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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
(TRAZ oh done)
Generic Available (U.S.)
Yes: Excludes extended release tablet
Index Terms
Medication Guide
An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:
Oleptro™ extended release tablets: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM202202.pdf
Trazodone tablets: http://dailymed.nlm.nih.gov/dailymed/medguide.cfm?id=37846
REMS Components
Oleptro™: Released from REMS requirement 5/11/2011
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of major depressive disorder
Use: Unlabeled
Potential augmenting agent for antidepressants, hypnotic
Pregnancy Risk Factor
C
Pregnancy Considerations
Trazodone is classified as pregnancy category C due to adverse effects observed in animal studies. When trazodone is taken during pregnancy, an increased risk of major malformations has not been observed in the small number of pregnancies studied. The long-term effects on neurobehavior have not been evaluated.Women treated for major depression and who are euthymic prior to pregnancy are more likely to experience a relapse when medication is discontinued as compared to pregnant women who continue taking antidepressant medications. Therapy during pregnancy should be individualized; treatment of depression during pregnancy should incorporate the clinical expertise of the mental health clinician, obstetrician, primary healthcare provider, and pediatrician. If treatment during pregnancy is required, consider tapering therapy during the third trimester to prevent potential withdrawal symptoms in the infant. If this is done and the woman is considered to be at risk of relapse from her major depressive disorder, the medication can be restarted following delivery. Treatment algorithms have been developed by the ACOG and the APA for the management of depression in women prior to conception and during pregnancy (Yonkers, 2009).
Lactation
Enters breast milk/use caution (AAP rates “of concern”; AAP 2001 update pending)
Breast-Feeding Considerations
Trazodone is excreted into breast milk; breast milk concentrations peak ~2 hours following administration. It is not known if the trazodone metabolite is found in breast milk. The long-term effects on neurobehavior have not been studied. The manufacturer recommends that caution be exercised when administering trazodone to nursing women.
Contraindications
Hypersensitivity to trazodone or any component of the formulation
Warnings/Precautions
Boxed warnings:
• Suicidal thinking/behavior: See “Major psychiatric warnings” below.
Major psychiatric warnings:
• Suicidal thinking/behavior: [U.S. Boxed Warning]: Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (18-24 years of age) with major depressive disorder (MDD) and other psychiatric disorders; consider risk prior to prescribing. Short-term studies did not show an increased risk in patients >24 years of age and showed a decreased risk in patients ≥65 years of age. Closely monitor patients for clinical worsening, suicidality, or unusual changes in behavior, particularly during the initial 1-2 months of therapy or during periods of dosage adjustments (increases or decreases); the patient's family or caregiver should be instructed to closely observe the patient and communicate condition with healthcare provider. A medication guide concerning the use of antidepressants should be dispensed with each prescription.Trazodone is not FDA approved for use in children.
• The possibility of a suicide attempt is inherent in major depression and may persist until remission occurs. Patients treated with antidepressants should be observed for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Worsening depression and severe abrupt suicidality that are not part of the presenting symptoms may require discontinuation or modification of drug therapy. Use caution in high-risk patients during initiation of therapy.
• Prescriptions should be written for the smallest quantity consistent with good patient care. The patient's family or caregiver should be alerted to monitor patients for the emergence of suicidality and associated behaviors such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania; patients should be instructed to notify their healthcare provider if any of these symptoms or worsening depression or psychosis occur.
Concerns related to adverse effects:
• Bleeding risk: Drugs that interfere with serotonin reuptake (eg, SSRIs) have been associated with bleeding ranging from relatively minor bruising and epistaxis to life-threatening hemorrhage; similar to these agents, trazodone may also impair platelet aggregation resulting in increased risk of bleeding events, particularly if used concomitantly with aspirin, NSAIDs, warfarin or other anticoagulants.
• Orthostatic hypotension/syncope: May cause orthostatic hypotension and syncope (risk is high relative to other antidepressants); use with caution in patients at risk of these effects or in those who would not tolerate transient hypotensive episodes (cerebrovascular disease, cardiovascular disease, hypovolemia, or concurrent medication use which may predispose to hypotension/bradycardia).
• Priapism: Painful erection >6 hours in duration; rare. Instruct patient to seek medical assistance for erection lasting >4 hours. Use with caution in patients who have conditions which may predispose them to priapism (eg, sickle cell anemia, multiple myeloma, leukemia).
• QT prolongation/proarrhythmia: Although the risk of conduction abnormalities is low relative to other antidepressants, QT prolongation (with or without torsade de pointes) and ventricular tachycardia has been observed with the use of trazodone (reports limited to immediate-release formulation); use with caution in patients with pre-existing cardiac disease. Other arrhythmias reported include isolated PVCs, ventricular couplets, and tachycardia with syncope. Concurrent use of CYP3A4 inhibitors may increase the risk of QT prolongation and/or proarrhythmia.
• Sedation: May cause sedation, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). The degree of sedation is very high relative to other antidepressants.
• Serotonin syndrome (SS)/neuroleptic malignant syndrome (NMS)-like reactions: SS and NMS-like reactions may occur with trazodone when used alone, particularly if used with other serotonergic agents (eg, serotonin/norepinephrine reuptake inhibitors [SNRIs], selective serotonin reuptake inhibitors [SSRIs], or triptans), drugs that impair serotonin metabolism (eg, MAO inhibitors), or antidopaminergic agents (eg, antipsychotics). Identification and differentiation of SS (eg, tremor, myoclonus, agitation) and more severe NMS-like reactions (eg, hyperthermia, muscle rigidity, autonomic instability, mental status changes) can be complex; monitor patients closely for either syndrome. Discontinue treatment (and any concomitant serotonergic and/or antidopaminergic agents) immediately if signs/symptoms arise.
• SIADH and hyponatremia: Some antidepressant agents (eg, SSRIs) have been associated with the development of SIADH; hyponatremia has been reported (including severe cases with serum sodium <110 mmol/L), predominately in the elderly. Volume depletion and/or concurrent use of diuretics likely increases risk.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with a history of cardiovascular disease (including previous MI, stroke, tachycardia, or conduction abnormalities); the risk conduction abnormalities with this agent is low relative to other antidepressants. Not recommended for use in a patient during the acute recovery phase of MI.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Mania/hypomania: May worsen psychosis in some patients or precipitate a shift to mania or hypomania in patients with bipolar disorder. Monotherapy in patients with bipolar disorder should be avoided. Patients presenting with depressive symptoms should be screened for bipolar disorder. Trazodone is not FDA approved for the treatment of bipolar depression.
• Renal impairment: Use with caution in patients with renal impairment.
• Seizure disorder: Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcoholism, or concurrent therapy with medications which may lower seizure threshold.
Concurrent drug therapy issues:
• Antihypertensives: Use with caution in patients taking antihypertensives; may increase the risk of hypotension or syncope.
• Cytochrome P450-mediated interactions: Use with caution in patients taking strong CYP3A4 inhibitors and moderate or strong CYP3A4 inducers (see Drug Interactions); monitor or consider alternative agents that avoid or lessen the potential for CYP-mediated interactions.
• Drugs with QT prolongation potential: Concurrent use with other drugs known to prolong QTc interval is not recommended.
• MAO inhibitors: Trazodone should be initiated with caution in patients who are receiving concurrent or recent therapy with a MAO inhibitor. Oleptro™: Avoid use in combination with or within 14 days of an MAO inhibitor.
• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.
• Serotonergic agents (eg, SSRIs, SNRIs, triptans): If concurrent use is clinically warranted, carefully observe patient during treatment initiation and dose increases. Do not use concurrently with serotonin precursors (eg, tryptophan).
Special populations:
• Elderly: Use with caution in the elderly.
Other warnings/precautions:
• Discontinuation of therapy: Therapy should not be abruptly discontinued in patients receiving high doses for prolonged periods; gradually reduce dosage prior to complete discontinuation to avoid withdrawal symptoms (eg, anxiety, agitation, sleep disturbance).
• Electroconvulsive therapy: May increase the risks associated with electroconvulsive therapy; consider discontinuing, when possible, prior to ECT treatment.
Adverse Reactions
>10%:
Central nervous system: Sedation (≤46%), headache (10% to 33%), dizziness (20% to 28%), fatigue (6% to 15%)
Gastrointestinal: Xerostomia (15% to 34%), nausea (10% to 21%)
Ocular: Blurred vision (5% to 15%)
1% to 10%:
Cardiovascular: Edema (3% to 7%), hypotension (≤7%), syncope (≤5%), hypertension (1% to 2%)
Central nervous system: Confusion (5% to 6%), incoordination (2% to 5%), concentration decreased (1% to 3%), disorientation (≤2%), memory impairment (≤1%), agitation, migraine
Endocrine & metabolic: Libido decreased (1% to 2%)
Gastrointestinal: Diarrhea (5% to 9%), constipation (7% to 8%), abdominal pain, abnormal taste, flatulence, vomiting, weight gain/loss
Genitourinary: Ejaculation disorder (2%), urinary urgency
Neuromuscular & skeletal: Back pain (≤5%), tremor (1% to 5%), paresthesia (≤1%), myalgia
Ocular: Visual disturbance
Respiratory: Nasal congestion (3% to 6%), dyspnea
Miscellaneous: Night sweats
<1%, postmarketing, and/or case reports (limited to important or life-threatening): Abnormal dreams, abnormal orgasm, acne, akathisia, allergic reactions, alopecia, amylase increased, anemia, anxiety, aphasia, apnea, appetite increased, arrhythmia, ataxia, atrial fibrillation, bladder pain, bradycardia, breast enlargement/engorgement, cardiac arrest, cardiospasm, cerebrovascular accident, chest pain, CHF, chills, cholestasis, clitorism, conduction block, diplopia, early menses, erectile dysfunction, extrapyramidal symptoms, eye pain, flushing, gait disturbance, hallucination, hearing loss (partial), hematuria, hemolytic anemia, hepatitis, hirsutism, hyperbilirubinemia, hyperhidrosis, hypersalivation, hypersensitivity, hypoesthesia, hypomania, impaired speech, impotence, insomnia, jaundice, lactation, leukocytosis, leukonychia, libido increased, liver enzyme alteration, methemoglobinemia, MI, muscle twitching, orthostatic hypotension, palpitation, paranoia, photophobia, photosensitivity reaction, priapism, pruritus, psoriasis, psychosis, QT prolongation, rash, reflux esophagitis, retrograde ejaculation, salivation increased, seizure, SIADH, speech impairment, stupor, tachycardia, tardive dyskinesia, tinnitus, torsade de pointes, urinary frequency increased, urinary retention, urinary incontinence, urticaria, vasodilation, ventricular ectopy, ventricular tachycardia, vertigo, dry eyes, weakness
Metabolism/Transport Effects
Substrate of CYP2D6 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP3A4 (weak); Induces P-glycoprotein
Drug Interactions
Antipsychotic Agents (Phenothiazines): May enhance the adverse/toxic effect of Antidepressants (Serotonin Reuptake Inhibitor/Antagonist). Specifically, this may be manifest as symptoms consistent with serotonin syndrome or neuroleptic malignant syndrome. Antidepressants (Serotonin Reuptake Inhibitor/Antagonist) may enhance the hypotensive effect of Antipsychotic Agents (Phenothiazines). Risk C: Monitor therapy
Antipsychotics: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Risk C: Monitor therapy
BusPIRone: May enhance the serotonergic effect of Antidepressants (Serotonin Reuptake Inhibitor/Antagonist). Risk C: Monitor therapy
Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Risk X: Avoid combination
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
Dabigatran Etexilate: P-glycoprotein/ABCB1 Inducers may decrease the serum concentration of Dabigatran Etexilate. Management: Avoid concurrent use of dabigatran with a p-glycoprotein inducer when possible. Closely monitor for decreased levels/effects of dabigatran if concomitantly administering a p-glycoprotein inducer, particularly strong inducers. Risk X: Avoid combination
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
Fosphenytoin: TraZODone may increase the serum concentration of Fosphenytoin. Fosphenytoin may decrease the serum concentration of TraZODone. Risk C: Monitor therapy
Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Linagliptin: P-glycoprotein/ABCB1 Inducers may decrease the serum concentration of Linagliptin. Management: Strongly consider using an alternative to any strong P-glycoprotein inducer in patients who are being treated with linagliptin. If this combination is used, monitor patients closely for evidence of reduced linagliptin effectiveness. Risk D: Consider therapy modification
Linezolid: May enhance the serotonergic effect of TraZODone. This could result in serotonin syndrome. Management: Consider alternatives. When this combination is indicated, closely monitor for signs/symptoms of serotonin toxicity/serotonin syndrome. If such symptoms occur, consider discontinuation of one or both agents. Risk D: Consider therapy modification
MAO Inhibitors: May enhance the adverse/toxic effect of Antidepressants (Serotonin Reuptake Inhibitor/Antagonist). Risk X: Avoid combination
MAO Inhibitors: May enhance the orthostatic hypotensive effect of Orthostatic Hypotension Producing Agents. Risk C: Monitor therapy
Methylene Blue: TraZODone may enhance the serotonergic effect of Methylene Blue. This could result in serotonin syndrome. Risk X: Avoid combination
Metoclopramide: Serotonin Modulators may enhance the adverse/toxic effect of Metoclopramide. This may be manifest as symptoms consistent with serotonin syndrome or neuroleptic malignant syndrome. Risk C: Monitor therapy
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
P-glycoprotein/ABCB1 Substrates: P-glycoprotein/ABCB1 Inducers may decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy
Phenytoin: TraZODone may increase the serum concentration of Phenytoin. Phenytoin may decrease the serum concentration of TraZODone. Risk C: Monitor therapy
Protease Inhibitors: May increase the serum concentration of TraZODone. Risk D: Consider therapy modification
Saquinavir: May enhance the adverse/toxic effect of TraZODone. Saquinavir may increase the serum concentration of TraZODone. Risk X: Avoid combination
Selective Serotonin Reuptake Inhibitors: May enhance the serotonergic effect of Antidepressants (Serotonin Reuptake Inhibitor/Antagonist). This may cause serotonin syndrome. Risk C: Monitor therapy
Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Risk D: Consider therapy modification
Telaprevir: May increase the serum concentration of TraZODone. Risk C: Monitor therapy
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Venlafaxine: May enhance the serotonergic effect of TraZODone. This could result in serotonin syndrome. Risk D: Consider therapy modification
Ethanol/Nutrition/Herb Interactions
Ethanol: May increase CNS depression; monitor for increased effects with coadministration. Caution patients about effects.
Food: Time to peak serum levels may be increased if immediate release trazodone is taken with food.
Herb/Nutraceutical: Avoid valerian, St John's wort, SAMe, kava kava (may increase risk of serotonin syndrome and/or excessive sedation).
Storage
Immediate release tablet: Store at room temperature; avoid temperatures >40°C (>104°F). Protect from light.
Extended release tablet: Store at room temperature of 15ºC to 30ºC (59ºF to 86ºF). Protect from light.
Mechanism of Action
Inhibits reuptake of serotonin, causes adrenoreceptor subsensitivity, and induces significant changes in 5-HT presynaptic receptor adrenoreceptors. Trazodone also significantly blocks histamine (H1) and alpha1-adrenergic receptors.
Pharmacodynamics/Kinetics
Onset of action: Therapeutic (antidepressant): Up to 6 weeks; sleep aid: 1-3 hours
Absorption: Well absorbed; Extended release: Cmax increases ~86% when taken shortly after ingestion of a high-fat meal compared to fasting conditions
Protein binding: 85% to 95%
Metabolism: Hepatic via CYP3A4 (extensive) to an active metabolite (mCPP)
Half-life elimination: 7-10 hours
Time to peak, serum:
Immediate release: 30-100 minutes; delayed with food (up to 2.5 hours)
Extended release: 9 hours; not significantly affected by food
Excretion: Primarily urine (<1% excreted unchanged); secondarily feces
Dosage
Oral: Therapeutic effects may take up to 6 weeks to occur; therapy is normally maintained for 6-12 months after optimum response is reached to prevent recurrence of depression
Children 6-12 years: Depression (unlabeled use): Initial: 1.5-2 mg/kg/day in divided doses; increase gradually every 3-4 days as needed; maximum: 6 mg/kg/day in 3 divided doses
Adolescents: Depression (unlabeled use): Initial: 25-50 mg/day; increase to 100-150 mg/day in divided doses
Adults:
Depression: Initial: 150 mg/day in 3 divided doses (may increase by 50 mg/day every 3-7 days); maximum dose: 600 mg/day
Extended release formulation: Initial: 150 mg once daily at bedtime (may increase by 75 mg/day every 3 days); maximum dose: 375 mg/day; once adequate response obtained, gradually reduce with adjustment based on therapeutic response
Note: Therapeutic effects may take up to 6 weeks. Therapy is normally maintained for 6-12 months after optimum response is reached to prevent recurrence of depression.
Sedation/hypnotic (unlabeled use): 25-50 mg at bedtime (often in combination with daytime SSRIs); may increase up to 200 mg at bedtime
Elderly: 25-50 mg at bedtime with 25-50 mg/day dose increase every 3 days for inpatients and weekly for outpatients, if tolerated; usual dose: 75-150 mg/day
Administration: Oral
Immediate release tablet: Dosing after meals may decrease lightheadedness and postural hypotension
Extended release tablet: Take on an empty stomach; swallow whole or as a half tablet without food. Tablet may be broken along the score line, but do not crush or chew.
Monitoring Parameters
Baseline liver function prior to and periodically during therapy; suicide ideation (especially at the beginning of therapy or when doses are increased or decreased)
Reference Range
Plasma levels do not always correlate with clinical effectiveness
Therapeutic: 0.5-2.5 mcg/mL
Potentially toxic: >2.5 mcg/mL
Toxic: >4 mcg/mL
Test Interactions
May interfere with urine detection of amphetamine/methamphetamine (false-positive).
Patient Education
It may take 2-4 weeks to achieve desired results. Take immediate release tablet after meals. Extended release tablet should be taken on an empty stomach. Do not crush or chew tablet. Avoid excessive alcohol. Maintain adequate hydration unless instructed to restrict fluid intake. You may experience drowsiness, lightheadedness, dizziness, postural hypotension, nausea, dry mouth, constipation, or diarrhea. Report persistent dizziness or headache; muscle cramping, tremors, or altered gait; blurred vision or eye pain; chest pain or irregular heartbeat; suicide ideation; or worsening of condition. Report prolonged or inappropriate erections.
Geriatric Considerations
Very sedating, but little anticholinergic effects.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Significant xerostomia (normal salivary flow resumes upon discontinuation).
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
Trazodone inhibits reuptake of both serotonin and norepinephrine and also blocks some serotonin receptors. No precautions with vasoconstrictors appear to be necessary.
Nursing: Physical Assessment/Monitoring
Initiate at lower doses and taper dosage slowly when discontinuing.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, oral, as hydrochloride: 50 mg, 100 mg, 150 mg, 300 mg
Tablet, extended release, oral, as hydrochloride:
Oleptro™: 150 mg, 300 mg [scored]
Pricing: U.S. (www.drugstore.com)
Tablet, 24-hour (Oleptro)
150 mg (30): $109.99
Tablets (TraZODone HCl)
50 mg (30): $11.99
100 mg (30): $13.99
150 mg (30): $20.87
300 mg (100): $402.20
References
American Academy of Pediatrics Committee on Drugs, "Transfer of Drugs and Other Chemicals Into Human Milk," Pediatrics, 2001, 108(3):776-89.
Battistella PA, Ruffilli R, Cernetti R, et al, “A Placebo-Controlled Crossover Trial Using Trazodone in Pediatric Migraine,” Headache, 1993, 33(1):36-9.
Bayer AJ, Pathy MSJ, and Ankier SI, “Pharmacokinetic and Pharmacodynamic Characteristics of Trazodone in the Elderly,” Br J Clin Pharmacol, 1983, 16:371-6.
Fishbain DA, “Re: Priapism Associated With Trazodone Therapy,” J Urol, 1989, 142(3):831.
Gerson SC, Plotkin DA, and Jarvik LF, “Antidepressant Drug Studies, 1964-1986: Empirical Evidence for Aging Patients,” J Clin Psychopharmacol, 1988, 8(5):311-22.
Lejoyeux M, Ades J, and Rouillon F, “Serotonin Syndrome: Incidence, Symptoms, and Treatment,” CNS Drugs, 1994, 2(2):132-43.
Lesar T, Kingston R, Dahms R, et al, “Trazodone Overdose,” Ann Emerg Med, 1982, 12(4):221-3.
Mokhlesi B, Leikin JB, Murray P, et al, “Adult Toxicology in Critical Care: Part II: Specific Poisonings,” Chest, 2003, 123(3):897-922.
Pass SE and Simpson RW, “Discontinuation and Reinstitution of Medications During the Perioperative Period,” Am J Health Syst Pharm, 2004, 61(9):899-912.
Reeves RR and Bullen JA, “Serotonin Syndrome Produced by Paroxetine and Low-Dose Trazodone,” Psychosomatics, 1995, 36(2):159-60.
Roberge RJ, Luellen JR, and Reed, S, “False-Positive Amphetamine Screen Following a Trazodone Overdose,” Clin Toxicol, 2001, 39(2):181-2.
Yonkers KA, Wisner KL, Stewart DE, et al, “The Management of Depression During Pregnancy: A Report From the American Psychiatric Association and the American College of Obstetricians and Gynecologists,” Obstet Gynecol, 2009, 114(3):703-13.
Zmitek A, “Trazodone-Induced Mania,” Br J Psychiatry, 1987, 151:274-5.
Zubieta JK and Alessi NE, “Acute and Chronic Administration of Trazodone in the Treatment of Disruptive Behavior Disorders in Children,” J Clin Psychopharmacol, 1992, 12(5):346-51.
International Brand Names
Lexi-Comp.com
Last full review/revision February 2012
Content last modified February 2012
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