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Lansoprazole: Drug information

Lansoprazole: Drug information
(For additional information see "Lansoprazole: Patient drug information" and see "Lansoprazole: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • FT Acid Reducer [OTC];
  • GoodSense Lansoprazole [OTC];
  • Heartburn Treatment 24 Hour [OTC] [DSC];
  • Prevacid;
  • Prevacid SoluTab
Brand Names: Canada
  • APO-Lansoprazole;
  • M-Lansoprazole;
  • MYLAN-Lansoprazole;
  • PMS-Lansoprazole [DSC];
  • Prevacid;
  • Prevacid FasTab;
  • RIVA-Lansoprazole;
  • SANDOZ Lansoprazole;
  • TARO-Lansoprazole;
  • TEVA-Lansoprazole
Pharmacologic Category
  • Proton Pump Inhibitor;
  • Substituted Benzimidazole
Dosing: Adult
Eosinophilic esophagitis

Eosinophilic esophagitis (off-label use): Oral: 30 mg twice daily for an 8-week trial (Bonis 2021; Laserna-Mendieta 2020; Lucendo 2016; Vazquez-Elizondo 2013). Once 8-week trial is complete and remission is achieved, the dose may be gradually lowered to an individualized maintenance level (Laserna-Mendieta 2020). Some experts initiate with once-daily dosing and increase to twice-daily dosing after 4 weeks if symptoms fail to improve (Bonis 2021).

Gastroesophageal reflux disease, erosive or nonerosive

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 (Shin 2013). For patients with alarm symptoms (eg, dysphagia), referral to a specialist is recommended (ACG [Katz 2022]).

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 (Kahrilas 2022).

Oral: 15 mg once daily (Bigard 2005; Earnest 1998); if symptoms persist after 4 to 8 weeks, increase to 30 mg once daily (Kahrilas 2022). Discontinue therapy after 8-week treatment course (ACG [Katz 2013]). Note: Some experts continue therapy until patient has been asymptomatic for 8 weeks (Kahrilas 2022).

Severe or frequent symptoms (≥2 episodes/week) without erosive esophagitis or Barrett esophagus: Oral: 30 mg once daily for 8 weeks (ACG [Katz 2022]; Zheng 2009). Note: Some experts continue therapy until patient has been asymptomatic for 8 weeks (Kahrilas 2022).

Erosive esophagitis or Barrett esophagus: Oral: 30 mg once daily indefinitely (ACG [Shaheen 2022]; AGA [Targownik 2022]; Sontag 1997).

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 (Fass 2022). For patients requiring concomitant H2RA therapy, some experts administer the H2RA at bedtime (Fass 2022; Wang 2009); however, others advocate concurrent administration to ensure adherence (Abdul-Hussein 2015; Fändriks 2007; Sugimoto 2006).

Recurrent symptoms after discontinuing acid suppression:

Intermittent symptoms: Oral: 15 mg once daily as needed (ACG [Katz 2022]; Bigard 2005; Juul-Hansen 2009). Note : Some experts do not recommend intermittent use due to reduced efficacy (Kahrilas 2022; Wolfe 2022).

Persistent symptoms (eg consistent with symptoms at diagnosis):

Recurrent symptoms after ≥3 months: Repeat an 8-week course at the previously effective dose (Kahrilas 2022).

Recurrent symptoms after <3 months: Long-term maintenance at the lowest effective dose; referral to a specialist is recommended (ACG [Katz 2022]; Kahrilas 2022).

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 (manufacturer's labeling).

Hypersecretory conditions

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

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.

Helicobacter pylori eradication: Oral: 30 mg 3 times daily administered with amoxicillin 1,000 mg 3 times daily for 14 days or 30 mg twice daily administered with amoxicillin 1,000 mg and clarithromycin 500 mg twice daily for 10 to 14 days

American College of Gastroenterology guidelines (Chey 2007; Chey 2017):

Clarithromycin triple regimen: 30 to 60 mg twice daily in combination with clarithromycin 500 mg twice daily and either amoxicillin 1 g twice daily or metronidazole 500 mg 3 times per day for 14 days. Note: Avoid use of clarithromycin triple therapy in patients with risk factors for macrolide resistance (eg, prior macrolide exposure, local clarithromycin resistance rates ≥15%, eradication rates with clarithromycin-based regimens ≤85%) (ACG [Chey 2017]; Fallone 2016).

Sequential regimen: 30 mg twice daily plus amoxicillin 1 g twice daily for 5 to 7 days; then follow with clarithromycin 500 mg twice daily, either metronidazole or tinidazole 500 mg twice daily, and lansoprazole 30 mg twice daily for 5 to 7 days

Levofloxacin triple regimen: 30 mg twice daily in combination with amoxicillin 1 g twice daily and levofloxacin 500 mg once daily for 10 to 14 days

Bismuth quadruple regimen: 30 mg twice daily in combination with tetracycline 500 mg 4 times daily, metronidazole 250 mg 4 times daily or 500 mg 3 or 4 times daily, and either bismuth subcitrate 120 to 300 mg 4 times daily or bismuth subsalicylate 300 mg 4 times daily for 10 to 14 days

Concomitant regimen: 30 mg twice daily in combination with amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and either metronidazole or tinidazole 500 mg twice daily for 10 to 14 days

Hybrid regimen: 30 mg twice daily plus amoxicillin 1 g twice daily for 7 days; then follow with amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, either metronidazole or tinidazole 500 mg twice daily, and lansoprazole 30 mg twice daily for 7 days

NSAID-associated gastric ulcer

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

Stress ulcer prophylaxis in critically ill patients (off-label use): Note: Used in critically ill patients with risk factors for GI bleeding (eg, coagulopathy, mechanical ventilation for >48 hours, traumatic brain injury, history of GI ulceration or bleeding within past year, extensive burns) (SSC [Evans 2021]; Weinhouse 2022).

Oral: 30 mg once daily (Brophy 2010; Olsen 2008). Discontinue prophylaxis once risk factors have resolved (SSC [Evans 2021]; Weinhouse 2022).

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 (Kim 2018).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

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).

Dosing: Hepatic Impairment: Adult

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.

Dosing: Older Adult

Refer to adult dosing. Avoid scheduled use for >8 weeks unless given for high-risk patients (eg, oral corticosteroid or chronic nonsteroidal anti-inflammatory drugs 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) (Ref).

Dosing: Pediatric

(For additional information see "Lansoprazole: Pediatric drug information")

Gastroesophageal reflux disease, symptomatic

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 (NASPGHAN/ESPGHAN [Rosen 2018]). 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 (NASPGHAN/ESPGHAN [Rosen 2018]); 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 (Springer 2008).

Children and Adolescents: Oral: 0.7 to 3 mg/kg/day (AAP [Lightdale 2013]); maximum daily dose: 30 mg/day (NASPGHAN/ESPGHAN [Rosen 2018]).

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 (Khoshoo 2008).

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

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 (Kim 2018).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Children and Adolescents: No dosage adjustments are needed.

Dosing: Hepatic Impairment: Pediatric

Children and Adolescents: Drug exposure is increased in hepatic impairment; consider dose reduction for severe impairment

Adverse Reactions

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)

Contraindications

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.

Warnings/Precautions

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:

• Appropriate use: Helicobacter pylori eradication: Short-term combination therapy (≤7 days) has been associated with a higher incidence of treatment failure. The American College of Gastroenterology recommends 10 to 14 days of therapy (triple or quadruple) for eradication of H. pylori (Chey 2017).

• 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.

Warnings: Additional Pediatric Considerations

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).

Dosage Forms Considerations

First-Lansoprazole suspension is a compounding kit. Refer to manufacturer's labeling for compounding instructions.

Dosage Forms: US

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)]

Heartburn Treatment 24 Hour: 15 mg [DSC] [sodium 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

Generic Equivalent Available: US

Yes

Pricing: US

Capsule, delayed release (Lansoprazole Oral)

15 mg (per each): $4.72 - $5.90

30 mg (per each): $0.66 - $5.99

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.

Dosage Forms: Canada

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]

Administration: Adult

Oral: Administer 30 to 60 minutes before a meal; best if taken before breakfast (ACG [Katz 2013]). If administering twice daily, first dose should be administered before breakfast and the second dose before dinner (ACG [Katz 2013]; Hershcovici 2010). 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.

Nasogastric tube administration:

Capsule: Capsule can be opened, the granules mixed (not crushed) with 40 mL of apple juice and then administered through the NG tube into the stomach, then flush tube with additional apple juice. Do not mix with other liquids. Thirty milligrams has also been suspended in 10 mL of 8.4% sodium bicarbonate solution (or apple juice) or divided into 4 equal parts and flushed with water and administered via NG tube (Brophy 2010; Tsai 2000).

Orally disintegrating tablet: Nasogastric tube ≥8 French: Place a 15 mg tablet in a syringe and draw up ~4 mL water, or place the 30 mg tablet in a syringe and draw up ~10 mL water. After tablet has dispersed, administer within 15 minutes (gently shake syringe immediately prior to administration). Refill the syringe with ~5 mL water, shake gently, and then flush the nasogastric tube.

Administration: Pediatric

Oral: Administer before eating; best if taken 30 minutes before a meal (AAP [Lightdale 2013]); intact granules should not be chewed or crushed

Capsules: Swallow whole; do not chew or crush. For patients with difficulty swallowing the capsule, capsules may be opened and the intact granules sprinkled on 1 tablespoon of applesauce, Ensure pudding, cottage cheese, yogurt, or strained pears; the mixture should be swallowed immediately. Capsules may also be opened and emptied into ~60 mL of apple juice, orange juice, or tomato juice; mix and swallow immediately. Rinse the glass with additional juice and swallow to assure complete delivery of the dose.

For nasogastric tube ≥16 French: Capsule can be opened, the granules mixed (not crushed) with 40 mL of apple juice and then injected through the NG tube into the stomach, then flush tube with additional apple juice. Do not mix with other liquids based on manufacturer labeling; additional information may be available for NG administration; contact manufacturer to obtain current recommendations.

Tablet, orally-disintegrating: 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 (Teitelbaum 2015). Place the tablet on the tongue and allow to disintegrate with or without water until the particles can be swallowed.

Administration 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. 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.

For nasogastric tube ≥8 French: Place a 15 mg tablet in a syringe and draw up ~4 mL water, or place the 30 mg tablet in a syringe and draw up ~10 mL water. Shake gently. After tablet has dispersed, administer within 15 minutes. Refill the syringe with ~5 mL water, shake gently, and then flush the nasogastric tube.

Medication Guide and/or Vaccine Information Statement (VIS)

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

Use: Labeled Indications

Gastroesophageal reflux disease, erosive or nonerosive: Short-term (up to 8 weeks) treatment of symptomatic gastroesophageal reflux disease in children ≥1 year of age and adults; short-term (up to 8 weeks in children ≥12 years and adults; up to 12 weeks in children 1 to 11 years) treatment for all grades of erosive esophagitis; to maintain healing of erosive esophagitis in adults.

Hypersecretory conditions: Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults.

Peptic ulcer disease: Short-term (4 weeks) treatment of active duodenal ulcers in adults; maintenance treatment of healed duodenal ulcers in adults; as part of a multidrug regimen for Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence in adults; short-term (up to 8 weeks) treatment of active benign gastric ulcer in adults; treatment of NSAID-associated gastric ulcer; to reduce the risk of NSAID-associated gastric ulcer in adults with a history of gastric ulcer who require an NSAID.

OTC labeling: Relief of frequent heartburn (≥2 days/week).

Use: Off-Label: Adult

Eosinophilic esophagitis; Stress ulcer prophylaxis in critically ill patients

Medication Safety Issues
Sound-alike/look-alike issues:

Lansoprazole may be confused with aripiprazole, dexlansoprazole

Prevacid may be confused with Pravachol, Prevpac, PriLOSEC, Prinivil

Older Adult: High-Risk Medication:

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]).

Metabolism/Transport Effects

Substrate of CYP2C19 (major), CYP2C9 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acalabrutinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Acalabrutinib. This interaction is only applicable to acalabrutinib capsules. Risk X: Avoid combination

Amphetamine: Inhibitors of the Proton Pump (PPIs and PCABs) may increase the absorption of Amphetamine. Risk C: Monitor therapy

Atazanavir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the 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 the 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 diminish the therapeutic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy

Bosutinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the 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 diminish the therapeutic effect of Capecitabine. Risk C: Monitor therapy

Cefditoren: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Cefditoren. Risk X: Avoid combination

Cefpodoxime: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Cefpodoxime. Risk C: Monitor therapy

Cefuroxime: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the absorption of Cefuroxime. Risk X: Avoid combination

Clopidogrel: Lansoprazole may decrease serum concentrations of the active metabolite(s) of Clopidogrel. Risk C: Monitor therapy

CYP2C19 Inducers (Strong): May decrease the serum concentration of Lansoprazole. Risk X: Avoid combination

CYP2C19 Inhibitors (Moderate): May increase the serum concentration of Lansoprazole. Risk C: Monitor therapy

CYP2C19 Inhibitors (Strong): May increase the serum concentration of Lansoprazole. Risk C: Monitor therapy

Cysteamine (Systemic): Inhibitors of the Proton Pump (PPIs and PCABs) may diminish the therapeutic effect of Cysteamine (Systemic). Risk C: Monitor therapy

Dacomitinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the 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 combination

Dasatinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Dasatinib. Management: Antacids (taken 2 hours before or after dasatinib administration) can be used in place of PPIs or PCABs if some acid-reducing therapy is needed. Risk X: Avoid combination

Delavirdine: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Delavirdine. Management: Chronic therapy with PPIs or PCABs should be avoided in patients treated with delavirdine. The clinical significance of short-term PPI or PCAB therapy with delavirdine is uncertain, but such therapy should be undertaken with caution. Risk X: Avoid combination

Dextroamphetamine: Inhibitors of the Proton Pump (PPIs and PCABs) may increase the absorption of Dextroamphetamine. Specifically, the dextroamphetamine absorption rate from mixed amphetamine salt extended release (XR) capsules may be increased in the first hours after dosing. Risk C: Monitor therapy

Doxycycline: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the bioavailability of Doxycycline. Risk C: Monitor therapy

Enoxacin: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the absorption of Enoxacin. Risk C: Monitor therapy

Erlotinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Erlotinib. Risk X: Avoid combination

Gefitinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the 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 diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Indinavir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Indinavir. Risk C: Monitor therapy

Infigratinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentrations of the active metabolite(s) of Infigratinib. Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Infigratinib. Risk X: Avoid combination

Itraconazole: Inhibitors of the Proton Pump (PPIs and PCABs) may increase the 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 the 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): Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the absorption of Ketoconazole (Systemic). Ketoconazole (Systemic) may increase the serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). 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 the 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 the absorption of Levoketoconazole. Levoketoconazole may increase the serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). Risk X: Avoid combination

Lumacaftor and Ivacaftor: May decrease the serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). Risk C: Monitor therapy

Methotrexate: Inhibitors of the Proton Pump (PPIs and PCABs) may increase the 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 the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, the absorption of iron may be decreased. Risk C: Monitor therapy

Mycophenolate: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Mycophenolate. Specifically, concentrations of the active mycophenolic acid may be reduced. Risk C: Monitor therapy

Nelfinavir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease serum concentrations of the active metabolite(s) of Nelfinavir. Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration 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 the serum concentration of Neratinib. Specifically, proton pump inhibitors may reduce neratinib absorption. Risk X: Avoid combination

Nilotinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the 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 D: Consider therapy modification

Nirogacestat: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Nirogacestat. Risk X: Avoid combination

Octreotide: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Octreotide. Risk C: Monitor therapy

Palbociclib: Inhibitors of the Proton Pump (PPIs and PCABs) may diminish the therapeutic effect of Palbociclib. Specifically, this has been reported with the use of palbociclib capsules. Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the 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 the serum concentration of PAZOPanib. Risk X: Avoid combination

Pexidartinib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the 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 combination

Posaconazole: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the 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 the serum concentration of Rilpivirine. Risk X: Avoid combination

Riociguat: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Riociguat. Risk C: Monitor therapy

Risedronate: Inhibitors of the Proton Pump (PPIs and PCABs) may diminish the therapeutic effect of Risedronate. Inhibitors of the Proton Pump (PPIs and PCABs) may increase the 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 the serum concentration of Saquinavir. Risk C: Monitor therapy

Secretin: Inhibitors of the Proton Pump (PPIs and PCABs) may diminish the diagnostic effect of Secretin. 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 the 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 the absorption of SORAfenib. Risk C: Monitor therapy

Sotorasib: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Sotorasib. Risk X: Avoid combination

Sparsentan: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the serum concentration of Sparsentan. Risk X: Avoid combination

St John's Wort: May decrease the serum concentration of Lansoprazole. Risk X: Avoid combination

Tacrolimus (Systemic): Inhibitors of the Proton Pump (PPIs and PCABs) may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy

Technetium Tc 99m Sestamibi: Inhibitors of the Proton Pump (PPIs and PCABs) may diminish the diagnostic effect of Technetium Tc 99m Sestamibi. 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: Inhibitors of the Proton Pump (PPIs and PCABs) may diminish the diagnostic effect of Technetium Tc 99m Tetrofosmin. Risk C: Monitor therapy

Thiazolidinediones: Inhibitors of the Proton Pump (PPIs and PCABs) may enhance the adverse/toxic effect of Thiazolidinediones. Specifically, the risk of osteoporosis or fracture may be increased. Risk C: Monitor therapy

Tipranavir: May decrease the serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). These data are derived from studies with Ritonavir-boosted Tipranavir. Risk C: Monitor therapy

Velpatasvir: Inhibitors of the Proton Pump (PPIs and PCABs) may decrease the 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 (eg, warfarin): Lansoprazole may increase the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy

Voriconazole: May increase the serum concentration of Inhibitors of the Proton Pump (PPIs and PCABs). Inhibitors of the Proton Pump (PPIs and PCABs) may increase the serum concentration of Voriconazole. Risk C: Monitor therapy

Food Interactions

Prolonged treatment (≥2 years) may lead to malabsorption of dietary vitamin B12 and subsequent vitamin B12 deficiency (Lam 2013).

Pregnancy Considerations

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).

Breastfeeding Considerations

It is not known if lansoprazole is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Dietary Considerations

Should be taken before eating; best if taken before breakfast. Some products may contain phenylalanine.

Monitoring Parameters

Patients with Zollinger-Ellison syndrome should be monitored for gastric acid output, which should be maintained at ≤10 mEq/hour during the last hour before the next lansoprazole dose; bone loss and fractures, CBC, Clostridioides difficile-associated diarrhea, liver function, kidney function, serum gastrin levels, magnesium (baseline and periodically thereafter; especially if taking concomitant digoxin, diuretics, or other drugs known to cause hypomagnesemia), and calcium (baseline and periodically in patients at risk [eg, hypoparathyroidism]).

Mechanism of Action

Decreases acid secretion in gastric parietal cells through inhibition of (H+, K+)-ATPase enzyme system, blocking the final step in gastric acid production.

Pharmacokinetics (Adult Data Unless Noted)

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

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

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.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AT) Austria: Agopton | Lansoprazol +Pharma | Lansoprazol Arcana | Lansoprazol teva;
  • (AU) Australia: Apo Lansoprazole | Apo lansoprazole odt | Lanzopran | Noumed lansoprazole | Zopral | Zoton;
  • (BE) Belgium: Dakar;
  • (BF) Burkina Faso: Lanzocap | Monolitum;
  • (BG) Bulgaria: Lanzul;
  • (BR) Brazil: Lansoprazol | Prazol;
  • (CH) Switzerland: Agopton | Lansoprazol mepha;
  • (CI) Côte d'Ivoire: Lansopral | Lansoprazol generis | Nefian;
  • (CL) Chile: Langastrol;
  • (CN) China: Da Ke Pu Long | Heng kun | Jian li si | Ke yi lin | Lan xi duo | Lan yi xin | Richwe | Takepron | U bi le;
  • (CO) Colombia: Helycopep | Lacopen | Lanpraz | Lanproton | Lansopep | Lansoprazol | Lopral | Lopral md | Monolitum flas | Ogastro;
  • (DE) Germany: Agopton | Lansogamma | Lansoprazol ct;
  • (DK) Denmark: Lansopram | Zolt;
  • (DO) Dominican Republic: Lan | Lancelot | Lansofran | Lansoprazol | Lansoprazol cinfa | Lansoprazol MK | Lanzol | Lanzoprazol | Pincell;
  • (EC) Ecuador: Lansoquilab | Lanzap | Lanzoprazol;
  • (EE) Estonia: Lanobax | Lanzul | Zoton;
  • (EG) Egypt: Gastrocare | Lansokan | Lantanon | Lanzofutal | Lanzyplex | Zollipack | Zollipak;
  • (ES) Spain: Bamalite | Estomil Flas | Lansoprazol aristo | Lansoprazol flas sandoz | Lansoprazol mylan | Lansoprazol pharma combix | Lansoprazol qualigen | Lansoprazol Tarbis | Lansoprazol teva | Monolitum flas | Opiren | Protoner;
  • (FI) Finland: Lansoprazol Alpharma | Lanzo;
  • (FR) France: Lansoprazole arrow | Lansoprazole biogaran | Lansoprazole Dci | Lansoprazole EG | Lansoprazole mylan | Lansoprazole Sandoz | Lansoprazole zentiva | Lansoprazole Zydus | Ogastoro;
  • (GB) United Kingdom: Lansoprazole Teva | Lantorol | Zoton;
  • (GR) Greece: Apradil | Lansoprazole/teva | Laprazol | Zoletad;
  • (HK) Hong Kong: Lasoprol | Takepron;
  • (HR) Croatia: Lanzul | Lanzul S | Larona;
  • (HU) Hungary: Emillan | Lansoprazol Pliva | Refluxon;
  • (ID) Indonesia: Betalans | Caprazol | Dobrizol | Gastrolan | Inazol | Inhipraz | Lanvell | Lapraz | Laproton | Lasgan | Loprezol | Prosogan | Protica | Pysolan | Solans | Sopralan;
  • (IE) Ireland: Lansoprazole rowex | Lansoprazole Teva | Razolager | Zoton;
  • (IL) Israel: Zoton;
  • (IN) India: Biolan | Capcid kid | Ensoact | Junior bravia | Juniorlanzol | Lancor | Lanfil | Langerd | Lankure junior | Lanpro | Lansojoy | Lanspro | Lanswift kid | Lanzofast | Lanzopase | Lanzoprax kid | Lanzor | Lesozap | Levant | Olez | Xom kid;
  • (IQ) Iraq: Lansosaf | Lansosam;
  • (IT) Italy: Lansoprazolo | Lansoprazolo Age | Lansoprazolo Almus | Lansoprazolo aristo | Lansoprazolo Dr Red | Lansoprazolo eg | Lansoprazolo Mgi | Lansoprazolo sandoz | Lansoprazolo zentiva | Lansox | Limpidex | Zoton;
  • (JO) Jordan: Lanzopral | Lanzotec | Lazal | Peptazol;
  • (JP) Japan: Lansoprazole towa | Lasopran | Stanzome | Takepron | Tapizol;
  • (KE) Kenya: Degastrol | Lannez | Lanzol dt junior | Lasoprol | Seflan | Selanz sr | Zapacid;
  • (KR) Korea, Republic of: Aprogen lansoprazole | Dapura | Elpran | Hupzole | Kms lansoprazole | Lancept | Lancetin | Langaton | Lanopra | Lanozole | Lanpra | Lanprazol | Lanprazole | Lanprol | Lanprole | Lanpton | Lansec | Lansojin | Lansol | Lanson | Lansopra | Lansoprazen | Lansoq | Lansorozole | Lansozole | Lanspazole | Lanston lfdt | Lapzol | Lapzole | Lasotec | Monolitum flas | Neonazole | Praton | Rp lansoprazole | Seoul lansoprazole | Sopra | Upra | WUILANTON;
  • (LB) Lebanon: Degastrol | Lanzor | Lanzotec | Lpz;
  • (LV) Latvia: Lanzol | Lanzor;
  • (MX) Mexico: Amdory | Bonzol | Galzo | Gavonad | Lafin | Lanodizol | Lansoprazol | Olan | Palatrin | Sorifran | Uldapril;
  • (MY) Malaysia: Gastrovex | Lanpro | Lans | Lanxid | Lazol | Levant | Prevacid;
  • (NG) Nigeria: Glansoprex | Lansocure | Lanzotec;
  • (NL) Netherlands: Lansoprazol | Lansoprazol A | Lansoprazol KR | Lansoprazol ratiopharm | Lansoprazol sandoz | Prezal;
  • (NO) Norway: Lanzo;
  • (NZ) New Zealand: Solox;
  • (PE) Peru: Gastropec | Vivax;
  • (PH) Philippines: Aprevaz | Lansodin | Lanz | Lanzohex | Lanzole | Prevacid | Prolanzo | Promp | Pylison | Suprecid;
  • (PK) Pakistan: A lenso | Accion | Culanz | Exazole | Gerd | Hisozol | Lancerid | Lanfaas | Lansiczole | Lansim | Lansjup | Lansofed | Lansogut | Lansokan | Lansomed | Lansor | Lansotech | Lansozet | Lanspro | Lanzac | Lanzol | Lanzprazole | Lapravis | Legzol | Logerd | Selanz | Sopra praz | Soprazon | Vinzole;
  • (PL) Poland: Lanbax | Lantrea | Lanzul | Rapilazole | Zalanzo;
  • (PR) Puerto Rico: Prevacid | Prevacid solutab;
  • (PT) Portugal: Gastribien | Lansoprazol | Lansoprazol apceuticals | Lansoprazol ciclum | Lansoprazol mylan | Lansoprazol ratiopharm | Lansoprazol teva | Monolitum | Ogasto;
  • (PY) Paraguay: Lansomed | Lansoprazol genfar | Lansoprazol la sante | Monolitum flas;
  • (QA) Qatar: Degastrol | Lanfast | Lansazol | Lansomid | Lanzol | Lanzopral | Lanzor | Peptazol (Spimaco) | Takepron | Ultrazole | Zollipak;
  • (RU) Russian Federation: Epicur | Lansofed | Lansoprazol | Lansoprazol stada | Lanzabel | Lanzap | Loenzar sanovel;
  • (SA) Saudi Arabia: Lanzor;
  • (SE) Sweden: Lansoprazol 2care4 | Lansoprazol abacus medicine | Lansoprazol agp | Lansoprazol arrow | Lansoprazol ebb | Lansoprazol krka | Lansoprazol Merck NM | Lansoprazol mylan | Lansoprazol ranbaxy | Lansoprazol teva | Lanzo;
  • (SG) Singapore: Lasoprol | Prevacid;
  • (SI) Slovenia: Lantrea;
  • (TH) Thailand: Prevacid;
  • (TR) Turkey: Degastrol | Zoprol;
  • (TW) Taiwan: E wei an | Lavezol | Takepron;
  • (UA) Ukraine: Helicol | Lancerol | Lanpro | Lansol | Lansosandoz | Lanza | Lanzap;
  • (UG) Uganda: Lan | Lanac | Lancid | Lanpro | Selanz sr | Zapacid | Zolanas;
  • (UY) Uruguay: Lansoprazol | Lanzopral ER;
  • (VE) Venezuela, Bolivarian Republic of: Degastrol | Galsan;
  • (VN) Viet Nam: Agi lanso | Lanikson | Lansotop | Lansovie | Lastro | Lazocolic | Synpraz;
  • (ZA) South Africa: Aspen-lansoprazole | Lansoloc | Lansoloc otc | Lansoprazole unicorn | Lanzor hb | Lozpras | Simayla lansoprazole;
  • (ZM) Zambia: Lan | Lanocid | Lanzol | Lasoprol | Zolanas;
  • (ZW) Zimbabwe: Lan
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