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22 Psychiatric Medications for Monitoring in Primary Care
Medication
Warnings, Precautions, and Adverse Events
Comments
Class: SSRI
Fluvoxamine
Used much less than SSRIs in the group of eight medications for prescribing, probably because it has no Warnings and Precautions: Similar to other SSRIs FDA indication for MDD or any anxiety disorder. Still Adverse Events: Similar to other SSRIs somewhat popular as a medication for OCD. Monitoring: Same as other SSRIs
Citalopram
Escitalopram, one of the SSRIs in the group of medications for prescribing, is an active metabolite of Warnings and Precautions: Similar to other SSRIs citalopram. Escitalopram reportedly has fewer AEs and Adverse Events: Similar to other SSRIs less interaction with hepatic metabolic enzymes than citalopram but is otherwise essentially identical. Citalopram offers no advantage other than price, as Monitoring: Same as other SSRIs escitalopram is branded until 2012. Paroxetine
Paroxetine used much less than the SSRIs for prescribing, probably because of its nonlinear kinetics. Adult: MDD, OCD, Panic Disorder, Generalized Anxiety Warnings and Precautions: Similar to other SSRIs A study of children and adolescents showed doubling Disorder, Social Anxiety Disorder, Posttraumatic Stress Disorder Adverse Events: Similar to other SSRIs the dose of paroxetine from 10 mg/day to 20 mg/day resulted in a 7-fold increase in blood levels (Findling et al, 1999). Thus, once metabolic enzymes are saturated, paroxetine levels can increase dramatically with dose increases and decrease dramatically with dose decreases, sometimes leading to adverse events. Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011. Medication
Warnings, Precautions, and Adverse Events
Comments
Class: SNRI
Venlafaxine
Venlafaxine was compared to a second SSRI in children Warnings and Precautions: Serotonin syndrome, and adolescents with depression who had not responded sustained hypertension, mydriasis, discontinuation to initial treatment with an SSRI (TORDIA study; Brent symptoms — especially anxiety and insomnia, et al, 2008). The second SSRI and venlafaxine showed decreased appetite and weight, height deceleration, comparable efficacy, however, venlafaxine was activation of mania/hypomania, hyponatremia, Monitoring: BP, HR, Ht, Wt, suicidality seizures, increased risk of bleeding events, serum cholestoral elevation, interstitial lung disease and eosinophilic pneumonia Adverse Events: Asthenia, sweating, nausea, constipation, anorexia, vomiting, somnolence, dry mouth, dizziness, nervousness, anxiety, tremor, blurred vision, abnormal ejaculation/orgasm and impotence in men Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011. Medication
Warnings, Precautions, and Adverse Events
Comments
Class: TRICYCLIC ANTIDEPRESSANTS
Nortriptyline
Venlafaxine was compared to a second SSRI in children Warnings and Precautions: Serotonin syndrome, and adolescents with depression who had not responded sustained hypertension, mydriasis, discontinuation to initial treatment with an SSRI (TORDIA study; Brent symptoms — especially anxiety and insomnia, et al, 2008). The second SSRI and venlafaxine showed decreased appetite and weight, height deceleration comparable efficacy, however, venlafaxine was activation of mania/hypomania, hyponatremia, Monitoring: BP, HR, Ht, Wt, suicidality seizures, increased risk of bleeding events, serum cholestoral elevation, interstitial lung disease and eosinophilic pneumonia Adverse Events: Asthenia, sweating, nausea, constipation, anorexia, vomiting, somnolence, dry mouth, dizziness, nervousness, anxiety, tremor, blurred vision, abnormal ejaculation/orgasm and impotence in men Clomipramine
Boxed Warnings: Suicidality The most selectively serotonergic of the TCAs, Warnings and Precautions: Seizures, orthostatic clomipramine is used for refractory OCD. decreases in BP and increases in HR, psychosis, confusion, mania or hypomania, hepatic enzyme increases, hematologic changes, hyperthermia, sexual dysfunction, weight gain, withdrawal symptoms with Monitoring: Orthostatic BP, HR, blood levels, EKGs to rule out Adverse Events: Gastrointestinal, including dry mouth, constipation, nausea, dyspepsia, and anorexia; nervous system complaints, including somnolence, tremor, dizziness, nervousness, and myoclonus; genitourinary complaints, including changed libido, ejaculatory failure, impotence, and micturition disorder; and other miscellaneous complaints, including fatigue, sweating, increased appetite, weight gain, and visual changes Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011. Medication
Warnings, Precautions, and Adverse Events
Comments
Class: OTHER ANTIDEPRESSANTS
Buproprion
Because of its structural similarity to stimulants, bupropion is sometimes used to treat both depression Warnings and Precautions: Seizures, hepatotoxicity, agitation and insomnia, psychosis and confusion, weight gain or loss, allergic reactions, hypertension Adverse Events: Agitation, dry mouth, insomnia, headache/migraine, nausea/vomiting, constipation, Monitoring: BP, HR, HT, WT, suicidality Mirtazapine
Adverse Events: Somnolence, increased appetite, Mirtazapine is a tetra-cyclic atypical antidepressant. It is associated with more somnolence, appetite increase and Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011. Medication
Warnings, Precautions, and Adverse Events
Comments
Class: ANXIOLYTICS
Buspirone (azaspirone anxiolytic)
Buspirone is one of the safest and easiest to monitor of psychiatric medications used to treat children and Warnings: Co-administration with an MAOI can cause elevated blood pressure adolescents. However, two large, multisite 6-week RCTs found no significant differences between Precautions: Interference with cognitive and motor performance, potential for withdrawal reactions in buspirone and placebo with regard to the symptoms of sedative/hypnotic/anxiolytic drug-dependent patients, generalized anxiety disorder (GAD) following doses Monitoring: None beyond general health possible concerns (e.g., a syndrome of restlessness) recommended for the treatment of GAD in adults. shortly after initiation of treatment Lorazepam (benzodiazepine)
Primarily because of the possibility of physical and psychological dependence with prolonged use of Warnings: Worsening or emergence of depression, suicidality, respiratory depression, interference with benzodiazepines, lorazepam is generally recommended cognitive and motor performance, physical and only for short-term use (days to a few weeks) for psychological dependence, risk of use in pregnancy, treatment of acute and severe anxiety following a trauma or preceding a medical procedure. Precautions: Paradoxical reactions (i.e., behavioral disinhibition), should not be used with alcohol. Adverse Events: In a sample of about 3500 adult patients treated for anxiety, the most frequent adverse reaction was sedation (15.9%), followed by dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%) Clonazepam (benzodiazepine)
Clonazepam is similar to lorazepam, except for its shorter half-life and once daily dosing. Warnings: Interference with cognitive and motor performance, suicidality, physical and psychological dependence, risk of use in pregnancy, withdrawal Precautions: Worsening of seizures, hypersalivation, should not be used with alcohol Adverse Events: Somnolence, coordination abnormal, ataxia, depression Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011. Medication
Warnings, Precautions, and Adverse Events
Comments
Class: SECOND GENERATION ANTIPSYCHOTICS
Risperidone
Risperidone was the first second generation antipsychotic (SGA) approved by the FDA (in 1993) for Adult: Schizophrenia, acute manic or mixed episodes associated Warnings and Precautions: Neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia and marketing in the United States. It, along with the other diabetes mellitus, hyperprolactinemia, orthostatic SGAs, is most commonly used to treat bipolar spectrum Child/Adolescent: Schizophrenia (13-17 years), acute manic or hypotension, leucopenia, neutropenia and disorders. It is generally effective and safe for short- mixed episodes (10-17 years), “irritability” associated with agranulocytosis, potential for cognitive and motor term use, but there are concerns about adverse effects of impairment, seizures, dysphagia, priapism, TTP, long-term use, such as obesity, diabetes, metabolic Uses: Schizophrenia spectrum disorders, bipolar spectrum disruption of body temperature regulation, antiemetic disorders, “irritability” in autism effect, suicidality Adverse Events: Most common adverse reactions in Monitoring: HT/WT, glucose, HbA1c, total, LDL, HDL clinical trials (≥10%): somnolence, increased appetite, cholesterol, triglycerides, abnormal involuntary movements fatigue, insomnia, sedation, parkinsonism, akathisia, vomiting, cough, constipation, nasopharyngitis, drooling, rhinorrhea, dry mouth, abdominal pain upper, dizziness, nausea, anxiety, headache, nasal congestion, rhinitis, tremor, rash Quetiapine
Boxed Warnings: Suicidality with antidepressant Marketed since 1997, quetiapine is associated with more Adult: Schizophrenia, manic episodes associated with bipolar I or II disorder Warnings and Precautions: Neuroleptic malignant syndrome, hyperglycemia and diabetes mellitus, Child/Adolescent: Schizophrenia (13-17 years), manic episodes hyperlipidemia, weight gain, tardive dyskinesia, associated with bipolar I disorder (10-17) orthostatic hypotension, increased blood pressure, Uses: Schizophrenia & bipolar spectrum disorders leucopenia, neutropenia and agranulocytosis, cataracts Adverse Events: Most common adverse events in Monitoring: HT/WT, glucose, HbA1c, total, LDL, HDL clinical trials in children and adolescents (incidence cholesterol, triglycerides, abnormal involuntary movements ≥5% and twice placebo): somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased Aripiprazole
Boxed Warnings: Suicidality with antidepressant Marketed since 2002, aripiprazole has a somewhat different mechanism of action than other SGAs. It is Adult: Schizophrenia, acute treatment-manic or mixed episodes associated with less weight gain than other SGAs except of bipolar I disorder, maintenance treatment-bipolar I disorder, Warnings and Precautions: Neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia and diabetes mellitus, orthostatic hypotension, leucopenia, Child/Adolescent: Schizophrenia (13-17 yrs), manic or mixed episodes (10-17 yrs), “irritability” associated with autistic seizures/convulsions, potential for cognitive and Adverse Events: Most common adverse reactions in Uses: Schizophrenia & bipolar spectrum disorders, “irritability” clinical trials in children and adolescents (incidence ≥5% and twice placebo): somnolence, extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision, Monitoring: HT/WT, glucose, HbA1c, total, LDL, HDL salivary hypersecretion, dizziness , tremor, sedation, cholesterol, triglycerides, abnormal involuntary movements Ziprasidone
Marketed since 2001, ziprasidone is associated with less weight gain than other SGAs. Because of its potential Adult: Schizophrenia, manic or mixed episodes associated with Warnings and Precautions: QT interval prolongation, neuroleptic malignant syndrome, to prolong the QT interval, ECG monitoring is needed. bipolar I disorder, adjunctive maintenance therapy of bipolar I tardive dyskinesia, hyperglycemia and diabetes disorder, agitation in schizophrenic patients (intramuscular mellitus, rash, orthostatic hypotension, leucopenia, neutropenia and agranulocytosis, seizures, potential Uses: Schizophrenia and bipolar spectrum disorders Adverse Events: Most common adverse reactions in clinical trials (incidence ≥5% and twice placebo): Monitoring: HT/WT, glucose, HbA1c, total, LDL, HDL Somnolence, extrapyramidal symptoms, dizziness, cholesterol, triglycerides, abnormal involuntary movements, QTc akathisia, abnormal vision, asthenia, vomiting Olanzapine
Marketed since 1996, olanzapine is associated with more weight gain and related metabolic side effects in Adult: Schizophrenia, acute treatment of manic or mixed Warnings and Precautions: Suicide, neuroleptic malignant syndrome, hyperglycemia, hyperlipidemia, adolescents than other SGAs (Sikich et al 2008; Correll episodes associated in bipolar I disorder weight gain, tardive dyskinesia, orthostatic Child/Adolescent: Schizophrenia (13-17 years), manic or mixed hypotension, leucopenia, neutropenia and episodes of bipolar I disorder (13-17 years) agranulocytosis, seizures, potential for cognitive and Uses: Schizophrenia & bipolar spectrum disorders motor impairment, hyperprolactinemia. Adverse Events: Most common adverse reactions in Monitoring: HT/WT, glucose, HbA1c, total, LDL, HDL clinical trials of adolescents (≥5% and at least twice cholesterol, triglycerides, abnormal involuntary movements that for placebo): sedation, weight increased, headache, increased appetite, dizziness, abdominal pain, pain in extremity, fatigue, dry mouth. Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011. Medication
Warnings, Precautions, and Adverse Events
Comments
Class: FIRST GENERATION ANTIPSYCHOTICS
Perphenazine
Perphenazine, a “mid-potency” antipsychotic, was shown to have comparable effectiveness as the SGAs in Warnings and Precautions: Tardive dyskinesia, neuroleptic malignant syndrome, leucopenia, a large study of adults with schizophrenia (the “CATIE” neutropenia, agranulocytosis, hyperprolactinemia, study; Lieberman et al. 2005). In the CATIE study, Uses: Schizophrenia spectrum disorders, bipolar spectrum potential for cognitive/motor impairment, impaired perphenazine was associated with less weight gain and metabolic side effects than the SGAs. Adverse Events: Acute dystonic reaction, Monitoring: HT/WT, glucose, HbA1c, cholesterol extrapyramidal symptoms, withdrawal-emergent (total/LDL/HDL), triglycerides, liver enzymes, abnormal dyskinesia, akathisia, somnolence, drowsiness, autonomic effects (e.g., dry mouth, GI upset, blurry vision) Haloperidol
Haloperidol, a “high potency” antipsychotic, has been marketed in the US for over 50 years; it was the most Adult: Schizophrenia, control of tics in Tourette’s Disorder Warnings and Precautions: QT interval prolongation, tardive dyskinesia, neuroleptic malignant syndrome, commonly prescribed antipsychotic in children and leucopenia, neutropenia and agranulocytosis, adolescents prior to the introduction of the SGAs in the hyperprolactinemia, seizures, potential for cognitive 1990s. It is associated with more neurologic adverse Uses: Schizophrenia spectrum disorders, bipolar spectrum and motor impairment, impaired liver function events, but less weight gain and metabolic adverse Adverse Events: Acute dystonic reaction, extrapyramidal symptoms, withdrawal emergent Monitoring: HT/WT, glucose, HbA1c, total, LDL, HDL dyskinesia, akathisia, somnolence, drowsiness, cholesterol, triglycerides, liver enzymes, abnormal involuntary various autonomic effects (e.g., dry mouth, GI upset, Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011. Medication
Warnings, Precautions, and Adverse Events
Comments
Class: MOOD STABILIZERS
Lithium (Element of the alkali-metal group)
Boxed Warnings: Toxicity closely related to serum Introduced in the US in the early 1960s, it was the levels; can occur close to therapeutic dose levels original mood stablilizer. It has clear, documented Manic episodes of bipolar disorder, maintenance treatment evidence of effectiveness for acute and maintenance Warnings: Very high risk of toxicity: significant cardiovascular or renal disease, severe debilitation, treatment for mania and bipolar disorder in adults. Child/Adolescent: Appears to have “grandfathered” indication dehydration, sodium depletion, taking diuretics or There has been no well-powered study for mania in angiotensin converting enzyme (ACE) inhibitors. children and adolescents, in large part because of the Uses: Acute mania in bipolar disorder, also maintenance therapy Chronic use may lower renal concentrating ability, ethical and practical difficulties with doing placebo- can present as nephrogenic diabetes insipidus, with controlled studies. Evidence is mixed from several Monitoring: Pregnancy testing, serum levels, ECG, CBC, thyroid polyuria/polydipsia. Encephalopathic syndrome (i.e., smaller studies (Geller et al 1998, Kafantaris et al 2004, weakness, lethargy, fever, tremulousness and Kowatch et al 2007). Its indication for 12-17 year olds confusion, leukocytosis, extrapyramidal symptoms, is not based on rigorous safety and efficacy data. elevated serum enzymes, BUN and FBS) may occur Unpopular with children and adolescents because of with lithium and a neuroleptic, often haloperidol. common side effects and the need for repeated Precautions: Hypothyroidism, impaired mental or venipunctures for serum level monitoring. physical abilities, any concomitant medications, i.e., diuretics, ACE inhibitors, carbamazepine, fluoxetine Adverse Events: Mild <1.5 mEq/L; Mild/moderate 1.5-2.5 mEq/L; Moderate/severe ≥2.0 mEq/L. <2.0 mEq/L: early signs of toxicity-diarrhea, vomiting, drowsiness, muscular weakness and lack of coordination; At higher levels: giddiness, ataxia, blurred vision, tinnitus, large output of dilute urine; At >3.0 mEq/L: complex clinically with multiple organs and organ systems Valproic Acid (anticonvulsant)
Boxed Warnings: Hepatotoxicity — can be fatal, Valproic acid to treat mania in adults is supported by usually in first 6 months of use in children <2 years. substantial data. A yet unpublished, 24-week RCT had Adult: Acute treatment of manic episodes associated with bipolar Teratogenic, includes neural tube defects, e.g., spina response rates of divalproex = 54%, lithium = 42% and disorder, therapy of complex partial seizures and simple and bifida. Pancreatitis — can be fatal, hemorrhagic cases placebo = 29% (Kowatch et al 2007). A recent, complex absence seizures, prophylaxis of migraine headaches industry-funded, multisite RCT in youth with mania and Child/Adolescent: None for psychiatric disorders Warnings and Precautions: Suicidality, thrombocytopenia, multiorgan hypersensitivity bipolar disorder did not show efficacy of valproic acid reaction, hypothermia, hyperammonemia, CNS versus placebo (Wagner et al 2009). The usefulness of “depression” when used with sedating drugs. Hepatic valproic acid in child psychiatric disorders is debatable Monitoring: Pregnancy testing, serum levels, CBC, liver function enzyme induction can affect many other drug levels given that the only published RCT of valproate for Adverse Events: Most common adverse reactions in clinical trials of mania (incidence ≥5% & >5% above placebo): Nausea, vomiting, somnolence, dizziness Carbamazepine/Oxycarbamazepine (anticonvulsant)
Boxed Warnings: Serious, potentially fatal Carbamazepine was introduced in the US in 1968 for dermatologic reactions (toxic epidermal necrolysis treatment of seizures but has well-documented efficacy and Stevens-Johnson Syndrome), aplastic anemia, for treating mania in bipolar disorder in adults. There Child/Adolescent: None for psychiatric disorders have been no RCTs in children and adolescents with Warnings and Precautions: Suicidality. Can affect bipolar disorder. The medication can be difficult to manage because of its numerous drug interactions Monitoring: CBC with platelets, serum levels, Chinese ancestry- test for HLA-B*1502 before starting treatment Adverse Events: The most frequently observed adverse reactions, particularly during the initial phases of therapy, are dizziness, drowsiness, unsteadiness, nausea, and vomiting Lamotrigine (anticonvulsant)
Box Warnings: Life-threatening rash (e.g., Stevens- There are no RCTs of lamotrigine in children and Johnson syndrome), toxic epidermal necrolysis, Adult: Maintenance treatment of bipolar disorder, including higher risk in: youth than adults, use with valproate, exceed recommended initial dose/dose escalation. May be benign — unable to predict if serious rash, stop at first sign unless clearly not drug-related. Warnings and Precautions: Hypersensitivity reaction, Monitoring: CBC and liver function studies suicidality, acute multiorgan failure, blood dyscrasias, clinicial worsening and emergence of new symptoms in bipolar disorder, aseptic meningitis, medication errors because of name similarities to other drugs Adverse Events: >5% in adult bipolar studies: nausea, insomnia, somnolence, back/abdominal pain, fatigue, rhinitis, xerostomia Compiled by Mark A. Riddle, MD, and Susan dosReis, PhD, Center for Mental Health Services in Pediatric Primary Care, Johns Hopkins School of Public Health. Updated July 2011.

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