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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Pronunciation
(met oh KLOE pra mide)
Generic Available (U.S.)
Yes: Excludes oral-disintegrating tablet
Medication Guide
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Metozolv™ ODT: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022246s000lbl.pdf
Reglan® injection: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM176362.pdf
Reglan® tablet: http://www.alavenpharm.com/downloads/ReglanTablets_MedicationGuide.pdf
REMS Components
Oral solution, tablets: Medication Guide
U.S. Brand Names
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Oral: Symptomatic treatment of diabetic gastroparesis; gastroesophageal reflux
I.V., I.M.: Symptomatic treatment of diabetic gastroparesis; postpyloric placement of enteral feeding tubes; prevention and/or treatment of nausea and vomiting associated with chemotherapy, or postsurgery; to stimulate gastric emptying and intestinal transit of barium during radiological examination of the stomach/small intestine
Use: Dental
Increases gastric emptying; promotes emptying of the stomach following procedures in which swallowing blood may cause GI upset
Pregnancy Risk Factor
B
Pregnancy Considerations
Teratogenic effects were not observed in animal studies; however, there are no adequate and well-controlled studies in pregnant women. Crosses the placenta; available evidence suggests safe use during pregnancy.
Lactation
Enters breast milk/use caution
Breast-Feeding Considerations
Enters breast milk; may increase milk production
Contraindications
Hypersensitivity to metoclopramide or any component of the formulation; GI obstruction, perforation or hemorrhage; pheochromocytoma; history of seizures or concomitant use of other agents likely to increase extrapyramidal reactions
Warnings/Precautions
Boxed warnings:
• Tardive dyskinesia: See “Concerns related to adverse effects” below.
Concerns related to adverse effects:
• Depression: Mental depression has occurred, symptoms range from mild to severe (suicidal ideation and suicide); use with caution in patients with a history of mental illness.
• Extrapyramidal symptoms (EPS): May cause extrapyramidal symptoms, generally manifested as acute dystonic reactions within the initial 24-48 hours of use. Risk of these reactions is increased at higher doses, and in pediatric patients and adults <30 years of age. Pseudoparkinsonism (eg, bradykinesia, tremor, rigidity) may also occur (usually within first 6 months of therapy) and is generally reversible following discontinuation.
• Neuroleptic malignant syndrome (NMS): Use may be associated (rarely) with neuroleptic malignant syndrome (NMS); monitor for mental status changes, fever, muscle rigidity and/or autonomic instability; discontinue use if signs/symptoms appear.
• Tardive dyskinesia: [U.S. Boxed Warning]: May cause tardive dyskinesia, which is often irreversible; duration of treatment and total cumulative dose are associated with an increased risk. Therapy durations >12 weeks should be avoided (except in rare cases following risk:benefit assessment). Risk appears to be increased in the elderly, women, and diabetics; however, it is not possible to predict which patients will develop tardive dyskinesia. Therapy should be discontinued in any patient if signs/symptoms appear.
Disease-related concerns:
• Edematous conditions: Use with caution in patients who are at risk of fluid overload (HF, cirrhosis). May cause transient increase in serum aldosterone; use lowest recommended doses initially and discontinue use if signs/symptoms appear.
• Hypertension: Use with caution in patients with hypertension.
• NADH-cytochrome b5 reductase deficiency: Patients with NADH-cytochrome b5 reductase deficiency are at increased risk of methemoglobinemia and/or sulfhemoglobinemia.
• Parkinson's disease: Use with caution or avoid in patients with parkinson's disease; may have increased risk of EPS.
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment may be needed.
• Surgical anastomosis/closure: Use with caution following surgical anastomosis/closure; promotility agents may theoretically increase pressure in suture lines.
Special populations:
• Elderly: Use with caution in the elderly; may have increased risk of tardive dyskinesia, particularly older women.
• Pediatrics: EPS are increased in pediatric patients. In neonates, prolonged clearance of metoclopramide may lead to increased serum concentrations. Neonates may also have decreased levels of NADH-cytochrome b5 reductase which increases the risk of methemoglobinemia.
Other warnings/precautions:
• Discontinuation of therapy: Abrupt discontinuation may (rarely) result in withdrawal symptoms (dizziness, headache, nervousness).
Adverse Reactions
Frequency not always defined.
Cardiovascular: AV block, bradycardia, HF, fluid retention, flushing (following high I.V. doses), hyper-/hypotension, supraventricular tachycardia
Central nervous system: Drowsiness (~10% to 70%; dose related), acute dystonic reactions (<1% to 25%; dose and age related), fatigue (2% to 10%), lassitude (~10%), restlessness (~10%), headache (4% to 5%), dizziness (1% to 4%), somnolence (2% to 3%), akathisia, confusion, depression, hallucinations (rare), insomnia, neuroleptic malignant syndrome (rare), Parkinsonian-like symptoms, suicidal ideation, seizure, tardive dyskinesia
Dermatologic: Angioneurotic edema (rare), rash, urticaria
Endocrine & metabolic: Amenorrhea, galactorrhea, gynecomastia, hyperprolactinemia, impotence
Gastrointestinal: Nausea (4% to 6%), vomiting (1% to 2%), diarrhea
Genitourinary: Incontinence, urinary frequency
Hematologic: Agranulocytosis, leukopenia, neutropenia, porphyria
Hepatic: Hepatotoxicity (rare)
Ocular: Visual disturbance
Respiratory: Bronchospasm, laryngeal edema (rare), laryngospasm (rare)
Miscellaneous: Allergic reactions, methemoglobinemia, sulfhemoglobinemia
Metabolism/Transport Effects
Substrate (minor) of CYP1A2, 2D6; Inhibits CYP2D6 (weak)
Drug Interactions
Anti-Parkinson's Agents (Dopamine Agonist): Metoclopramide may diminish the therapeutic effect of Anti-Parkinson's Agents (Dopamine Agonist). Risk C: Monitor therapy
Antipsychotics: Metoclopramide may enhance the adverse/toxic effect of Antipsychotics. Risk X: Avoid combination
CycloSPORINE: Metoclopramide may increase the absorption of CycloSPORINE. Risk C: Monitor therapy
CycloSPORINE (Systemic): Metoclopramide may increase the absorption of CycloSPORINE (Systemic). Risk C: Monitor therapy
Droperidol: May enhance the adverse/toxic effect of Metoclopramide. Risk X: Avoid combination
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Posaconazole: Metoclopramide may decrease the serum concentration of Posaconazole. Risk C: Monitor therapy
Promethazine: Metoclopramide may enhance the adverse/toxic effect of Promethazine. Risk X: Avoid combination
Quinagolide: Metoclopramide may diminish the therapeutic effect of Quinagolide. Risk C: Monitor therapy
Selective Serotonin Reuptake Inhibitors: Metoclopramide may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Management: Seek alternatives to this combination when possible. Monitor patients receiving metoclopramide with selective serotonin reuptake inhibitors for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Risk D: Consider therapy modification
Tetrabenazine: Metoclopramide may enhance the adverse/toxic effect of Tetrabenazine. Risk X: Avoid combination
Tricyclic Antidepressants: Metoclopramide may enhance the adverse/toxic effect of Tricyclic Antidepressants. Management: Seek alternatives to this combination when possible. Monitor patients receiving metoclopramide with tricyclic antidepressants for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Risk D: Consider therapy modification
Venlafaxine: Metoclopramide may enhance the adverse/toxic effect of Venlafaxine. Specifically, the risk of serotonin syndrome may be increased. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Ethanol: Avoid ethanol (may increase CNS depression).
Storage
Injection: Store intact vial at controlled room temperature; injection is photosensitive and should be protected from light during storage; parenteral admixtures in D5W or NS are stable for at least 24 hours and do not require light protection if used within 24 hours.
Tablet: Store at controlled room temperature of 20°C to 25°C (68°F to 77°F).
Compatibility
Stable in D51/2NS, D5W, mannitol 20%, LR, NS; variable stability (consult detailed reference) in TPN.
Y-site administration: Compatible: Acyclovir, aldesleukin, amifostine, aztreonam, bleomycin, caffeine citrate, ciprofloxacin, cisatracurium, cisplatin, cladribine, clarithromycin, cyclophosphamide, cytarabine, diltiazem, docetaxel, doxorubicin, droperidol, etoposide phosphate, famotidine, filgrastim, fluconazole, fludarabine, fluorouracil, foscarnet, gatifloxacin, gemcitabine, granisetron, heparin, hetastarch in lactated electrolyte injection, idarubicin, leucovorin calcium, levofloxacin, linezolid, melphalan, meperidine, meropenem, methotrexate, mitomycin, morphine, ondansetron, paclitaxel, palonosetron, piperacillin/tazobactam, remifentanil, sargramostim, sufentanil, tacrolimus, teniposide, thiotepa, topotecan, vinblastine, vincristine, vinorelbine, zidovudine. Incompatible: Allopurinol, amphotericin B cholesteryl sulfate complex, amsacrine, cefepime, doxorubicin liposome, furosemide, pantoprazole, propofol. Variable (consult detailed reference): TPN.
Compatibility in syringe: Compatible: Aminophylline, ascorbic acid injection, atropine, benztropine, bleomycin, butorphanol, chlorpromazine, cisplatin, cyclophosphamide, cytarabine, dexamethasone sodium phosphate, diamorphine, dimenhydrinate, diphenhydramine, doxorubicin, droperidol, fentanyl, fluorouracil, heparin, hydrocortisone sodium phosphate, hydroxyzine, insulin (regular), leucovorin calcium, lidocaine, magnesium sulfate, meperidine, methotrimeprazine, methylprednisolone sodium succinate, midazolam, mitomycin, morphine, ondansetron, pentazocine, perphenazine, prochlorperazine edisylate, promazine, promethazine, ranitidine, scopolamine, sufentanil, vinblastine, vincristine, vitamin B complex with C. Incompatible: Ampicillin, calcium gluconate, chloramphenicol, furosemide, penicillin G potassium, sodium bicarbonate. Variable (consult detailed reference): Methotrexate.
Compatibility when admixed: Compatible: Cimetidine, clindamycin, meperidine, meropenem, morphine, multivitamins, potassium acetate, potassium chloride, potassium phosphate, verapamil. Incompatible: Dexamethasone sodium phosphate with lorazepam and diphenhydramine, erythromycin lactobionate, floxacillin, fluorouracil, furosemide.
Mechanism of Action
Blocks dopamine receptors and (when given in higher doses) also blocks serotonin receptors in chemoreceptor trigger zone of the CNS; enhances the response to acetylcholine of tissue in upper GI tract causing enhanced motility and accelerated gastric emptying without stimulating gastric, biliary, or pancreatic secretions; increases lower esophageal sphincter tone
Pharmacodynamics/Kinetics
Onset of action: Oral: 30-60 minutes; I.V.: 1-3 minutes; I.M.: 10-15 minutes
Duration: Therapeutic: 1-2 hours, regardless of route
Absorption: Oral: Rapid
Distribution: Vd: ~3.5 L/kg
Protein binding: ~30%
Bioavailability: Oral: Range: 65% to 95%
Half-life elimination: Normal renal function: Children: ~4 hours; Adults: 5-6 hours (may be dose dependent)
Time to peak, serum: Oral: 1-2 hours
Excretion: Urine (~85%)
Dosage
Children:
Gastroesophageal reflux (unlabeled use): Oral: 0.1-0.2 mg/kg/dose 4 times/day
Antiemetic (chemotherapy-induced emesis) (unlabeled): I.V.: 1-2 mg/kg 30 minutes before chemotherapy and every 2-4 hours (maximum: 5 doses/day); pretreatment with diphenhydramine will decrease risk of extrapyramidal reactions to this dosage
Postpyloric feeding tube placement: I.V.:
<6 years: 0.1 mg/kg as a single dose
6-14 years: 2.5-5 mg as a single dose
>14 years: Refer to adult dosing.
Adults:
Gastroesophageal reflux: Oral: 10-15 mg/dose up to 4 times/day 30 minutes before meals or food and at bedtime; single doses of 20 mg are occasionally needed prior to provoking situations. Treatment >12 weeks is not recommended.
Diabetic gastroparesis:
Oral: 10 mg/dose up to 4 times/day 30 minutes before meals or food and at bedtime for 2-8 weeks
I.M., I.V. (for severe symptoms): 10 mg over 1-2 minutes; 10 days of I.V. therapy may be necessary before symptoms are controlled to allow transition to oral administration
Chemotherapy-induced emesis prophylaxis: I.V.: 1-2 mg/kg 30 minutes before chemotherapy and repeated every 2 hours for 2 doses, then every 3 hours for 3 doses (manufacturer labeling); pretreatment with diphenhydramine will decrease risk of extrapyramidal reactions
Alternate dosing: Note: Metoclopramide is considered an antiemetic with a low therapeutic index; use is generally reserved for agents with low emetogenic potential or in patients intolerant/refractory to first-line antiemetics.
Low-risk chemotherapy (unlabeled): I.V., Oral: 10-40 mg prior to dose, then every 4-6 hours as needed (NCCN Antiemesis guidelines, v.4.2009)
Breakthrough treatment (unlabeled): I.V., Oral: 10-40 mg every 4-6 hours (NCCN Antiemesis guidelines, v.4.2009)
Delayed-emesis prophylaxis (unlabeled): Oral: 20-40 mg/dose (or 0.5 mg/kg/dose) 2-4 times/day for 3-4 days (in combination with dexamethasone [ASCO guidelines, 2006])
Refractory or intolerant to antiemetics with a higher therapeutic index (unlabeled; Hesketh, 2008):
I.V.: 1-2 mg/kg/dose before chemotherapy and repeat 2 hours after chemotherapy
Oral: 0.5 mg/kg every 6 hours on days 2-4
Postoperative nausea and vomiting prophylaxis: I.M., I.V. (unlabeled route): 10-20 mg near end of surgery. Note: Guidelines discourage use of 10 mg metoclopramide as being ineffective (Gan, 2007); comparative study indicates higher dose (20 mg) may be efficacious (Quaynor, 2002)
Postpyloric feeding tube placement, radiological exam: I.V.: 10 mg as a single dose
Elderly: Initial: Dose at the lower end of the recommended range. Refer to adult dosing.
Dosing adjustment in renal impairment: Clcr <40 mL/minute: Administer at 50% of normal dose
Hemodialysis: Not dialyzable (0% to 5%); supplemental dose is not necessary
Dental Usual Dosing
Adults: Promotion of gastric emptying (unlabeled): Oral: 5-15 mg administered 30-60 minutes before procedure to promote gastric motility
Administration: Oral
Orally-disintegrating tablets: Administer on an empty stomach at least 30 minutes prior to food. Do not remove from packaging until time of administration. If tablet breaks or crumbles while handling, discard and remove new tablet. Using dry hands, place tablet on tongue and allow to dissolve. Swallow with saliva.
Administration: I.M.
May be administered I.M.
Administration: I.V.
Injection solution may be given I.M., direct I.V. push, short infusion (15-30 minutes), or continuous infusion; lower doses (≤10 mg) of metoclopramide can be given I.V. push undiluted over 1-2 minutes; higher doses (>10 mg) to be diluted in 50 mL of compatible solution (preferably NS) and given IVPB over at least 15 minutes; continuous SubQ infusion and rectal administration have been reported. Note: Rapid I.V. administration may be associated with a transient (but intense) feeling of anxiety and restlessness, followed by drowsiness.
Administration: Other
Continuous SubQ infusion and rectal administration have been reported
Administration: I.V. Detail
pH: 3.0-6.5
Monitoring Parameters
Dystonic reactions; signs of hypoglycemia in patients using insulin and those being treated for gastroparesis; agitation, and confusion
Test Interactions
Increased aminotransferase [ALT/AST] (S), increased amylase (S)
Patient Education
Oral: Take 30 minutes prior to eating. Avoid alcohol; may increase adverse effects. May cause dizziness, drowsiness, insomnia, or blurred vision. Report persistent CNS changes (restlessness, anxiety, depression), spasticity or involuntary movements, unresolved diarrhea, or visual disturbances.
Geriatric Considerations
Elderly are more likely to develop tardive dyskinesia syndrome (especially elderly females) reactions than younger adults. Use lowest recommended doses initially. Must consider renal function (estimate creatinine clearance). It is recommended to do involuntary movement assessments on elderly using this medication at high doses and for long-term therapy.
Anesthesia and Critical Care Concerns/Other Considerations
Evidence-Based Information: The consensus guidelines for postoperative nausea and vomiting (Gan, 2007) notes that metoclopramide is ineffective for PONV prevention when used at a dose of 10 mg (I.V.), and thus does not recommend the use of metoclopramide. However, a study comparing a higher metoclopramide dose (20 mg I.V.) to ondansetron 8 mg I.V. in 122 patients undergoing laparoscopic cholecystectomy revealed no significant difference in the incidence of PONV or need for rescue anti-emetic therapy (Quaynor, 2002).
Cardiovascular Considerations
Metoclopramide dose not cause QT prolongation.
Dental Health: Effects on Dental Treatment
Metoclopramide has relatively few adverse effects when used in low doses; however, extrapyramidal effects including akathisia (motor restlessness), acute dystonia (spasmodic contractures), pseudoparkinsonism, and tardive dyskinesia can occur. These effects are more likely in the elderly, patients taking other dopamine antagonists (including antipsychotic agents and some antiemetic agents), and patients with Parkinson's disease. Metoclopramide will increase gastric emptying which will aid in the absorption of orally administered anxiolytic or sedative agents used for minimal or moderate sedation as well as promote the emptying of the stomach following procedures during which blood may be swallowed causing GI upset.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
Drowsiness and restlessness are common; may cause insomnia or depression. Depression has occurred in patients with and without a prior history of depression. Symptoms have ranged from mild to severe, and have included suicidal ideation and suicide. Metoclopramide is a D2 blocker; may cause extrapyramidal symptoms especially when used in high dosages (dystonia) or in the elderly (tardive dyskinesia). Dystonic reactions occur in approximately 1 in 500 patients with the usual adult dosage of 30-40 mg/day. These reactions are usually seen during the first 1-2 days of therapy with metoclopramide, occurring more frequently in pediatric patients and adults <30 years of age, and are more frequent when higher doses are used in prophylaxis of vomiting due to cancer chemotherapy. NMS has rarely been reported.
Mental Health: Effects on Psychiatric Treatment
Anticholinergics may antagonize metoclopramide's effects; concurrent use with psychotropic may produce additive sedation
Nursing: Physical Assessment/Monitoring
Vital signs should be monitored during intravenous administration. Inpatients should use safety measures to prevent falls (eg, side rails up, call light within reach) and caution patient to call for assistance with ambulation. Monitor for CNS changes (sedation, extrapyramidal effects, Parkinsonian-like reactions).
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution [preservative free]: 5 mg/mL (2 mL)
Reglan®: 5 mg/mL (2 mL, 10 mL, 30 mL)
Solution, oral: 5 mg/5 mL (10 mL, 473 mL)
Tablet, oral: 5 mg, 10 mg
Reglan®: 5 mg
Reglan®: 10 mg [scored]
Tablet, orally disintegrating, oral:
Metozolv™ ODT: 5 mg, 10 mg [mint flavor]
Pricing: U.S. (www.drugstore.com)
Solution (Metoclopramide HCl)
5 mg/5 mL (240): $14.99
Tablets (Metoclopramide HCl)
5 mg (30): $12.99
10 mg (90): $16.99
Tablets (Reglan)
5 mg (30): $52.99
References
“American Academy of Pediatrics Committee on Drugs. The Transfer of Drugs and Other Chemicals Into Human Milk,” Pediatrics, 2001, 108(3):776-89.
Bruera E, Seifert L, Watanabe S, et al, "Chronic Nausea in Advanced Cancer Patients: A Retrospective Assessment of a Metoclopramide-Based Antiemetic Regimen," J Pain Symptom Manage, 1996, 11(3):147-53.
Desmond PV and Watson KJ, "Metoclopramide - A Review," Med J Aust, 1986, 144(7):366-9.
DiPalma JR, “Metoclopramide: A Dopamine Receptor Antagonist,” Am Fam Physician, 1990, 41(3):919-24.
Gan TJ, Meyer TA, Apfel CC, et al, “Society for Ambulatory Anesthesia Guidelines for the Management of Postoperative Nausea and Vomiting,” Anesth Analg, 2007, 105(6):1615-28.
Harrington RA, Hamilton CW, Brogden RN, et al, “Metoclopramide. An Updated Review of Its Pharmacological Properties and Clinical Use,” Drugs, 1983, 25(5):451-94.
Hart J, "Pediatric Gastroesophageal Reflux," Am Fam Physician, 1996, 54(8):2463-72.
Hesketh PJ, “Chemotherapy-Induced Nausea and Vomiting,” N Engl J Med, 2008, 358(23):2482-94.
Karadsheh NS, Shaker Q, and Ratroat B, “Metoclopramide-induced Methemoglobinemia in a Patient With Co-Existing Deficiency of Glucose-6-Phosphate Dehydrogenase and NADH-Cytochrome b5 Reductase: Failure of Methylene Blue Treatment,” Haematologica, 2001, 86(6):659-60.
Kris MG, Hesketh PJ, Somerfield MR, et al, “American Society of Clinical Oncology Guideline for Antiemetics in Oncology: Update 2006,” J Clin Oncol, 2006, 24(18):2932-46.
Martindale RG, McClave SA, Vanek VW, et al, “Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.),” JPEN J Parenter Enteral Nutr, 2007, 33(3):277-316.
Mary AM and Bhupalam L, “Metoclopramide-induced Methemoglobinemia in an Adult,” J KY Med Assoc, 2000, 98(6):245-7.
Matok I, Gorodischer R, Koren G, et al, “The Safety of Metoclopramide Use in the First Trimester of Pregnancy,” N Engl J Med, 2009, 360(24):2528-35.
McGovern EM, Grevel J, and Bryson SM, “Pharmacokinetics of High-Dose Metoclopramide in Cancer Patients,” Clin Pharmacokinet, 1986, 11(6):415-24.
Multinational Association of Supportive Care in Cancer (MASCC), “Antiemetic Guidelines,” Updated April 2010. Available at http://data.memberclicks.com/site/mascc/MASCC_Guidelines_English_2010.pdf
National Comprehensive Cancer Network® (NCCN), “Clinical Practice Guidelines in Oncology™: Antiemesis,” Version 2.2010. Available at http://www.nccn.org/professionals/physician_gls/PDF/antiemesis.pdf
Parrish RH and Bonzo SM, “Use of Metoclopramide Suppositories,” Clin Pharm, 1983, 2(5):395-6.
Patterson JF, “Neuroleptic Malignant Syndrome Associated With Metoclopramide,” South Med J, 1988, 81(5):674-5.
Quaynor H and Raeder JC, “Incidence and Severity of Postoperative Nausea and Vomiting are Similar After Metoclopramide 20 mg and Ondansetron 8 mg Given by the End of Laparoscopic Cholecystectomies,” Acta Anaesthesiol Scand, 2002, 46(1):109-13.
Schulze-Delrieu K, “Drug Therapy. Metoclopramide,” N Engl J Med, 1981, 305(1):28-33.
Van Veldhuizen PJ and Wyatt A, “Metoclopramide-induced Sulfhemoglobinemia,” Am J Gastroenterol, 1995, 90(6):1010-1.
International Brand Names
Lexi-Comp.com
Last full review/revision May 2011
Content last modified May 2011
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