Lansoprazole

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t_1/2 = 3 - 10 hours (slow metabolizers)

LansoprazoleQuick Reference

IUPAC Name
2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole
Chemical Information
Empirical Formula	C16H14F3N3O2S
Molecular Weight	369.37
General Drug Information
Classification	Proton Pump Inhibitor (PPI)
Schedule	Legend
How Supplied	Delayed release oral capsules (15mg 30mg) Delayed release orally disintegrating tablets (15mg 30mg) Lansoprazole for delayed release oral suspension (15mg 30mg)
Trade Names	Prevacid
Pregnancy Category	"B"
Breast Feeding	Lansoprazole has been identified in animal breast milk. No human studies to date. Caution is advised.
Generic Availability	Generic not available
Patent Expiration Date	May 10, 2009
Administration Information
Routes	Oral
Methods	Method 1: Swallow capsule whole with a full (8 oz.) glass of water. See "administration" for alternatives methods of administration of capsules, solutabs, and oral suspension.	Pharmacokinetic Information
Absorption	F = >80%
	Cmax Proportional to administered dose
	tmax = 1.7 hours
Distribution	Vd = 0.6-0.9 L/Kg
	Protein binding ~97%
Metabolism	Extensively hepatically metabolized
Excretion	t1/2 < 2 hours
	33% urine 18% feces

Contents 1 Brand/Trade Names of Drug 2 Generic Name of Drug 3 Description 4 Mechanism of action 5 Time Required for Therapeutic Response 6 Pharmacokinetics 6.1 Absorption 6.2 Distribution 6.3 Metabolism 6.4 Excretion 7 Special Population Pharmacokinetics 8 Indications 8.1 FDA Approved Indications 8.2 Non-FDA Approved Indications 9 Dosage 10 Administration 11 Contraindications/Precautions 11.1 Contraindications 11.2 Precautions 11.3 Pregnancy indications 11.4 Breast-feeding indications 12 Drug-Drug Interactions 13 Drug-Food-Herb Interactions 14 Adverse Reactions/Side Effects 15 Overdosage Measures 16 Product Information and Distribution 17 Pharmacogenomic information 18 Patient Information 19 References 20 PUBMED References 20.1 Efficacy Trial Articles 20.2 Therapeutic Class Comparison Trial Articles 20.3 Pharmacokinetics Articles 20.4 Drug Interaction Articles 21 External Links

Brand/Trade Names of Drug

Prevacid,PREVPAC, and NapraPAC

Generic Name of Drug

Lansoprazole (lan SOP ra zole) Click Here

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Description

Lansoprazole belongs to a class of medications known as Proton Pump Inhibitors, abbreviated PPI's. Lansoprazole is indicated for the short term treatment of erosive esophagitis associated with gastroesophageal refux disease (GERD), maintenance of healing of erosive esophagitis, and hypersecratory conditions such as Zollinger-Ellison syndrome.^[1] Studies have shown lansoprazole to be effective in the management of duodenal ulcer or gastric ulcers, including those caused by H. pylori.^[2] Since lansoprazole does not significantly effect hepatic enzymes, it has a relatively low risk for drug-drug interactions compared to other PPI's. Lansoprazole is available in an orally disintegrating tablet, and a powder for delayed-release oral suspension. Lansoprazole is indicated for the treatment of pediatric patients >=1 year old.^[1]

Several studies have shown that a decrease in the amount of gastric acid production was beneficial for patients with erosive esophagitis, symptomatic GERD, NSAID-Associated Gastric Ulcers, H. pylori, and hypersecretory disorders such as Zollinger-Ellison Syndrome.^[1] For other indications, such as patients with H. pylori infections, PUD, or ulcers associated with NSAID usage, PPI’s have been shown to be efficacious in symptomatic relief and the healing of gastric damage.^[3][4]

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Mechanism of action

Lansoprazole as with other PPI's suppresses the final step in gastric acid production by covalently bonding to the (H⁺,K⁺)-ATPase enzyme system (proton or H⁺ pump) on the gastric parietal cells, resulting in inhibition of both basal and stimulated gastric acid secretion. PPIs are all lipophilic weak bases and work by accumulating in the secretory canaliculus of the acid-secreting parietal cell where they are protonated to the active form, a cationic sulfonamide. This active form then binds to a sulfhydryl group on the proton pump and prevents secretion of acid into the gastric lumen.^[5] The formed covalent bond is irreversible and, and inhibits acid secretion for the life of the bonded parietal cell (~18-24 hours).^[5] Since inhibition lasts 24 hours or more (at all doses above 20mg/day), lansoprazole (as with other PPI's) is dosed once daily.^[1]

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Time Required for Therapeutic Response

• Initial: ~1 day^[6]
• Maximum: ~7 days^[6]

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Pharmacokinetics

Absorption

Lansoprazole delayed release tablets include an enteric coating to prevent absorption of lansoprazole until the tablet has passed the stomach. Once past the stomach absorption of lansoprazole is rapid (T_max = 2.5 hours) and extensive, with little first pass metabolism (F = ~77%).^[1] While food may delay absorption by up to 2 hours, it does not alter the extent of absorption, the C_max (2.5 mcg/mL), or the AUC, therefore lansoprazole may be administered without regard to meals.

Lansoprazole for IV administration has a bioavailability (F) of 100%, and a slightly higher C_max of 5.52 mcg/mL.^[1]

Distribution

The apparent volume of distribution of both IV and oral lansoprazole is approximately 11.0-23.6 L, indicating that distribution is mainly into the extracellular fluid. Serum protein binding is approximately 98%, primarily to albumin.^[1][7]

Metabolism

Lansoprazole is almost exclusively hepatically metabolized via the cytochrome P450 system. The primary pathway for metabolism is demethylation via CYP2C19 (major) with subsequent sulfation. There are many alternative pathways including oxidation via CYP3A4 (minor).^[1][7] The metabolite byproducts of lansoprazole breakdown are all inactive.

Excretion

The inactive metabolites of lansoprazole are renally (~33%)and fecally excreted (~66%). It is thought that the majority of the metabolites are undergo biliary excretion, resulting in the high percentage of fecal elimination. No unchanged lansoprazole is excreted in the urine. The elimination half life (t_1/2) for the oral formulations of lansoprazole is less than 2 hours. Elimination is complete with no accumulation of drug, even in special pharmacokinetic populations.^[1]

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Special Population Pharmacokinetics

• Renal insufficiency

Patients with renal impairment (including those requiring hemodialysis), have demonstrated in pharmacokinetic studies to have pharmacokinetic parameters similar to those of healthy volunteers. The manufacturer therefore claims that no dosage adjustment is necessary in patients with renal impairment or in patients undergoing hemodialysis.^[1]

• Hepatic insufficiency

Although lansoprazole is extensively hepatically metabolized, hepatic impairment appears to have little impact on the dosing of lansoprazole. Pharmacokinetic studies have shown that although elimination half life increases to 7-9 hours, and AUC increased 5-7 fold, there was minimal evidence of drug accumulation when lansoprazole 40mg was administered once daily. The manufacturer therefore claims taht no dosage adjustment is necessary in patients with mild to severe hepatic impairment.^[1]

• Hemodialysis

According to the manufacturer no dosage adjustment is necessary.^[1]

• Geriatric

After repeated IV dosing, pharmacokinetic parameters in patients aged 65-76 years were similar to those of younger study subjects.^[1]

• Pediatric

There is limited experience with lansoprazole in patients under the age of 9, however 2 small studies have demonstrated that for children 6-13 years of age, lansoprazole 20mg was effective, safe, and well tolerated. The limited data available for the pediatric population suggests that there are no significant differences in pharmacokinetic parameters. The manufacturer does not recommend the administration of lansoprazole to any patient under the age of 9 due to lack of clinical data.^[1][8][9]

• Gender

After oral administration there is a slight increase in lansoprazole AUC and C_max in women compared to men. However, weight-normalized clearance values are similar in women and men. No dosage adjustment is warranted based on gender. ^[1]

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Indications

FDA Approved Indications

• Treatment of Gastroesophegeal Reflux Disease (GERD) with or without erosive esophagitis
• Maintenance of healing of erosive esophagitis
• Zollinger-Ellison Syndrome

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Non-FDA Approved Indications

• Prevention of Stress Related Mucosal Damage (SRMD) during inpatient procedures
• Duodenal Ulcer
• NSAID associated ulcer prophylaxis
• Treatment of Heliocobacter pylori H. pylori Ulcer as part of a triple drug therapy (ex. PPI, amoxicillin, and clarithromycin)

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Dosage

• • The recommended adult oral dose is 30 mg given three times daily as part of a dual therapy, or twice daily as part of a triple therapy.^[1]

• GERD (with or without erosive esophagitis) and short term treatment of duodenal ulcer
  • The recommended adult oral dose is 30 mg given once daily for up to 4 weeks. For those patients who have not healed after 4 weeks of treatment, an additional 4-8 week course of lansoprazole may be considered.^[1]
  • Children 1—11 years: 15—30 mg PO once daily in the morning at least 30 minutes before a meal for up to 12 weeks (15 mg/day for weight <= 30 kg; 30 mg/day for weight > 30 kg); the dosage was increased (up to 30 mg PO twice daily) in some children who were symptomatic after 2 weeks in trials.^[1]

• Maintenance of Healing of Erosive Esophagitis
  • 40mg of lansoprazole taken once daily.^[1]

• Hypersecretory conditions such as Zollinger-Ellison syndrome
  • The recommended adult starting dose is 40 mg twice daily. Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated (beyond 2 years in certain case). Doses up to 240 mg daily have been administered.^[1]

IV

• Treatment of Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis
  • The recommended adult dose is 40 mg lansoprazole given once daily by intravenous infusion for 7 to 10 days.^[7] IV treatment should be discontinued as soon as the patient can tolerate oral lansoprazole therapy. Treatment safety and efficacy of IV administration beyond 10 days has not been evaluated.

• Maxium Dosage Limits^[1][2][7]
  • Adults (PO/IV) 40mg/day
  • Adults (Zollinger-Ellison Syndrome) 240mg/day
  • Elderly (PO/IV) 40mg/day
  • Elderly (Zollinger-Ellison Syndrome) 240mg/day
  • Adolescents > 17 years (PO) 40mg/day
  • Children and Adolescents 9-17 years (PO) 40mg/day
  • Children under 9 Safety and efficacy data is insufficient to establish guidelines

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Administration

• Delayed-Release Tablet^[1]
  • Route: Oral
    • Method: Swallow tablet whole with a full (8 ounce) glass of water. Tablet should be taken once daily with or without food in the stomach. It is theoretically best if daily dose is taken one-half to one hour prior to a meal. Medication should be taken at approximately the same time each day.

• Freeze-Dried Powder for Intravenous Injection^[7]
  • Route: Intravenous
    • Method:Reconstitute each 40 mg vial with 10 ml 0.9% sodium chloride injection, each vial will have a final concentration of 4 mg/ml.
      • Two minute infusion: According to the manufacturer, the 4 mg/ml dilution may be stored for up to 2 hours at room temperature prior to administration. However, one study concluded that this dilution is stable for at least 96 hours at room temperature. The preparation should be stored at 3—5 degrees F or 23—25 degrees C if it is to be stored beyond 48 hours.^[10] Infuse required diluted IV dose slowly over 2 minutes.
      • Fifteen minute infusion: The reconstituted vial should be further admixed with 100 ml (for one vial) or 80 ml (for 2 vials) of 5% dextrose injection, 0.9% sodium chloride injection, or Lactated Ringer’s injection to a final concentration of 0.4 mg/ml or 0.8 mg/ml, respectively. The final product may be stored for up to 22 hours at room temperature prior to administration (according to the manufacturer) but one study suggests stability up to 96 hours if the product is kept at room temperature. Due to the possibility of discoloration when stored passed 48 hours, this dilution should be kept at 3—5 degrees F or 23—25 degrees C if not used within 48 hours.^[10] Infuse diluted IV dose over at least 15 minutes at a rate of 7 ml/min.
    • Special Concideration: Lansoprazole for Injection may be administered intravenously through a dedicated line or through a Y-site. The intravenous line should be flushed before and after administration of lansoprazole for injection with either 5% dextrose injection, 0.9% sodium chloride injection, or Lactated Ringer’s injection.

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Contraindications/Precautions

Contraindications

• Benzimidazole hypersensitivity^[1]

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Precautions

• Gastric malignancy
• Pregnancy
• Breast feeding

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Pregnancy indications

• Pregnancy Category: B
  • To date, there have been teratology studies done in rats without any shown harm to the fetus. No studies have been performed in pregnant females. There are sporadic case reports of congenital abnormalities in infants born to mothers receiving lansoprazole therapy (relation to therapy unproven). Lansoprazole therapy should only be continued during pregnancy if the benefit to the mother outweighs the possible risk to the fetus^[1]

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Breast-feeding indications

• Concentrations of lansoprazole and its inactive metabolites have been identified in breast milk. The clinical relevance remains unstudied, however discontinuation of patoprazole in nursing mothers is advised if the benefit of treatment does not outweigh the risk to the infant.

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Drug-Drug Interactions

Lansoprazole Drug/Drug Interaction Chart

Severity Level	Increased Effect/Toxicity	Decreased Effect
4	None identified	atazanavir[11] nelfinavir[12]
3	None identified	ampicillin[2] delavirdine[13] iron salts[1] itraconazole[1] ketoconazole[1] H2 Blockers[14]
2	alendronate[15] warfarin[16] carbamazepine[17] fluvastatin[18] mefloquine[19]	gefitinib[20]
1	dexmethylphenidate[21] digoxin[1] methylphenidate [21]	theophylline [1].

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Drug-Food-Herb Interactions

Lansoprazole Drug/Food/Herb Interaction Chart

Severity Level	Increased Effect/Toxicity	Decreased Effect
4	None identified	None identified
3	None identified	None identified
2	None identified	None identified
1	None identified	None identified

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Adverse Reactions/Side Effects

Lansoprazole is generally well tolerated in both IV and oral dosage forms. Lansoprazole has a relatively low incidence of side effects and a very low rate of discontinuation (<1%).

Lansoprazole Adverse Reactions Chart

Incidence	Body System	Adverse Reactions
> 10 %	All	None identified
1-10%	CNS	Headache
	CV	None identified
	Dermatologic	None identified
	GI	Abdominal pain, Nausea, Diarrhea, Constipation,
	GU	None identified
	Neuromuscular & skeletal	None identified
	Respiratory	None identified
	Misc	None identified
< 1%	All	abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic pain, angina, arrhythmia, bradycardia, cerebrovascular accident/cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation, abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, oral moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis, diabetes mellitus, goiter, hypothyroidism, anemia, hemolysis, lymphadenopathy, gout, dehydration, hyperglycemia/hypoglycemia, peripheral edema, weight gain/loss, arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, synovitis, abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, vertigo, asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridor, acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, urticaria, abnormal vision, blurred vision, conjunctivitis, deafness, dry eyes, ear disorder, eye pain, otitis media, parosmia, photophobia, retinal degeneration, taste loss, taste perversion, tinnitus, visual field defect, abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary tract infection, urinary urgency, urination impaired, vaginitis

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Overdosage Measures

Lansoprazole is not removed by hemodialysis. In one reported overdose, a patient consumed 600 mg of lansoprazole with no adverse reaction.^[1]

Single intravenous doses of lansoprazole at 378, 230, and 266 mg/kg (38, 46, and 177 times the recommended human dose based on body surface area) were lethal to mice, rats and dogs, respectively. The symptoms of toxicity included hypoactivity, ataxia, hunched sitting, limb-splay, lateral position, segregation, absence of ear reflex, and tremor. There is limited experience regarding cases of human overdosage, and treatment should be symptomatic and supportive.^[1]

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Product Information and Distribution

Lansoprazole Product Availability Information

Name	Manufacturer	Dosage Form	Strength	Quantity	NDC	Storage
Prevacid[1]	TAP Pharmaceuticals	Oral Delayed Release Capsules	15 mg	30	00300-1541-30	25°C (77°F)
				unit dose packages of 100	00300-1541-11
				1000	00300-1541-19
			Delayed Release Powder for Oral Suspension	15 mg	unit dose carton of 30		00300-7309-30
				30 mg	unit dose carton of 30		00300-7311-30
			SoluTabs (Orally Disintegrating Tablets)	15 mg	unit dose packages of 30		00300-1543-30
		30 mg		unit dose packages of 30	00300-1544-30

Lansoprazole Combination Product Availability Information

Name'	Manufacturer	Dosage Form	Strength	Quantity	NDC	Storage
Prevacid[1]	TAP Pharmaceuticals	Prevacid PREVPAC	lansoprazole 30mg caps, amoxicillin 500mg caps, and clarithromycin 500mg tabs	Daily administration pack	00300-3702-01	20°C - 25°C (68°F - 77°F
				Daily administration card	00300-3702-11
		Prevacid NapraPAC	lansoprazole 15 mg caps and naproxen 500 mg tabs	Weekly Blister Card	00300-1546-07
				One Month Administration Pack	00300-1546-30

• Manufacturers/Distributors
  • TAP Pharmaceuticals, Lake Forest, IL 60045

• Inactive ingredient
  • hydroxypropyl cellulose
  • colloidal silicon dioxide
  • magnesium carbonate
  • methacrylic acid copolymer
  • starch
  • polysorbate 80
  • sugar sphere
  • sucrose
  • polyethylene glycol
  • sodium lauryl sulfate
  • titanium dioxide
  • talc

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Pharmacogenomic information

Lansoprazole Pharmacogenomic Information

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Patient Information

• Should not be taken within 30 minutes after meals.
• Swallow capsules whole with a 8 ounces of water at the same time each day.

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References

1. ↑ ^{1.00 1.01 1.02 1.03 1.04 1.05 1.06 1.07 1.08 1.09 1.10 1.11 1.12 1.13 1.14 1.15 1.16 1.17 1.18 1.19 1.20 1.21 1.22 1.23 1.24 1.25 1.26 1.27 1.28 1.29 1.30 1.31 1.32} Prevacid (lansoprazole) delayed release tablets package insert Philadelphia, PA 19101; Wyeth Pharmaceuticals; 2005 December.
2. ↑ ^{2.0 2.1 2.2} Lexi-Comp (2003). Drug Information Handbook. 11th Edition., APhA
3. ↑ Integrative Inflammation Pharmacology: Peptic Ulcer Disease. Eds: Golan DE., et al. Principles of Pharmacology: The Pathophysiologic Basis of Drug Therapy. pgs: 389-69. Baltimore, Lippincott Williams & Wilkins.
4. ↑ Yeomans, Neville D.; Tulassay, Zsolt; Juhasz, Laszlo; Racz, Istvan; Howard, John M.; van Rensburg, Christoffel J.; Swannell, Anthony J.; Hawkey, Christopher J. A Comparison of Omeprazole with Ranitidine for Ulcers Associated with Nonsteroidal Antiinflammatory Drugs.N Engl J Med 1998;338:719-726.
5. ↑ ^5.0 5.1 Der G. An overview of proton pump inhibitors. Gastroenterology Nursing. 26(5):182-90, 2003 Sep-Oct.
6. ↑ ^6.0 6.1 Simon,B; Müller, P; Pascu, O. Intra-oesophageal pH profiles and pharmacokinetics of pantoprazole and esomeprazole: a crossover study in patients with gastro-oesophageal reflux disease. European Journal of Gastroenterology & Hepatology. Volume 15(7), July 2003, pp 791-799.
7. ↑ ^{7.0 7.1 7.2 7.3 7.4} Protonix (lansoprazole sodium) for injection package insert Philadelphia, PA 19101; Wyeth Pharmaceuticals; 2005 December.
8. ↑ Kearns GL. Winter HS. Proton pump inhibitors in pediatrics: relevant pharmacokinetics and pharmacodynamics. Journal of Pediatric Gastroenterology & Nutrition. 37 Suppl 1:S52-9, 2003 Nov-Dec.
9. ↑ Madrazo-de la Garza A. Dibildox M. Vargas A. Delgado J. Gonzalez J. Yanez P. Efficacy and safety of oral pantoprazole 20 mg given once daily for reflux esophagitis in children. Journal of Pediatric Gastroenterology & Nutrition. 36(2):261-5, 2003 Feb.
10. ↑ ^10.0 10.1 Johnson CE. Stability of lansoprazole in 0.9% sodium chloride injection in polypropylene syringes. Am J Health-Syst Pharm 2005;62:2410—2
11. ↑ Reyataz (atazanavir) package insert. Princeton, NJ: Bristol-Myers Squibb Company; 2007 Mar.
12. ↑ Viracept® (nelfinavir mesylate) package insert. La Jolla, CA: Agouron Pharmaceuticals, Inc.; 2006 Nov.
13. ↑ Rescriptor (delavirdine) package insert. La Jolla, CA: Agouron Pharmaceuticals; 2006 Feb.
14. ↑ Soll AH, for the Practice Parameters Committee of the American College of Gastroenterology. Medical Treatment of Peptic Ulcer Disease: Practice Guidelines. JAMA 1996;275:622—9.
15. ↑ Fosamax® (alendronate sodium) package insert. Whitehouse Station, NJ; Merck & Co.Inc; 2006 Nov.
16. ↑ Steinijans VW, Huber R, Hartmann M, et al. Lack of pantoprazole drug interactions in man: an updated review. Int J Clin Pharmacol Ther 1996;34(S1):S31—50.
17. ↑ Dixit RK, Chawla AB, Kumar N, et al. Effect of omeprazole on the pharmacokinetics of sustained-release carbamazepine in healthy male volunteers. Methods Find Exp Clin Pharmacol 2001;23:37—9.
18. ↑ Lescol® (fluvastatin) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2005 Jan.
19. ↑ Kolawole JA, Mustapha A, Abudu-Auguve I, et al. Mefloquine pharmacokinetics in healthy subjects and in peptic ulcer patients after cimetidine administration. Eur J Drug Metab Pharmacokinet 2000;25(3):165—70.
20. ↑ Iressa® (gefitinib) package insert. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2003 May.
21. ↑ ^21.0 21.1 Focalin™ XR(dexmethylphenidate extended-release) package insert. East Hanover, NJ: Novartis Pharmaceutical Corp.; 2006 August.

PUBMED References

Efficacy Trial Articles

1. Tsou VM. Baker R. Book L. Hammo AH. Soffer EF. Wang W. Comer GM. 326 Study Group. Multicenter, randomized, double-blind study comparing 20 and 40 mg of pantoprazole for symptom relief in adolescents (12 to 16 years of age) with gastroesophageal reflux disease (GERD). Clinical Pediatrics. 45(8):741-9, 2006 Oct.
2. Der G. An overview of proton pump inhibitors. Gastroenterology Nursing. 26(5):182-90, 2003 Sep-Oct.
3. Simon,B; Müller, P; Pascu, O. Intra-oesophageal pH profiles and pharmacokinetics of pantoprazole and esomeprazole: a crossover study in patients with gastro-oesophageal reflux disease. European Journal of Gastroenterology & Hepatology. Volume 15(7), July 2003, pp 791-799.
4. Kearns GL. Winter HS. Proton pump inhibitors in pediatrics: relevant pharmacokinetics and pharmacodynamics. Journal of Pediatric Gastroenterology & Nutrition. 37 Suppl 1:S52-9, 2003 Nov-Dec.
5. Madrazo-de la Garza A. Dibildox M. Vargas A. Delgado J. Gonzalez J. Yanez P. Efficacy and safety of oral pantoprazole 20 mg given once daily for reflux esophagitis in children. Journal of Pediatric Gastroenterology & Nutrition. 36(2):261-5, 2003 Feb.
6. Der G. An overview of proton pump inhibitors. Gastroenterology Nursing. 26(5):182-90, 2003 Sep-Oct.

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Therapeutic Class Comparison Trial Articles

1. Florent C. Forestier S. Twenty-four-hour monitoring of intragastric acidity: comparison between lansoprazole 30mg and pantoprazole 40mg. European Journal of Gastroenterology & Hepatology. 9(2):195-200, 1997 Feb.
2. Hartmann D. Eickhoff A. Damian U. Riemann JF. Schilling D. Effect of intravenous application of esomeprazole 40 mg versus pantoprazole 40 mg on 24-hour intragastric pH in healthy adults. European Journal of Gastroenterology & Hepatology. 19(2):133-7, 2007 Feb.

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Pharmacokinetics Articles

1. Blume H. Donath F. Warnke A. Schug BS. Pharmacokinetic drug interaction profiles of proton pump inhibitors. Drug Safety. 29(9):769-84, 2006.
2. Steinijans VW, Huber R, Hartmann M, et al. Lack of pantoprazole drug interactions in man: an updated review. Int J Clin Pharmacol Ther 1996;34(S1):S31—50.
3. Kolawole JA, Mustapha A, Abudu-Auguve I, et al. Mefloquine pharmacokinetics in healthy subjects and in peptic ulcer patients after cimetidine administration. Eur J Drug Metab Pharmacokinet 2000;25(3):165—70.

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Drug Interaction Articles

1. Steinijans VW, Huber R, Hartmann M, et al. Lack of pantoprazole drug interactions in man: an updated review. Int J Clin Pharmacol Ther 1996;34(S1):S31—50
2. Troger U, Martens-Lobenhoffer J, Gollnick H, et al. Severe myalgia from an interaction between treatments with pantoprazole and methotrexate. BMJ 2002;324:1497.
3. Marcuard SP, Albernaz L, Khazanie PG. Omeprazole therapy causes malabsorption of cyanocobalamin vitamin B12). Ann Intern Med 1994;120:211—5.

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External Links

• Manufacturers/Distributors

Wyeth Pharmaceuticals; Wyeth

• Clinical treatment guidelines

GERD: VHA/DoD treatment guidelines

• Patient information pages

Wyeth Protonix Page; Protonix Patient Page

• Healthcare professional information pages

Protonix healthcare professional information; Protonix Package Insert

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