Professional Drug Information > Lansoprazole

Lansoprazole (Systemic)

VA CLASSIFICATION
Primary: GA304

Commonly used brand name(s): Prevacid.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Gastric acid pump inhibitor—

antiulcer agent—

Indications

Accepted

Gastroeosphageal reflux disease [GERD] (prophylaxis and treatment) —Lansoprazole is indicated for the short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD) ^{36}. Lansoprazole is indicated for the short-term (up to 8 weeks) treatment for symptom relief and healing of all grades of erosive esophagitis (associated with GERD) ^{36}. Lansoprazole may be indicated for an additional 8 weeks of treatment in patients in whom healing has not occurred ^{{01} {36}}. If erosive esophagitis recurs, an additional course of lansoprazole treatment may be considered ^{{01} {36}}. Lansoprazole also is indicated to maintain healing of erosive esophagitis ^{36}.

Ulcer, gastric (treatment) ^{{03} {04} {06} {09} {13} {16} {18} {24} {30} {33} {35} {36} {37}}—Lansoprazole is indicated for short-term (up to 8 weeks) treatment in patients with active benign gastric ulcer ^{{30} {36}}.

Ulcer, duodenal (prophylaxis and treatment) ^{{01} {03} {04} {05} {06} {10} {13} {14} {16} {18} {22} {24} {26} {36} {37}}—Lansoprazole is indicated for short-term (up to 4 weeks) treatment for symptom relief and healing in patients with active duodenal ulcer ^{{01} {36}}. Lansoprazole also is indicated to maintain healing of duodenal ulcers ^{36}.

Ulcer, duodenal, Helicobacter pylori –associated (treatment)—Lansoprazole is indicated in combination with amoxicillin plus clarithromycin for the treatment of duodenal ulcer associated with H. pylori infection ^{{36} {37}}. Lansoprazole also is indicated in combination with amoxicillin in patients who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected ^{{36} {37}}. Eradication of H. pylori has been shown to reduce the risk of ulcer recurrence ^{{36} {37}}.

Hypersecretory conditions, gastric (treatment) ^{{01} {05} {18}}—Lansoprazole is indicated for the long-term treatment of pathological hypersecretory conditions ^{{01} {05} {18} {36} {37}}, including Zollinger-Ellison syndrome ^{{01} {03} {04} {05} {06} {17} {18} {19} {20} {21} {36} {37}}.


Pharmacology/Pharmacokinetics

Note: A wide range of intersubject variability has been observed in the pharmacokinetic parameters of lansoprazole ^{{03} {04} {06} {07} {08} {26}}.


Physicochemical characteristics:

Note: Lansoprazole is chemically ^{{03} {06} {19} {20} {21}} and pharmacologically ^{{04} {19} {21}} related to omeprazole.


Chemical group—
    Substituted benzimidazole ^{{01} {03} {04} {05} {06} {07} {08} {10} {11} {12} {18} {19} {20} {26}}.
Molecular weight—
    369.37 ^{{01} {02} {06} {30}}

pKa—
    8.5 ^{06}

Mechanism of action/Effect:

Lansoprazole is a selective ^{{08} {18} {24}} and irreversible ^{{18} {20}} proton pump inhibitor ^{{01} {05} {06} {07} {08} {09} {10} {11} {12} {13} {16} {20} {21} {22} {23} {24} {25} {26} {30}}. In the acidic environment of the gastric parietal cell ^{{03} {04}}, lansoprazole is converted to active ^{{03} {04} {05} {06}} sulphenamide derivatives ^{{03} {04}} that bind to the sulfhydryl group ^{{03} {04}} of (H ⁺, K ⁺)-adenosine triphosphatase [(H ⁺, K ⁺ )-ATPase] ^{{03} {04} {05}}, also known as the proton pump ^{{01} {08} {24}}. (H ⁺, K ⁺)-ATPase catalyzes ^{{03} {04} {06}} the final step in the gastric acid secretion pathway ^{{03} {04} {05} {06} {19}}. Lansoprazole's inhibition of (H ⁺, K ⁺)-ATPase results in inhibition of both centrally and peripherally mediated gastric acid secretion ^{{03} {04} {18} {24}}. The inhibitory effect is dose-related ^{{01} {03} {04} {06} {12}}. Lansoprazole inhibits both basal and stimulated gastric acid secretion regardless of the stimulus ^{{01} {04} {12} {18}}.

Following oral administration, lansoprazole significantly decreases basal acid output and significantly increases the mean gastric pH and percent of time the gastric pH remains above 3 and 4 ^{01}. It also significantly reduces meal-stimulated gastric acid output ^{01} and secretion volume ^{{01} {03}}, as well as pentagastrin-stimulated acid output ^{01}. In addition, lansoprazole inhibits the normal increases in secretion volume, acidity, and acid output induced by insulin ^{01}.

Lansoprazole does not have anticholinergic or histamine H ₂-receptor antagonist properties ^{01}.


Other actions/effects:

Due to the normal physiologic effects caused by the inhibition of gastric acid secretion, blood flow in the antrum, pylorus, and duodenal bulb is decreased by about 17% ^{01}; however, mucosal blood flow in the fundus of the stomach is not significantly affected by lansoprazole ^{01}. Gastric emptying of digestible solids following intake of lansoprazole is significantly slowed ^{01}. Lansoprazole increases serum pepsinogen levels and decreases pepsin activity ^{{01} {03} {04}} under basal conditions and in response to meal stimulation or insulin injection ^{01}. As with other agents that elevate intragastric pH, lansoprazole may cause an increase in the number of nitrate-reducing bacteria ^{01} and an elevation in the nitrate concentration of gastric secretions in patients with gastric ulcer ^{01}; however, significantly elevated nitrosamine levels have not been reported to date ^{01}, suggesting no risk of carcinogenesis by this mechanism ^{{06} {34}}.

Lansoprazole ^{{04} {05} {13} {22} {23}} and its active metabolites ^{03} have demonstrated antimicrobial activity in vitro against Helicobacter pylori ^{{04} {05} {13} {22} {23}}, a gram-negative bacilli strongly associated with peptic ulcers ^{05}. Lansoprazole may influence the mucosal immune response to H. pylori ^{22}. Mucosal H. pylori –specific IgA response is significantly enhanced after short-term treatment with lansoprazole, strongly suggesting that the secretory immune system is actively involved in host defense against H. pylori , and that the efficacy of such a system at the gastric mucosal level is crucial for complete eradication of H. pylori ^{22}. Although lansoprazole alone has a relatively low clearance effect on H. pylori ^{22}, it may enhance the ability of other agents to eradicate the organism ^{13}; lansoprazole's activity as an antisecretory agent may be the more important factor explaining its effectiveness ^{23}.

Lansoprazole has the ability to inhibit the hepatic cytochrome P450 enzyme system ^{{03} {04}}.

Absorption:

Since lansoprazole is acid-labile ^{{01} {03} {04} {05} {06} {08} {10} {11} {18} {30}}, it is administered as a capsule containing enteric-coated granules ^{32} to prevent gastric decomposition ^{{03} {04} {06} {30}} and to increase bioavailability ^{{03} {04} {30}}. Once lansoprazole has left the stomach, absorption is rapid ^{{01} {12} {30}} and relatively complete ^{01}, with absolute bioavailability over 80% ^{{01} {04} {05} {06} {10} {30}}. Bioavailability may be decreased if lansoprazole is administered within 30 minutes of ^{01} food intake ^{{01} {03} {04} {06}} as compared to that of a fasting state ^{01}. Absorption may be delayed in patients with hepatic cirrhosis ^{{04} {10}}.

Distribution:

Distributed in tissue, particularly gastric parietal cells ^{33}. Apparent oral volume of distribution following administration of 30 mg of lansoprazole is about 0.5 liters per kilogram (L/kg) ^{{06} {10}}.

Protein binding:

Very high (around 97%) ^{{01} {03} {04} {05} {06} {10} {30}}; protein binding remains constant over the concentration range of 0.05 to 5 mcg per mL ^{01}. In patients with renal function impairment, protein binding may be decreased by 1 to 1.5% ^{01}.

Biotransformation:

Lansoprazole is extensively metabolized in the liver ^{{01} {05} {06} {10} {12} {18}} to two main excretory metabolites that are inactive ^{{01} {03} {04}}. In the acidic environment of the gastric parietal cell ^{{03} {04} {18}}, lansoprazole is converted to two active compounds that inhibit acid secretion by (H+, K+)-ATPase ^{{01} {03} {04} {18} {30}} within the parietal cell canaliculus ^{{01} {04}}, but that are not present in the systemic circulation ^{{01} {30}}.

Half-life:


Elimination:

Normal renal function: Approximately 1.5 hours ^{{01} {03} {04} {06} {12} {18}}.

Renal function impairment: Shortened elimination half-life ^{01}.

Elderly patients: 1.9 to 2.9 hours ^{{01} {03} {04} {06} {10} {11} {12} {18}}.

Hepatic function impairment: 3.2 to 7.2 hours ^{{01} {04} {06} {10}}.


Onset of action:

An increase in gastric pH is seen within 2 to 3 hours following a single 15-mg dose, 1 to 2 hours following a single 30-mg dose or a 15-mg multiple-dose regimen, and 1 hour following a 30-mg multiple-dose regimen ^{01}.

Time to peak concentration:

Approximately 1 to 2 hours ^{{01} {03} {04} {05} {06} {07} {18} {30}}. Time to peak concentration (t _max) is shorter when lansoprazole is administered in the morning as opposed to the evening. ^{08}

Peak serum concentration

Mean peak serum concentrations (C _max) ranged from 0.75 to 1.15 milligrams per Liter (mg/L) following administration of a single oral 30-mg dose of lansoprazole to volunteers ^{{04} {06}}. Although there is no correlation with serum concentrations of lansoprazole per se ^{{03} {08}}, inhibition of gastric secretion appears to be dose-proportional ^{{03} {04} {06}}. Serum concentrations after morning dosing may be increased by twofold or more as compared to evening dosing regimens ^{08}. Both C _max and the area under the plasma concentration–time curve (AUC) decrease by about 50% when lansoprazole is administered within 30 minutes of food intake as opposed to fasting conditions ^{{01} {30}}. The concentration of lansoprazole and its active metabolites within the gastric parietal cell is the main determining factor of antisecretory efficacy ^{03}.

Duration of action:

More than 24 hours ^{{01} {03}}. Following discontinuation of lansoprazole, gastric acid levels do not increase to half the basal output until 39 hours have elapsed ^{{19} {21}}. No rebound gastric acidity has been observed following discontinuation of lansoprazole ^{{01} {06} {12}}. In patients with Zollinger-Ellison syndrome, the duration of action of lansoprazole is prolonged ^{17}.

Elimination:
    Renal ^{{01} {03} {04} {05} {06} {10} {18} {26}}—Approximately 14 to 25% of a dose of lansoprazole is excreted in the urine ^{{03} {04} {06}}, as conjugated and unconjugated hydroxylated metabolites ^{{03} {04} {06} {10} {18}}. Less than 1% of unchanged lansoprazole is detectable in the urine ^{11}.
    Biliary/fecal ^{{01} {04} {05} {10} {18}}—Approximately two-thirds of a dose of lansoprazole is detected as metabolites in the feces ^{{01} {18} {30}}.
    In dialysis—Lansoprazole and its metabolites are not significantly dialyzed; no appreciable fraction is removed by hemodialysis ^{{18} {30}}.

Note: Elimination is prolonged in healthy elderly subjects ^{{03} {04} {06} {10}}, in adult and elderly patients with mild renal impairment ^{04}, and in patients with severe liver disease ^{{03} {04} {06} {10}}.



Precautions to Consider

Carcinogenicity

In 2-year studies in rats receiving up to 40 times the recommended human dose, lansoprazole produced dose-related gastric enterochromaffin-like (ECL) cell hyperplasia and ECL cell carcinoids in both male and female rats ^{01}. Lansoprazole also increased the incidence of intestinal metaplasia of the gastric epithelium, and produced dose-related increases in the incidence of testicular interstitial adenomas ^{01}. In a 1-year toxicity study in rats receiving 13 times the recommended human dose, testicular interstitial cell adenoma also occurred in 1 of 30 rats ^{01}. In a 2-year study in mice receiving up to 80 times the recommended human dose, lansoprazole produced an increased incidence of liver tumors (hepatocellular adenomas and carcinomas), a dose-related increase in the incidence of gastric ECL cell hyperplasia, and adenomas of the rete testis in males ^{01}.

Mutagenicity

Lansoprazole was not genotoxic in the Ames test, the ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) test, the in vivo mouse micronucleus test, or the rat bone marrow cell chromosomal aberration test ^{01}. It was positive in in vitro human lymphocyte chromosomal aberration assays ^{01}.

Pregnancy/Reproduction
Fertility—
Reproduction studies in rats and rabbits have shown no evidence of impaired fertility ^{01}.

Pregnancy—
Adequate and well-controlled studies in humans have not been done ^{01}.

Reproductive studies in rats and rabbits at doses 40 times the recommended human dose have not shown that lansoprazole causes adverse effects in the fetus ^{01}.

FDA Pregnancy Category B ^{01}.

Breast-feeding

It is not known whether lansoprazole is distributed into breast milk ^{01}. However, lansoprazole or its metabolites are distributed into the milk of rats ^{01}. Because lansoprazole has been shown to cause tumorigenic effects in animals, a decision should be made as to whether nursing should be discontinued or the medication withdrawn, taking into account the importance of lansoprazole to the mother ^{01}.

Pediatrics

No information is available on the relationship of age to the effects of lansoprazole in pediatric patients up to 18 years of age. Safety and efficacy have not been established ^{01}.


Geriatrics


Studies in elderly patients indicate that the clearance of lansoprazole is decreased in the elderly ^{{01} {03} {04} {06} {10}}, resulting in a 50 to 100% increase in the elimination half-life ^{01}. Because the mean half-life in the elderly remains between 1.9 and 2.9 hours ^{{01} {03} {04} {06} {10} {11} {12} {18} {30}}, repeated once-daily dosing does not result in accumulation of lansoprazole ^{{01} {06} {11} {30}}. However, subsequent doses higher than 30 mg a day should not be administered unless additional gastric acid suppression is necessary ^{01}.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Only specific interactions between lansoprazole and other medications have been identified in this monograph. However, lansoprazole, by increasing gastric pH, has the potential to affect the bioavailability of any medication whose absorption is pH-dependent. ^{33} Also, lansoprazole may prevent the degradation of acid-labile drugs. ^{33}
Possible interactions of lansoprazole with medications known to be metabolized by the hepatic cytochrome P450 enzyme system should be considered ^{03}. To date, however, lansoprazole appears to interact minimally with other agents ^{{03} {04}}, and no clinically relevant interactions have been reported with antipyrine ^{01}; diazepam ^{{01} {04} {06} {15} {25} {26}}; ibuprofen ^{01}, indomethacin ^{01}, or other nonsteroidal anti-inflammatory drugs (NSAIDs) ^{15}; oral contraceptives ^{{04} {06} {25}}; phenytoin ^{{01} {04} {06}}; prednisone or prednisolone ^{{01} {04} {06}}; propranolol ^{{01} {04} {06}}; or warfarin ^{{03} {04} {06} {15} {25}}.
Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Ampicillin esters ^{01} or
Digoxin ^{01} or
Iron salts ^{01} or
Ketoconazole ^{01}    (lansoprazole causes prolonged inhibition of gastric acid secretion, and thereby may interfere with the absorption of these medications and others for which bioavailability is determined by gastric pH ^{01})


Cyanocobalamin ^{{04} {33}}    (lansoprazole appears to produce a dose-dependent decrease in the absorption of cyanocobalamin; this may be due to lansoprazole-induced hypochlorhydria or achlorhydria ^{04})


» Sucralfate ^{{01} {05} {30}}    (lansoprazole absorption is delayed and bioavailability is decreased; lansoprazole should be taken at least 30 minutes prior to sucralfate ^{{01} {30} {37}})


Theophylline ^{{01} {05} {06} {15} {25} {31}}    (minor increases in the clearance of theophylline may occur ^{{01} {05} {06} {15} {25}}, but the interaction is unlikely to be clinically significant ^{31}; however, some patients may require adjustment of theophylline dosage when initiating or stopping lansoprazole therapy to maintain clinically effective concentrations of theophylline ^{{01} {06}})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Although abnormalities in test values reported to date have generally not been of substantial clinical significance ^{{03} {06} {13} {24}}, the following have been selected on the basis of their potential clinical significance.

With physiology/laboratory test values
Alanine aminotransferase (ALT [SGPT]) ^{{01} {03} {04} {13} {16} {20} {30}} and
Alkaline phosphatase ^{{01} {03} {04} {13} {16} {20} {30}} and
Aspartate aminotransferase (AST [SGOT]) ^{{01} {03} {04} {13} {16} {20} {30}} and
Bilirubin ^{01} and
Gamma-glutamyltransferase (GGT) ^{{01} {03} {04} {13} {16} {20} {30}} and
Globulins ^{01} and
Lactate dehydrogenase (LDH) ^{{01} {03} {04} {13} {16} {20}}    (serum values may be increased ^{{01} {03} {04} {13} {16} {20} {30}})


Albumin/globulin (AG) ratio ^{01}    (may be abnormal ^{01})


Cholesterol ^{{01} {03} {13}} and
Electrolytes ^{01}    (serum concentrations may be increased or decreased)


Creatinine, serum ^{{01} {30}} and
Glucocorticoids ^{01} and
Triglycerides, serum ^{01} and
Uric acid ^{04}    (concentrations may be increased ^{01})


Gastrin, serum ^{{01} {04} {06} {08} {09} {19} {20} {21} {24}}    (concentrations may be increased; median fasting gastrin concentrations may increase 50 to 100% from baseline but remain in the normal range following treatment with lansoprazole at doses of 15 to 60 mg; observations in over 2100 patients showed that elevations reached a plateau after 2 months of therapy and returned to baseline after treatment was discontinued ^{01})


Hematocrit ^{04} and
Hemoglobin ^{04}    (levels may be increased)


Platelet count ^{{01} {03}} and
Red blood cell (RBC) count ^{{01} {03} {13}} and
White blood cell (WBC) count ^{{01} {03} {13} {30}}    (may be increased or decreased, and abnormalities may be present ^{01})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Hepatic function impairment ^{01}    (dosage reduction may be required in patients with severe hepatic disease because of the prolonged plasma half-life of lansoprazole ^{01})


Sensitivity to lansoprazole ^{01}


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
    
Diarrhea^{{01}{04}{05}{06}{13}{15}{24}{26}}
    
skin rash or itching^{{01}{04}{06}{13}{24}{39}}

Incidence less frequent
    
Abdominal or stomach pain^{{01}{04}{05}{06}{15}}
    
arthralgia (joint pain)
    
increased or decreased appetite^{{01}{03}{04}{13}}
    
nausea^{{01}{04}{05}{06}{15}{24}}
    
vomiting^{39}

Incidence rare
    
Anxiety^{01}{04}
    
constipation^{{01}{03}{04}{06}{13}{15}}
    
influenza-like syndrome^{01}{04} (flu-like symptoms)
    
increased cough^{01}{04}
    
mental depression^{01}{04}
    
myalgia^{01}{04} (muscle pain)
    
thrombocytopenia^{01}{03}{27} (unusual bleeding or bruising)
    
ulcerative colitis^{01}{04} (diarrhea, abdominal pain, rectal bleeding)
    
upper respiratory tract inflammation or infection^{01}{04} (cold symptoms)



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Dizziness^{{01}{03}{04}{06}{13}{15}}
    
headache^{{01}{04}{06}{08}{15}{24}}





Overdose
For information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Clinical effects of overdose
Experience with lansoprazole overdose is limited. In one case in which a patient consumed 600 mg of lansoprazole, no adverse reaction was noted ^{01}.

Treatment of overdose
There is no specific antidote for lansoprazole. Treatment is essentially symptomatic and supportive ^{30}.

To decrease absorption—Any unabsorbed material should be removed from the gastrointestinal tract. ^{39}

Monitoring—The patient should be carefully monitored. ^{39}

To enhance elimination—Hemodialysis does not remove an appreciable fraction of the total quantity of lansoprazole or its metabolites. ^{{18} {30}}

Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation ^{29}.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Lansoprazole (Systemic) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to lansoprazole





Breast-feeding—Distributed into milk in rat studies; may cause potentially serious adverse effects in nursing infants





Use in children—Safety and efficacy not established in children up to 18 years of age

Other medications, especially sucralfate

Proper use of this medication
» Importance of taking before a meal, preferably in the morning

» Swallowing capsule whole without crushing, breaking, or chewing; however, if patient cannot swallow whole, capsule may be opened and intact granules sprinkled on one tablespoon of applesauce or dispersed in juice and swallowed immediately; granules should not be chewed or crushed

» Compliance with therapy

» Proper dosing
Missed dose: Taking as soon as possible; not taking if almost time for next dose; not doubling doses

» Proper storage

Precautions while using this medication
» Regular visits to physician to check progress


Side/adverse effects
Signs of potential side effects, especially diarrhea, skin rash or itching, abdominal or stomach pain, arthralgia, increased or decreased appetite, nausea, vomiting, anxiety, constipation, influenza-like syndrome, increased cough, mental depression, myalgia, thrombocytopenia, ulcerative colitis, upper respiratory tract inflammation or infection


General Dosing Information
Since lansoprazole is acid-labile ^{{01} {03} {04} {05} {06} {08} {10} {11} {18}}, it is administered as a capsule containing enteric-coated granules ^{{03} {04} {05} {06} {08} {10} {11} {18} {32}} to prevent gastric decomposition ^{{03} {04} {06}} and to increase bioavailability ^{{03} {04}}. Capsules should be swallowed whole, and not chewed or crushed ^{01}. However, if the patient has difficulty swallowing capsules, the capsule may be opened and the intact granules may be sprinkled on one tablespoon of applesauce or dispersed in juice and swallowed immediately; granules should not be chewed or crushed ^{32}. For patients who have a nasogastric tube in place, lansoprazole capsules may be opened and the intact granules mixed in 40 milliliters (mL) of apple juice and administered through the tube into the stomach ^{36}. After administration, the tube should be flushed with additional apple juice to clear the tube ^{36}.

Symptomatic response to therapy does not preclude the presence of gastric malignancy ^{01}.

In patients with hypersecretory conditions such as Zollinger-Ellison syndrome, dosing should be adjusted according to individual needs and should continue for as long as clinically indicated ^{{01} {36} {37}}. In general, treatment goals are to maintain basal acid output below 10 mEq per hour (<10 mmol/hr) ^{{01} {03} {04} {17} {19} {20} {21}}. Doses up to 90 mg two times a day have been administered, in some cases for as long as four years ^{01}.

Lansoprazole may be taken with antacids ^{{36} {37}}.

Diet/Nutrition
Lansoprazole capsules should be taken before breakfast ^{37} if dosing is once a day, and before meals ^{{38} {39}} if dosing is two or three times a day.


Oral Dosage Forms

LANSOPRAZOLE DELAYED-RELEASE CAPSULES

Usual adult dose
Gastroesophageal reflux disease
Oral, 15 mg once a day ^{36} for the relief of heartburn and regurgitation. For the treatment of erosive esophagitis, 30 mg once a day for eight weeks is recommended ^{{36} {37}}. An additional eight-week course may be helpful for patients who do not heal in the first eight weeks ^{{01} {36}}. For recurrence of erosive esophagitis, a third eight-week course of treatment may be considered ^{{01} {36}}. In patients requiring maintenance therapy, a dose of 15 mg once a day is recommended ^{{36} {37}}.

Ulcer, gastric
Oral, 15 ^{{30} {33} {37}} to 30 mg once a day ^{{33} {36}}, preferably in the morning ^{33} before breakfast, for up to eight weeks ^{{36} {30} {37}}.

Ulcer, duodenal
Oral, 15 ^{{01} {04} {05} {30} {33} {36} {37}} to 30 ^{{03} {04} {05} {06} {07} {14} {16} {33}} mg once a day, preferably in the morning ^{{04} {08} {33}} before a meal ^{{01} {33}}, for up to four weeks ^{{01} {03} {04} {14} {37}}. In patients requiring maintenance therapy, doses of 15 mg once a day have been used ^{{36} {37}}.

Ulcer, duodenal, associated with H. pylori infection
Oral, triple therapy regimens of lansoprazole 30 mg, plus amoxicillin 1 gram, plus clarithromycin 500 mg, in which all three medications are taken before meals twice a day for ten ^{38} to fourteen days ^{{36} {37} {38} {39}}. For dual therapy regimens, lansoprazole 30 mg plus amoxicillin 1 gram, with both medications taken before meals three times a day for fourteen days ^{{36} {37} {38} {39}}.

Note: For the eradication of H. pylori , amoxicillin and clarithromycin should not be administered to patients with renal impairment since the appropriate dosage in this patient population has not yet been established ^{37}.


Hypersecretory conditions, gastric, including Zollinger-Ellison syndrome
Oral, initially 60 mg once a day ^{{01} {04} {05} {19} {21} {36} {37}}, preferably in the morning ^{{04} {08} {33}} before a meal, the dosage being increased as needed ^{{01} {03} {04} {19} {21} {36} {37}}, and therapy continued for as long as clinically indicated ^{{36} {37}}. Some patients have received doses as high as 90 mg two times a day for as long as four years. ^{{01} {36} {37}} Daily dosages greater than 120 mg should be administered in divided doses ^{{01} {36} {37}}.


Note: Dosage reduction should be considered in patients with severe hepatic function impairment ^{01}; the dose generally should not exceed 30 mg a day in these patients ^{{06} {30} {37}}.


Usual adult prescribing limits
For duodenal and gastric ulcers
30 mg a day. ^{33}

For hypersecretory conditions
180 mg a day. ^{{01} {33}}


Usual pediatric dose
Safety and efficacy in children up to 18 years of age have not been established. ^{{01} {03} {04} {36} {37}}

Usual geriatric dose
See Usual adult dose. ^{01}

Usual geriatric prescribing limits
30 mg a day. ^{{03} {04} {30} {33} {37}}

Strength(s) usually available
U.S.—


15 mg (Rx) [Prevacid]


30 mg (Rx) [Prevacid]

Canada—


15 mg (Rx) [Prevacid]


30 mg (Rx) [Prevacid]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. ^{01}

Preparation of dosage form:
For patients who cannot take oral solids

The capsule may be opened and the intact granules may be sprinkled on one tablespoon of applesauce and swallowed immediately. ^{38} Alternatively, the intact granules may be dispersed in juice and swallowed immediately. Lansoprazole granules have been shown to remain intact in vitro in apple, cranberry, grape, orange, pineapple, prune, tomato, or V-8 vegetable juice for up to thirty minutes. ^{38} For administration via a nasogastric tube: the capsule may be opened and the intact granules mixed in 40 milliliters (mL) of apple juice and administered through the tube. ^{36} After administration, the tube should be flushed with additional apple juice to clear the tube. ^{36}

Auxiliary labeling:
   • Take before meals.

Revised: 06/11/1999

References

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4. Spencer CM, Faulds D. Lansoprazole. A reappraisal of its pharmacodynamic and pharmacokinetic properties, and its therapeutic efficacy in acid-related disorders. Drugs 1994; 48(3): 404-30.
   

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