Version July 2025
The FDA has requested that Azurity Pharmaceuticals stop distributing unapproved drugs marketed as "Unit-of-Use Prescription Compounding Kits," including FIRST Lansoprazole, FIRST Pantoprazole, and FIRST Metronidazole. These kits have not been proven safe and effective and do not qualify for exemptions under the compounding provisions in sections 503A and 503B of the Federal Food, Drug and Cosmetic Act.
Further information may be found at https://www.fda.gov/drugs/enforcement-activities-fda/fda-notification-regarding-unapproved-drugs-included-kits.
Gastroesophageal reflux disease (GERD): Note: Routine use is not recommended in preterm neonates (Ref). The manufacturer recommends not using lansoprazole in neonates due to lack of clinical efficacy data and the potential for adverse effects (ie, heart valve thickening) observed in animal models (rats). Limited data available; dose not established; ideal dose-response not established.
Term and preterm neonates: Oral: 0.5 to 1.5 mg/kg/day as a single dose or divided twice daily has been shown to be well tolerated and improve gastric pH; 0.5 to 1 mg/kg administered once daily was evaluated in 24 neonates (mean PNA: 3.7 ± 4 weeks, mean weight: 3.015 ± 0.893 kg); this regimen resulted in increased gastric pH and was associated with a decreased frequency of GERD symptoms (Ref). In another study, 10 VLBW premature neonates (mean PNA: 3.6 ± 1.49 weeks, mean weight: 1.13 ± 0.03 kg) received 1.5 mg/kg/day divided twice daily; although gastric pH increased it was not adequate to protect from esophagitis (Ref). A pharmacokinetic study showed patients <10 weeks of age had substantially decreased clearance and suggests a lower dose should be used (~0.2 mg/kg/day) (Ref).
Gastroesophageal reflux disease (GERD), symptomatic: Note: Guidelines recommend a 4- to 8-week treatment course; if improvement seen after 4 to 8 weeks, consider possible wean; if no response after 4 to 8 weeks, reevaluate diagnosis and consider referral to pediatric GI specialist (Ref). The manufacturer recommends not using lansoprazole in infants due to lack of clinical efficacy data and the potential for adverse effects (ie, heart valve thickening) observed in animal models (rats).
Weight-based dosing:
Infants: Oral: 2 mg/kg/day (Ref); a dose of 1 mg/kg/day has also been shown to increase gastric pH in infants and decrease frequency of GERD symptoms (eg, regurgitation/vomiting, feeding refusal, crying, back arching) from baseline (Ref).
Children and Adolescents: Oral: 0.7 to 3 mg/kg/day (Ref); maximum daily dose: 30 mg/day (Ref).
Fixed dosing:
Infants ≥3 months: 7.5 mg twice daily or 15 mg once daily was shown to provide better symptom relief compared to dietary management in 68 patients (Ref).
Children ≤11 years:
≤30 kg: 15 mg once daily.
>30 kg: 30 mg once daily.
Children ≥12 years and Adolescents: Oral: 15 mg once daily.
Erosive esophagitis, treatment: Note: Duration of therapy is dependent on age: Children ≤11 years recommended duration is up to 12 weeks and children ≥12 years and adolescent duration is up to 8 weeks.
Children ≤11 years:
≤30 kg: 15 mg once daily.
>30 kg: 30 mg once daily.
Children ≥12 years and Adolescents: Oral: 30 mg once daily.
Discontinuation of therapy: Oral: Based on experience in adults, some experts recommend a step-down approach in order to avoid worsening or rebound symptoms. One recommendation is to decrease the dose by 50% over 2 to 4 weeks. If the patient is already on the lowest possible dose, alternate day therapy may be considered. If symptoms worsen during treatment or after discontinuation, patient should be reevaluated (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Children and Adolescents: No dosage adjustments are needed.
Children and Adolescents: Drug exposure is increased in hepatic impairment; consider dose reduction for severe impairment
(For additional information see "Lansoprazole: Drug information")
Eosinophilic esophagitis (off-label use): Oral: 30 mg twice daily for an 8-week trial (Ref). Once 8-week trial is complete and remission is achieved, the dose may be gradually lowered to an individualized maintenance level (Ref). Some experts initiate with once-daily dosing and increase to twice-daily dosing after 4 weeks if symptoms fail to improve (Ref).
Gastroesophageal reflux disease, erosive or nonerosive:
Note: For maximal efficacy, administer 30 to 60 minutes prior to a meal. Maximal acid suppression is generally observed after ~3 days of continuous therapy (Ref). For patients with alarm symptoms (eg, dysphagia), referral to a specialist is recommended (Ref).
Initial therapy:
Mild and intermittent symptoms (<2 episodes/week) without erosive esophagitis or Barrett esophagus:
Note: Some experts reserve proton pump inhibitors (PPIs) as alternatives to H2-receptor antagonists (H2RAs) for patients who have residual acid reflux symptoms despite twice-daily H2RA (Ref).
Oral: 15 mg once daily (Ref); if symptoms persist after 4 to 8 weeks, increase to 30 mg once daily (Ref). Discontinue therapy after 8-week treatment course (Ref). Note: Some experts continue therapy until patient has been asymptomatic for 8 weeks (Ref).
Severe or frequent symptoms (≥2 episodes/week) without erosive esophagitis or Barrett esophagus: Oral: 30 mg once daily for 8 weeks (Ref). Note: Some experts continue therapy until patient has been asymptomatic for 8 weeks (Ref).
Erosive esophagitis or Barrett esophagus: Oral: 30 mg once daily indefinitely (Ref).
Residual symptoms despite 30 mg once daily:
Note: Referral to a specialist is recommended. Options include splitting the PPI dose, doubling the PPI dose, switching to a different PPI, or adding an H2RA (Ref). For patients requiring concomitant H2RA therapy, some experts administer the H2RA at bedtime (Ref); however, others advocate concurrent administration to ensure adherence (Ref).
Recurrent symptoms after discontinuing acid suppression:
Intermittent symptoms: Oral: 15 mg once daily as needed (Ref). Note : Some experts do not recommend intermittent use due to reduced efficacy (Ref).
Persistent symptoms (eg consistent with symptoms at diagnosis):
Recurrent symptoms after ≥3 months: Repeat an 8-week course at the previously effective dose (Ref).
Recurrent symptoms after <3 months: Long-term maintenance at the lowest effective dose; referral to a specialist is recommended (Ref).
OTC labeling (patient-guided therapy): Heartburn, frequent symptoms (≥2 episodes/week): Oral: 15 mg once daily for 14 days (maximum: 15 mg/day); may repeat 14-day course every 4 months, if needed. Seek medical referral if symptoms do not resolve within 14 days of treatment; do not take for >14 days or more often than every 4 months unless directed by a physician (Ref).
Helicobacter pylori eradication: Oral: 30 to 60 mg twice daily for 14 days as part of an appropriate combination regimen with antibiotics. Dose depends on selected regimen (Ref).
Hypersecretory conditions: Oral: Initial: 60 mg once daily; adjust dose based upon patient response and to reduce acid secretion to <10 mEq/hour (5 mEq/hour in patients with prior gastric surgery); doses of 90 mg twice daily have been used; administer doses >120 mg/day in divided doses.
Peptic ulcer disease:
Duodenal ulcer: Oral: Short-term treatment: 15 mg once daily for 4 weeks; maintenance therapy: 15 mg once daily.
Gastric ulcer: Oral: Short-term treatment: 30 mg once daily for up to 8 weeks. Some clinical trial data suggests a dose of 15 mg once daily for up to 8 weeks may also be effective.
NSAID-associated gastric ulcer:
Prevention: Oral: 15 mg once daily for up to 12 weeks; controlled studies did not extend past 12 weeks.
Treatment: Oral: 30 mg once daily for 8 weeks; controlled studies did not extend past 8 weeks.
Stress ulcer prophylaxis in critically ill patients (off-label use):
Oral: 30 mg once daily; discontinue prophylaxis once risk factors have resolved (Ref).
Discontinuation of therapy: Oral: Some experts recommend a step-down approach in order to avoid worsening or rebound symptoms. One strategy is to decrease the dose by 50% over 2 to 4 weeks. If the patient is already on the lowest possible dose, alternate-day therapy may be considered. If symptoms worsen during treatment or after discontinuation, patient should be re-evaluated (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: No dosage adjustment necessary for any degree of kidney impairment (Ref).
Hemodialysis, intermittent (thrice weekly): Not significantly dialyzed: No supplemental dose or dosage adjustment necessary (Ref).
Peritoneal dialysis: Unlikely to be dialyzed (highly protein bound): No dosage adjustment necessary (Ref).
CRRT: No dosage adjustment necessary (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref).
Mild or moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): 15 mg once daily. Note: Dosage recommendation is based on pharmacokinetic data using a single 30 mg dose.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Gastrointestinal: Abdominal pain (adults and adolescents: 2% to 5%), constipation (children: 5%; adults 1%), diarrhea (adults: ≤7%), nausea (adolescents: 3%; adults <1%)
Nervous system: Dizziness (adolescents: 3%; adults: <1%), headache (children and adolescents: 3% to 7%)
<1%:
Cardiovascular: Acute myocardial infarction, angina pectoris, bradycardia, cardiac arrhythmia, cerebral infarction, cerebrovascular accident, chest pain, circulatory shock, edema, hypertension, hypotension, palpitations, peripheral edema, syncope, tachycardia, vasodilation
Dermatologic: Acne vulgaris, alopecia, contact dermatitis, diaphoresis, hair disease, maculopapular rash, nail disease, pruritus, skin rash, urticaria, xeroderma
Endocrine & metabolic: Decreased libido, dehydration, diabetes mellitus, goiter, gout, gynecomastia, heavy menstrual bleeding, hyperglycemia, hypoglycemia, hypothyroidism, increased libido, increased thirst, menstrual disease (including abnormal menses), vitamin deficiency, weight gain, weight loss
Gastrointestinal: Abdominal distention, abnormal stools, ageusia, anorexia, aphthous stomatitis, bezoar formation, cholelithiasis, colitis (including microscopic) (Verhaegh 2016), dysgeusia, dyspepsia, dysphagia, enteritis, eructation, esophageal achalasia, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastritis, gastroenteritis, gastrointestinal candidiasis, gastrointestinal hemorrhage, gingival hemorrhage, glossitis, halitosis, hematemesis, hiccups, increased appetite, melena, oral mucosa ulcer, rectal disease, sialorrhea, stomatitis, tenesmus, tongue disease, ulcerative colitis, vomiting, xerostomia
Genitourinary: Breast hypertrophy, breast tenderness, difficulty in micturition, dysmenorrhea, dysuria, impotence, leukorrhea, mastalgia, pelvic pain, penile disease, testicular disease, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, vaginitis
Hematologic & oncologic: Anemia, carcinoma, hemolysis, lymphadenopathy, malignant neoplasm of larynx, polyp (fundic gland polyp and gastric nodules), rectal hemorrhage, skin carcinoma
Hypersensitivity: Fixed drug eruption, hypersensitivity reaction
Infection: Candidiasis, infection
Nervous system: Abnormal dreams, abnormality in thinking, agitation, altered sense of smell, amnesia, anxiety, apathy, chills, confusion, dementia, depersonalization, depression, dizziness, drowsiness, emotional lability, hallucination, hemiplegia, hostility, hypertonia, hypoesthesia, insomnia, malaise, migraine, myasthenia, nervousness, neurosis, pain, paresthesia, seizure, sleep disorder, vertigo
Neuromuscular & skeletal: Arthralgia, arthritis, arthropathy, asthenia, back pain, bone disease, hyperkinetic muscle activity, lower limb cramp, musculoskeletal pain, myalgia, neck pain, neck stiffness, synovitis, tremor
Ophthalmic: Amblyopia, blepharitis, blepharoptosis, blurred vision, cataract, conjunctivitis, diplopia, dry eye syndrome, eye pain, glaucoma, photophobia, retinal degeneration, retinopathy, visual disturbance, visual field defect
Otic: Deafness, ear disease, otitis media, tinnitus
Renal: Nephrolithiasis, polyuria, renal pain
Respiratory: Asthma, bronchitis, cough, dyspnea, epistaxis, flu-like symptoms, hemoptysis, pharyngitis, pleural disease, pneumonia, pulmonary fibrosis, rhinitis, sinusitis, stridor, upper respiratory tract infection, upper respiratory tract inflammation
Miscellaneous: Fever
Frequency not defined:
Endocrine & metabolic: Abnormal albumin-globulin ratio, albuminuria, decreased serum cholesterol, electrolyte disorder (decreased/increased), glycosuria, hyperlipidemia, increased gamma-glutamyl transferase, increased gastrin, increased lactate dehydrogenase, increased serum glucocorticoids, increased serum potassium
Gastrointestinal: Occult blood in stools
Genitourinary: Crystalluria, hematuria
Hematologic & oncologic: Abnormal erythrocytes, eosinophilia, leukocyte disorder, leukocytosis, platelet disorder (abnormal platelets), quantitative disorders of platelets (decreased/increased)
Hepatic: Hyperbilirubinemia, increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase
Immunologic: Increased serum globulins
Renal: Acute interstitial nephritis, increased blood urea nitrogen, increased serum creatinine
Postmarketing:
Dermatologic: Acute generalized exanthematous pustulosis, cutaneous lupus erythematosus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis
Endocrine & metabolic: Hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia
Gastrointestinal: Clostridioides difficile associated diarrhea, pancreatitis
Hematologic: Agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombotic thrombocytopenic purpura
Hepatic: Hepatoxicity (Chalasani 2021)
Hypersensitivity: Anaphylaxis, nonimmune anaphylaxis
Immunologic: Drug reaction with eosinophilia and systemic symptoms
Nervous system: Speech disturbance
Neuromuscular & skeletal: Bone fracture, myositis, systemic lupus erythematosus
Renal: Interstitial nephritis, renal disease (chronic; Lazarus 2016)
Hypersensitivity (eg, anaphylaxis, angioedema, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, urticaria) to lansoprazole or any component of the formulation; concomitant use with products that contain rilpivirine.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• Carcinoma: No reports of enterochromaffin-like (ECL) cell carcinoids, dysplasia, or neoplasia has occurred.
• Clostridioides difficile-associated diarrhea (CDAD): Use of proton pump inhibitors (PPIs) may increase risk of CDAD, especially in hospitalized patients; consider CDAD diagnosis in patients with persistent diarrhea that does not improve. Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.
• Cutaneous and systemic lupus erythematosus: Has been reported as new onset or exacerbation of existing autoimmune disease; most cases were cutaneous lupus erythematosus (CLE), most commonly, subacute CLE (occurring within weeks to years after continuous therapy). Systemic lupus erythematosus (SLE) is less common (typically occurs within days to years after initiating treatment) and occurred primarily in young and older adults. Discontinue therapy if signs or symptoms of CLE or SLE occur and refer to a specialist for evaluation; most patients improve 4 to 12 weeks after discontinuation of lansoprazole.
• Dermatologic reactions: Severe cutaneous adverse reactions, including acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported.
• Fractures: Increased incidence of osteoporosis-related bone fractures of the hip, spine, or wrist may occur with PPI therapy. Patients on high-dose or long-term therapy should be monitored. Use the lowest effective dose for the shortest duration of time, use vitamin D and calcium supplementation, and follow appropriate guidelines to reduce risk of fractures in patients at risk.
• Fundic gland polyps: Use of PPIs increases risk of fundic gland polyps, especially with long-term use >1 year. May occur without symptoms, but nausea, vomiting, or abdominal pain may occur; GI bleeding and/or anemia may occur with ulcerated polyps. Diagnosis of polyps may also increase risk for small intestinal blockage. Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.
• Hypomagnesemia: Reported rarely, usually with prolonged PPI use of ≥3 months (most cases >1 year of therapy). May be symptomatic or asymptomatic; severe cases may cause tetany, seizures, and cardiac arrhythmias. Hypomagnesemia may lead to or exacerbate hypocalcemia in patients at risk (eg, hypoparathyroidism). Hypomagnesemia may also lead to hypokalemia. Hypomagnesemia and hypocalcemia may be corrected by magnesium/calcium supplementation, although discontinuation of lansoprazole may be necessary.
• Tubulointerstitial nephritis: Acute tubulointerstitial nephritis has been observed in patients taking PPIs; may occur at any time during therapy. Patients may present with symptomatic hypersensitivity reaction to nonspecific symptoms of impaired kidney function (eg, anorexia, malaise, nausea); may be diagnosed with biopsy and in the absence of extra-kidney manifestations (eg, fever, rash, arthralgia). Discontinue and evaluate patients if acute tubulointerstitial nephritis is suspected.
• Vitamin B12 deficiency: Prolonged treatment (≥2 years) may lead to vitamin B12 malabsorption and subsequent vitamin B12 deficiency. The magnitude of the deficiency is dose-related and the association is stronger in females and those younger in age (<30 years of age); prevalence is decreased after discontinuation of therapy (Lam 2013).
Disease-related concerns:
• Gastric malignancy: Relief of symptoms does not preclude the presence of a gastric malignancy.
• Gastrointestinal infection (eg, Salmonella, Campylobacter): Use of PPIs may increase risk of these infections.
• Hepatic impairment: Patients with severe liver dysfunction may require dosage reductions.
Concurrent drug therapy issues:
• Clopidogrel: PPIs may diminish the therapeutic effect of clopidogrel thought to be due to reduced formation of the active metabolite of clopidogrel. The manufacturer of clopidogrel recommends either avoidance of both omeprazole (even when scheduled 12 hours apart) and esomeprazole or use of a PPI with comparatively less effect on the active metabolite of clopidogrel (eg, pantoprazole). Although lansoprazole exhibits the most potent CYP2C19 inhibition in vitro (Li 2004; Ogilvie 2011), an in vivo study of extensive CYP2C19 metabolizers showed less reduction of the active metabolite of clopidogrel by lansoprazole/dexlansoprazole compared to esomeprazole/omeprazole (Frelinger 2012). The manufacturer of lansoprazole states that no dosage adjustment is necessary for clopidogrel when used concurrently. In contrast to these warnings, others have recommended the continued use of PPIs, regardless of the degree of inhibition, in patients with a history of GI bleeding or multiple risk factors for GI bleeding who are also receiving clopidogrel since no evidence has established clinically meaningful differences in outcome; however, a clinically significant interaction cannot be excluded in those who are poor metabolizers of clopidogrel (Abraham 2010; Levine 2011).
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer's labeling.
• Phenylalanine: Some products may contain phenylalanine, which can be harmful to patients with phenylketonuria (PKU). Before prescribing, consider the combined daily amount of phenylalanine from all sources.
Other warnings/precautions:
• Laboratory test interference: Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acid; may cause false-positive results in diagnostic investigations for neuroendocrine tumors. Temporarily stop lansoprazole treatment at least 14 days before CgA test; if CgA level is high, repeat test to confirm. Use same commercial laboratory for testing to prevent variable results.
• Self-medication (OTC use): When used for self-medication, patients should be instructed not to use if they have difficulty swallowing, are vomiting blood, or have bloody or black stools. Prior to use, patients should contact healthcare provider if they have liver disease, heartburn for >3 months, heartburn with dizziness, lightheadedness, or sweating, MI symptoms, frequent chest pain, frequent wheezing (especially with heartburn), unexplained weight loss, nausea/vomiting, stomach pain, or are taking antifungals, atazanavir, digoxin, tacrolimus, theophylline, or warfarin. Patients should stop use and consult a healthcare provider if heartburn continues or worsens, or if they need to take for >14 days or more often than every 4 months. Patients should be informed that it may take 1 to 4 days for full effect to be seen.
Special populations:
• Bariatric surgery: Presurgical assessment of the indication for use, symptoms, and goals of therapy should be documented to enable postsurgical assessment. Monitor for continued efficacy after bariatric surgery and consider switching to an alternative medication if symptoms worsen.
Use in neonatal and pediatric patients <12 months of age is not recommended in the product labeling; neonatal and infant animal models (rat) have shown mitral valve heart thickening in 2 nonclinical, oral toxicity studies. Heart valve thickening occurred at doses 6.2 times (neonates) and 4.2 times (infants) the pediatric daily dose of 15 mg; duration of treatment associated with valve thickening ranged from 5 days to 8 weeks. Valve thickening reversed or trended towards reversibility 4 weeks after discontinuation. The risk of heart valve thickening does not appear to occur at ≥1 year of age. Evaluate risk vs benefit when considering use in neonates and infants.
Use of gastric acid inhibitors, including proton pump inhibitors (PPIs) and H2 blockers, has been associated with an increased risk for development of acute gastroenteritis and community-acquired pneumonia in pediatric patients 4 to 36 months of age (Canani 2006). Routine use in preterm infants is not recommended (AAP [Eichenwald 2018]).
Gastric acid suppression medications have been associated with an increase in Clostridioides difficile infection (CDI) and recurrent CDI in pediatric patients (Nylund 2014). In a retrospective, observational, case control study of pediatric patients 1 to 18 years old who were hospitalized for diarrhea and abdominal pain, the use of PPIs was significantly higher in patients who tested positive for C. difficile compared to patients who tested negative for C. difficile (22.1% vs 5.9%) (Turco 2010). Consider CDI diagnosis in patients with persistent diarrhea that does not improve. Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.
A large retrospective cohort study reviewed records for patients with a low baseline risk for fractures who were initiated on acid suppression therapy in the first year of life and evaluated the fracture risk in the first 5 years of life; a total of 97,286 patients were prescribed acid suppression therapy; 73% were prescribed H2 blockers, 9% were prescribed PPIs, and 18% were prescribed both. H2 blocker use alone was not associated with an increased fracture hazard; however, PPI use was associated with a 21% increase and use of PPI plus H2 blocker was associated with a 30% increase. Longer duration of therapy and earlier age at initiation seemed to also increase the fracture hazard. Study findings do not establish a causal relationship between PPI use and fractures. If acid suppression therapy is necessary in the first year of life, limiting therapy to a single drug and limiting the duration should be considered (Malchodi 2019). A second large cohort study reviewed records for 115,933 children <18 years initiated on a PPI. PPI initiation was associated with a statistically significant 11% relative increase in risk of any fracture in patients ≥6 years. The increased risk also seemed to be more pronounced with a longer cumulative duration of PPI use (Wang 2020).
First-Lansoprazole suspension is a compounding kit. Refer to manufacturer's labeling for compounding instructions.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule Delayed Release, Oral:
FT Acid Reducer: 15 mg [gluten free, sodium free; contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), quinoline yellow (d&c yellow #10)]
GoodSense Lansoprazole: 15 mg [gluten free; contains fd&c blue #1 (brilliant blue), quinoline yellow (d&c yellow #10)]
Prevacid: 15 mg [DSC], 30 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye)]
Generic: 15 mg, 30 mg
Tablet Delayed Release Disintegrating, Oral:
Prevacid SoluTab: 15 mg, 30 mg [contains aspartame]
Generic: 15 mg, 30 mg
Yes
Capsule, delayed release (Lansoprazole Oral)
15 mg (per each): $4.72 - $5.90
30 mg (per each): $0.66 - $5.90
Capsule, delayed release (Prevacid Oral)
30 mg (per each): $16.60
Tablet Delayed Release Disintegrating (Lansoprazole Oral)
15 mg (per each): $15.77
30 mg (per each): $15.77
Tablet Delayed Release Disintegrating (Prevacid SoluTab Oral)
15 mg (per each): $16.60
30 mg (per each): $16.60
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule Delayed Release, Oral:
Prevacid: 15 mg, 30 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), polysorbate 80]
Generic: 15 mg, 30 mg
Tablet Delayed Release Disintegrating, Oral:
Prevacid FasTab: 15 mg, 30 mg [contains aspartame]
Note: A lansoprazole oral suspension (3 mg/mL) is commercially available as a compounding kit (First-Lansoprazole).
3 mg/mL Oral Suspension (ASHP Standard Concentration) (ASHP 2017)
A 3 mg/mL oral solution (Simplified Lansoprazole Solution [SLS]) may be made with capsules and sodium bicarbonate. Empty the contents of ten lansoprazole 30 mg capsules into a beaker. Add 100 mL sodium bicarbonate 8.4% and gently stir until dissolved (about 15 minutes). Transfer solution to an amber-colored syringe or bottle. A prior study showed that SLS was stable for 8 hours at room temperature or for 14 days refrigerated (DiGiancinto 2000). However, a more recent study, demonstrated SLS to be stable for 48 hours at room temperature in oral syringes and for only 7 days when refrigerated (Morrison 2013).
The following recommendations are based upon the best available evidence and clinical expertise. Senior editorial team: Joseph I. Boullata, PharmD, RPh, CNS-S, FASPEN, FACN; Peggi A. Guenter, PhD, RN, FASPEN; Kathleen Gura, PharmD, BCNSP, FASHP, FASPEN, FPPA, FMSHP; Mark G. Klang, MS, RPh, BCNSP, PhD, FASPEN; Linda Lord, NP, ACNP-BC, CNSC, FASPEN; Lucas E. Orth, PharmD, BCPPS; Russel J. Roberts, PharmD, BCCCP, FCCM.
Note: Recommendations may not account for differences in inactive ingredients, osmolality, or other formulation properties that may vary among products from different manufacturers.
Oral: Administer before eating; best if taken 30 minutes before a meal (Ref); intact granules should not be chewed or crushed
Capsules: Swallow whole; do not chew or crush.
Oral administration in apple juice: Open capsule and empty contents into ~60 mL of apple juice, orange juice, or tomato juice; mix and swallow immediately. Rinse the glass with additional juice and swallow to ensure complete delivery of the dose.
Oral administration in applesauce: Open capsule and sprinkle intact granules on 1 tablespoon of applesauce, Ensure pudding, cottage cheese, yogurt, or strained pears; the mixture should be swallowed immediately.
Administration via feeding tube: Note: Lansoprazole oral capsule is not recommended for post-pyloric (eg, J-tube) administration due to formulation properties and risk of tube clogging (Ref). While the manufacturer's labeling recommends mixing capsule contents with apple juice for administration via gastric tubes, fruit juices may cause lansoprazole granules to become sticky and occlude enteral feeding tubes. Due to risk of clogging enteral feeding tubes, consider alternative medications when possible (Ref).
Gastric (eg, NG, G-tube) tubes (≥16 French): To optimize effectiveness, lansoprazole should be separated from enteral nutrition (Ref). Open capsule(s) and disperse contents in 30 to 40 mL apple juice; mix briefly (Ref). Draw up mixture into enteral dosing syringe and administer via feeding tube. Rinse syringe with additional apple juice and administer via feeding tube; repeat rinse of syringe and administer via feeding tube to ensure entire dose is administered (Ref).
General guidance: Hold enteral nutrition 30 to 60 minutes prior to lansoprazole administration (Ref). Flush feeding tube with the lowest volume of purified water necessary to clear the tube prior to administration based on size of patient and/or feeding tube (eg, neonates: 1 to 3 mL; infants and children: 2 to 5 mL; adolescents: 15 mL); refer to institutional policies and procedures (Ref). Following administration process described above, flush feeding tube with an appropriate volume of purified water and restart enteral nutrition (Ref).
Tablet, orally disintegrating: Place the tablet on the tongue and allow to disintegrate with or without water until the particles can be swallowed. Should not be swallowed whole, broken, cut, or chewed. Splitting of orally disintegrating tablets may result in significant differences in amount of lansoprazole-containing microgranules in each half, clinical relevance of this difference is not well-described (Ref).
Oral administration via syringe: Place the 15 mg tablet in an oral syringe and draw up ~4 mL water, or place the 30 mg tablet in an oral syringe and draw up ~10 mL water. Shake gently. After tablet has dispersed, administer within 15 minutes. Refill the syringe with water (2 mL for the 15 mg tablet; 5 mL for the 30 mg tablet), shake gently, then administer any remaining contents.
Administration via feeding tube: Note: Although post-pyloric administration of orally disintegrating lansoprazole tablets has not been evaluated, some institutions have successfully administered properly prepared tablets; consider the risks vs benefits and ensure tablets are sufficiently dispersed prior to administration and adequate flushing occurs following administration (Ref).
Gastric (eg, NG, G-tube) tubes (≥8 French): To optimize effectiveness, lansoprazole should be separated from enteral nutrition (Ref). Place a 15 mg tablet in an enteral dosing syringe and draw up ~4 mL purified water, or place the 30 mg tablet in an enteral dosing syringe and draw up ~10 mL purified water; gently shake syringe. After tablet has dispersed, gently shake the syringe to keep the granules from settling and administer via feeding tube; administer mixture within 15 minutes of preparation. Following administration, refill syringe with 5 mL purified water; shake gently and administer via feeding tube (Ref).
General guidance: Hold enteral nutrition 30 to 60 minutes prior to lansoprazole administration (Ref). Flush feeding tube with the lowest volume of purified water necessary to clear the tube prior to administration based on size of patient and/or feeding tube (eg, neonates: 1 to 3 mL; infants and children: 2 to 5 mL; adolescents: 15 mL); refer to institutional policies and procedures (Ref). Following the administration process described above, flush feeding tube with an appropriate volume of purified water and restart enteral nutrition (Ref).
Oral: Administer 30 to 60 minutes before a meal; best if taken before breakfast (Ref). If administering twice daily, first dose should be administered before breakfast and the second dose before dinner (Ref). The intact granules should not be chewed or crushed; however, several options are available for those patients unable to swallow capsules:
Capsules may be opened and the intact granules sprinkled on 1 tablespoon of applesauce, Ensure pudding, cottage cheese, yogurt, or strained pears. The granules should then be swallowed immediately.
Capsules may be opened and emptied into ~60 mL orange juice, apple juice, or tomato juice; mix and swallow immediately. Rinse the glass with 2 or more volumes of juice and swallow immediately to assure complete delivery of the dose.
Orally disintegrating tablets: Should not be swallowed whole, broken, cut, or chewed. Place tablet on tongue; allow to dissolve (with or without water) until particles can be swallowed. Orally-disintegrating tablets may also be administered via an oral syringe: Place the 15 mg tablet in an oral syringe and draw up ~4 mL water, or place the 30 mg tablet in an oral syringe and draw up ~10 mL water. After tablet has dispersed, administer within 15 minutes. Refill the syringe with water (2 mL for the 15 mg tablet; 5 mL for the 30 mg tablet), shake gently, then administer any remaining contents.
Bariatric surgery: Lansoprazole is available as delayed-release formulations. Bariatric surgery may significantly alter the release characteristics in an unknown manner. Providers should determine if the condition being treated can be safely monitored or if a switch to an alternative medication is necessary (Ref).
Enteral feeding tube:
The following recommendations are based upon the best available evidence and clinical expertise. Senior editorial team: Joseph I. Boullata, PharmD, RPh, CNS-S, FASPEN, FACN; Peggi A. Guenter, PhD, RN, FASPEN; Kathleen Gura, PharmD, BCNSP, FASHP, FASPEN, FPPA, FMSHP; Mark G. Klang, MS, RPh, BCNSP, PhD, FASPEN; Linda Lord, NP, ACNP-BC, CNSC, FASPEN; Lucas E. Orth, PharmD, BCPPS; Russel J. Roberts, PharmD, BCCCP, FCCM.
Oral capsule:
Note: Lansoprazole oral capsule is not recommended for post-pyloric (eg, J-tube) administration due to formulation properties and risk of tube clogging (Ref). The manufacturer’s labeling recommends using apple juice for administration of capsule contents; however, fruit juices may cause lansoprazole granules to become sticky and occlude enteral feeding tubes; consider alternative medications if possible (Ref).
Gastric (eg, NG, G-tube ) tubes (≥16 French): To optimize effectiveness, lansoprazole should be separated from enteral nutrition (EN) (Ref). Open capsule(s) and disperse contents in 30 to 40 mL apple juice; mix briefly (Ref). Draw up mixture into enteral dosing syringe and administer via feeding tube. Rinse syringe with additional apple juice and administer via feeding tube; repeat rinse of syringe and administer via feeding tube to ensure entire dose is administered (Ref).
General guidance: Hold EN 30 to 60 minutes prior to lansoprazole administration (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 15 mL) before administration (Ref). Following the administration process described above, flush feeding tube with an appropriate volume of purified water (eg, 30 mL) and restart EN (Ref).
Oral tablet, disintegrating:
Note: Although post-pyloric administration of orally dissolving lansoprazole has not been evaluated, some institutions have successfully administered properly prepared tablets; consider the risks versus benefits and ensure tablets are sufficiently dispersed prior to administration and adequate flushing occurs following administration (Ref).
Gastric (eg, NG, G-tube) tubes (≥8 French): To optimize effectiveness, lansoprazole should be separated from EN (Ref). Place a 15 mg tablet in an enteral dosing syringe and draw up ~4 mL purified water or place the 30 mg tablet in an enteral dosing syringe and draw up ~10 mL purified water; gently shake syringe. After tablet has dispersed, gently shake the syringe to keep the granules from settling and administer via feeding tube; administer mixture within 15 minutes of preparation. Following administration, refill syringe with 5 mL purified water, shake gently and administer via feeding tube (Ref).
General guidance: Hold EN 30 to 60 minutes prior to lansoprazole administration (Ref). Flush feeding tube with an appropriate volume of purified water (eg, 15 mL) before administration (Ref). Following the administration process described above, flush feeding tube with an appropriate volume of purified water (eg, 20 mL) and restart EN (Ref).
No te: Recommendations may not account for differences in inactive ingredients, osmolality, or other formulation properties that may vary among products from different manufacturers.
Capsules, orally disintegrating tablets: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture.
Powder for suspension (First Lansoprazole compounding kit): Prior to compounding, store at 2°C to 8°C (36°F to 46°F). Once compounded, the product is stable for at least 30 days at 2°C to 8°C (36°F to 46°F); protect from freezing. Protect from light.
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Prevacid capsules, orally disintegrating tablets: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020406s095,021428s042lbl.pdf#page=45
Short-term treatment of symptomatic gastroesophageal reflux disease (GERD) (FDA approved in ages ≥1 year and adults); short-term treatment for healing and symptomatic relief of all grades of erosive esophagitis (FDA approved in ages ≥1 year and adults); maintenance of healed erosive esophagitis (FDA approved in adults); short-term treatment (up to 8 weeks) of active benign gastric ulcer (FDA approved in adults); short-term treatment (≤4 weeks) for healing and symptomatic relief of active duodenal ulcer (FDA approved in adults); maintenance treatment of healed duodenal ulcers (FDA approved in adults); treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome (FDA approved in adults); treatment (in combination with amoxicillin ± clarithromycin) for Helicobacter pylori eradication in patients with duodenal ulcers (active or up to 1-year history) to reduce the recurrence of duodenal ulcer (FDA approved in adults); prevention (for patients at high risk) and treatment of NSAID-associated gastric ulcers (FDA approved in adults); relief of frequent heartburn (≥2 days/week) (OTC product: FDA approved in adults)
Lansoprazole may be confused with aripiprazole, dexlansoprazole
Prevacid may be confused with Pravachol, Prevpac, PriLOSEC, Prinivil
Beers Criteria: Lansoprazole is identified in the Beers Criteria as potentially inappropriate medications to be avoided (as scheduled use for >8 weeks) in patients 65 years and older due to its risk of C. difficile infection, pneumonia, GI malignancies, and bone loss/fractures unless given for high-risk patients (eg, oral corticosteroid or chronic nonsteroidal anti-inflammatory use), patients with erosive esophagitis, Barrett esophagitis, a pathological hypersecretory condition, or if the patient has demonstrated a need for maintenance therapy (eg, failure of drug discontinuation trial or failure of H2 blockers) (Beers Criteria [AGS 2023]).
Substrate of CYP2C19 (Major with inhibitors), CYP2C19 (Minor with inducers), CYP2C9 (Minor), CYP3A4 (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Acalabrutinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Acalabrutinib. This interaction is only applicable to acalabrutinib capsules. Risk X: Avoid
Afatinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease therapeutic effects of Afatinib. Risk C: Monitor
Amphetamines: Inhibitors of the Proton Pump (PPIs and PCABs) may increase absorption of Amphetamines. Specifically, the amphetamine absorption rate may be increased in the first hours after dosing. Risk C: Monitor
Atazanavir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Atazanavir. Management: Avoid use in treatment-experienced patients. In treatment-naive patients, administer boosted atazanavir 12 hours after the PPI and the PPI dose should not exceed the equivalent of 20 mg omeprazole. Monitor for reduced atazanavir efficacy. Risk D: Consider Therapy Modification
Belumosudil: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Belumosudil. Management: Increase the dose of belumosudil to 200 mg twice daily when coadministered with inhibitors of the proton pump (PPIs and PCABs). Risk D: Consider Therapy Modification
Bisphosphonate Derivatives: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease therapeutic effects of Bisphosphonate Derivatives. Risk C: Monitor
Bosutinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Bosutinib. Management: Consider alternatives to proton pump inhibitors and potassium-competitive acid blockers, such as short-acting antacids or histamine-2 receptor antagonists. Administer alternative agents more than 2 hours before or after bosutinib. Risk D: Consider Therapy Modification
Capecitabine: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease therapeutic effects of Capecitabine. Risk C: Monitor
Cefditoren: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Cefditoren. Risk X: Avoid
Cefpodoxime: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Cefpodoxime. Risk C: Monitor
Cefuroxime: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease absorption of Cefuroxime. Management: Avoid concomitant use of oral cefuroxime axetil and proton pump inhibitors (PPIs) or potassium-competitive acid blockers (PCABs) when possible. If combined, ensure oral cefuroxime axetil is taken with food to minimize the magnitude of this interaction. Risk D: Consider Therapy Modification
Clopidogrel: Lansoprazole may decrease active metabolite exposure of Clopidogrel. Risk C: Monitor
CYP2C19 Inducers (Strong): May decrease serum concentration of Lansoprazole. Risk X: Avoid
CYP2C19 Inhibitors (Moderate): May increase serum concentration of Lansoprazole. Risk C: Monitor
CYP2C19 Inhibitors (Strong): May increase serum concentration of Lansoprazole. Risk C: Monitor
Cysteamine (Systemic): Inhibitors of the Proton Pump (PPIs and PCABs) may decrease therapeutic effects of Cysteamine (Systemic). Risk C: Monitor
Dacomitinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Dacomitinib. Management: Avoid concurrent use of dacomitinib with PPIs and PCABs. Antacids may be used. Histamine H2-receptor antagonists (HR2A) may be used if dacomitinib is given at least 6 hours before or 10 hours after the H2RA. Risk X: Avoid
Dasatinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Dasatinib. Management: Do not administer PPIs/PCABs with dasatinib. Antacids (taken 2 hours before or after dasatinib) can be used instead if some acid-reducing therapy is needed. No interaction is expected with the Phyrago brand of dasatinib. Risk X: Avoid
Doxycycline: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease bioavailability of Doxycycline. Risk C: Monitor
Erlotinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Erlotinib. Risk X: Avoid
Gefitinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Gefitinib. Management: Avoid use of inhibitors of the proton pump (PPIs or PCABs) with gefitinib when possible. If required, administer gefitinib 12 hours after the PPI/PCAB or 12 hours before the next dose of the PPI/PCAB. Closely monitor clinical response to gefitinib. Risk D: Consider Therapy Modification
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Inhibitors of the Proton Pump (PPIs and PCABs) may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor
Indinavir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Indinavir. Risk C: Monitor
Itraconazole: Inhibitors of the Proton Pump (PPIs and PCABs) may increase serum concentration of Itraconazole. This specifically applies to the super bioavailable itraconazole products (eg, Tolsura brand). Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Itraconazole. This specifically applies to the non-super bioavailable itraconazole products (eg, Sporanox brand and its generics). Management: Exposure to Tolsura brand itraconazole may be increased by PPIs or PCABs ; consider itraconazole dose reduction. Exposure to Sporanox brand itraconazole may be decreased. Give Sporanox brand itraconazole at least 2 hrs before or 2 hrs after PPIs or PCABs. Risk D: Consider Therapy Modification
Ketoconazole (Systemic): May increase serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). Inhibitors of the Proton Pump (PPIs and PCABs) may decrease absorption of Ketoconazole (Systemic). Management: Administer ketoconazole with an acidic beverage, such as non-diet cola, to increase gastric acidity and improve absorption if concomitant use with proton pump inhibitors or potassium-competitive acid blockers is necessary. Risk D: Consider Therapy Modification
Ledipasvir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Ledipasvir. Management: PPI or PCAB doses equivalent to omeprazole 20 mg or lower may be given with ledipasvir under fasted conditions. Use of ledipasvir with higher doses or with food, or 2 hours after a these agents, may reduce ledipasvir bioavailability. Risk D: Consider Therapy Modification
Levoketoconazole: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease absorption of Levoketoconazole. Levoketoconazole may increase serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). Risk X: Avoid
Lumacaftor and Ivacaftor: May decrease serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). Risk C: Monitor
Methotrexate: Inhibitors of the Proton Pump (PPIs and PCABs) may increase serum concentration of Methotrexate. Management: Consider temporarily interrupting PPI or PCAB therapy in patients receiving high-dose methotrexate. If coadministered, monitor for increased methotrexate toxicity (eg, mucositis, myalgias) and/or delayed methotrexate elimination. Risk D: Consider Therapy Modification
Multivitamins/Minerals (with ADEK, Folate, Iron): Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, the absorption of iron may be decreased. Risk C: Monitor
Mycophenolate: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Mycophenolate. Specifically, concentrations of the active mycophenolic acid may be reduced. Risk C: Monitor
Nelfinavir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Nelfinavir. Inhibitors of the Proton Pump (PPIs and PCABs) may decrease active metabolite exposure of Nelfinavir. Management: Due to potentially significant reductions in nelfinavir exposure, avoid concurrent use of nelfinavir with a PPI or PCAB when possible. If unavoidable, consider PPI or PCAB use for a short duration (less than 30 days) and closely monitor viral load. Risk D: Consider Therapy Modification
Neratinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Neratinib. Specifically, proton pump inhibitors may reduce neratinib absorption. Risk X: Avoid
Nilotinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Nilotinib. Management: Avoid this combination. Histamine H2 receptor antagonists (H2RAs) given 10 hours before or 2 hours after nilotinib, or antacids given 2 hours before or 2 hours after nilotinib are acceptable alternatives. Risk X: Avoid
Nirogacestat: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Nirogacestat. Risk X: Avoid
Octreotide: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Octreotide. Risk C: Monitor
Palbociclib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease therapeutic effects of Palbociclib. Specifically, this has been reported with the use of palbociclib capsules. Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Palbociclib. Specifically, this may occur with the use of palbociclib capsules, and to the greatest extent when taken without food. Management: Carefully evaluate potential risks and benefits of coadministration of palbociclib capsules and proton pump inhibitors or potassium-competitive acid blockers due to the risk of reduced palbociclib efficacy. Palbociclib capsules should be taken with food. Risk D: Consider Therapy Modification
PAZOPanib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of PAZOPanib. Risk X: Avoid
PEMEtrexed: Inhibitors of the Proton Pump (PPIs and PCABs) may increase adverse/toxic effects of PEMEtrexed. Specifically, the risk of hematological toxicities may be increased. Risk C: Monitor
Pexidartinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Pexidartinib. Management: Avoid this combination. If acid-reduction is needed, consider administering an antacid 2 hours before or after pexidartinib, or administer pexidartinib 2 hours before or 10 hours after an H2 receptor antagonist. Risk X: Avoid
Posaconazole: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Posaconazole. Management: Avoid coadministration of PPIs or PCABs and posaconazole oral suspension. Posaconazole delayed-release tablets do not appear to be sensitive to this interaction and do not required dose adjustment if coadministered with PPIs or PCABs. Risk D: Consider Therapy Modification
Rilpivirine: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Rilpivirine. Risk X: Avoid
Riociguat: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Riociguat. Risk C: Monitor
Risedronate: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease therapeutic effects of Risedronate. Inhibitors of the Proton Pump (PPIs and PCABs) may increase serum concentration of Risedronate. This applies specifically to use of delayed-release risedronate. Management: Coadministration of PPIs or PCABs with delayed-release risedronate formulations is not recommended. Limit PPI/PCAB dose and duration during coadministration with risedronate as possible. Patients over age 70 are at higher risk of adverse effects. Risk D: Consider Therapy Modification
Saquinavir: Inhibitors of the Proton Pump (PPIs and PCABs) may increase serum concentration of Saquinavir. Risk C: Monitor
Secretin: Coadministration of Inhibitors of the Proton Pump (PPIs and PCABs) and Secretin may alter diagnostic results. Specifically, use of PPIs may cause a hyperresponse in gastrin secretion in response to secretin stimulation testing, falsely suggesting gastrinoma. Management: Avoid concomitant use of PPIs or PCABs and secretin, and discontinue PPI or PCAB several weeks prior to secretin administration, with the duration of separation determined by the specific acid suppressant. See full monograph for details. Risk D: Consider Therapy Modification
Selpercatinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Selpercatinib. Management: Coadministration of selpercatinib and PPIs or PCABs should be avoided. If coadministration cannot be avoided, selpercatinib and PPIs or PCABs should be administered simultaneously with food. Risk D: Consider Therapy Modification
SORAfenib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease absorption of SORAfenib. Risk C: Monitor
Sotorasib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Sotorasib. Risk X: Avoid
Sparsentan: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Sparsentan. Risk X: Avoid
St John's Wort: May decrease serum concentration of Lansoprazole. Risk X: Avoid
Sulpiride: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Sulpiride. Management: Consider alternatives to this combination due to the possibility of reduced sulpiride absorption and efficacy. If gastric acid suppressing therapy is required, consider use of antacids administered at least 2 hours after sulpiride. Risk D: Consider Therapy Modification
Tacrolimus (Systemic): Inhibitors of the Proton Pump (PPIs and PCABs) may increase serum concentration of Tacrolimus (Systemic). Risk C: Monitor
Technetium Tc 99m Sestamibi: Coadministration of Inhibitors of the Proton Pump (PPIs and PCABs) and Technetium Tc 99m Sestamibi may alter diagnostic results. Management: Consider holding/stopping proton pump inhibitor therapy for at least 3 days prior to the use technetium Tc 99m sestamibi in cardiac imaging procedures. Risk D: Consider Therapy Modification
Technetium Tc 99m Tetrofosmin: Coadministration of Inhibitors of the Proton Pump (PPIs and PCABs) and Technetium Tc 99m Tetrofosmin may alter diagnostic results. Risk C: Monitor
Thiazolidinediones: Inhibitors of the Proton Pump (PPIs and PCABs) may increase adverse/toxic effects of Thiazolidinediones. Specifically, the risk of osteoporosis or fracture may be increased. Risk C: Monitor
Tipranavir: May decrease serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). These data are derived from studies with Ritonavir-boosted Tipranavir. Risk C: Monitor
Velpatasvir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentration of Velpatasvir. Management: Sofosbuvir/velpatasvir should be administered with food and taken 4 hours before omeprazole 20 mg. Sofosbuvir/velpatasvir/voxilaprevir can be administered with omeprazole 20 mg. Use with other PPIs or PCABs has not been studied. Risk D: Consider Therapy Modification
Vitamin K Antagonists: Lansoprazole may increase anticoagulant effects of Vitamin K Antagonists. Risk C: Monitor
Voriconazole: May increase serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). Inhibitors of the Proton Pump (PPIs and PCABs) may increase serum concentration of Voriconazole. Risk C: Monitor
Prolonged treatment (≥2 years) may lead to malabsorption of dietary vitamin B12 and subsequent vitamin B12 deficiency (Lam 2013).
Should be taken before eating; best if taken before breakfast. Some products may contain phenylalanine.
Outcome data following use of proton pump inhibitors (PPIs) during pregnancy are available (Choi 2023; Hussain 2022; Peron 2023). Based on available studies, an increased risk of adverse pregnancy outcomes has not been observed following maternal use of lansoprazole.
Recommendations for the treatment of gastroesophageal reflux disease in pregnant patients are available. When initiating treatment during pregnancy, a step-up approach, starting with diet and lifestyle modifications, is recommended. PPIs are considered acceptable for use during pregnancy when other medications are not effective (Ali 2022; Dunbar 2022; Thélin 2020).
Magnesium (baseline and periodically thereafter, especially in patients receiving digoxin or drugs known to cause hypomagnesemia [eg, diuretics] or who are receiving prolonged treatment); calcium (baseline and periodically in patients at risk [eg, hypoparathyroidism]); CBC, liver function, renal function, and serum gastrin levels. Patients with Zollinger-Ellison syndrome should be monitored for gastric acid output, which should be maintained at 10 mEq/hour or less during the last hour before the next lansoprazole dose.
Decreases acid secretion in gastric parietal cells through inhibition of (H+, K+)-ATPase enzyme system, blocking the final step in gastric acid production.
Onset of action: Gastric acid suppression: Oral: 1 to 3 hours
Duration: Gastric acid suppression: Oral: >1 day
Absorption: Rapid
Distribution: Vd: Children: 0.61 to 0.9 L/kg; Adults: 15.7 ± 1.9 L
Protein binding: 97%
Metabolism: Hepatic via CYP2C19 and 3A4 to inactive metabolites, and in parietal cells to two active metabolites that are not present in systemic circulation
Bioavailability: >80%; decreased 50% to 70% if given 30 minutes after food
Half-life elimination: Children: 1.2 to 1.5 hours; Adults: 1.5 ± 1 hour; Older adults: 1.9 to 2.9 hours; Hepatic impairment: 4 to 7.2 hours
Time to peak, plasma: 1.7 hours
Excretion: Feces (67%); urine (33%; 14% to 25% as metabolites and <1% as unchanged drug)
Clearance:
Children: 0.57 to 0.71 L/hour/kg
Adults: 11.1 ± 3.8 L/hour; Hepatic impairment: 3.2 to 7.2 hours
Hepatic function impairment: In patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, AUC increased ~3-fold and half-life increased from 1.5 hours to 4 or 5 hours, respectively. In patients with compensated and decompensated cirrhosis, AUC increased 6- and 5-fold, respectively.
Older adult: Clearance is decreased with t½ increasing ~50% to 100%. Because mean t½ remains between 1.9 to 2.9 hours, repeated once daily dosing does not accumulate.
