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ARIPiprazole

Pronunciation

Pronunciation

(ay ri PIP ray zole)

Index Terms

  • BMS 337039
  • OPC-14597

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intramuscular:

Abilify: 9.75 mg/1.3 mL (1.3 mL [DSC])

Solution, Oral:

Abilify: 1 mg/mL (150 mL [DSC]) [contains methylparaben, propylene glycol, propylparaben; orange cream flavor]

Generic: 1 mg/mL (150 mL)

Suspension Reconstituted, Intramuscular:

Abilify Maintena: 300 mg (1 ea); 400 mg (1 ea)

Tablet, Oral:

Abilify: 2 mg

Abilify: 5 mg [contains fd&c blue #2 aluminum lake]

Abilify: 10 mg, 15 mg, 20 mg, 30 mg

Generic: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, 30 mg

Tablet Dispersible, Oral:

Abilify Discmelt: 10 mg [DSC], 15 mg [DSC] [contains aspartame, fd&c blue #2 aluminum lake]

Generic: 10 mg, 15 mg

Brand Names: U.S.

  • Abilify
  • Abilify Discmelt [DSC]
  • Abilify Maintena

Pharmacologic Category

  • Second Generation (Atypical) Antipsychotic

Pharmacology

Aripiprazole is a quinolinone antipsychotic which exhibits high affinity for D2, D3, 5-HT1A, and 5-HT2A receptors; moderate affinity for D4, 5-HT2C, 5-HT7, alpha1 adrenergic, and H1 receptors. It also possesses moderate affinity for the serotonin reuptake transporter; has no affinity for muscarinic (cholinergic) receptors. Aripiprazole functions as a partial agonist at the D2 and 5-HT1A receptors, and as an antagonist at the 5-HT2A receptor.

Absorption

IM: Extended-release: Slow, prolonged

Oral: Well absorbed

Distribution

Vd: 4.9 L/kg

Metabolism

Hepatic, via CYP2D6, CYP3A4 (dehydro-aripiprazole metabolite has affinity for D2 receptors similar to the parent drug and represents 40% of the parent drug exposure in plasma)

Excretion

Feces (55%, ~18% of the total dose as unchanged drug); urine (25%, <1% of the total dose as unchanged drug)

Onset of Action

Initial: 1 to 3 weeks

Time to Peak

Plasma:

IM:

Immediate release: 1 to 3 hours

Extended release (after multiple doses): 4 days (deltoid administration); 5 to 7 days (gluteal administration)

Tablet: 3 to 5 hours

With high-fat meal: Aripiprazole: Delayed by 3 hours; dehydro-aripiprazole: Delayed by 12 hours

Half-Life Elimination

Aripiprazole: 75 hours; dehydro-aripiprazole: 94 hours; IM, extended release (terminal): ~30 to 47 days (dose-dependent)

CYP2D6 poor metabolizers: Aripiprazole: 146 hours

Protein Binding

≥99%, primarily to albumin

Special Populations: Renal Function Impairment

In severe renal impairment (CrCl <30 mL/minute), Cmax increased by 36% (aripiprazole) and 53% (dehydro-aripiprazole), but AUC was 15% lower for aripiprazole and 7% higher for dehydro-aripiprazole.

Special Populations: Hepatic Function Impairment

AUC increased by 31% in mild hepatic impairment and by 8% in moderate impairment, and decreased by 20% in severe impairment.

Special Populations: Elderly

In patients ≥65 years of age who were administered a single oral dose, clearance was 20% lower than that observed in younger patients.

Special Populations: Gender

Cmax and AUC are 30% to 40% higher in women than in men.

Use: Labeled Indications

Oral:

Bipolar I disorder: Acute treatment of manic and mixed episodes associated with bipolar I disorder.

Irritability associated with autistic disorder: Treatment of irritability associated with autistic disorder.

Major depressive disorder: Adjunctive treatment of major depressive disorder.

Schizophrenia: Treatment of schizophrenia.

Tourette disorder: Treatment of Tourette disorder.

Injection:

Agitation associated with schizophrenia or bipolar mania (immediate-release injection only): Treatment of agitation associated with schizophrenia or bipolar mania.

Schizophrenia (extended-release injection only): Treatment of schizophrenia.

Use: Unlabeled

Depression with psychotic features; Tourette syndrome (children); psychosis/agitation related to Alzheimer's dementia

Contraindications

Hypersensitivity (eg, anaphylaxis, pruritus, urticaria) to aripiprazole or any component of the formulation.

Dosing: Adult

Note: Oral solution may be substituted for the oral tablet on a mg-per-mg basis, up to 25 mg. Patients receiving 30 mg tablets should be given 25 mg oral solution. Orally disintegrating tablets (Abilify Discmelt) are bioequivalent to the immediate-release tablets (Abilify).

Acute agitation (schizophrenia/bipolar mania): IM, immediate release: 9.75 mg as a single dose (range: 5.25 to 15 mg; a lower dose of 5.25 mg IM may be considered when clinical factors warrant); repeated doses may be given at ≥2-hour intervals to a maximum of 30 mg/day. Note: If ongoing therapy with aripiprazole is necessary, transition to oral therapy as soon as possible.

Bipolar I disorder (acute manic or mixed episodes): Oral:

Monotherapy: Initial: 15 mg once daily. May increase to 30 mg once daily if clinically indicated (maximum 30 mg/day); safety of doses >30 mg/day has not been evaluated

Adjunct to lithium or valproic acid: Initial: 10 to 15 mg once daily. May increase to 30 mg once daily if clinically indicated (maximum 30 mg/day); safety of doses >30 mg/day has not been evaluated.

Depression (adjunctive with antidepressants): Oral: Initial: 2 to 5 mg/day (range: 2 to 15 mg/day); dose adjustments of up to 5 mg/day may be made in intervals of ≥1 week, up to a maximum of 15 mg/day. Note: Dosing based on patients already receiving antidepressant therapy.

Schizophrenia:

Oral: 10 or 15 mg once daily; may be increased to a maximum of 30 mg once daily (efficacy at dosages above 10 to 15 mg has not been shown to be increased). Dosage titration should not be more frequent than every 2 weeks.

IM, extended release: 400 mg once monthly (doses should be separated by ≥26 days); Note: Tolerability should be established using oral aripiprazole prior to initiation of parenteral therapy; due to the half-life of oral aripiprazole it may take up to 2 weeks to fully assess tolerability. Continue oral aripiprazole (or other oral antipsychotic) for 14 days during initiation of parenteral therapy.

Missed doses:

Second or third doses missed:

>4 weeks but <5 weeks since last dose: Administer next dose as soon as possible

>5 weeks since last dose: Administer oral aripiprazole for 14 days with next injection

Fourth or subsequent doses missed:

>4 weeks but <6 weeks since last dose: Administer next dose as soon as possible

>6 weeks since last dose: Administer oral aripiprazole for 14 days with next injection

Dosage adjustment for adverse effects: Consider reducing dose to 300 mg once monthly

Dosage adjustment with concurrent CYP450 inducer or inhibitor therapy:

Oral and IM, immediate release: Note: Dose reduction does not apply when adjunctive aripiprazole is administered to patients with major depressive disorder; follow usual dosing recommendations.

CYP3A4 inducers (eg, carbamazepine, rifampin): Aripiprazole dose should be doubled over 1 to 2 weeks; dose should be subsequently reduced to the original level over 1 to 2 weeks if concurrent inducer agent is discontinued.

Strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin): Aripiprazole dose should be reduced to 50% of the usual dose, and proportionally increased upon discontinuation of the inhibitor agent.

Strong CYP2D6 inhibitors (eg, quinidine, fluoxetine, paroxetine): Aripiprazole dose should be reduced to 50% of the usual dose, and proportionally increased upon discontinuation of the inhibitor agent.

CYP3A4 and CYP2D6 inhibitors: Aripiprazole dose should be reduced to 25% of the usual dose. In patients receiving inhibitors of differing (eg, moderate 3A4/strong 2D6) or same (eg, moderate 3A4/moderate 2D6) potencies (excluding concurrent strong inhibitors), further dosage adjustments can be made to achieve the desired clinical response. In patients receiving strong CYP3A4 and 2D6 inhibitors, aripiprazole dose is proportionally increased upon discontinuation of one or both inhibitor agents.

IM, extended release: Note: Dosage adjustments are not recommended for concomitant use of CYP3A4 inhibitors, CYP2D6 inhibitors or CYP3A4 inducers for <14 days. In patients who had their aripiprazole dose adjusted for concomitant therapy, the aripiprazole dose may need to be increased if the CYP3A4 and/or CYP2D6 inhibitor is withdrawn.

CYP3A4 inducers: Avoid use; aripiprazole serum concentrations may fall below effective levels.

Strong CYP3A4 or CYP2D6 inhibitors:

Current aripiprazole dose of 300 mg once monthly: Reduce aripiprazole dose to 200 mg once monthly

Current aripiprazole dose of 400 mg once monthly: Reduce aripiprazole dose to 300 mg once monthly

Strong CYP3A4 inhibitors and CYPD2D6 inhibitors:

Current aripiprazole dose of 300 mg once monthly: Reduce aripiprazole dose to 160 mg once monthly

Current aripiprazole dose of 400 mg once monthly: Reduce aripiprazole dose to 200 mg once monthly

Dosage adjustment based on CYP2D6 metabolizer status:

Oral and IM, immediate release: Aripiprazole dose should be reduced to 50% of the usual dose in CYP2D6 poor metabolizers and to 25% of the usual dose in poor metabolizers receiving a concurrent strong CYP3A4 inhibitor (eg, itraconazole, clarithromycin); subsequently adjust dose for favorable clinical response.

IM, extended release: Reduce aripiprazole dose to 300 mg once monthly in CYP2D6 poor metabolizers; reduce dose to 200 mg once monthly in CYP2D6 poor metabolizers receiving a concurrent CYP3A4 inhibitor for >14 days.

Dosing: Geriatric

Refer to adult dosing.

Psychosis/agitation related to dementia (off-label use):

IM, immediate release: Initial: 2.5 to 10 mg once; a repeat dose of 2.5 to 5 mg may be given at ≥2-hour intervals not to exceed 15 mg/day (Rapport, 2009).

Oral: Initial: 2 mg once daily; if necessary gradually increase based on response and tolerability not to exceed 15 mg daily. Consider periodic dosage adjustments to reduce or discontinue therapy as clinically indicated (APA [Rabins, 2007]; De Deyn 2005; Mintzer 2007; Streim 2008).

Dosing: Pediatric

Note: Oral solution may be substituted for the oral tablet on a mg-per-mg basis, up to 25 mg. Patients receiving 30 mg tablets should be given 25 mg oral solution. Orally disintegrating tablets (Abilify Discmelt) are bioequivalent to the immediate-release tablets (Abilify).

Bipolar I disorder (acute manic or mixed episodes):

US labeling: Children ≥10 years and Adolescents: Oral: Initial: 2 mg once daily for 2 days, followed by 5 mg once daily for 2 days with a further increase to target dose of 10 mg once daily as monotherapy or as adjunct to lithium or valproic acid; subsequent dose increases may be made in 5 mg increments, up to a maximum of 30 mg/day.

Canadian labeling: Adolescents ≥13 years: Oral: Initial: 2 mg once daily for 2 days, followed by 5 mg once daily for 2 days with a further increase to target dose of 10 mg once daily as monotherapy; subsequent dose increases may be made in 5 mg increments, up to a maximum of 30 mg/day. Note: Not approved for maintenance or as adjunctive therapy.

Irritability associated with autistic disorder: Children ≥6 years and Adolescents: Oral: Initial: 2 mg once daily for 7 days, followed by an increase to 5 mg once daily; subsequent dose increases may be made in 5 mg increments at intervals of ≥1 week, up to a maximum of 15 mg/day. The need for ongoing treatment should be assessed periodically.

Schizophrenia: Adolescents ≥13 years (US labeling) or ≥15 years (Canadian labeling): Oral: Initial: 2 mg once daily for 2 days, followed by 5 mg once daily for 2 days with a further increase to target dose of 10 mg once daily; subsequent dose increases may be made in 5 mg increments up to a maximum of 30 mg/day (30 mg/day not shown to be more efficacious than 10 mg/day)

Tourette syndrome: Children ≥6 years and Adolescents: Oral:

<50 kg: Initial: 2 mg/day for 2 days then increase to a target dose of 5 mg/day; may increase dose up to a maximum of 10 mg/day based on response and tolerability; dosage adjustments should occur gradually at intervals of no less than 1 week. Assess the need for ongoing treatment periodically.

≥50 kg: Initial: 2 mg/day for 2 days, then increase to 5 mg/day for 5 days with a target dose of 10 mg/day on day 8; may increase dose up to a maximum of 20 mg/day, based on response and tolerability, in 5 mg/day increments at intervals no less than 1 week. Assess the need for ongoing treatment periodically.

Dosage adjustment with concurrent CYP450 inducer or inhibitor therapy, or adjustment based on CYP2D6 metabolizer status: Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment necessary.

Dosing: Hepatic Impairment

No dosage adjustment necessary.

Reconstitution

Injection, powder (extended release):

Prefilled syringe: Reconstitute at room temperature. Rotate the syringe plunger rod to release diluent. Shake vigorously for 20 seconds or until the suspension is uniform; the resulting suspension will be milky white and opaque. (Refer to manufacturer’s labeling for full preparation technique.) Inject full syringe contents immediately following reconstitution.

Vial for reconstitution: Reconstitute using 1.5 mL sterile water for injection (SWFI) (provided) for the 300 mg vial or 1.9 mL SWFI (provided) for the 400 mg vial to a final concentration of 200 mg/mL; residual SWFI should be discarded after reconstitution. Shake vigorously for 30 seconds or until the suspension is uniform; the resulting suspension will be milky white and opaque. If the suspension is not administered immediately after reconstitution, shake vigorously for 60 seconds prior to administration.

Administration

Injection: For IM use only; do not administer SubQ or IV; Note: Immediate-release and extended-release parenteral products are not interchangeable.

Immediate release: Inject slowly into deep muscle mass

Extended release: Inject slowly into deltoid or gluteal muscle using the appropriate provided needle; for non-obese patients, use the 1 inch (25 mm) needle with deltoid administration or the 1.5 inch (38 mm) needle with gluteal administration; for obese patients, use the 1.5 inch (38 mm) needle with deltoid administration or the 2 inch (50 mm) needle with gluteal administration. Do not massage muscle after administration. Rotate injection sites between the two deltoid or gluteal muscles. Administer monthly (doses should be separated by ≥26 days).

Oral: Administer with or without food. Tablet and oral solution may be interchanged on a mg-per-mg basis, up to 25 mg. Doses using 30 mg tablets should be exchanged for 25 mg oral solution. Orally disintegrating tablets (Abilify Discmelt) are bioequivalent to the immediate-release tablets (Abilify).

Orally disintegrating tablet: Remove from foil blister by peeling back (do not push tablet through the foil). Place tablet in mouth immediately upon removal. Tablet dissolves rapidly in saliva and may be swallowed without liquid. If needed, can be taken with liquid. Do not split tablet.

Dietary Considerations

Some products may contain phenylalanine.

Storage

Injection, powder (extended release):

Prefilled syringe: Store below 30°C (86°F). Do not freeze. Protect from light and store in original package.

Vial for reconstitution: Store unused vials at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). If the suspension is not administered immediately after reconstitution, store at room temperature in the vial (do not store in a syringe).

Injection, solution (immediate release): Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Retain in carton until time of use.

Oral solution and tablets: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Use oral solution within 6 months after opening.

Drug Interactions

Abiraterone Acetate: May increase the serum concentration of CYP2D6 Substrates. Management: Avoid concurrent use of abiraterone with CYP2D6 substrates that have a narrow therapeutic index whenever possible. When concurrent use is not avoidable, monitor patients closely for signs/symptoms of toxicity. Consider therapy modification

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

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

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

Anti-Parkinson's Agents (Dopamine Agonist): Antipsychotic Agents (Second Generation [Atypical]) may diminish the therapeutic effect of Anti-Parkinson's Agents (Dopamine Agonist). Management: Consider using an alternative antipsychotic agent when possible in patients with Parkinson's 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

Asunaprevir: May increase the serum concentration of CYP2D6 Substrates. Consider therapy modification

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

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

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants. Consider therapy modification

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

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Exceptions: Levocabastine (Nasal). Monitor therapy

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

CYP2D6 Inhibitors (Moderate): May increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy

CYP2D6 Inhibitors (Strong): May increase the serum concentration of ARIPiprazole. Management: See full interaction monograph for details. Consider therapy modification

CYP2D6 Inhibitors (Weak): May increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy

CYP3A4 Inducers: May decrease the serum concentration of ARIPiprazole. Management: Double the oral aripiprazole dose and closely monitor response. Reduce oral aripiprazole dose to 10-15 mg/day (for adults) if the inducer is discontinued. Avoid use of CYP3A4 inducers for more than 14 days with extended-release injectable aripiprazole. Consider therapy modification

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy

CYP3A4 Inhibitors (Strong): May increase the serum concentration of ARIPiprazole. Management: See full interaction monograph for details. Consider therapy modification

CYP3A4 Inhibitors (Weak): May increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy

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

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

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. 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

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Consider therapy modification

DULoxetine: ARIPiprazole may enhance the adverse/toxic effect of DULoxetine. ARIPiprazole may enhance the serotonergic effect of DULoxetine. This could result in serotonin syndrome. DULoxetine may increase the serum concentration of ARIPiprazole. Monitor therapy

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

FLUoxetine: May enhance the adverse/toxic effect of ARIPiprazole. Specifically, the risk of neuroleptic malignant syndrome may be increased. ARIPiprazole may enhance the serotonergic effect of FLUoxetine. This could result in serotonin syndrome. FLUoxetine may increase the serum concentration of ARIPiprazole. Management: Aripiprazole dose should be reduced by at least half, except when used adjunctively for depression. Consult full interaction monograph or aripiprazole prescribing information for complete details. 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

Haloperidol: ARIPiprazole may enhance the QTc-prolonging effect of Haloperidol. ARIPiprazole may diminish the therapeutic effect of Haloperidol. Haloperidol may increase the serum concentration of ARIPiprazole. Management: See full interaction monograph. Aripiprazole dose adjustment may not be required when used as adjunctive therapy for major depressive disorder. Consider therapy modification

Highest Risk QTc-Prolonging Agents: 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

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

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

Idelalisib: May increase the serum concentration of CYP3A4 Substrates. 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

Lithium: May enhance the neurotoxic effect of Antipsychotic Agents. Lithium may decrease the serum concentration of Antipsychotic Agents. Specifically noted with chlorpromazine. Monitor therapy

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

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

Mequitazine: Antipsychotic Agents may enhance the arrhythmogenic effect of Mequitazine. Management: Consider alternatives to one of these agents when possible. While this combination is not specifically contraindicated, mequitazine labeling describes this combination as discouraged. Consider therapy modification

Methadone: May enhance the CNS depressant effect of ARIPiprazole. ARIPiprazole may enhance the QTc-prolonging effect of Methadone. Methadone may increase the serum concentration of ARIPiprazole. Management: See full interaction monograph. Aripiprazole dose adjustment may not be required when used as adjunctive therapy for major depressive disorder. Consider therapy modification

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 increase the serum concentration of CYP3A4 Substrates. Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Mifepristone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying). Management: Though the drugs listed here have uncertain QT-prolonging effects, they all have some possible association with QT prolongation and should generally be avoided when possible. Consider therapy modification

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

Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. 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: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy

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

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

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

Osimertinib: May increase the serum concentration of CYP3A4 Substrates. Osimertinib may decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

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

Panobinostat: May increase the serum concentration of CYP2D6 Substrates. Management: Avoid concurrent use of sensitive CYP2D6 substrates when possible, particularly those substrates with a narrow therapeutic index. Consider therapy modification

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

PARoxetine: May enhance the adverse/toxic effect of ARIPiprazole. Specifically, the risk of neuroleptic malignant syndrome may be increased. ARIPiprazole may enhance the serotonergic effect of PARoxetine. This could result in serotonin syndrome. PARoxetine may increase the serum concentration of ARIPiprazole. Management: Aripiprazole dose adjustment is recommended, except when used adjunctively for depression. Consult full interaction monograph or aripiprazole prescribing information for complete details. Consider therapy modification

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates. Monitor therapy

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

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

Ritonavir: ARIPiprazole may enhance the adverse/toxic effect of Ritonavir. The risk of metabolic disturbances (e.g. hyperglycemia, weight gain, hyperlipidemia) may be increased. Ritonavir may increase the serum concentration of ARIPiprazole. Management: See full interaction monograph. Aripiprazole dose adjustment may not be required when used as adjunctive therapy for major depressive disorder. 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. Monitor therapy

Sertraline: May enhance the adverse/toxic effect of ARIPiprazole. Sertraline may increase the serum concentration of ARIPiprazole. Management: See full interaction monograph. Aripiprazole dose adjustment may not be required when used as adjunctive therapy for major depressive disorder. Consider therapy modification

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: May decrease the serum concentration of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. 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

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

Trimeprazine: May increase the serum concentration of ARIPiprazole. Monitor therapy

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

Adverse Reactions

Unless otherwise noted, frequency of adverse reactions is shown as reported for adult patients receiving aripiprazole monotherapy with oral administration. Spectrum and incidence of adverse effects similar in children; exceptions noted when incidence much higher in children.

>10%:

Central nervous system: Headache (adults 27%; children & adolescents 10% to 13%; injection 12%), extrapyramidal reaction (dose-related; children & adolescents 6% to 27%; adults 5% to 13% ), drowsiness (children & adolescents 10% to 26%; adults 8% to 13%), akathisia (dose-related; adults 2% to 25%; children & adolescents 6% to 11%), fatigue (dose-related; children & adolescents 4% to 22%; adults 6%; injection 1% to 2%), sedation (dose-related; children & adolescents 9% to 21%; adults 5% to 7%), agitation (oral 19%; injection <1%), insomnia (18%; injection ≥1%), anxiety (oral 17%; injection ≥1%)

Endocrine & metabolic: Weight gain (children & adolescents 3% to 26%; injection 17% to 22%; adults 2% to 8%), increased serum cholesterol (injection 4% to 22%; oral 1% to 2%), increased serum triglycerides (adults 7% to 10%; children and adolescents 5%; injection 7% to 20%; oral 5% to 10%), increased serum glucose (adults 8% to 18%; children and adolescents 3% to 5%), decreased HDL cholesterol (injection 14%; children & adolescents 4%), increased LDL cholesterol (injection 10% to 14%)

Gastrointestinal: Nausea (8% to 15%), vomiting (oral 8% to 14%; injection: 3%), constipation (10% to 11%; children & adolescents 3%)

Neuromuscular & skeletal: Tremor (dose-related; oral 5% to 12%; injection 3%)

1% to 10%:

Cardiovascular: Tachycardia (injection ≤2%), hypertension (≥1%), peripheral edema (≥1%), orthostatic hypotension (including injection; ≤1%)

Central nervous system: Dizziness (3% to 10%), drooling (children & adolescents 3% to 9%), restlessness (oral 5% to 6%; injection ≥1%), lethargy (older adults 5%; children 3% to 5%; injection <1%), pain (3%), dystonia (2%), irritability (children & adolescents 2%; injection <1%), ataxia (≥1%), hypersomnia (≤1%)

Dermatologic: Skin rash (≤2%)

Endocrine & metabolic: Weight loss (injection 4%; oral ≥1%), increased thirst (children & adolescents 1%)

Gastrointestinal: Dyspepsia (oral 9%; injection <1%), sialorrhea (dose-related; 3% to 8%), decreased appetite (children & adolescents 5% to 7%; injection <1%), increased appetite (children & adolescents 7%), xerostomia (5%; injection: 4%; children & adolescents 1%), toothache (4%), diarrhea (3% to 4%), gastric distress (3%), upper abdominal pain (children & adolescents 3%; injection <1%), abdominal distress (2% to 3%), anorexia (≥1%)

Genitourinary: Urinary incontinence (older adults ≤5%; injection <1%), dysmenorrhea (children & adolescents 2%)

Hematologic & oncologic: Neutropenia (injection 6%)

Local: Pain at injection site (5%), injection site reaction (injection ≥1%; including erythema, induration, inflammation, hemorrhage, pruritus, swelling, rash)

Neuromuscular & skeletal: Arthralgia (injection 4%; children & adolescents 1%), back pain (injection 4%), limb pain (4%), myalgia (2% to 4%), stiffness (2% to 4%), musculoskeletal pain (injection 3%), muscle cramps (2%), muscle rigidity (children & adolescents 2%), muscle spasm (2%), weakness (1% to 2%), dyskinesia (children & adolescents 1%)

Ophthalmic: Blurred vision (oral 3% to 8%; injection <1%)

Respiratory: Nasopharyngitis (children & adolescents 6% to 9%; injection <1%), upper respiratory tract infection (4%), cough (3%), pharyngolaryngeal pain (3%), epistaxis (children & adolescents 2%), nasal congestion (injection: 2%; oral <1% ), rhinorrhea (children & adolescents 2%), aspiration pneumonia (≥1%), dyspnea (≥ 1%)

Miscellaneous: Fever (children & adolescents 4% to 9%; injection <1%)

<1% (Limited to important or life-threatening): Abnormal bilirubin levels, abnormal gait, abnormal hepatic function tests, agranulocytosis, akinesia, alopecia, altered serum glucose, amenorrhea, angina pectoris, anorgasmia, atrial fibrillation, atrial flutter, atrioventricular block, bradycardia, bruxism, cardiopulmonary arrest, cardiorespiratory arrest, catatonia, cerebrovascular accident, chest discomfort, choreoathetosis, cogwheel rigidity, convulsions, decreased serum cholesterol, decreased serum triglycerides, delirium, depression, diabetes mellitus, diabetic ketoacidosis, diplopia, disruption of body temperature regulation, drug-induced Parkinson's disease, dry tongue, dysgeusia, dystonia (oromandibular), edema, erectile dysfunction, esophagitis, extrasystoles, eyelid edema, falling, gastroesophageal reflux disease, gynecomastia, hepatitis, hirsutism, homicidal ideation, hostility, hyperglycemia, hyperhidrosis, hyperinsulinism, hyperlipidemia, hypersensitivity, hypersexuality, hypertonia, hypoglycemia, hypokalemia, hypokinesia, hyponatremia, hypotension, hypotonia, impulse control disorder (including pathologic gambling and hypersexuality; Health Canada, Nov 2, 2015), increased blood urea nitrogen, increased creatinine clearance, increased creatine phosphokinase, increased gamma-glutamyl transferase, increased lactate dehydrogenase, increased serum prolactin, intentional injury, ischemic heart disease, jaundice, joint stiffness, leukopenia, mastalgia, memory impairment, mobility disorder, muscle twitching, myasthenia,myocardial infarction, myoclonus, neuroleptic malignant syndrome, obesity, oculogyric crisis, pancreatitis, panic attack, photopsia, pollakiuria presyncope, priapism, prolonged Q-T interval on ECG, psychosis, rhabdomyolysis, seizure (including injection), skin photosensitivity, sleep talking, somnambulism, suicidal ideation, suicidal tendencies, supraventricular tachycardia, syncope, tardive dyskinesia, thrombocytopenia, tics, tongue spasm, tonic-clonic seizures, transient ischemic attacks, urinary retention, ventricular tachycardia

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. Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.

Suicidality and antidepressant drugs:

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 behaviors with antidepressant use in patients older than 24 years; there was a reduction in risk with antidepressant use in patients 65 years and older. Closely monitor patients of all ages who are started on antidepressant therapy for clinical worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the health care provider.

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 to 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 patients for clinical worsening, suicidality, or unusual changes in behavior, particularly during the initial 1 to 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. Aripiprazole is not FDA approved for adjunctive treatment of depression in children.

• The possibility of a suicide attempt is inherent in major depression and may persist until remission occurs. 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. Patients should be screened for bipolar disorder prior to initiation of treatment of major depression.

• 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 reactions:

• Altered cardiac conduction: May alter cardiac conduction; life-threatening arrhythmias have occurred with therapeutic doses of antipsychotics.

• Blood dyscrasias: Leukopenia, neutropenia, and agranulocytosis (sometimes fatal) have been reported in clinical trials and postmarketing reports with antipsychotic use; presence of risk factors (eg, preexisting low WBC/ANC 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 <1,000/mm3.

• Cerebrovascular effects: An increased incidence of cerebrovascular effects (eg, transient ischemic attack, stroke), including fatalities, has been reported in placebo-controlled trials of aripiprazole for the unapproved use in elderly patients with dementia-related psychosis.

• 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, driving).

• Dyslipidemia: Has been reported with atypical antipsychotics; risk profile may differ between agents. In clinical trials, lipid changes observed with aripiprazole monotherapy were similar to those observed with placebo.

• Esophageal dysmotility/aspiration: Antipsychotic use has been associated with esophageal dysmotility and aspiration; use with caution in patients at risk for aspiration pneumonia (eg, Alzheimer dementia).

• 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; frequencies reported are similar to placebo). 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. Use with caution in patients with diabetes or other disorders of glucose regulation; monitor for worsening of glucose control. Patients with risk factors for diabetes (eg, obesity or family history) should have a baseline fasting blood sugar (FBS) and periodic assessment of glucose regulation. Reports of hyperglycemia with aripiprazole therapy have been few and specific risk associated with this agent is not known.

• 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.

• 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, hypovolemia, or concurrent medication use which may predispose to hypotension/bradycardia).

• Pathologic gambling: Case reports of new or worsening pathologic gambling have been reported in patients receiving aripiprazole (Gaboriau, 2014; Moore, 2014; Smith, 2011); patients with prior history of gambling disorders may be at increased risk.

• 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 (>7% of baseline weight) has been observed with antipsychotic therapy; incidence varies with product. Monitor waist circumference and BMI.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiac disease, cerebrovascular disease, prior myocardial infarction, ischemic heart disease, or conditions which predispose to hypotension.

• 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 (APA [Rabins, 2007]). Aripiprazole is not approved for the treatment of dementia-related psychosis.

• Parkinson disease: Use with caution in patients with Parkinson disease; antipsychotics may aggravate motor disturbances (APA [Lehman , 2004; Rabins, 2007]).

• 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.

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.

Dosage form specific issues:

• Lactose: Tablets may contain lactose; avoid use in patients with galactose intolerance or glucose-galactose malabsorption.

• Phenylalanine: Orally disintegrating tablets may contain phenylalanine.

• Product interchangeability: Injection: There are two formulations available for intramuscular administration: Abilify is an immediate-release short-acting formulation and Abilify Maintena is an extended-release formulation. These products are not interchangeable.

Monitoring Parameters

Mental status; vital signs (as clinically indicated); blood pressure (baseline; repeat 3 months after antipsychotic initiation, then yearly); 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 preexisting low WBC or history of drug-induced leukopenia/neutropenia); electrolytes and liver function (annually and as clinically indicated); personal and family history of obesity, diabetes, dyslipidemia, hypertension, or cardiovascular disease (baseline; repeat annually); 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- to 5-year intervals or more frequently if clinical indicated); changes in menstruation, libido, development of galactorrhea, erectile and ejaculatory function (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); ocular examination (yearly in patients >40 years; every 2 years in younger patients) (ADA, 2004; Lehman, 2004; Marder, 2004).

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Aripiprazole crosses the placenta; aripiprazole and dehydro-aripiprazole can be detected in the cord blood at delivery (Nguyen, 2011; Watanabe, 2011). 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.

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 exposed to aripiprazole during pregnancy in the National Pregnancy Registry for Atypical Antipsychotics (866-961-2388 or http://www.womensmentalhealth.org/clinical-and-research-programs/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 fatigue, agitation, anxiety, headache, nausea, vomiting, weight gain, constipation, insomnia, polyphagia, lack of appetite, rhinitis, pharyngitis, dry mouth, tremors, or drooling. Have patient report immediately to prescriber signs of infection, signs of depression (suicidal ideation, anxiety, emotional instability, illogical thinking), signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), abnormal movements, twitching, change in balance, dysphagia, vision changes, eye pain, eye irritation, difficulty speaking, severe dizziness, passing out, loss of strength and energy, blurred vision, strong urges that are hard to control (such as gambling or sex), 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), or signs of tardive dyskinesia (unable to control body movements; tongue, face, mouth, or jaw sticking out; mouth puckering; and puffing cheeks) (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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