Dosing and uses of Prevacid, Prevacid Solu Tab (lansoprazole)
Adult dosage forms and strengths
capsule/tablet
- 15mg
- 30mg
tablet, oral-disintegrating
- 15mg
- 30mg
oral suspension
- 3 mg/mL
Duodenal Ulcer
Active: 15 mg PO qDay for 4 weeks
Maintenance: 15 mg PO qDay
Gastric Ulcer
30 mg PO qDay for 8 weeks
NSAID-associated GU
Treatment: 30 mg PO qDay for 8 weeks
Prevention: 15 mg PO qDay for 12 weeks
Gastroesophageal Reflux Disease
15 mg PO qDay for 8 weeks
Erosive Esophagitis
30 mg PO qDay for 8-16 weeks
Maintenance: 15 mg PO qDay
Hypersecretory Condition (eg, Zollinger-Ellison Syndrome)
60 mg PO qDay initially; up to 180 mg q12hr used
If dose >120 mg/day PO, administer in divided doses q12hr
Helicobacter Pylori Infection
Triple therapy: Lansoprazole 30 mg + amoxicillin 1 g + clarithromycin 500 mg PO q12hr for 10-14 days
Dual therapy (clarithromycin resistant): Lansoprazole 30 mg + amoxicillin 1 g PO q8hr for 14 days
Penicillin allergy: Lansoprazole 30 mg + clarithromycin 500 mg + metronidazole 500 mg q12hr for 10-14 days
Heartburn
OTC product: 15 mg PO qDay for 14 days; may repeat q4Months
Administration
Administer before meals
Swallow capsule whole; do not chew, crush, or split
Do not chew orally disintegrating tablets
Powder for oral suspension: dissolve packet contents in 30 mL of water; do not use any other liquid; stir well and drink immediately
Safety and efficacy of maintenance therapy past 1 year not established
Dosing Modifications
Severe hepatic impairment: Administer a lower dose
Pediatric dosage forms and strengths
capsule/tablet
- 15mg
- 30mg
oral suspension
- 3mg/mL
GERD, Erosive Esophagitis
<1 year
- Safety and efficacy not established
1-12 years
- <30 kg: 15 mg PO qDay for 8-12 weeks
- >30 kg: 30 mg PO qDay for 8-12 weeks
- May increase dose to 30 mg PO q12hr after >2 weeks of initial therapy if still symptomatic
>12 years
- 30 mg PO qDay for up to 8 weeks
Nonerosive GERD
<12 years: Safety and efficacy not established
≥12 years: 15 mg PO qDay for up to 8 weeks
Prevacid, Prevacid Solu Tab (lansoprazole) adverse (side) effects
1-10%
Headache (3-7%)
Diarrhea (1-5%)
Constipation (1-5%)
Nausea (1-3%)
Abdominal pain (1-3%)
<1%
Anxiety
Angina
Palpitations
Syncope
Edema
Anorexia
Dry mouth
Tenesmus
Flatulence
Melena
Myalgia
Tinnitus
Allergic reaction
Postmarketing Reports
Bone fracture
Warnings
Contraindications
Hypersensitivity to lansoprazole or other proton pump inhibitors
Cautions
Proton pump inhibitors (PPIs) are possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve
Liver disease may require dosage reduction
Contains enteric coated granules (acid labile); do not chew or crush
Published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, particularly with prolonged (>1 yr), high-dose therapy
Decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels
Hypomagnesemia may occur with prolonged use (ie, >1 year); adverse effects may result and include tetany, arrhythmias, and seizures; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued
PPIs may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite
Gastric atrophy reported with long-term use of another PPI
Relief of symptoms does not eliminate the possibility of a gastric malignancy
Therapy increases risk of Salmonella, Campylobacter, and other infections
Acute interstitial nephritis reported in patients taking proton pump inhibitors
Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin
Pregnancy and lactation
Pregnancy category: B
Lactation: Not known whether distributed into breast milk; do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Prevacid, Prevacid Solu Tab (lansoprazole)
Mechanism of action
Proton pump inhibitor; binds to H+/K+-exchanging ATPase (proton pump) in gastric parietal cells, resulting in suppression of basal and stimulated acid secretion
Absorption
Bioavailability: 81-91%; decreased 50-70% if given 30 min after meals
Peak plasma time: 1.7 hr; food increases time to 3.7 hr
Duration (at steady state): >24 hr (PUD, esophagitis); 40 hr (Zollinger-Ellison syndrome)
AUC: Food decreases AUC by 50%
Onset
- Gastric acid suppression: 1-3 hr
- PUD: 1 week (initial); 4-8 days (peak)
- Esophagitis: 1-4 weeks (initial); 8 weeks (peak)
Distribution
Protein bound: 97-99%
Vd: 14-18 L
Metabolism
Metabolized by hepatic CYP2C19; slow metabolizers are deficient in CYP2C19 enzyme and can have plasma concentration increase of 5-fold or higher
Gastric parietal cells: Acidic pH converts lansoprazole to its active sulfenamide metabolites
Active metabolites: Cyclic sulfenamide and disulfide metabolite
Inactive metabolites: 5-hydroxy-lansoprazole, sulfide metabolite, omeprazole sulfone, sulfone metabolite, hydroxysulfide metabolite, hydroxysulfone metabolite
Enzymes inhibited: CYP2C19
Elimination
Half-life: 0.9-1.5 hr
Dialyzable: No
Total renal clearance: 517 mL/min
Total body clearance: 0.7 L/hr/kg
Excretion: feces (bile), 67%; urine, 33%
Administration
IV Preparation
Inject 5 mL sterile water for injection (SWI) into vial and gently dissolve to obtain a 6 mg/mL solution; can be stored at 77°F (25°C) for 1 hr
Dilute in 50 mL NS, LR, or D5W; resulting solution can be stored at 77°F (25°C) for 24 hr (NS, LR) or 12 hr (D5W); refrigeration not necessary.
Alternatively, can be reconstituted directly into 50 mL NS, LR, or D5W using Baxter's MINI-BAG Plus Container
Prime in-line filter as directed in manufacturer's package insert
IV Administration
In-line filter must be used (supplied)
Administer over 30 min
Flush IV line with NS, LR, or D5W before and after use
Do not administer with other drugs
