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. |
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 | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for PREVACID IV (PREVACID IV).
| Breastfeeding | Lansoprazole is excreted in human milk; the milk-to-plasma ratio is approximately 0.5. Breastfeeding is not recommended due to potential for serious adverse effects in nursing infants, unless the benefit outweighs the risk. Infant exposure through milk is low but may cause gastrointestinal disturbance or theoretical risk of tumorigenesis. |
| 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. |
■ FDA Black Box Warning
No FDA boxed warning for PREVACID IV.
| Serious Effects |
["Hypersensitivity to lansoprazole or any component of the formulation","Co-administration 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."] |
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| 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. |