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Pronunciation
(am LOE di peen)
Generic Available (U.S.)
Yes
Index Terms
U.S. Brand Names
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of hypertension; treatment of symptomatic chronic stable angina, vasospastic (Prinzmetal's) angina (confirmed or suspected); prevention of hospitalization due to angina with documented CAD (limited to patients without heart failure or ejection fraction <40%)
Pregnancy Risk Factor
C
Pregnancy Considerations
Embryotoxic effects have been demonstrated in animal studies. No well-controlled studies have been conducted in pregnant women. Use in pregnancy only when clearly needed and when the benefits outweigh the potential hazard to the fetus.
Lactation
Excretion in breast milk unknown/not recommended
Contraindications
Hypersensitivity to amlodipine or any component of the formulation
Warnings/Precautions
Concerns related to adverse effects:
• Angina/MI: Increased angina and/or MI have occurred with initiation or dosage titration of dihydropyridine calcium channel blockers. Reflex tachycardia may occur resulting in angina and/or MI in patients with obstructive coronary disease, especially in the absence of concurrent beta-blockade.
• Hypotension/syncope: Symptomatic hypotension with or without syncope can rarely occur; blood pressure must be lowered at a rate appropriate for the patient's clinical condition.
• Peripheral edema: The most common side effect is peripheral edema; occurs within 2-3 weeks of starting therapy.
Disease-related concerns:
• Aortic stenosis: Use amlodipine with extreme caution in patients with severe aortic stenosis; may reduce coronary perfusion resulting in ischemia.
• Hepatic impairment: Use with caution in patients with hepatic impairment; may require lower starting dose; titrate slowly in patients with severe hepatic impairment.
• Hypertrophic cardiomyopathy (HCM) with outflow tract obstruction: Use amlodipine with caution in patients with HCM and outflow tract obstruction since reduction in afterload may worsen symptoms associated with this condition.
Special populations:
• Elderly: Initiate at a lower dose in the elderly.
Other warnings/precautions:
• Titration: Peak antihypertensive effect is delayed; dosage titration should occur after 7-14 days on a given dose.
Adverse Reactions
>10%: Cardiovascular: Peripheral edema (2% to 15% dose related; HF patients: 27% [Packer, 1996])
1% to 10%:
Cardiovascular: Flushing (1% to 5% dose related), palpitation (1% to 5% dose related)
Central nervous system: Dizziness (1% to 3% dose related), fatigue (5%), somnolence (1% to 2%)
Dermatologic: Rash (1% to 2%), pruritus (1% to 2%)
Endocrine & metabolic: Male sexual dysfunction (1% to 2%)
Gastrointestinal: Nausea (3%), abdominal pain (1% to 2%), dyspepsia (1% to 2%)
Neuromuscular & skeletal: Muscle cramps (1% to 2%), weakness (1% to 2%)
Respiratory: Dyspnea (1% to 2%), pulmonary edema (HF patients: 27% [Packer, 1996])
<1%, postmarketing, and/or case reports: Abnormal dreams, abnormal vision, abnormal visual accommodation, acute interstitial nephritis, allergic reactions, agitation, alopecia, amnesia, angioedema, anorexia, anxiety, apathy, appetite increased, arrhythmia, arthralgia, arthrosis, ataxia, atrial fibrillation, back pain, bradycardia, cardiac failure, chest pain, cholestasis, cold and clammy skin, conjunctivitis, constipation, cough, depersonalization, depression, dermatitis, diaphoresis increased, diarrhea, diplopia, dysphagia, dysuria, epistaxis, erythema multiforme, exfoliative dermatitis, extrasystoles, eye pain, female sexual dysfunction, flatulence, gastritis, gingival hyperplasia, gynecomastia, hepatitis, hot flushes, hyperglycemia, hypertonia, hypoesthesia, hypotension, insomnia, jaundice, leukocytoclastic vasculitis, leukopenia, loose stools, malaise, micturition disorder, micturition frequency, migraine, muscle weakness, myalgia, nervousness, nocturia, nonthrombocytopenic purpura, pain, pancreatitis, paresthesia, parosmia, peripheral ischemia, peripheral neuropathy, phototoxicity, polyuria, postural dizziness, postural hypotension, pulse irregularity, purpura, rash erythematous, rash maculopapular, rhinitis, rigors, skin discoloration, skin dryness, Stevens-Johnson syndrome, syncope, tachycardia, taste perversion, thirst, thrombocytopenia, tinnitus, transaminases increased, tremor, twitching, urticaria, vasculitis, ventricular tachycardia, vertigo, vomiting, weight gain/loss, xerophthalmia, xerostomia
Metabolism/Transport Effects
Substrate of CYP3A4 (major); Inhibits CYP1A2 (moderate), 2A6 (weak), 2B6 (weak), 2C8 (weak), 2C9 (weak), 2D6 (weak), 3A4 (weak)
Drug Interactions
Alpha1-Blockers: May enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy
Amifostine: Antihypertensives may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, antihypertensive medications should be withheld for 24 hours prior to amifostine administration. If antihypertensive therapy can not be withheld, amifostine should not be administered. Risk D: Consider therapy modification
Antifungal Agents (Azole Derivatives, Systemic): May decrease the metabolism of Calcium Channel Blockers. Risk D: Consider therapy modification
Antihypertensives: May enhance the hypotensive effect of other Antihypertensives. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Calcium Channel Blockers. Management: Monitor for decreased therapeutic effects of calcium channel blockers with concomitant barbiturate therapy. Calcium channel blocker dose adjustments may be necessary. Nimodipine Canadian labeling contraindicates concomitant use with phenobarbital. Risk C: Monitor therapy
Beta-Blockers: Calcium Channel Blockers (Dihydropyridine) may enhance the hypotensive effect of Beta-Blockers. Bradycardia and signs of heart failure have also been reported. Exceptions: Levobunolol; Metipranolol. Risk C: Monitor therapy
Calcium Channel Blockers (Nondihydropyridine): Calcium Channel Blockers (Dihydropyridine) may enhance the hypotensive effect of Calcium Channel Blockers (Nondihydropyridine). Calcium Channel Blockers (Nondihydropyridine) may increase the serum concentration of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor therapy
Calcium Salts: May diminish the therapeutic effect of Calcium Channel Blockers. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Calcium Channel Blockers (Dihydropyridine). Management: Consider calcium channel blocker (CCB) dose adjustments or alternative therapy in patients receiving concomitant carbamazepine. Nimodipine Canadian labeling contraindicates concurrent use with carbamazepine. Risk D: Consider therapy modification
Clopidogrel: Calcium Channel Blockers may diminish the therapeutic effect of Clopidogrel. Risk C: Monitor therapy
Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Management: Upon completion/discontinuation of conivaptan, allow at least 7 days before initiating therapy with drugs that are CYP3A4 substrates. Risk D: Consider therapy modification
CycloSPORINE: May decrease the metabolism of Calcium Channel Blockers (Dihydropyridine). Nicardipine may likewise inhibit the metabolism of cyclosporine. Cyclosporine dosage adjustments might be needed. Risk C: Monitor therapy
CycloSPORINE (Systemic): May decrease the metabolism of Calcium Channel Blockers (Dihydropyridine). Risk C: Monitor therapy
CYP1A2 Substrates: CYP1A2 Inhibitors (Moderate) may decrease the metabolism of CYP1A2 Substrates. Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Risk D: Consider therapy modification
Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Diazoxide: May enhance the hypotensive effect of Antihypertensives. Risk C: Monitor therapy
Fluconazole: May decrease the metabolism of Calcium Channel Blockers. Risk C: Monitor therapy
Fosphenytoin: Calcium Channel Blockers may increase the serum concentration of Fosphenytoin. Management: Monitor for phenytoin toxicity with concomitant use of a calcium channel blocker (CCB) or decreased phenytoin effects with CCB discontinuation. Monitor for decreased CCB therapeutic effects. Nimodipine Canadian labeling contraindicates use with phenytoin. Risk D: Consider therapy modification
Grapefruit Juice: May increase the serum concentration of AmLODIPine. Risk C: Monitor therapy
Herbs (CYP3A4 Inducers): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensives. Risk C: Monitor therapy
Herbs (Hypotensive Properties): May enhance the hypotensive effect of Antihypertensives. Risk C: Monitor therapy
Hypotensive Agents: May enhance the adverse/toxic effect of other Hypotensive Agents. Risk C: Monitor therapy
Macrolide Antibiotics: May decrease the metabolism of Calcium Channel Blockers. Exceptions: Azithromycin; Azithromycin (Systemic); Spiramycin. Risk D: Consider therapy modification
Magnesium Salts: Calcium Channel Blockers may enhance the adverse/toxic effect of Magnesium Salts. Magnesium Salts may enhance the hypotensive effect of Calcium Channel Blockers. Risk C: Monitor therapy
MAO Inhibitors: May enhance the hypotensive effect of Antihypertensives. MAO Inhibitors may enhance the orthostatic hypotensive effect of Antihypertensives. Risk C: Monitor therapy
Methylphenidate: May diminish the antihypertensive effect of Antihypertensives. Risk C: Monitor therapy
Nafcillin: May increase the metabolism of Calcium Channel Blockers. Risk D: Consider therapy modification
Neuromuscular-Blocking Agents (Nondepolarizing): Calcium Channel Blockers may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents (Nondepolarizing). Risk C: Monitor therapy
Nitroprusside: Calcium Channel Blockers may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy
Pentoxifylline: May enhance the hypotensive effect of Antihypertensives. Risk C: Monitor therapy
Phenytoin: Calcium Channel Blockers may increase the serum concentration of Phenytoin. Management: Monitor for phenytoin toxicity with concomitant use of a calcium channel blocker (CCB) or decreased phenytoin effects with CCB discontinuation. Monitor for decreased CCB therapeutic effects. Nimodipine Canadian labeling contraindicates use with phenytoin. Risk D: Consider therapy modification
Phosphodiesterase 5 Inhibitors: May enhance the antihypertensive effect of Antihypertensives. Risk C: Monitor therapy
Prostacyclin Analogues: May enhance the hypotensive effect of Antihypertensives. Risk C: Monitor therapy
Protease Inhibitors: May decrease the metabolism of Calcium Channel Blockers (Dihydropyridine). Risk D: Consider therapy modification
QuiNIDine: May increase the serum concentration of Calcium Channel Blockers (Dihydropyridine). Calcium Channel Blockers (Dihydropyridine) may decrease the serum concentration of QuiNIDine. Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of QuiNIDine. Risk C: Monitor therapy
Rifamycin Derivatives: May increase the metabolism of Calcium Channel Blockers. This primarily affects oral forms of calcium channel blockers. Management: The labeling for some U.S. and Canadian calcium channel blockers contraindicate use with rifampin however recommendations vary. Consult appropriate labeling. Risk D: Consider therapy modification
RiTUXimab: Antihypertensives may enhance the hypotensive effect of RiTUXimab. Risk D: Consider therapy modification
Tacrolimus: Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of Tacrolimus. Risk C: Monitor therapy
Tacrolimus (Systemic): Calcium Channel Blockers (Dihydropyridine) may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Yohimbine: May diminish the antihypertensive effect of Antihypertensives. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Food: Grapefruit juice may modestly increase amlodipine levels.
Herb/Nutraceutical: St John's wort may decrease amlodipine levels. Avoid herbs with hypertensive properties (bayberry, blue cohosh, cayenne, ephedra, ginger, ginseng [American], kola, licorice). Avoid herbs with hypotensive properties (black cohosh, California poppy, coleus, garlic, goldenseal, hawthorn, mistletoe, periwinkle, quinine, shepherd's purse).
Storage
Store at room temperature of 15°C to 30°C (59°F to 86°F).
Mechanism of Action
Inhibits calcium ion from entering the “slow channels” or select voltage-sensitive areas of vascular smooth muscle and myocardium during depolarization, producing a relaxation of coronary vascular smooth muscle and coronary vasodilation; increases myocardial oxygen delivery in patients with vasospastic angina. Amlodipine directly acts on vascular smooth muscle to produce peripheral arterial vasodilation reducing peripheral vascular resistance and blood pressure.
Pharmacodynamics/Kinetics
Duration of antihypertensive effect: 24 hours
Absorption: Oral: Well absorbed
Distribution: Vd: 21 L/kg
Protein binding: 93% to 98%
Metabolism: Hepatic (>90%) to inactive metabolites
Bioavailability: 64% to 90%
Half-life elimination: Terminal: 30-50 hours; increased with hepatic dysfunction
Time to peak, plasma: 6-12 hours
Excretion: Urine (10% of total dose as unchanged drug, 60% of total dose as metabolites)
Dosage
Oral:
Children 6-17 years: Hypertension: 2.5-5 mg once daily
Adults:
Hypertension: Initial dose: 5 mg once daily; maximum dose: 10 mg once daily. In general, titrate in 2.5 mg increments over 7-14 days. Usual dosage range (JNC 7): 2.5-10 mg once daily.
Angina: Usual dose: 5-10 mg; most patients require 10 mg for adequate effect
Elderly: Dosing should start at the lower end of dosing range and titrated to response due to possible increased incidence of hepatic, renal, or cardiac impairment. Elderly patients also show decreased clearance of amlodipine.
Hypertension: 2.5 mg once daily
Angina: 5 mg once daily
Dosage adjustment in renal impairment: Dialysis: Hemodialysis and peritoneal dialysis do not enhance elimination. Supplemental dose is not necessary.
Dosage adjustment in hepatic impairment:
Angina: Administer 5 mg once daily.
Hypertension: Administer 2.5 mg once daily.
Administration: Oral
May be administered without regard to meals.
Monitoring Parameters
Heart rate, blood pressure, peripheral edema
Dietary Considerations
May be taken without regard to meals.
Patient Education
May cause headache or constipation. Report unrelieved headache, severe constipation, peripheral or facial swelling, weight gain, respiratory changes, or worsening of chest pain or pressure.
Geriatric Considerations
Elderly may experience a greater hypotensive response. Constipation may be more of a problem in elderly. Calcium channel blockers are no more effective in elderly than other therapies, however, they do not cause significant CNS effects which is an advantage over some antihypertensive agents.
Anesthesia and Critical Care Concerns/Other Considerations
Amlodipine may be used safely to treat hypertension and/or angina in patients with heart failure.
Cardiovascular Considerations
Hypertension: Amlodipine therapy should be continued for 4-6 weeks before the dose is increased. Daily doses >10 mg are associated with an increase in side effects (eg, edema) without further reductions in blood pressure. The ALLHAT study (ALLHAT Collaborative Group, 2002) compared CV outcomes of lisinopril, amlodipine, or chlorthalidone in hypertensive patients having at least one other risk factor for coronary heart disease. Investigators found no difference between the groups on the primary outcome of fatal coronary disease or nonfatal MI. The ASCOT-BPLA trial evaluated two regimens (calcium channel blocker/ACE inhibitor vs beta-blocker/thiazide diuretic) to test their efficacy in the primary prevention of coronary disease (nonfatal MI and fatal coronary artery disease). Patients 40-79 years of age were recruited; their blood pressures were either >160 systolic or >100 diastolic (untreated) or >140 systolic or >90 diastolic (treated). Treatment with a calcium channel blocker/ACE inhibitor was more effective at reducing cardiovascular outcomes than the beta-blocker/diuretic regimen.
Coronary Artery Disease: The Comparison of Amlodipine versus Enalapril to Limit Occurrences of Thrombosis (CAMELOT) trial compared a calcium channel blocker and ACE inhibitor in normotensive patients with coronary artery disease (Nissen, 2004). The primary outcome of CV events occurred in 151 (23.1%: placebo), 110 (16.6%: amlodipine), and 136 (20.2%: enalapril) of the patients. The only significant difference being a reduction in CV events with amlodipine compared with placebo, mainly representing a reduction in coronary revascularization and hospitalizations for angina with amlodipine. In the treatment of unstable angina/non-ST-segment elevation MI, oral long-acting calcium antagonists may also be considered in addition to beta-blockers and nitrates.
Heart Failure: The ACC/AHA 2009 guidelines for management of heart failure state that calcium channel blockers are not indicated for the routine treatment of heart failure patients with current/prior symptoms of heart failure and reduced LVEF. Only amlodipine has been shown not to adversely affect survival but most experience is not in patients on concurrent beta-blockers.
Dental Health: Effects on Dental Treatment
Fewer reports of gingival hyperplasia with amlodipine than with other CCBs (usually resolves upon discontinuation); consultation with physician is suggested.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause drowsiness; rarely may produce insomnia and nervousness
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Assess therapeutic effectiveness (blood pressure, angina pattern, weight, and peripheral edema).
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, oral: 2.5 mg, 5 mg, 10 mg
Norvasc®: 2.5 mg, 5 mg, 10 mg
Pricing: U.S. (www.drugstore.com)
Tablets (AmLODIPine Besylate)
2.5 mg (90): $18.99
5 mg (90): $22.99
10 mg (90): $23.99
Tablets (Norvasc)
2.5 mg (30): $76.06
5 mg (30): $76.06
10 mg (30): $99.55
Extemporaneously Prepared
A 1 mg/mL oral suspension may be made with tablets and either a 1:1 mixture of simple syrup and 1% methylcellulose or a 1:1 mixture of Ora-Plus® and Ora-Sweet®. Crush fifty 5 mg tablets in a mortar and reduce to a fine powder. Add small portions of the chosen vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 250 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 250 mL. Label “shake well” and “refrigerate”. Stable for 56 days at room temperature or 91 days refrigerated.
Nahata MC, Morosco RS, and Hipple TF, "Stability of Amlodipine Besylate in Two Liquid Dosage Forms," J Am Pharm Assoc (Wash), 1999, 39(3):375-7.
References
ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group, "Major Outcomes in High-Risk Hypertensive Patients Randomized to Angiotensin-Converting Enzyme Inhibitor or Calcium Channel Blocker vs Diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)," JAMA, 2002, 288(23):2981-97.
Aronow WS, Fleg JL, Pepine CJ, et al, “ACCF/AHA 2011 Expert Consensus Document on Hypertension in the Elderly: A Report of the American College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents,” Circulation, 2011 [epub ahead of print].
Braunwald E, Antman EM, Beasley JW, et al, “ACC/AHA Guidelines for the Management of Patients With Unstable Angina and Non-ST-Segment Elevation Myocardial Infarction. A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina),” J Am Coll Cardiol, 2000, 36(3):970-1062.
Chobanian AV, Bakris GL, Black HR, et al, “The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: The JNC 7 Report,” JAMA, 2003, 289(19):2560-71.
Davies RF, Habibi H, Klinke WP, et al, “Effect of Amlodipine, Atenolol and Their Combination on Myocardial Ischemia During Treadmill Exercise and Ambulatory Monitoring. Canadian Amlodipine/Atenolol in Silent Ischemia Study (CASIS) Investigators,” J Am Coll Cardiol, 1995, 25(3):619-25.
Grassi G, Spaziani D, Seravalle G, et al, “Effects of Amlodipine on Sympathetic Nerve Traffic and Baroreflex Control of Circulation in Heart Failure,” Hypertension, 1999, 33(2):671-5.
Hall WD, Reed JW, Flack JM, et al, “Comparison of the Efficacy of Dihydropyridine Calcium Channel Blockers in African American Patients With Hypertension. ISHIB Investigators Group. International Society on Hypertension in Blacks,” Arch Intern Med, 1998, 158(18):2029-34.
Hunt SA, Abraham WT, Chin MH, et al, “2009 Focused Update Incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines Developed in Collaboration With the International Society for Heart and Lung Transplantation,” J Am Coll Cardiol, 2009, 53(15):e1-e90.
Joseffsson M, Zackrisson AL, and Ahlner J, “Effect of Grapefruit Juice on the Pharmacokinetics of Amlodipine in Healthy Volunteers,” Eur J Clin Pharmacol, 1996, 51(2):189-93.
Lindenfeld J, Albert NM, Boehmer JP, et al, “HFSA 2010 Comprehensive Heart Failure Practice Guideline,” J Card Fail, 2010, 16(6):e1-194.
Meredith PA and Elliott HL, "Clinical Pharmacokinetics of Amlodipine," Clin Pharmacokinet , 1992, 22(1):22-31.
National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents, “The Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents,” Pediatrics, 2004, 114(2 Suppl):555-76.
Neaton JD, Grimm RH Jr, Prineas RJ, et al, “Treatment of Mild Hypertension Study. Final Results. Treatment of Mild Hypertension Study Research Group,” JAMA, 1993, 270(6):713-24.
Nissen SE, Tuzcu EM, Libby P, et al, "Effect of Antihypertensive Agents on Cardiovascular Events in Patients With Coronary Disease and Normal Blood Pressure: The CAMELOT Study: A Randomized Controlled Trial," JAMA, 2004, 292(18):2217-25.
Packer M, O'Connor CM, Ghali JK, et al, “Effect of Amlodipine on Morbidity and Mortality in Severe Chronic Heart Failure. Prospective Randomized Amlodipine Survival Evaluation Study Group,” N Engl J Med, 1996, 335(15):1107-14.
Sever PS, Dahlof B, Poulter NR, et al, "Rationale, Design, Methods and Baseline Demography of Participants of the Anglo-Scandinavian Cardiac Outcomes Trial. ASCOT Investigators," J Hypertens, 2001, 19(6):1139-47.
Steele RM, Schuna AA, and Schreiber RT, “Calcium Antagonist-Induced Gingival Hyperplasia,” Ann Intern Med, 1994, 120(8):663-4.
Vincent J, Harris SI, Foulds G, et al, “Lack of Effect of Grapefruit Juice on the Pharmacokinetics and Pharmacodynamics of Amlodipine,” Br J Clin Pharmacol, 2000, 50(5):455-63.
International Brand Names
Lexi-Comp.com
Last full review/revision June 2011
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