Lansoprazole (Lexi-Drugs)

Pronunciation

(lan SOE pra zole)

Brand Names: US

GoodSense Lansoprazole [OTC]; Heartburn Treatment 24 Hour [OTC]; Prevacid; Prevacid 24HR [OTC]; Prevacid SoluTab

Brand Names: Canada

APO-Lansoprazole; DOM-Lansoprazole; Lansoprazole-15 [DSC]; Lansoprazole-30 [DSC]; MYLAN-Lansoprazole; PMS-Lansoprazole; Prevacid; Prevacid FasTab; Q-Lansoprazole [DSC]; RAN-Lansoprazole; RIVA-Lansoprazole; SANDOZ Lansoprazole; TEVA-Lansoprazole

Dosing: Adult

Gastroesophageal reflux disease (GERD), treatment: Note: Administer 30 to 60 minutes before a meal (breakfast is preferred). Lifestyle and dietary modifications are also recommended (ACG [Katz 2013]).

Initial therapy:

Mild and intermittent symptoms (<2 episodes/week), and no evidence of erosive esophagitis: Note: Some experts consider PPI use in these patients only if symptoms persist following standard-doses of histamine 2 receptor antagonists (Kahrilas 2019). Oral: 15 mg once daily for 8 weeks; if symptoms persist after 8 weeks, increase to 30 mg once daily; once symptoms are controlled, continue treatment for at least 8 weeks. Discontinue therapy when asymptomatic for 8 weeks with therapy (consider tapering before discontinuing) (Kahrilas 2019).

Severe or frequent symptoms (≥2 episodes/week), erosive esophagitis, or Barrett esophagus: Oral: 30 mg once daily; once symptoms are controlled, continue treatment for at least 8 weeks. In patients with severe erosive esophagitis or Barrett esophagus, long-term maintenance therapy with 30 mg once daily is warranted. In patients without severe erosive esophagitis or Barrett esophagus, continue at the lowest dose for the shortest duration appropriate, discontinue therapy in all asymptomatic patients (consider tapering before discontinuing) (Kahrilas 2019; Ramakrishnan 2002).

Refractory:

Persistent symptoms despite 30 mg once daily dosing regimen: Note: Referral to a specialist is recommended: Oral: 30 mg twice daily (before breakfast and dinner) (ACG [Katz 2013]; Fass 2019; Hershcovici 2010) or some experts consider splitting the 30 mg once daily dose and administering 15 mg twice daily before breakfast and dinner (Fass 2019).

Recurrent symptoms after discontinuing acid suppression:

Recurrent symptoms ≥3 months: Repeat an 8-week course at the previously effective dose (Kahrilas 2019).

Recurrent symptoms <3 months: Long-term maintenance at the lowest effective dose necessary; upper endoscopy is also recommended (if not already performed) (ACG [Katz 2013]; Kahrilas 2019).

OTC labeling (patient-guided therapy): Heartburn, frequent symptoms (≥2 episodes/week): 15 mg once daily for 14 days (maximum: 15 mg/day); may repeat a 14-day course every 4 months, if needed.

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

Dyspepsia (off label use): Oral: 15 or 30 mg once daily for up to 8 weeks (Peura 2004; Pinto-Sanchez 2017; Suzuki 2013)

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 (healing): Oral: 30 mg once daily for 8 weeks; controlled studies did not extend past 8 weeks

NSAID-associated gastric ulcer (to reduce risk): Oral: 15 mg once daily for up to 12 weeks; controlled studies did not extend past 12 weeks

Stress ulcer prophylaxis in critically-ill patients (off-label use): Oral: 30 mg once daily (Brophy 2010; Olsen 2008). Note: Intended for patients with associated risk factors (eg, coagulopathy, mechanical ventilation for >48 hours, sepsis/septic shock); discontinue use once risk factors have resolved (Rhodes 2017).

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).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

No dosage adjustment necessary.

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: Pediatric

GERD, symptomatic:

Weight-based dosing:

Infants: 1 to 2 mg/kg/day (Orenstein, 2009; Springer, 2008; Zhang, 2008). Note: 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) (Zhang, 2008).

Children: 0.7 to 3 mg/kg/day (AAP [Lightdale], 2013)

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 1 to 11 years:

≤30 kg: 15 mg once daily for up to 12 weeks

>30 kg: 30 mg once daily for up to 12 weeks

Children ≥12 years and Adolescents: Oral: 15 mg once daily for up to 8 weeks

Erosive esophagitis:

Children 1-11 years:

≤30 kg: 15 mg once daily for up to 12 weeks

>30 kg: 30 mg once daily for up to 12 weeks

Children ≥12 years and Adolescents: Oral: 30 mg once daily for up to 8 weeks

Dosing: Renal Impairment: Pediatric

Children and Adolescents: No dosage adjustments are recommended

Dosing: Hepatic Impairment: Pediatric

Children and Adolescents: Bioavailability increased in hepatic impairment; consider dose reduction for severe impairment

Use: Labeled Indications

Gastroesophageal reflux disease (GERD): Short-term (up to 8 weeks) treatment of symptomatic GERD 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

  DyspepsiaLevel of Evidence [A, G]

Data from multicentre, randomized, double-blinded, placebo-controlled trials support the use of omeprazole for the treatment of dyspepsia Ref. In addition, data from a systematic review support the use of lansoprazole for the treatment of patients with ulcer and reflux-like functional dyspepsia Ref.

Based on the American College of Gastroenterology (ACG) and Canadian Association of Gastroenterology (CAG) guidelines for the management of dyspepsia, the use of lansoprazole is effective and recommended treatment for dyspepsia and functional dyspepsia in patients <60 years of age who are H. pylori negative or who remain symptomatic after H. pylori eradication therapy Ref.

  Stress ulcer prophylaxis in critically-ill patientsLevel of Evidence [B, G]

Data from a prospective, randomized comparison of lansoprazole suspension and intermittent IV famotidine in critically ill neurosurgical patients and data from a randomized comparison of enteral and IV lansoprazole also in critically ill patients support the use of lansoprazole in patients requiring stress-ulcer prophylaxis while in the intensive care unit Ref.

Based on the Surviving Sepsis Campaign International Guidelines for the Management of Severe Sepsis and Septic Shock, stress ulcer prophylaxis using a proton pump inhibitor or a histamine H2-receptor antagonist is recommended in sepsis or septic shock patients who have GI bleeding risk factors.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Barrett Esophagus:

ACG, “Diagnosis and Management of Barrett’s Esophagus,” January 2016

Critical Care:

“Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016,” March 2017

Drug-Induced Liver Injury:

American College of Gastroenterology (ACG), “2014 ACG Guideline for Idiosyncratic Drug-induced Liver Injury,” July 2014

Dyspepsia:

ACG/CAG “Guidelines for the Management of Dyspepsia,” June 2017

Gastroesophageal Reflux Disease:

ACG, “Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease,” March 2013

AGA, “Medical Position Statement on the Management of Gastroesophageal Reflux Disease,” October 2008

Helicobacter pylori Infection:

“ACG Guideline on the Management of Helicobacter pylori Infection,” August 2007

“ACG Guideline on the Treatment of Helicobacter pylori Infection,” February 2017

NSAID-Related Ulcers:

“ACG Guidelines for Prevention of NSAID-Related Ulcer Complications,” February 2009

Proton Pump Inhibitors & Thienopyridines:

“2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention,” November 2011

“ACCF/ACG/AHA 2010 Expert Consensus Document on the Concomitant Use of Proton Pump Inhibitors and Thienopyridines,” December 2010

“The Use of Antiplatelet Therapy in the Outpatient Setting: Canadian Cardiovascular Society Guidelines,” 2011

Administration: 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.

Administration: Other

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 (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. 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.

Dietary Considerations

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

Storage/Stability

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 15°C to 30°C (59°F to 86°F). Once compounded, the product is stable for 30 days at 2°C to 8°C (36°F to 46°F); protect from freezing. Protect from light.

Extemporaneously Prepared

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).

DiGiancinto JL, Olsen KM, Bergman KL, et al, “Stability of Suspension Formulations of Lansoprazole and Omeprazole Stored in Amber-Colored Plastic Oral Syringes,” Ann Pharmacother, 2000, 34(5):600-605.[PubMed 10852086]

Morrison JT, Lugo RA, Thigpen JC, et al, “Stability of Extemporaneously Prepared Lansoprazole Suspension at Two Temperatures,” J Pediatr Pharmacol Ther, 2013, 18(2):122-127.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, abdominal pain, nausea, diarrhea, or constipation. Have patient report immediately to prescriber signs of low magnesium (mood changes; muscle pain or weakness; muscle cramps or spasms; seizures; tremors; lack of appetite; severe nausea or vomiting; or an abnormal heartbeat), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, angina or shortness of breath, or swelling in the arms or legs), severe dizziness, passing out, tachycardia, bone pain, signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  Geriatric Patients: High-Risk Medication:
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/2018/020406s087s088,021428s034s035lbl.pdf#page=38

Contraindications

Hypersensitivity (eg, anaphylaxis, angioedema, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria) to lansoprazole or any component of the formulation; concomitant use with products that contain rilpivirine

Warnings/Precautions

Concerns related to adverse effects:

• Carcinoma: No reports of enterochromaffin-like (ECL) cell carcinoids, dysplasia, or neoplasia has occurred.

• Clostridioides (formerly Clostridiumdifficile-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 adults up to elderly patients. 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.

• Fractures: Increased incidence of osteoporosis-related bone fractures of the hip, spine, or wrist may occur with proton pump inhibitor (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. Consider obtaining serum magnesium concentrations prior to beginning long-term therapy, especially if taking concomitant digoxin, diuretics, or other drugs known to cause hypomagnesemia; and periodically thereafter. Hypomagnesemia may be corrected by magnesium supplementation, although discontinuation of lansoprazole may be necessary; magnesium levels typically return to normal within 1 week of stopping.

• Interstitial nephritis: Acute interstitial nephritis has been observed in patients taking PPIs; may occur at any time during therapy and is generally due to an idiopathic hypersensitivity reaction. Discontinue if acute interstitial nephritis develops.

• 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: Proton pump inhibitors (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).

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

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.

Geriatric Considerations

The clearance of lansoprazole is decreased in the elderly; however, the half-life is only increased by 50% to 100%, resulting in a continued short half-life with no accumulation in the elderly. No dosage adjustment is required with normal hepatic function. The rate of healing and side effects are similar to younger adults.

Use has been associated with C. difficile infection, bone loss and fractures, and hypomagnesemia. Refer to Medication Safety Issues for Beers Criteria information.

Pregnancy Considerations

Available data have not shown an increased risk of major birth defects following maternal use of lansoprazole during pregnancy.

Recommendations for the treatment of GERD in pregnancy are available. As in nonpregnant patients, lifestyle modifications followed by other medications are the initial treatments (ACG [Katz 2013]; Body 2016; Huerta-Iga 2016; van der Woude 2014). Based on available data, proton pump inhibitors may be used when clinically indicated (Body 2016; Matok 2012; Pasternak 2010; van der Woude 2014).

Breast-Feeding 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.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

1% to 10%:

Central nervous system: Headache (3% to 7%), dizziness (adolescents: 3%; adults: <1%)

Gastrointestinal: Diarrhea (≤7%), abdominal pain (2% to 5%), constipation (children: 5%; adults 1%), nausea (adolescents: 3%; adults <1%)

Frequency not defined:

Endocrine & metabolic: Abnormal albumin-globulin ratio, albuminuria, decreased serum cholesterol, 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, blood platelet disorder (abnormal platelets), leukocyte disorder, leukocytosis

Hepatic: Abnormal hepatic function tests, hyperbilirubinemia, increased serum alkaline phosphatase, increased serum ALT, increased serum AST

Immunologic: Increased serum globulins

Renal: Acute interstitial nephritis, increased blood urea nitrogen, increased serum creatinine

<1%, postmarketing, and/or case reports: Abdominal distention, abnormal dreams, abnormal stools, abnormality in thinking, acne vulgaris, ageusia, agitation, agranulocytosis, alopecia, altered sense of smell, amblyopia, amnesia, anaphylactoid reaction, anaphylaxis, anemia, angina pectoris, anorexia, anxiety, apathy, aphthous stomatitis, aplastic anemia, arthralgia, arthritis, arthropathy, asthma, back pain, bezoar formation, blepharitis, blepharoptosis, blurred vision, bone disease, bone fracture, bradycardia, breast hypertrophy, breast tenderness, bronchitis, candidiasis, carcinoma, cardiac arrhythmia, cataract, cerebral infarction, cerebrovascular accident, change in platelet count (decreased/increased), chest pain, chills, cholelithiasis, circulatory shock, Clostridioides (formerly Clostridiumdifficile-associated diarrhea, colitis, confusion, conjunctivitis, contact dermatitis, cough, cutaneous lupus erythematosus, deafness, decreased libido, dehydration, dementia, depersonalization, depression, dermatological disease, diabetes mellitus, diaphoresis, difficulty in micturition, diplopia, dizziness, drowsiness, dry eye syndrome, dysgeusia, dysmenorrhea, dyspepsia, dysphagia, dyspnea, dysuria, ear disease, edema, electrolyte disturbance (decreased/increased), emotional lability, enteritis, eosinophilia, epistaxis, eructation, erythema multiforme, esophageal achalasia, esophageal stenosis, esophageal ulcer, esophagitis, eye pain, fecal discoloration, fever, fixed drug eruption, flatulence, flu-like symptoms, gastritis, gastroenteritis, gastrointestinal hemorrhage, GI moniliasis, gingival hemorrhage, glaucoma, glossitis, glycosuria, goiter, gout, gynecomastia, hair disease, halitosis, hallucination, hematemesis, hemiplegia, hemolysis, hemolytic anemia, hemoptysis, hepatotoxicity, hiccups, hostility, hyperkinesia, hypermenorrhea, hypersensitivity reaction, hypertension, hypertonia, hypoesthesia, hypoglycemia, hypomagnesemia, hypotension, hypothyroidism, impotence, increased appetite, increased libido, increased thirst, infection, insomnia, interstitial nephritis, leg cramps, leukopenia, leukorrhea, lymphadenopathy, maculopapular rash, malaise, malignant neoplasm of larynx, mastalgia, melena, menstrual disease (includes abnormal menses), migraine, musculoskeletal pain, myalgia, myasthenia, myocardial infarction, myositis, nail disease, neck pain, neck stiffness, nephrolithiasis, nervousness, neutropenia, oral mucosa ulcer, otitis media, pain, palpitations, pancreatitis, pancytopenia, paresthesia, pelvic pain, penile disease, peripheral edema, pharyngitis, photophobia, pleural disease, pneumonia, polyp (gastric nodules and fundic gland polyp), polyuria, pruritus, psychoneurosis, pulmonary fibrosis, rectal disease, rectal hemorrhage, renal disease (chronic; Lazarus 2016), renal pain, respiratory tract disease, retinal degeneration, retinopathy, rhinitis, seizure, sialorrhea, sinusitis, skin carcinoma, skin rash, sleep disorder, speech disturbance, Stevens-Johnson syndrome, stomatitis, stridor, syncope, synovitis, systemic lupus erythematosus, tachycardia, tenesmus, testicular disease, thrombocytopenia, thrombotic thrombocytopenic purpura, tinnitus, tremor, tongue disease, toxic epidermal necrolysis, ulcerative colitis, upper respiratory tract inflammation, upper respiratory tract infection, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urticaria, vaginitis, vasodilatation, vertigo, visual disturbance, visual field defect, vitamin deficiency, vomiting, weakness, weight gain, weight loss, xeroderma, xerostomia

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

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

Drug Interactions 

Acalabrutinib: Proton Pump Inhibitors may decrease the serum concentration of Acalabrutinib. Risk X: Avoid combination

Amphetamine: Proton Pump Inhibitors may increase the absorption of Amphetamine. Risk C: Monitor therapy

Atazanavir: Proton Pump Inhibitors may decrease the serum concentration of Atazanavir. Management: See full drug interaction monograph for details. Risk D: Consider therapy modification

Bisphosphonate Derivatives: Proton Pump Inhibitors may diminish the therapeutic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Bosutinib: Proton Pump Inhibitors may decrease the serum concentration of Bosutinib. Management: Consider alternatives to proton pump inhibitors, such as antacids or H2 receptor antagonists. Administer alternative agents more than 2 hours before or after bosutinib. Risk D: Consider therapy modification

Capecitabine: Proton Pump Inhibitors may diminish the therapeutic effect of Capecitabine. Risk C: Monitor therapy

Cefditoren: Proton Pump Inhibitors may decrease the serum concentration of Cefditoren. Management: If possible, avoid use of cefditoren with proton pump inhibitors (PPIs). Consider alternative methods to minimize/control acid reflux (eg, diet modification) or alternative antimicrobial therapy if use of PPIs can not be avoided. Risk D: Consider therapy modification

Cefpodoxime: Proton Pump Inhibitors may decrease the serum concentration of Cefpodoxime. Risk C: Monitor therapy

Cefuroxime: Proton Pump Inhibitors 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 (Moderate): May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP2C19 Inducers (Strong): May increase the metabolism of CYP2C19 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

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

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP2C19 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Dacomitinib: Proton Pump Inhibitors may decrease the serum concentration of Dacomitinib. Management: Avoid concurrent use of dacomitinib with proton pump inhibitors. 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: Proton Pump Inhibitors may decrease the serum concentration of Dasatinib. Management: Antacids (taken 2 hours before or after dasatinib administration) can be used in place of the proton pump inhibitor if some acid-reducing therapy is needed. Risk X: Avoid combination

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

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

Dexmethylphenidate: Proton Pump Inhibitors may increase the absorption of Dexmethylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Focalin XR brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy

Dextroamphetamine: Proton Pump Inhibitors 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: Proton Pump Inhibitors may decrease the bioavailability of Doxycycline. Risk C: Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP2C19 Substrates (High risk with Inducers). Conversely, concentrations of active metabolites may be increased for those drugs activated by CYP2C19. Management: Concurrent use of enzalutamide with CYP2C19 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP2C19 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Erlotinib: Proton Pump Inhibitors may decrease the serum concentration of Erlotinib. Risk X: Avoid combination

Fluconazole: May increase the serum concentration of Proton Pump Inhibitors. Risk C: Monitor therapy

Gefitinib: Proton Pump Inhibitors may decrease the serum concentration of Gefitinib. Management: Avoid use of proton pump inhibitors (PPIs) with gefitinib when possible. If required, administer gefitinib 12 hours after administration of the PPI or 12 hours before the next dose of the PPI. Risk D: Consider therapy modification

Imatinib: Lansoprazole may enhance the dermatologic adverse effect of Imatinib. Risk C: Monitor therapy

Indinavir: Proton Pump Inhibitors may decrease the serum concentration of Indinavir. Risk C: Monitor therapy

Iron Salts: Proton Pump Inhibitors may decrease the absorption of Iron Salts. Exceptions: Ferric Carboxymaltose; Ferric Citrate; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Isomaltoside; Iron Sucrose. Risk C: Monitor therapy

Itraconazole: Proton Pump Inhibitors may increase the serum concentration of Itraconazole. Proton Pump Inhibitors may decrease the serum concentration of Itraconazole. Management: Administer Sporanox brand itraconazole at least 2 hours before or 2 hours after administration of any proton pump inhibitors (PPIs). Exposure to Tolsura brand itraconazole may be increased by PPIs; consider itraconazole dose reduction. Risk D: Consider therapy modification

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Ketoconazole (Systemic): Proton Pump Inhibitors may decrease the serum concentration of Ketoconazole (Systemic). Ketoconazole (Systemic) may increase the serum concentration of Proton Pump Inhibitors. Risk D: Consider therapy modification

Ledipasvir: Proton Pump Inhibitors may decrease the serum concentration of Ledipasvir. Management: PPI doses equivalent to omeprazole 20 mg or lower may be given with ledipasvir under fasted conditions. Administration with higher doses of PPIs, 2 hours after a PPI, or in combination with food and PPIs may reduce ledipasvir bioavailability. Risk D: Consider therapy modification

Lorlatinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. Risk D: Consider therapy modification

Mesalamine: Proton Pump Inhibitors may diminish the therapeutic effect of Mesalamine. Proton pump inhibitor-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Consider avoiding concurrent administration of high-dose proton pump inhibitors (PPIs) with sustained-release mesalamine products. Risk D: Consider therapy modification

Methotrexate: Proton Pump Inhibitors may increase the serum concentration of Methotrexate. Risk C: Monitor therapy

Methylphenidate: Proton Pump Inhibitors may increase the absorption of Methylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Risk C: Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Risk D: Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): Proton Pump Inhibitors 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: Proton Pump Inhibitors may decrease the serum concentration of Mycophenolate. Specifically, concentrations of the active mycophenolic acid may be reduced. Risk C: Monitor therapy

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

Neratinib: Proton Pump Inhibitors may decrease the serum concentration of Neratinib. Specifically, proton pump inhibitors may reduce neratinib absorption. Risk X: Avoid combination

Nilotinib: Proton Pump Inhibitors may decrease the serum concentration of Nilotinib. Management: Avoid this combination when possible since separation of doses is not likely to be an adequate method of minimizing the interaction. Risk D: Consider therapy modification

PAZOPanib: Proton Pump Inhibitors may decrease the serum concentration of PAZOPanib. Risk X: Avoid combination

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Risk D: Consider therapy modification

Posaconazole: Proton Pump Inhibitors may decrease the serum concentration of Posaconazole. Risk D: Consider therapy modification

Raltegravir: Proton Pump Inhibitors may increase the serum concentration of Raltegravir. Risk C: Monitor therapy

Rilpivirine: Proton Pump Inhibitors may decrease the serum concentration of Rilpivirine. Risk X: Avoid combination

Riociguat: Proton Pump Inhibitors may decrease the serum concentration of Riociguat. Risk C: Monitor therapy

Risedronate: Proton Pump Inhibitors may diminish the therapeutic effect of Risedronate. Proton Pump Inhibitors may increase the serum concentration of Risedronate. This applies specifically to use of delayed-release risedronate. Risk X: Avoid combination

Saquinavir: Proton Pump Inhibitors may increase the serum concentration of Saquinavir. Risk C: Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Secretin: Proton Pump Inhibitors 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 proton pump inhibitors (PPIs) and secretin, and discontinue PPIs several weeks prior to secretin administration, with the duration of separation determined by the specific PPI. See full monograph for details. Risk D: Consider therapy modification

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

St John’s Wort: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

Tacrolimus (Systemic): Proton Pump Inhibitors may increase the serum concentration of Tacrolimus (Systemic). Management: Tacrolimus dose adjustment may be required. Rabeprazole, pantoprazole, or selected H2-receptor antagonists (i.e., ranitidine or famotidine) may be less likely to interact. Genetic testing may predict patients at highest risk. Risk D: Consider therapy modification

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

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Velpatasvir: Proton Pump Inhibitors may decrease the serum concentration of Velpatasvir. Risk X: Avoid combination

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 Proton Pump Inhibitors. Proton Pump Inhibitors may increase the serum concentration of Voriconazole. Management: In patients receiving omeprazole 40 mg/day or greater, reduce omeprazole dose by half when initiating 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).

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, CDAD, liver function, renal function, magnesium (baseline and periodically thereafter), and serum gastrin levels

Advanced Practitioners Physical Assessment/Monitoring

Obtain CBC, CDAD, liver function tests, renal function tests, serum magnesium levels, and serum gastrin levels. Evaluate gastric acid output in patients with Zollinger-Ellison syndrome; make sure maintained at ≤10 mEq/hour during last hour before the next lansoprazole dose. Assess other medicines patient may be taking; alternate therapy or dosage adjustments may be needed. Assess for effectiveness of ulcer symptom relief. Monitor for B12 deficiency with prolonged treatment (greater than 2 years). Assess for bone loss and bone fractures with long-term therapy.

Nursing Physical Assessment/Monitoring

Check ordered labs and report abnormalities. Monitor effectiveness of ulcer symptom relief.

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.

Capsule Delayed Release, Oral:

GoodSense Lansoprazole: 15 mg [gluten free; contains brilliant blue fcf (fd&c blue #1), fd&c yellow #10 (quinoline yellow)]

Heartburn Treatment 24 Hour: 15 mg [sodium free; contains brilliant blue fcf (fd&c blue #1), fd&c yellow #10 (quinoline yellow)]

Prevacid: 15 mg, 30 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40]

Prevacid 24HR: 15 mg [sodium free; contains brilliant blue fcf (fd&c blue #1), fd&c red #40]

Generic: 15 mg, 30 mg

Tablet Disintegrating, Oral:

Prevacid SoluTab: 15 mg, 30 mg [contains aspartame]

Generic: 15 mg, 30 mg

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 BRILLIANT BLUE FCF (FD&C BLUE #1), FD&C RED #40, POLYSORBATE 80]

Generic: 15 mg, 30 mg

Tablet Disintegrating, Oral:

Prevacid FasTab: 15 mg, 30 mg [contains ASPARTAME]

Anatomic Therapeutic Chemical (ATC) Classification
  • A02BC03
Generic Available (US)

Yes

Pricing: US

Capsule, delayed release (Lansoprazole Oral)

15 mg (per each): $4.72 – $5.90

30 mg (per each): $0.66 – $5.90

Capsule, delayed release (Prevacid 24HR Oral)

15 mg (per each): $0.72

Capsule, delayed release (Prevacid Oral)

15 mg (per each): $16.60

30 mg (per each): $16.60

Tablet, orally-disintegrating (Lansoprazole Oral)

15 mg (per each): $15.77

30 mg (per each): $15.77

Tablet, orally-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.

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.

Pharmacodynamics/Kinetics

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; Elderly: 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

Pharmacodynamics/Kinetics: Additional Considerations

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.

Geriatric: 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.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

FDA Approval Date
May 10, 1995
References

Abraham NS, Hlatky MA, Antman EM, et al. ACCF/ACG/AHA 2010 Expert Consensus Document on the Concomitant Use of Proton Pump Inhibitors and Thienopyridines: A Focused Update of the ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use: A Report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents. Circulation. 2010;122(24):2619-2633.[PubMed 21060077]

Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]

American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015;63(11):2227-2246. doi:10.1111/jgs.13702.[PubMed 26446832]

Anderka M, Mitchell AA, Louik C, et al. Medications Used to Treat Nausea and Vomiting of Pregnancy and the Risk of Selected Birth Defects. Birth Defects Res A Clin Mol Teratol.2012;94(1):22-30.[PubMed 22102545]

Bell AD, Roussin A, Cartier R, et al. The Use of Antiplatelet Therapy in the Outpatient Setting: Canadian Cardiovascular Society Guidelines. Can J Cardiol. 2011;27(suppl A):1-59.[PubMed 21640290]

Body C, Christie JA. Gastrointestinal diseases in pregnancy: nausea, vomiting, hyperemesis gravidarum, gastroesophageal reflux disease, constipation, and diarrhea. Gastroenterol Clin North Am. 2016;45(2):267-283.[PubMed 27261898]

Brophy GM, Brackbill ML, Bidwell KL, et al. Prospective, Randomized Comparison of Lansoprazole Suspension, and Intermittent Intravenous Famotidine on Gastric pH and Acid Production in Critically ill Neurosurgical Patients. Neurocrit Care. 2010;13(2):176-181.[PubMed 20596795]

Brunner G, Luna P, Hartmann M, et al. Optimizing the Intragastric pH as a Supportive Therapy in Upper GI Bleeding. Yale J Biol Med. 1996;69(3):225-231.[PubMed 9165691]

Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]

Chey WD, Leontiadis GI, Howden CW, Moss SF. ACG clinical guideline: treatment of Helicobacter pylori infection. Am J Gastroenterol. 2017;112(2):212-239. doi: 10.1038/ajg.2016.563.[PubMed 28071659]

Chey WD, Wong BC; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007;102(8):1808-1825. doi: 10.1111/j.1572-0241.2007.01393.x.[PubMed 17608775]

Chun AH, Eason CJ, Shi HH, et al. Lansoprazole: An Alternative Method of Administration of a Capsule Dosage Formulation. Clin Ther. 1995;17(3):441-447.[PubMed 7585848]

Cockayne SE, Glet RJ, Gawkrodger DJ, et al. Severe Erythrodermic Reactions to the Proton Pump Inhibitors Omeprazole and Lansoprazole. Br J Dermatol. 1999;141(1):173-175.[PubMed 10417548]

de Jager CP, Wever PC, Gemen EF, et al. Proton Pump Inhibitor Therapy Predisposes to Community-Acquired Streptococcus pneumoniae Pneumonia. Aliment Pharmacol Ther.2012;36(10):941-949.[PubMed 23034135]

Diav-Citrin O, Arnon J, Shechtman S, et al. The Safety of Proton Pump Inhibitors in Pregnancy: A Multicentre Prospective Controlled Study. Aliment Pharmacol Ther. 2005;21(3):269-275.[PubMed 15691301]

Erichsen R, Mikkelsen E, Pedersen L, Sørensen HT. Maternal use of proton pump inhibitors during early pregnancy and the prevalence of hypospadias in male offspring. Am J Ther. 2014;21(4):254-259. doi: 10.1097/MJT.0b013e3182456a8f.[PubMed 22314213]

Fallone CA, Chiba N, van Zanten SV, et al. The Toronto consensus for the treatment of Helicobacter pylori infection in adults. Gastroenterology. 2016;151(1):51-69.e14.[PubMed 27102658]

Fass R. Approach to refractory gastroesophageal reflux disease in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed February 11, 2019.

First Lansoprazole compounding kit [prescribing information]. Wilmington, MA: CutisPharma Inc; December 2014.

Frazzoni M, De Micheli E, Grisendi A, et al. Effective Intra-Oesophageal Acid Suppression in Patients With Gastro-Oesophageal Reflux Disease: Lansoprazole vs. Pantoprazole. Aliment Pharmacol Ther. 2003;17(2):235-241.[PubMed 12534408]

Frelinger AL 3rd, Lee RD, Mulford DJ, et al. A Randomized, 2-Period, Crossover Design Study to Assess the Effects of Dexlansoprazole, Lansoprazole, Esomeprazole, and Omeprazole on the Steady-State Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Volunteers. J Am Coll Cardiol. 2012;59(14):1304-1311.[PubMed 22464259]

Hershcovici T, Fass R. An algorithm for diagnosis and treatment of refractory GERD. Best Pract Res Clin Gastroenterol. 2010;24(6):923-936. doi: 10.1016/j.bpg.2010.10.004.[PubMed 21126704]

Huang JQ, Goldwater DR, Thomson AB, et al. Acid Suppression in Healthy Subjects Following Lansoprazole or Pantoprazole. Aliment Pharmacol Ther. 2002;16(3):425-433.[PubMed 11876695]

Huerta-Iga F, Bielsa-Fernández MV, Remes-Troche JM, Valdovinos-Díaz MA, Tamayo-de la Cuesta JL; en representación del Grupo para el estudio de la ERGE 2015. Diagnosis and treatment of gastroesophageal reflux disease: recommendations of the Asociación Mexicana de Gastroenterología. Rev Gastroenterol Mex. 2016;81(4):208-222.[PubMed 27595382]

“Inactive” ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Jung R, MacLaren R. Proton-Pump Inhibitors for Stress Ulcer Prophylaxis in Critically Ill Patients. Ann Pharmacother. 2002;36(12):1929-1937.[PubMed 12452757]

Kahrilas PJ. Medical management of gastroesophageal reflux disease in adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc.http://www.uptodate.com. Accessed February 11, 2019.

Kahrilas PJ, Shaheen NJ, Vaezi MF, et al. American Gastroenterological Association medical position statement on the management of gastroesophageal reflux disease. Gastroenterology. 2008;135(4):1383-1391.[PubMed 18789939]

Katz PO, Gerson LB, Vela MF. Guidelines for the Diagnosis and Management of Gastroesophageal Reflux Disease. Am J Gastroenterol. 2013;108(3):308-328.[PubMed 23419381]

Kim J, Blackett JW, Jodorkovsky D. Strategies for effective discontinuation of proton pump inhibitors. Curr Gastroenterol Rep. 2018;20(6):27. doi: 10.1007/s11894-018-0632-y.[PubMed 29767318]

Lam JR, Schneider JL, Zhao W, Corley DA. Proton pump inhibitor and histamine 2 receptor antagonist use and vitamin B12 deficiency. JAMA. 2013;310(22):2435-2422.[PubMed 24327038]

Lanza FL, Chan FK, and Quigley EM. Guidelines for Prevention of NSAID-Related Ulcer Complications. Am J Gastroenterol. 2009;140(3):728-738.[PubMed 19240698]

Lazarus B, Chen Y, Wilson FP, et al. Proton pump inhibitor use and the risk of chronic kidney disease. JAMA Intern Med. 2016:238-246.[PubMed 26752337]

Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011;124(23):e574-e651.[PubMed 22064601]

Li XQ, Andersson TB, Ahalström M, et al. Comparison of Inhibitory Effects of the Proton Pump-Inhibiting Drugs Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole and Rabeprazole on Human Cytochrome P450 Activities. Drug Metab Dispo. 2004;32(8):821-827.[PubMed 15258107]

Matok I, Levy A, Wiznitzer A, et al. The Safety of Fetal Exposure to Proton-Pump Inhibitors During Pregnancy. Dig Dis Sci. 2012;57(3):699-705.[PubMed 22038541]

Moayyedi PM, Lacy BE, Andrews CN, Enns RA, Howden CW, Vakil N. ACG and CAG clinical guideline: management of dyspepsia. Am J Gastroenterol. 2017;112(7):988-1013. doi: 10.1038/ajg.2017.154.[PubMed 28631728]

Natsch S, Vinks MH, Voogt AK, et al. Anaphylactic Reactions to Proton-Pump Inhibitors. Ann Pharmacother. 2000;34(4):474-476.[PubMed 10772433]

Ogilvie BW, Yerino P, Kazmi F, et al. The Proton Pump Inhibitor, Omeprazole, but not Lansoprazole or Pantoprazole, is a Metabolism-Dependent Inhibitor of CYP2C19: Implications for Coadministration With Clopidogrel. Drug Metab Dispos. 2011;39(11):2020-2033.[PubMed 21795468]

Olsen KM, Devlin JW. Comparison of the Enteral and Intravenous Lansoprazole Pharmacodynamic Responses in Critically Ill Patients. Aliment Pharmacol Ther. 2008;28(3):326-333.[PubMed 19086331]

Paoluzi P, Iacopini F, Crispino P, et al. 2-Week Triple Therapy for Helicobacter pylori Infection is Better Than 1-Week in Clinical Practice: a Large Prospective Single-Center Randomized Study. Helicobacter. 2006;11(6):562-568.[PubMed 17083378]

Pasternak B, Hviid A. Use of proton-pump inhibitors in early pregnancy and the risk of birth defects. N Engl J Med. 2010;363(22):2114-2123.[PubMed 21105793]

Peura DA, Kovacs TO, Metz DC, et al. Lansoprazole in the treatment of functional dyspepsia: two double-blind, randomized, placebo-controlled trials. Am J Med. 2004;116(11):740-748. doi: 10.1016/j.amjmed.2004.01.008.[PubMed 15144910]

Pinto-Sanchez MI, Yuan Y, Bercik P, et al. Proton pump inhibitors for functional dyspepsia. Cochrane Database Syst Rev. 2017;3:CD011194. doi: 10.1002/14651858.CD011194.pub2. Review. Update in: Cochrane Database Syst Rev. 2017;11:CD011194.[PubMed 28271513]

Prevacid and Prevacid Solutab (lansoprazole) [prescribing information]. Deerfield, IL: Takeda Pharmaceuticals America; June 2018.

Prevacid 24 Hour (lansoprazole) [prescribing information]. Warren, NJ: GSK Consumer Healthcare; received December 2017.

Ramakrishnan A, Katz PO. Pharmacologic management of gastroesophageal reflux disease. Curr Treat Options Gastroenterol. 2002;5(4):301-310.[PubMed 12095478]

Rhodes A, Evans LE, Alhazzani W, et al. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock: 2016. Intensive Care Med. 2017;43(3):304-377. doi: 10.1007/s00134-017-4683-6.[PubMed 28101605]

Spiegel B. Diagnostic testing in extraesophageal GERD: another case of “furor medicus” [published correction appears in: Am J Gastroenterol. 2013;108(10):1672.]? Am J Gastroenterol. 2013;108(6):912-914. doi: 10.1038/ajg.2013.80.[PubMed 23735914]

Suzuki H, Kusunoki H, Kamiya T, et al. Effect of lansoprazole on the epigastric symptoms of functional dyspepsia (ELF study): A multicentre, prospective, randomized, double-blind, placebo-controlled clinical trial. United European Gastroenterol J. 2013;1(6):445-452. doi: 10.1177/2050640613510904.[PubMed 24917996]

Talley NJ, Vakil N. Practice Parameters Committee of the American College of Gastroenterology. Guidelines for the Management of Dyspepsia. Am J Gastroenterol. 2005;100(10):2324-2337.[PubMed 16181387]

Tsai WL, Poon SK, YU HK, et al. Nasogastric lansoprazole is effective in suppressing gastric acid secretion in critically ill patients. Aliment Pharmacol Ther. 2000;14(1):123-127.[PubMed 10632655]

van der Woude CJ, Metselaar HJ, Danese S. Management of gastrointestinal and liver diseases during pregnancy. Gut. 2014;63(6):1014-1023.[PubMed 24429582]

Wolfe MM, Sachs G. Acid Suppression: Optimizing Therapy for Gastroduodenal Ulcer Healing, Gastroesophageal Reflux Disease, and Stress-Related Erosive Syndrome. Gastroenterology. 2000;118(2)(suppl 1):9-31.

Brand Names: International

Agopton (AT, CH, DE); Betalans (ID); Chexid (ET); Dakar (LU); Dapuaa (KR); Daxar (BE); Digest (ID); Dispepci (PT); Emlansa (HK); Estomil (ES); Gastevin (VN); Gastriben (PT); Gastrocure (EG); Gastrovex (MY); Hiza (PH); Imidex (MX); Inhipraz (ID); Julphasole (MY); Krovane (MT); Lacopen (CO); Lagas 30 (ID); Lan-30 (ZW); Lancerol (UA); Lancid (KR); Lanfast (AE, BH, KW, QA, SA); Langaton (KR); Lanodizol (MX); Lanpraz (CO); Lanpro (MY); Lanprol (AE, BH, CY, IQ, IR, JO, KR, KW, LB, LY, OM, QA, SA, SY, YE); Lanproton (CO); Lans OD (PH); Lans-OD (LK); Lansal (FI); Lansale (DK); Lanso (GR, MY); Lansodin (BD); Lansofast (EG); Lansol-30 (HK); Lansomid (QA); Lansomylan (BE); Lansone (HU); Lansopep (CO, CR, DO, GT, HN, NI, PA, SV); Lansopram (DK); Lansoprol (UA); Lansor (TR); Lansozole (KR); Lanspro-30 (PH); Lanster (KR); Lanston (KR); Lanton (IL); Lanvell (PH); Lanxid-OD (PH); Lanximed (CO); Lanz (BD); Lanzap (RO, RU); Lanzo (DK, IS, SE); Lanzo Melt (NO); Lanzohess (CR, DO, GT, HN, NI, PA, SV); Lanzol (ES, IE); Lanzol-30 (IN); Lanzole (LK); Lanzopra (BD); Lanzopral (AR, PE, PY, UY, VE); Lanzopran (AU); Lanzor (AE, BH, DE, EG, FR, JO, KW, LB, QA, SA); Lanzostad (LT, LV); Lanzul (CZ, EE, HR, LT, LV, PL, RO, SI, SK); Lapraz (ID); Laproton (ID); Lasgan (ID); Lasoprol (ET, MT, SG); Laz (ID); Lazo (BD); Lazol (HR); Loprezol (ID); Monolitum (ES); Ogast (FR); Ogastro (BB, BM, BS, BZ, CO, CR, DO, EC, FR, GT, GY, HN, JM, MX, NI, PA, PE, PR, SR, SV, TT); Olan (MX); Opiren (ES); Palatrin (MX); Prazex (VN); Prevacid (CN, MY, PH, PK, SG, TH); Prevacid FDT/IV (TH); Prezal (NL); Prilosan (MX); Prolanzo (PH); Prosogan fd (ID); Protonexa (BG); Pysolan (ID, PH); Quitulcer (TW); Razolager (IE); Safemar (MX); Solox (NZ); Sopralan-30 (ID); Sopranix (SE); Soprazol (LK); Sorifran (MX); Takepron (AE, BF, BH, BJ, CI, CN, ET, GH, GM, GN, JO, JP, KE, KW, LB, LR, MA, ML, MR, MU, MW, NE, NG, QA, SA, SC, SD, SL, SN, TN, TW, TZ, UG, ZA, ZM); Takepron OD (HK); Taquidine (TW); Uldapril (MX); Ulpax (MX); Versacid (PH); Xizhixin (CN); Zolcer (ID); Zomel (IE); Zopral (AU); Zopraz (PE); Zoton (AU, GB, IE, IT); Zoton Fastab (GB, IE)

Lansoprazole (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(lan SOE pra zole)

Brand Names: US

GoodSense Lansoprazole [OTC]; Heartburn Treatment 24 Hour [OTC]; Prevacid; Prevacid 24HR [OTC]; Prevacid SoluTab

Brand Names: Canada

Prevacid; Prevacid FasTab

What is this drug used for?
  • It is used to treat or prevent GI (gastrointestinal) ulcers caused by infection.
  • It is used to treat or prevent NSAID-associated gastric ulcers in patients with a history of ulcers.
  • It is used to treat gastroesophageal reflux disease (GERD; acid reflux).
  • It is used to treat heartburn.
  • It is used to treat syndromes caused by lots of stomach acid.
  • It is used to treat or prevent ulcers of the swallowing tube (esophagus).
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to lansoprazole or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are taking any of these drugs: Atazanavir, nelfinavir, or rilpivirine.
  • If you are taking any of these drugs: Rifampin or St. John’s wort.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Call your doctor if you have throat pain, chest pain, very bad belly pain, trouble swallowing, or signs of a bleeding ulcer like black, tarry, or bloody stools, throwing up blood, or throw up that looks like coffee grounds. These may be signs of a worse health problem.
  • This drug may raise the chance of hip, spine, and wrist fractures in people with weak bones (osteoporosis). The chance may be higher if you take this drug in high doses or for longer than a year, or if you are older than 50 years old. Talk with your doctor.
  • Use care if you have risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your doctor about your risks of osteoporosis.
  • Low magnesium levels have rarely happened in people taking drugs like this one for at least 3 months. Most of the time, this has happened after 1 year of care. You will need to have your blood work checked if you will be taking this drug for a long time or if you take certain other drugs like digoxin or water pills. Talk with your doctor.
  • Long-term treatment (for instance longer than 3 years) with drugs like this one has rarely caused low vitamin B-12 levels. Talk with the doctor.
  • Lupus has happened with this drug, as well as lupus that has gotten worse in people who already have it. Tell your doctor if you have lupus. Call your doctor right away if you have signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • This drug may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this drug, call your doctor right away.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • Oral-disintegrating tablet:
  • If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Dizziness or passing out.
  • A fast heartbeat.
  • Bone pain.
  • Fever.
  • This drug may raise the chance of a severe form of diarrhea called C diff-associated diarrhea (CDAD). Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with your doctor.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Headache.
  • Belly pain.
  • Constipation.
  • Diarrhea.
  • Upset stomach.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Take this drug before meals.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • If you also take sucralfate, take this drug at least 30 minutes before taking sucralfate.
  • Those who have feeding tubes may use this drug. Use as you have been told. Flush the feeding tube after this drug is given.
  • Capsules:
  • Swallow whole. Do not chew or crush.
  • You may sprinkle contents of capsule on 1 tablespoon (15 mL) of applesauce, Ensure® pudding, cottage cheese, yogurt, or strained pears. Do not chew granules.
  • You may mix contents of capsule with 60 mL of apple, orange, or tomato juice. Swallow right away. Do not chew granules.
  • After mixing, take your dose right away. Do not store for future use.
  • Oral-disintegrating tablet:
  • Place on your tongue and let it dissolve. Water is not needed. Do not swallow it whole. Do not chew, break, or crush it.
  • You may also dissolve the tablet in an oral syringe with water. Place the tablet in an oral syringe. For 15 mg tablets, draw up 4 mL of water. For 30 mg tablets, draw up 10 mL of water. Shake gently until the tablet dissolves. Take within 15 minutes of mixing. After taking, refill the syringe with 2 mL of water for 15 mg tablet or 5 mL of water for 30 mg tablet. Shake gently and swallow.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Lansoprazole (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(lan SOE pra zole)

Brand Names: US

GoodSense Lansoprazole [OTC]; Heartburn Treatment 24 Hour [OTC]; Prevacid; Prevacid 24HR [OTC]; Prevacid SoluTab

Brand Names: Canada

Prevacid; Prevacid FasTab

What is this drug used for?
  • It is used to treat gastroesophageal reflux disease (GERD; acid reflux).
  • It is used to treat or prevent ulcers of the swallowing tube (esophagus).
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child is taking any of these drugs: Atazanavir, nelfinavir, or rilpivirine.
  • If your child is taking any of these drugs: Rifampin or St. John’s wort.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Call the doctor if your child has throat pain, chest pain, very bad belly pain, trouble swallowing, or signs of a bleeding ulcer like black, tarry, or bloody stools, throwing up blood, or throw up that looks like coffee grounds. These may be signs of a worse health problem.
  • This drug may raise the chance of hip, spine, and wrist fractures in people with weak bones (osteoporosis). The chance may be higher if this drug is taken in high doses or for longer than a year. Talk with the doctor.
  • Use care if your child has risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your child’s doctor about your child’s risks of osteoporosis.
  • Low magnesium levels have rarely happened in people taking drugs like this one for at least 3 months. Most of the time, this has happened after 1 year of care. Your child will need to have their blood work checked if they will be taking this drug for a long time or if they take certain other drugs like digoxin or water pills. Talk with the doctor.
  • Long-term treatment (for instance longer than 3 years) with drugs like this one has rarely caused low vitamin B-12 levels. Talk with the doctor.
  • Lupus has happened with this drug, as well as lupus that has gotten worse in people who already have it. Tell your child’s doctor if your child has lupus. Call your child’s doctor right away if your child has signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • If your child is pregnant or breast-feeding a baby:
  • This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
  • Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.
  • Oral-disintegrating tablet:
  • If your child has phenylketonuria (PKU), talk with your child’s doctor. Some products have phenylalanine.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Dizziness or passing out.
  • A fast heartbeat.
  • Bone pain.
  • Fever.
  • This drug may raise the chance of a severe form of diarrhea called C diff-associated diarrhea (CDAD). Call your child’s doctor right away if your child has stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with your child’s doctor.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Headache.
  • Belly pain.
  • Constipation.
  • Diarrhea.
  • Upset stomach.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Give before meals.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • If your child also takes sucralfate, give this drug at least 30 minutes before giving sucralfate.
  • Those who have feeding tubes may use this drug. Use as you have been told. Flush the feeding tube after this drug is given.
  • Capsules:
  • Have your child swallow whole. Do not let your child chew or crush.
  • You may sprinkle contents of capsule on 1 tablespoon (15 mL) of applesauce, Ensure® pudding, cottage cheese, yogurt, or strained pears. Do not let your child chew the granules.
  • You may mix contents of capsule with 60 mL of apple, orange, or tomato juice. Have your child swallow right away. Do not let your child chew the granules.
  • Give the mixture right away. Do not store for use at a later time.
  • Oral-disintegrating tablet:
  • Place on your child’s tongue and let it dissolve. Water is not needed. Do not let your child swallow it whole. Do not let your child chew, break, or crush it.
  • You may also dissolve the tablet in an oral syringe with water. Place the tablet in an oral syringe. For 15 mg tablets, draw up 4 mL of water. For 30 mg tablets, draw up 10 mL of water. Shake gently until the tablet dissolves. Give within 15 minutes of mixing. After giving, refill the syringe with 2 mL of water for 15 mg tablet or 5 mL of water for 30 mg tablet. Shake gently and have your child swallow.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.