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QUEtiapine

Pronunciation

Pronunciation

(kwe TYE a peen)

Index Terms

  • Quetiapine Fumarate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

SEROquel: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg

Generic: 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg

Tablet Extended Release 24 Hour, Oral:

SEROquel XR: 50 mg, 150 mg, 200 mg, 300 mg, 400 mg

Brand Names: U.S.

  • SEROquel
  • SEROquel XR

Pharmacologic Category

  • Second Generation (Atypical) Antipsychotic

Pharmacology

Quetiapine is a dibenzothiazepine atypical antipsychotic. It has been proposed that this drug's antipsychotic activity is mediated through a combination of dopamine type 2 (D2) and serotonin type 2 (5-HT2) antagonism. It is an antagonist at multiple neurotransmitter receptors in the brain: Serotonin 5-HT1A and 5-HT2, dopamine D1 and D2, histamine H1, and adrenergic alpha1- and alpha2-receptors; but appears to have no appreciable affinity at cholinergic muscarinic and benzodiazepine receptors. Norquetiapine, an active metabolite, differs from its parent molecule by exhibiting high affinity for muscarinic M1 receptors.

Antagonism at receptors other than dopamine and 5-HT2 with similar receptor affinities may explain some of the other effects of quetiapine. The drug's antagonism of histamine H1-receptors may explain the somnolence observed. The drug's antagonism of adrenergic alpha1-receptors may explain the orthostatic hypotension observed.

Absorption

Rapidly absorbed following oral administration; high-fat meals (800 to 1000 calories) increase Cmax 8% and AUC 2% of quetiapine XR; light meals (300 calories) had no effect; parent compound AUC and Cmax were 41% and 39% lower, respectively, in pediatric patients (10-17 years) compared to adults when adjusted for weight, but pharmacokinetics of active metabolite were similar to adult values after adjusting for weight.

Distribution

Vd: 10 ± 4 L/kg

Metabolism

Primarily hepatic; via CYP3A4; forms the metabolite N-desalkyl quetiapine (active) and two inactive metabolites [sulfoxide metabolite (major metabolite) and parent acid metabolite]

Excretion

Urine (73% as metabolites, <1% of total dose as unchanged drug); feces (20%)

Time to Peak

Children and Adolescents 12 to 17 years: Immediate release: 0.5-3 hours (McConville 2000)

Adults: Plasma: Immediate release: 1.5 hours; Extended release: 6 hours

Half-Life Elimination

Children and Adolescents 12 to 17 years: Quetiapine: 5.3 hours (McConville 2000)

Adults: Mean: Terminal: Quetiapine: ~6 hours; Extended release: ~7 hours

Metabolite: N-desalkyl quetiapine: 12 hours

Protein Binding

Plasma: 83%

Special Populations: Renal Function Impairment

CrCl 10 to 30 mL/minute had 25% lower clearance; plasma concentrations were within the range of concentrations seen in normal subjects.

Special Populations: Hepatic Function Impairment

30% lower clearance; AUC and Cmax is threefold higher.

Special Populations: Elderly

Clearance reduced 40%.

Use: Labeled Indications

Bipolar disorder: Acute treatment of manic (both immediate release and extended release [ER]) or mixed (ER only) episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex; maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex; acute treatment of depressive episodes associated with bipolar disorder

Major depressive disorder (ER only): Adjunctive therapy to antidepressants for the treatment of major depressive disorder.

Schizophrenia: Treatment of schizophrenia.

Use: Unlabeled

Delirium in the critically-ill patient; psychosis/agitation related to Alzheimer's dementia; augmentation in treatment-resistant obsessive compulsive disorder

Contraindications

Hypersensitivity to quetiapine or any component of the formulation

Dosing: Adult

Bipolar disorder: Oral:

Depressive episodes: Note: In clinical trials, doses up to 600 mg/day were not associated with any further benefit compared to 300 mg/day.

Immediate release: Initial: 50 mg once daily at bedtime on day 1; increase to 100 mg once daily on day 2, further increase by 100 mg daily each day until 300 mg once daily is reached by day 4. Usual dose: 300 mg once daily; maximum dose: 300 mg once daily.

Extended release: Initial: 50 mg once daily on day 1; increase to 100 mg once daily on day 2, further increase by 100 mg once daily until 300 mg once daily is reached by day 4. Usual dose: 300 mg once daily; maximum dose: 300 mg once daily (US labeling) or 600 mg once daily (Canadian labeling).

Mania (monotherapy or as an adjunct to lithium or divalproex): Immediate release: Initial: 50 mg twice daily on day 1, further increase by 100 mg daily (administered twice daily) until 200 mg twice daily is reached by day 4; may further increase to 800 mg daily by day 6 in increments of ≤200 mg daily. Usual dosage range: 400 to 800 mg daily; maximum dose: 800 mg daily.

Manic or mixed (monotherapy or as an adjunct to lithium or divalproex): Extended release: Initial: 300 mg once daily on day 1; increase to 600 mg once daily on day 2 then adjust dose to between 400 to 800 mg once daily on day 3; usual dosage range: 400 to 800 mg once daily; maximum dose: 800 mg once daily.

Maintenance therapy (adjunct to lithium or divalproex): Immediate release or extended release: Usual dosage range: 400 to 800 mg daily; maximum dose: 800 mg daily. Note: In the maintenance phase, patients generally continue on the same dose on which they were stabilized. Average time of stabilization was 15 weeks in clinical trials. During maintenance treatment, periodically reassess need for continued therapy and the appropriate dose.

Major depressive disorder (adjunct to antidepressants): Oral: Extended release: Initial: 50 mg once daily on days 1 and 2; increase to 150 mg once daily on day 3. Usual dosage range: 150 to 300 mg daily; maximum dose: 300 mg once daily.

Schizophrenia: Oral:

Immediate release: Initial: 25 mg twice daily; increase in increments of 25 to 50 mg divided 2 to 3 times daily on days 2 and 3 to a range of 300 to 400 mg daily in 2 to 3 divided doses by day 4. Further adjustments as needed at intervals of at least 2 days in increments of 25 to 50 mg twice daily. Usual dosage range: 150 to 750 mg daily; maximum dose: 750 mg daily.

Extended release: Initial: 300 mg once daily; increase in increments of up to 300 mg once daily (in intervals of ≥1 day). Usual dosage range: 400 to 800 mg once daily; maximum dose: 800 mg once daily.

Maintenance therapy (monotherapy): Extended release: Usual dosage range: 400 to 800 mg once daily; maximum dose: 800 mg once daily. Note: During maintenance treatment, periodically reassess need for continued therapy and the appropriate dose.

Delusional parasitosis (off-label use): Oral: Initial: Immediate release:12.5 mg at bedtime; increase every 3 to 7 days based on response and tolerability up to 200 to 300 mg at bedtime or in divided doses. Maximum: 800 mg/day (Balsco-Fontecilla 2005; Freudenmann 2008; Heller 2013; Milia 2008). Additional data may be necessary to further define the role of quetiapine in this condition.

Generalized anxiety disorder, monotherapy (off-label): Oral: Extended release: Initial: 50 mg once daily at bedtime; based on response and tolerability, after 3 days increase dose to 150 mg once daily at bedtime; further dosage adjustments up to 300 mg once daily at bedtime may be considered after at least 2 days of 150 mg daily (Bandelow 2010; Katzman 2011; Merideth 2012).

ICU delirium (off-label use): Oral: Immediate release: Initial: 50 mg twice daily; may increase as necessary on a daily basis in increments of 50 mg twice daily to a maximum dose of 400 mg daily (Devlin 2010)

Obsessive-compulsive disorder, treatment-resistant (augmentation; off-label use): Oral: Immediate release: Initial: 25 to 50 mg once daily; increased gradually based on response and tolerability up to 400 mg/day (Atmaca 2002; Denys 2004; Fineberg 2005).

Post-traumatic stress disorder (off-label use): Oral: Immediate release: Initial: 25 mg at bedtime; increase dose at 25 mg increments every 1 to 2 days up to 100 mg at bedtime by the end of week 1; further adjust dose based on response and tolerability at increments of 25 mg/day or up to 100 mg/week, to a maximum dose of 400 mg/day administered in 1 or 2 divided doses. Average dose in clinical trials: 100 to 200 mg/day (range 25 to 400 mg/day) (Ahearn 2006; Hamner 2003; Kozaric-Kovacic 2007).

Switching from immediate release to extended release: May convert patients from immediate release to extended release tablets at the equivalent total daily dose and administer once daily; individual dosage adjustments may be necessary.

Reinitiation of treatment: Patients who have discontinued therapy for >1 week should generally be retitrated following reinitiation of therapy; patients who have discontinued <1 week, can generally be reinitiated on their previous maintenance dose

Dosage adjustment for concomitant therapy:

Concomitant use with a strong CYP3A4 inhibitor (eg, ketoconazole, itraconazole, indinavir, ritonavir, nefazodone): Immediate release or extended release: Decrease quetiapine to one-sixth of the original dose; when strong CYP3A4 inhibitor is discontinued, increase quetiapine by sixfold.

Concomitant use with a strong CYP3A4 inducer (eg, phenytoin, carbamazepine, rifampin, St John’s wort): Immediate release or extended release: Increase quetiapine up to fivefold of the original dose when combined with chronic treatment (>7 to 14 days) of a strong CYP3A4 inducer; titrate based on clinical response and tolerance; when the strong CYP3A4 inducer is discontinued, decrease quetiapine to the original dose within 7 to 14 days.

Dosing: Geriatric

Bipolar disorder or schizophrenia: Oral: Immediate release and extended release: Initial: 50 mg daily; may increase in increments of 50 mg daily to an effective dose, based on individual clinical response and tolerability

Major depressive disorder (adjunct to antidepressants): Oral:

US labeling: Extended release: 50 mg once daily; may increase by 50 mg once daily to an effective dose, based on individual clinical response and tolerability

Canadian labeling: Extended release: 50 mg once daily on days 1 to 3, based on response and tolerability, may increase to 100 mg/day on day 4 and 150 mg/day on day 8

Psychosis/agitation related to Alzheimer disease and other dementias (off-label use): Oral: Immediate release: Initial: 12.5 to 50 mg daily; if necessary, gradually increase based on response and tolerability not to exceed 200 to 300 mg daily. Consider periodic dosage adjustments to reduce or discontinue therapy as clinically indicated (APA [Rabins 2007]; Fujikawa 2004; McManus 1999; Scharre 2002).

Psychosis in Parkinson disease (off-label use): Oral: Immediate release: Initial: 25 mg daily in 1 to 2 divided doses; adjust dose gradually based on response and tolerability up to 200 mg daily; mean dose in clinical trials was ~91 mg daily (Merims 2006; Morgante 2004). Additional data may be necessary to further define the role of quetiapine in this condition.

Switching from immediate release to extended release: Refer to adult dosing.

Reinitiation of treatment: Refer to adult dosing.

Dosage adjustment for concomitant therapy: Refer to adult dosing.

Dosing: Pediatric

Note: Not approved for use in pediatric patients <18 years in Canadian labeling.

Bipolar disorder: Children ≥10 years and Adolescents ≤17 years: Oral: Mania (monotherapy):

Immediate release: Initial: 25 mg twice daily on day 1; increase to 50 mg twice daily on day 2, then increase by 100 mg daily (administered twice daily) each day until 200 mg twice day is reached on day 5. May further increase up to 600 mg daily in increments of ≤100 mg daily. Usual dosage range: 400 to 600 mg daily; maximum: 600 mg daily. Note: Total daily doses may also be divided into 3 doses per day, based on response and tolerability.

Extended release: Initial: 50 mg once daily on day 1; increase to 100 mg once daily on day 2, further increase by 100 mg once daily until 400 mg once daily is reached on day 5. Usual dosage range: 400 to 600 mg once daily; maximum dose: 600 mg once daily.

Schizophrenia: Adolescents 13 to ≤17 years: Oral:

Immediate release: Initial: 25 mg twice daily on day 1; increase to 50 mg twice daily on day 2, further increase by 100 mg daily each day (divided twice daily) until 400 mg twice daily is reached on day 5. May further increase up to 800 mg daily in increments of ≤100 mg daily. Usual dosage range: 400 to 800 mg daily; maximum dose: 800 mg daily. Note: Total daily doses may also be divided into 3 doses per day, based on response and tolerability.

Extended release: Initial: 50 mg once daily on day 1; increase to 100 mg once daily on day 2, further increase by 100 mg once daily until 400 mg once daily is reached on day 5. Usual dosage range: 400 to 800 mg once daily; maximum dose: 800 mg once daily.

Switching from immediate release to extended release: Refer to adult dosing.

Reinitiation of treatment: Refer to adult dosing.

Dosage adjustment for concomitant therapy: Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment necessary.

Dosing: Hepatic Impairment

Immediate release tablet: Initial: 25 mg daily, increase dose by 25 to 50 mg daily to effective dose, based on individual clinical response and tolerability

Extended release tablet: Initial: 50 mg once daily; increase dose by 50 mg once daily to effective dose, based on individual clinical response and tolerability

Administration

Oral:

Immediate release tablet: Administer with or without food.

Extended release tablet: Administer without food or with a light meal (≤300 calories), preferably in the evening. Swallow tablet whole; do not break, crush, or chew.

Nasogastric/enteral tube (off-label route): Hold tube feeds for 30 minutes before administration; flush with 25 mL of sterile water. Crush dose using immediate-release formulation, mix in 10 mL water and administer via NG/enteral tube; follow with a 50 mL flush of sterile water (Devlin 2010).

Dietary Considerations

Administer extended release tablet without food or with a light meal (≤300 calories).

Storage

Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).

Drug Interactions

AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy

Acetylcholinesterase Inhibitors (Central): May enhance the neurotoxic (central) effect of Antipsychotic Agents. Severe extrapyramidal symptoms have occurred in some patients. Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy

Amisulpride: Antipsychotic Agents may enhance the adverse/toxic effect of Amisulpride. Avoid combination

Amphetamines: Antipsychotic Agents may diminish the stimulatory effect of Amphetamines. Monitor therapy

Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy

Anti-Parkinson Agents (Dopamine Agonist): Antipsychotic Agents (Second Generation [Atypical]) may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Management: Consider using an alternative antipsychotic agent when possible in patients with Parkinson disease. If an atypical antipsychotic is necessary, consider using clozapine or quetiapine, which may convey the lowest interaction risk. Consider therapy modification

Aprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy

Bosentan: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

CarBAMazepine: QUEtiapine may increase serum concentrations of the active metabolite(s) of CarBAMazepine. CarBAMazepine may decrease the serum concentration of QUEtiapine. Management: Quetiapine dose increases to as much as 5 times the regular dose may be required to maintain therapeutic benefit. Reduce the quetiapine dose back to the previous/regular dose within 7 to 14 days of discontinuing carbamazepine. Consider therapy modification

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination

Clarithromycin: May enhance the QTc-prolonging effect of QUEtiapine. Clarithromycin may increase the serum concentration of QUEtiapine. Avoid combination

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of QUEtiapine. Management: Quetiapine dose increases to as much as 5 times the regular dose may be required to maintain therapeutic benefit. Reduce the quetiapine dose back to the previous/regular dose within 7-14 days of discontinuing the inducer. Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of QUEtiapine. Management: In quetiapine treated patients, reduce the quetiapine dose to one sixth of the regular dose following strong CYP3A4 inhibitor initiation. In patients receiving strong CYP3A4 inhibitors, initiate quetiapine at the lowest dose and up-titrate as needed. Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Dimethindene: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates. Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination

Highest Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of other Highest Risk QTc-Prolonging Agents. Avoid combination

HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Consider starting with a 20% to 30% lower hydrocodone dose when using together with any other CNS depressant. Dose reductions in the other CNS depressant may also be warranted. Consider therapy modification

Idelalisib: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Indapamide: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Consider therapy modification

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy

Ivabradine: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination

Luliconazole: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Methadone: May enhance the QTc-prolonging effect of QUEtiapine. QUEtiapine may increase the serum concentration of Methadone. Avoid combination

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification

Methylphenidate: Antipsychotic Agents may enhance the adverse/toxic effect of Methylphenidate. Methylphenidate may enhance the adverse/toxic effect of Antipsychotic Agents. Monitor therapy

Metoclopramide: May enhance the adverse/toxic effect of Antipsychotic Agents. Avoid combination

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy

MetyroSINE: May enhance the adverse/toxic effect of Antipsychotic Agents. Monitor therapy

MiFEPRIStone: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates. Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Moderate Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Netupitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: When oxycodone is combined with another CNS depressant, a dose reduction of one or both agents should be considered. The extended release oxycodone starting dose should be reduced 50% to 67% when initiated in patients already receiving CNS depressants. Consider therapy modification

Palbociclib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification

Piribedil [INT]: Antipsychotic Agents may diminish the therapeutic effect of Piribedil [INT]. Piribedil [INT] may diminish the therapeutic effect of Antipsychotic Agents. Management: Use of piribedil with antiemetic neuroleptics is contraindicated, and use with antipsychotic neuroleptics, except for clozapine, is not recommended. Avoid combination

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification

QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification

Quinagolide: Antipsychotic Agents may diminish the therapeutic effect of Quinagolide. Monitor therapy

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy

RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy

Ritonavir: May increase the serum concentration of QUEtiapine. Management: The ritonavir Canadian labeling states this combination should not be used. U.S. labeling recommends using an alternative when possible; if the combination must be used, quetiapine dose reductions are needed. Consider therapy modification

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. Consider therapy modification

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy

Serotonin Modulators: May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Exceptions: Nicergoline. Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification

St John's Wort: QUEtiapine may enhance the serotonergic effect of St John's Wort. This could result in serotonin syndrome. St John's Wort may decrease the serum concentration of QUEtiapine. Management: Quetiapine dose increases to as much as 5 times the regular dose may be required to maintain therapeutic benefit. Reduce the quetiapine dose back to the previous/regular dose within 7-14 days of discontinuing the inducer. Monitor closely. Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates. Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Sulpiride: Antipsychotic Agents may enhance the adverse/toxic effect of Sulpiride. Avoid combination

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Start tapentadol at a dose of one-third to one-half of the normal dose if being initiated in a patient who is taking another drug with CNS depressant effects. Monitor closely for evidence of excessive CNS depression. Consider therapy modification

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Vinflunine: May enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification

Test Interactions

May interfere with urine detection of methadone (false-positives); may cause false-positive serum TCA screen

Adverse Reactions

Actual frequency may be dependent upon dose and/or indication. Unless otherwise noted, frequency of adverse effects is reported for adult patients; spectrum and incidence of adverse effects similar in children (with significant exceptions noted).

>10%:

Cardiovascular: Hypertension (diastolic; children and adolescents 41%; adults 2%), systolic hypertension (children and adolescents 15%), tachycardia (1% to 11%)

Central nervous system: Drowsiness (16% to 57%), headache (17% to 21%), agitation (6% to 20%), dizziness (7% to 19%), fatigue (3% to 14%), extrapyramidal reaction (1% to 13%)

Endocrine & metabolic: Weight gain (dose related; 3% to 28%), increased serum triglycerides (≥200 mg/dL, 8% to 22%), decreased HDL cholesterol (≤40 mg/dL, 6% to 20%), total cholesterol increased (≥240 mg/dL, 7% to 18%), increased LDL cholesterol (≥160 mg/dL, 4% to 12%), hyperglycemia (≥200 mg/dL post glucose challenge or fasting glucose ≥126 mg/dL, 2% to 3%)

Gastrointestinal: Xerostomia (7% to 44%; children and adolescents 4% to 10%), increased appetite (2% to 12%), constipation (2% to 11%)

1% to 10%:

Cardiovascular: Orthostatic hypotension (2% to 7%; children and adolescents <1%), palpitations (4%), peripheral edema (4%), increased heart rate (2% to 4%), hypotension (3%), hypertension (1% to 2%), syncope (1% to 2%)

Central nervous system: Pain (7%), drug-induced Parkinson's disease (2% to ≤6%), lethargy (5%), dysarthria (2% to 5%), irritability (2% to 5%), akathisia (1% to 5%), hypertonia (4%), twitching (4%), anxiety (2% to 4%), abnormal dreams (2% to 3%), hypersomnia (2% to 3%), paresthesia (2% to 3%), aggressive behavior (children and adolescents 1% to 3%), depression (1% to 3%), dystonic reaction (1% to 3%), abnormality in thinking (2%), ataxia (2%), confusion (2%), decreased mental acuity (2%), disorientation (2%), disturbance in attention (2%), falling (2%), hypoesthesia (2%), lack of concentration (2%), migraine (2%), restless leg syndrome (2%), restlessness (2%), vertigo (2%)

Dermatologic: Skin rash (4%), acne vulgaris (children and adolescents 2% to 3%), diaphoresis (2%), pallor (children and adolescents 1% to 2%)

Endocrine & metabolic: Hyperprolactinemia (4%), increased thirst (children and adolescents 2%), decreased libido (≤2%), hypothyroidism (≤2%)

Gastrointestinal: Nausea (5% to 10%), vomiting (1% to 8%), dyspepsia (dose related; 2% to 7%), abdominal pain (1% to 7%), gastroenteritis (2% to 4%), toothache (2% to 3%), anorexia (1% to 3%), periodontal abscess (adolescents 1% to 3%), decreased appetite (2%), dysphagia (2%), flatulence (2%), gastroesophageal reflux disease (2%)

Genitourinary: Pollakiuria (2%), urinary tract infection (2%)

Hematologic & oncologic: Neutropenia (≤2%), leukopenia (≥1%)

Hepatic: Increased serum transaminases (1% to 6%)

Hypersensitivity: Seasonal allergy (2%)

Neuromuscular & skeletal: Weakness (1% to 10%), tremor (2% to 8%), back pain (1% to 5%), dyskinesia (3% to 4%), arthralgia (1% to 4%), muscle rigidity (3%), muscle spasm (1% to 3%), stiffness (children and adolescents 1% to 3%), limb pain (2%), myalgia (2%), neck pain (2%)

Ophthalmic: Blurred vision (1% to 4%), amblyopia (2% to 3%)

Otic: Otalgia (2%)

Respiratory: Pharyngitis (4% to 6%), nasal congestion (3% to 6%), rhinitis (3% to 4%), epistaxis (adolescents 3%), sinus congestion (2% to 3%), upper respiratory tract infection (2% to 3%), cough (≥1% to 3%), dyspnea (≥1% to 3%), sinus headache (2%), sinusitis (2%), influenza (1% to 2%)

Miscellaneous: Fever (2%)

<1% (Limited to important or life-threatening): Abnormality of blepharitis, abnormal T waves on ECG, accommodation, acute hepatic failure, acute renal failure, agranulocytosis, alcohol intolerance, amenorrhea, amnesia, anemia, angina pectoris, apathy, aphasia, arthritis, atrial fibrillation, atrioventricular block, bone pain, bruxism, buccoglossal syndrome, bundle branch block, cardiac failure, cardiomyopathy, cataract, catatonic reaction, cerebrovascular accident, choreoathetosis, cyanosis, cystitis, deafness, deep vein thrombophlebitis, dehydration, delirium, delusions, depersonalization, diabetes mellitus, dysmenorrhea, dysuria, ecchymosis, eosinophilia, facial edema, first degree atrioventricular block, flattened T wave on ECG, galactorrhea, glossitis, hemiplegia, hemolysis, hepatic injury (cholestatic or mixed), hepatitis (with or without jaundice), hyperkinesia, hyperlipemia, hypersensitivity, hyperthyroidism, hyperventilation, hypochromic anemia, hypoglycemia, increased creatinine phosphokinase, increased gamma-glutamyl transferase, increased libido, increased QRS duration, increased salivation, increased serum alkaline phosphatase, increased ST segment on ECG, intestinal obstruction, irregular pulse, leukocytosis, leukorrhea, liver steatosis, lymphadenopathy, malaise, manic reaction, melena, myasthenia, myocarditis, myoclonus, neuralgia, neuroleptic malignant syndrome, orchitis, pancreatitis, paranoid reaction, pathological fracture, pelvic pain, pneumonia, priapism, prolonged Q-T interval on ECG, pruritus, psoriasis, psychosis, rectal hemorrhage, rhabdomyolysis, seborrhea, seizure, SIADH, stomatitis, ST segment changes on ECG, stupor, subdural hematoma, suicidal ideation, tardive dyskinesia, thrombocytopenia, thrombophlebitis, tongue edema, uterine hemorrhage, vaginal hemorrhage, vaginitis, vasodilatation, vulvovaginal moniliasis, vulvovaginitis, widened QRS complex on ECG

ALERT: U.S. Boxed Warning

Increased mortality in elderly patients with dementia-related psychosis:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Quetiapine is not approved for the treatment of patients with dementia-related psychosis.

Suicidal thoughts and behavior:

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients older than 24 years; there was a reduction in risk with antidepressant use in patients 65 years and older. In patients of all ages who are started on antidepressant therapy, monitor closely for clinical worsening and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. Quetiapine is not approved for use in pediatric patients younger than 10 years.

Warnings/Precautions

Major psychiatric warnings:

• Suicidal thinking/behavior: [US 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. Closely monitor all 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 (increased 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. Quetiapine is not approved in the US for use in children <10 years of age.

- The possibility of a suicide attempt is inherent in major depression and may persist until remission occurs. Patients treated with antidepressants (for any indication) 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:

• Anticholinergic effects: May cause anticholinergic effects (confusion, agitation, constipation, xerostomia, blurred vision, urinary retention); use with caution in patients with decreased gastrointestinal motility, urinary retention, BPH, xerostomia, or visual problems. Relative to other antipsychotics, quetiapine has a moderate potency of cholinergic blockade.

• Blood dyscrasias: Leukopenia, neutropenia, and agranulocytosis (sometimes fatal) have been reported with antipsychotic use; presence of risk factors (eg, pre-existing low WBC or history of drug-induced leuko-/neutropenia) should prompt periodic blood count assessment. Discontinue therapy at first signs of blood dyscrasias or if absolute neutrophil count <1000/mm3.

• Cataracts: Use has been noted to cause cataracts in animals; lens changes have been observed in humans during long-term treatment. Lens examination, such as a slit-lamp exam, on initiation of therapy and every 6 months is recommended by manufacturer.

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery or driving).

• Esophageal dysmotility/aspiration: Antipsychotic use has been associated with esophageal dysmotility and aspiration; use with caution in patients at risk of aspiration pneumonia (ie, Alzheimer's disease).

• Extrapyramidal symptoms (EPS): May cause extrapyramidal symptoms, including pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia (risk of these reactions is generally much lower relative to typical/conventional antipsychotics). Risk of dystonia (and probably other EPS) may be greater with increased doses, use of conventional antipsychotics, males, and younger patients.

• Hyperglycemia: Atypical antipsychotics have been associated with development of hyperglycemia; in some cases, may be extreme and associated with ketoacidosis, hyperosmolar coma, or death. All patients should be monitored for symptoms of hyperglycemia (eg, polydipsia, polyuria, polyphagia, weakness) and undergo a fasting blood glucose test if symptoms develop during treatment. Patients with risk factors for diabetes (eg, obesity or family history) should have a baseline fasting blood sugar (FBS) and periodically during treatment.

• Hyperlipidemia: Increases in cholesterol and triglycerides have been noted. Use with caution in patients with pre-existing abnormal lipid profile.

• Hyperprolactinemia: May increase prolactin levels; clinical significance of hyperprolactinemia in patients with breast cancer or other prolactin-dependent tumors is unknown.

• Hypersensitivity: Anaphylactic reactions have been reported.

• Hypothyroidism: May cause dose-related decreases in thyroid levels, including cases requiring thyroid replacement therapy. Reversal of thyroid effects occurred in almost all cases following discontinuation. Measure both TSH and free T4, along with clinical assessment, at baseline and follow-up to determine thyroid status; measurement of TSH alone may not be accurate (exact mechanism of quetiapine’s effect on the thyroid axis is unknown).

• Neuroleptic malignant syndrome (NMS): Use may be associated with neuroleptic malignant syndrome (NMS); monitor for mental status changes, fever, muscle rigidity and/or autonomic instability. Rare cases have been reported with quetiapine.

• Orthostatic hypotension: May cause orthostatic hypotension; use with caution in patients at risk of this effect or in those who would not tolerate transient hypotensive episodes (cerebrovascular disease, cardiovascular disease, dehydration, hypovolemia, or concurrent medication use which may predispose to hypotension/bradycardia). Risk may be minimized by using a low initial dose (eg, immediate release 25 mg twice daily); if hypotension occurs during titration to the target dose, a return to the previous dose in the titration schedule is appropriate.

• QT prolongation: Use has been associated with QT prolongation; postmarketing reports have occurred in patients with concomitant illness, quetiapine overdose, or who were receiving concomitant therapy known to increase QT interval or cause electrolyte imbalance. Avoid use in patients at increased risk of torsade de pointes/sudden death (eg, hypokalemia, hypomagnesemia, history of cardiac arrhythmias, congenital prolongation of QT interval, concomitant medications with QTc interval-prolonging properties). Use with caution in patients at increased risk of QT prolongation (eg, cardiovascular disease, heart failure, cardiac hypertrophy, elderly, family history of QT prolongation).

• Temperature regulation: Impaired core body temperature regulation may occur; caution with strenuous exercise, heat exposure, dehydration, and concomitant medication possessing anticholinergic effects.

• Weight gain: Significant weight gain has been observed with antipsychotic therapy; incidence varies with product. Monitor waist circumference and BMI.

Disease-related concerns:

• Dementia: [US Boxed Warning]: Elderly patients with dementia-related psychosis treated with antipsychotics are at an increased risk of death compared to placebo. Most deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Use with caution in dementia with Lewy bodies; antipsychotics may worsen dementia symptoms and patients with dementia with Lewy bodies are more sensitive to the extrapyramidal side effects. Relative to other antipsychotics quetiapine has a lower propensity to cause extrapyramidal side effects (APA, [Rabins 2007]). Quetiapine is not approved for the treatment of dementia-related psychosis.

• Hepatic impairment: Use with caution in patients with hepatic disease or impairment; may increase transaminases (primarily ALT; transient, reversible). Dose adjustment recommended.

• Mania/hypomania: May precipitate a shift to mania or hypomania in patients with bipolar disorder. Patients presenting with depressive symptoms should be screened for bipolar disorder; the screening should include a detailed psychiatric history covering a family history of suicide, bipolar disorder, and depression. Quetiapine is approved in the US for the treatment of bipolar depression.

• Parkinson disease: Use with caution in patients with Parkinson disease; antipsychotics may aggravate the motor disturbances of Parkinson disease (APA, [Rabins 2007]).

• Renal impairment: Use with caution in patients with renal disease; experience is limited.

• Seizures: 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. Elderly patients may be at increased risk of seizures due to an increased prevalence of predisposing factors.

Special populations:

• Elderly: Dose escalation should be performed with caution in elderly patients; consider slower rates of dose titration and lower target doses.

• Pediatric: Pharmacologic treatment for pediatric bipolar I disorder or schizophrenia should be initiated only after thorough diagnostic evaluation and a careful consideration of potential risks vs benefits. If a pharmacologic agent is initiated, it should be a component of a total treatment program including psychological, educational and social interventions. Increased blood pressure (including hypertensive crisis) has been reported in children and adolescents; monitor blood pressure at baseline and periodically during use.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Withdrawal syndrome: Use caution when withdrawing therapy; decrease slowly and monitor for withdrawal symptoms. Abrupt cessation may cause acute withdrawal symptoms (eg, nausea, vomiting, or insomnia).

Monitoring Parameters

Mental status; vital signs (as clinically indicated); blood pressure (baseline; repeat 3 months after antipsychotic initiation, then yearly, particularly in children and adolescents); weight, height, BMI, waist circumference (baseline; repeat at 4, 8, and 12 weeks after initiating or changing therapy, then quarterly; consider switching to a different antipsychotic for a weight gain ≥5% of initial weight); CBC (as clinically indicated; monitor frequently during the first few months of therapy in patients with pre-existing low WBC or history of drug-induced leukopenia/neutropenia); electrolytes and liver function (annually and as clinically indicated); TSH, free T4, and thyroid clinical assessment (baseline and follow-up); fasting plasma glucose level/HbA1c (baseline; repeat 3 months after starting antipsychotic, then yearly); fasting lipid panel (baseline; repeat 3 months after initiation of antipsychotic; if LDL level is normal, repeat at 2-5 year intervals or more frequently if clinically indicated); changes in menstruation, libido, development of galactorrhea, erectile and ejaculatory function (at each visit for the first 12 weeks after the antipsychotic is initiated or until the dose is stable, then yearly); abnormal involuntary movements or parkinsonian signs (baseline; repeat weekly until dose stabilized for at least 2 weeks after introduction and for 2 weeks after any significant dose increase); tardive dyskinesia (every 12 months; high-risk patients every 6 months); lens examination, such as a slit-lamp exam, on initiation of therapy and every 6 months is recommended by manufacturer; alternatively, experts suggest it may be reasonable to inquire yearly about visual changes and perform ocular examinations yearly in patients >40 years or every 2 years in younger patients (ADA 2004; Lehman 2004; Marder 2004).

Pregnancy Risk Factor

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Pregnancy Considerations

Adverse events were observed in animal reproduction studies. Quetiapine crosses the placenta and can be detected in cord blood (Newport 2007). Congenital malformations have not been observed in humans (based on limited data). Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms [EPS]) and/or withdrawal symptoms in newborns following delivery. Symptoms in the newborn may include agitation, feeding disorder, hypertonia, hypotonia, respiratory distress, somnolence, and tremor; these effects may be self-limiting or require hospitalization. Quetiapine may cause hyperprolactinemia, which may decrease reproductive function in both males and females.

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). The ACOG recommends that therapy during pregnancy be individualized; treatment with psychiatric medications during pregnancy should incorporate the clinical expertise of the mental health clinician, obstetrician, primary healthcare provider, and pediatrician. Safety data related to atypical antipsychotics during pregnancy is limited and routine use is not recommended. However, if a woman is inadvertently exposed to an atypical antipsychotic while pregnant, continuing therapy may be preferable to switching to a typical antipsychotic that the fetus has not yet been exposed to; consider risk:benefit (ACOG 2008).

Healthcare providers are encouraged to enroll women 18-45 years of age exposed to quetiapine during pregnancy in the Atypical Antipsychotics Pregnancy Registry (1-866-961-2388 or http://www.womensmentalhealth.org/pregnancyregistry).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience anxiety, constipation, dry mouth, fatigue, weight gain, nausea, vomiting, or abdominal pain. Have patient report immediately to prescriber signs of depression (suicidal ideation, anxiety, emotional instability, illogical thinking), signs of infection, signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), severe dizziness, passing out, severe headache, tachycardia, arrhythmia, angina, abnormal movements, twitching, change in balance, dysphagia, difficulty speaking, tremors, difficulty moving, rigidity, loss of strength and energy, bruising, bleeding, vision changes, burning or numbness feeling, enlarged breasts, nipple discharge, sexual dysfunction, amenorrhea, signs of neuroleptic malignant syndrome (fever, muscle cramps or stiffness, dizziness, very bad headache, confusion, change in thinking, fast heartbeat, abnormal heartbeat, or sweating a lot), signs of tardive dyskinesia (unable to control body movements; tongue, face, mouth, or jaw sticking out; mouth puckering; and puffing cheeks), or priapism (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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