | Limited human data; animal studies not indicative of fetal harm. Use only if clearly needed. |
| 2nd trimester | No evidence of risk in human studies; consider maternal benefit. |
| 3rd trimester | No evidence of risk in human studies; consider maternal benefit. |
Clinical note
Comprehensive clinical and safety monograph for PREVACID IV (PREVACID IV).
| Placental transfer | Lansoprazole crosses the placenta in animals; human data limited. Based on molecular weight and properties, placental transfer is likely. |
| Breastfeeding | Lansoprazole is excreted in human milk in low amounts (estimated relative infant dose <1% maternal weight-adjusted dose). No adverse effects reported in breastfed infants. Use with caution, especially while nursing a premature or newborn infant. |
■ FDA Black Box Warning
No FDA boxed warning for PREVACID IV.
| Serious Effects |
Hypersensitivity to lansoprazole or any component of the formulationHypersensitivity to other proton pump inhibitors (e.g., omeprazole, pantoprazole, etc.)Concomitant use with rilpivirine-containing products
| Precautions | Gastric Malignancy: Symptomatic response does not preclude presence of gastric malignancy., Acute Interstitial Nephritis: Observed in patients taking PPIs; discontinue if suspected., Cyanocobalamin (Vitamin B12) Deficiency: Long-term use may lead to malabsorption., Clostridium difficile-Associated Diarrhea: PPIs may increase risk., Bone Fracture: Long-term use may increase risk of osteoporosis-related fractures, especially with high doses., Hypomagnesemia: Reported with prolonged use; monitor magnesium levels if on diuretics or for extended periods., Interaction with Methotrexate: PPIs may increase methotrexate levels., Severe Cutaneous Adverse Reactions: Discontinue if signs of Stevens-Johnson syndrome or toxic epidermal necrolysis appear. |
| Food/Dietary | No direct food interactions with IV PREVACID. However, when transitioning to oral therapy, avoid eating foods that can increase stomach acid (e.g., spicy or fatty foods) and avoid alcohol. High-calcium foods are generally safe, but calcium supplements may interfere with oral PPI absorption if taken simultaneously. |
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| Lactation Rating |
| L2 (Limited data - probably compatible) |
| Teratogenic Risk | Pregnancy Category B. Studies in animals at doses up to 30 mg/kg/day (approximately 30 times the human dose) revealed no evidence of teratogenicity. However, adequate well-controlled studies in pregnant women are lacking. Use during first trimester only if clearly needed; benefits may outweigh risks. Second and third trimester: limited data show no increased risk of major congenital malformations. |
| Fetal Monitoring | Monitor maternal acid-related symptoms and endoscopic findings if applicable. No specific fetal monitoring required beyond routine prenatal care. Observe infant for signs of gastrointestinal distress or allergic reactions if breastfeeding occurs during therapy. |
| Fertility Effects | In animal studies, lansoprazole at high doses (up to 150 mg/kg/day) caused decreased fertility and reproductive performance in male and female rats. Human data are lacking; however, potential impact on fertility cannot be excluded. Proton pump inhibitors have been associated with decreased sperm motility in some studies. |
| Clinical Pearls | PREVACID IV (lansoprazole) is a proton pump inhibitor (PPI) for intravenous use when oral therapy is not feasible. Administer over 30 minutes via IV infusion; do not administer as bolus. For stress ulcer prophylaxis in critically ill patients, typical dose is 30 mg IV daily. Monitor for hypomagnesemia with prolonged use (>1 year). Adjust dose in hepatic impairment (Child-Pugh Class B/C: maximum 15 mg IV daily). Avoid concomitant use with clopidogrel due to reduced antiplatelet effect; consider alternative PPI (e.g., pantoprazole) if needed. |
| Patient Advice | This medication reduces stomach acid and is used to treat conditions like erosive esophagitis and GERD. · You will receive this medicine as an intravenous infusion, typically once daily over 30 minutes. · Report any signs of low magnesium such as muscle spasms, irregular heartbeat, or seizures. · Long-term use may increase risk of bone fractures, especially in older adults; ensure adequate calcium and vitamin D intake. · Do not stop or change the dose without consulting your healthcare provider. |