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Amisulpride

Medically reviewed by Drugs.com. Last updated on May 7, 2020.

Index Terms

  • Aminosultopride
  • Amisulpiride

Pharmacologic Category

  • Antipsychotic Agent, Benzamide
  • Second Generation (Atypical) Antipsychotic

Pharmacology

Amisulpride is a benzamide atypical antipsychotic with selective binding to D2 and D3 dopamine receptors; lacks affinity for D1, D4, or D5 receptors. At high doses, may predominantly block dopamine receptors in the limbic system as opposed to the striatum. At low doses, preferential binding to presynaptic D2 and D3 receptors leads to dopamine release and disinhibitory effects. Has little to no affinity for serotonin, alpha-adrenergic, histamine (H1), or cholinergic receptors.

Special Populations: Renal Function Impairment

AUC increased twofold with mild renal impairment and tenfold with moderate renal impairment.

Use: Labeled Indications

Note: Not approved in US and/or Canada

Schizophrenia: Treatment of acute or chronic schizophrenia

Contraindications

Hypersensitivity to amisulpride or any component of the formulation; pheochromocytoma (known/suspected); prolactin-dependent tumors (eg, pituitary gland prolactinomas, breast cancer); use in prepubescent children (or children <15 years of age); breastfeeding.

Additional contraindications (may vary per region; consult product labeling): Severe renal impairment (CrCl <10 mL/minute); congenital galactosemia; glucose or galactose malabsorption syndrome; lactase deficiency; concomitant use with sultopride, levodopa, dopaminergic agonists (cabergoline, quinagolide); Class Ia antiarrhythmic agents (eg, quinidine, disopyramide), Class III antiarrhythmic agents (eg, amiodarone, sotalol), bepridil, cisapride, thioridazine, methadone, IV erythromycin, IV vincamine, halofantrine, pentamidine, sparfloxacin, citalopram, escitalopram, domperidone, hydroxyzine, piperaquine.

Dosing: Adult

Schizophrenia: Oral: Note: Use lowest effective dose based on individual clinical response.

Acute psychotic episodes: 400 to 800 mg/day in 2 divided doses. In certain cases, may increase dose up to a maximum total daily dose of 1,200 mg.

Mixed (positive and negative) symptoms predominant: 400 to 800 mg/day in 2 divided doses. Adjust dose to maintain control of positive symptoms.

Negative symptoms predominant: 50 to 300 mg once daily.

Discontinuation of therapy: Gradual dose reduction is advised to avoid withdrawal symptoms (ie, insomnia, headache, and GI symptoms) unless discontinuation is due to significant adverse effects. When discontinuing chronic antipsychotic therapy in patients with schizophrenia or bipolar disorder, decreasing the dose very gradually over months to years with close monitoring is suggested to allow for detection of prodromal symptoms of disease recurrence (APA [Lehman 2004]; CPA 2005).

Switching antipsychotics: Limited data available; optimal universal strategy is unknown. Strategies include: Cross-titration (gradually discontinuing the first antipsychotic while gradually increasing the new antipsychotic) and abrupt change (abruptly discontinuing the first antipsychotic and either increasing the new antipsychotic gradually or starting it at a treatment dose). In patients with schizophrenia at high risk of relapse, the current medication may be maintained at full dose as the new medication is increased (ie, overlap); once the new medication is at therapeutic dose, the first medication is gradually decreased and discontinued over 1 to 2 weeks (Cerovecki 2013; Remington 2005; Takeuchi 2017). Based upon clinical experience, some experts generally prefer cross-titration and overlap approaches rather than abrupt change (Post 2018; Stroup 2018).

Dosing: Geriatric

Schizophrenia: Refer to adult dosing. Consider initiating at the lower end of the dosage range due to risk of hypotension and sedation.

Psychotic episodes associated with schizophrenia: (off-label dose): Oral: 100 to 400 mg once daily (Riedel 2009).

Administration

Oral: Doses >300 mg should be divided into 2 doses. Preferably administer before meals.

Storage

Solution: Store at <25°C (77°F); discard oral solution within 2 months of opening.

Tablet: Store at room temperature.

Drug Interactions

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

Alcohol (Ethyl): Amisulpride (Oral) may enhance the adverse/toxic effect of Alcohol (Ethyl). Avoid combination

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

Amifampridine: Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine. Monitor therapy

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 Agents (Dopamine Agonist): May diminish the therapeutic effect of Amisulpride (Oral). Amisulpride (Oral) may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Avoid combination

Antipsychotic Agents: Amisulpride (Oral) may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, the risk of neuroleptic malignant syndrome may be increased. Avoid combination

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

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

Brexanolone: CNS Depressants may enhance the CNS depressant effect of Brexanolone. Monitor therapy

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

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

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

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 at lower doses in patients already receiving CNS depressants. Consider therapy modification

BuPROPion: May enhance the neuroexcitatory and/or seizure-potentiating effect of Agents With Seizure Threshold Lowering Potential. Monitor therapy

Cabergoline: May diminish the therapeutic effect of Antipsychotic Agents. Avoid combination

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

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

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Consider therapy modification

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

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

Deutetrabenazine: May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Monitor therapy

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

Domperidone: QT-prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of Domperidone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Consider therapy modification

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

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

Fexinidazole [INT]: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Avoid combination

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

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

Haloperidol: Amisulpride (Oral) may enhance the QTc-prolonging effect of Haloperidol. Monitor therapy

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

Hypotension-Associated Agents: Amisulpride (Oral) may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic anticonvulsants. Consider therapy modification

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

Lemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Consider therapy modification

Levosulpiride: Benzamide Derivatives may enhance the adverse/toxic effect of Levosulpiride. 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

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. 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

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

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

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

Ondansetron: Amisulpride (Oral) may enhance the QTc-prolonging effect of Ondansetron. Monitor therapy

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

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

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

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

Pentamidine (Systemic): Amisulpride (Oral) may enhance the QTc-prolonging effect of Pentamidine (Systemic). 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

Pimozide: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Avoid combination

Piribedil: Antipsychotic Agents may diminish the therapeutic effect of Piribedil. Piribedil 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

QT-prolonging Agents (Highest Risk): May enhance the QTc-prolonging effect of Amisulpride (Oral). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even greater risk. Consider therapy modification

QT-prolonging Agents (Moderate Risk): Amisulpride (Oral) may enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Exceptions: Domperidone; Pimozide. Monitor therapy

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

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

Serotonergic Agents (High Risk): May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonergic agents may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. 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

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

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

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

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

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

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. 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

Test Interactions

A false-positive for buprenorphine by cloned enzyme donor immunoassay (CEDIA) was reported in patients taking amisulpride (Birch, 2013)

Adverse Reactions

Extrapyramidal symptoms are dose-related with a lower incidence reported in patients treated with 50 to 300 mg daily.

>10%:

Nervous system: Drug-induced extrapyramidal reaction (11%), akathisia

Neuromuscular & skeletal: Hypokinesia, muscle rigidity, tremor

1% to 10%:

Cardiovascular: Hypertension (1%), hypotension (1%), orthostatic hypotension (1%), prolonged QT Interval on ECG

Endocrine & metabolic: Weight gain (6%), amenorrhea (4%), galactorrhea not associated with childbirth (3%), menstrual disease (1%), increased serum prolactin

Gastrointestinal: Constipation (3%), sialorrhea (2%), dyspepsia (1%), nausea, vomiting, xerostomia

Genitourinary: Vaginitis (1%), orgasm disturbance

Nervous system: Insomnia (10%), anxiety (7%), agitation (5%), drowsiness (3%), nervousness (2%), depression (1%), dystonic reaction (1%)

Neuromuscular & skeletal: Dyskinesia (2%)

Ophthalmic: Oculogyric crisis (1%), blurred vision

Frequency not defined:

Dermatologic: Skin photosensitivity

Nervous system: Neonatal withdrawal, restless leg syndrome

<1%, postmarketing, and/or case reports: Agranulocytosis, angioedema, aspiration pneumonia, bradycardia, complex sleep-related disorder, confusion, deep vein thrombosis, hypercholesterolemia, hyperglycemia, hypersensitivity reaction, hypertriglyceridemia, hyponatremia, increased liver enzymes, leukopenia, nasal congestion, neutropenia, neuroleptic malignant syndrome, neutropenia, osteopenia, osteoporosis, prolactinoma, pulmonary embolism, seizure, severe hepatotoxicity, SIADH, somnambulism, tardive dyskinesia, torsades de pointes, urinary retention, urticaria, venous thromboembolism, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia, withdrawal syndrome

Warnings/Precautions

Concerns related to adverse effects:

• Altered cardiac conduction: May alter cardiac conduction; life-threatening arrhythmias have occurred with antipsychotics. Use caution with history of conduction abnormalities. Use has been associated with dose-dependent QT prolongation. Use with caution or avoid in patients with increased risk of QT prolongation (eg, cardiovascular disease, bradycardia (<55 bpm), hypokalemia, congenital prolongation of the QT interval, family history of QT prolongation). Avoid concomitant use with other antipsychotics, bradycardic agents, and/or QT-prolonging agents (including class Ia or III antiarrhythmics). Consider an ECG prior to initiation of long-term therapy.

• Blood dyscrasias: Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotic use (including amisulpride). Consider neutropenia in patients with infection or unexplained fever. Presence of risk factors (eg, preexisting low WBC or history of drug-induced leuko-/neutropenia) should prompt periodic blood count assessment; discontinue therapy with WBC decline without other causative factors. Carefully monitor patients with neutropenia for fever and signs/symptoms of infection and discontinue therapy if absolute neutrophil count <1,000/mm3.

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

• Dyslipidemia: Has been reported with atypical antipsychotics; risk profile may differ between agents (Rummel-Kluge 2010). Use with caution in patients with preexisting abnormal lipid profile.

• Esophageal dysmotility/aspiration: Antipsychotic use has been associated with esophageal dysmotility and aspiration; risk increases with age. Use with caution in patients at risk for aspiration pneumonia (ie, Alzheimer disease), particularly in patients >75 years of age (Herzig 2017; Maddalena 2004).

• Extrapyramidal symptoms (EPS): May cause extrapyramidal symptoms, including pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia. Risk of dystonia (and possibly other EPS) may be greater with increased doses, use of conventional antipsychotics, males, and younger patients. Factors associated with greater vulnerability to tardive dyskinesia include older in age, female gender combined with postmenopausal status, Parkinson disease, pseudoparkinsonism symptoms, affective disorders (particularly major depressive disorder), concurrent medical diseases such as diabetes, previous brain damage, alcoholism, poor treatment response, and use of high doses of antipsychotics (APA [Lehman 2004]; Soares-Weiser 2007). Consider therapy discontinuation with signs/symptoms of tardive dyskinesia.

• Falls: May increase the risk for falls due to somnolence, orthostatic hypotension, and motor or sensory instability. Complete fall risk assessments at baseline and periodically during treatment in patients with diseases or on medications that may also increase fall risk.

• Hepatic effects: Severe hepatic toxicity has been reported with amisulpride; symptoms may include asthenia, anorexia, nausea, vomiting, abdominal pain, or icterus. Assess liver function immediately in patients with symptoms of hepatic toxicity.

• Hyperglycemia: Atypical antipsychotics (including amisulpride) 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 and periodically during treatment.

• Hyperprolactinemia: Increased prolactin levels are commonly reported with amisulpride, even with low doses (Lee 2012); adverse reactions were not associated with elevated prolactin levels in one study (Kim 2012). Rapid reversal occurs with discontinuation (Juruena 2010). Cases of benign pituitary tumors have been reported with amisulpride use. In cases of very high prolactin levels or symptoms of pituitary tumor (visual field defect, headache), perform pituitary imaging. Use is contraindicated in patients with prolactin-dependent tumors. Clinical significance of hyperprolactinemia in patients with breast cancer or other prolactin-dependent tumors is unknown.

• Impulse control disorders: Has been associated with compulsive behaviors and/or loss of impulse control, which has manifested as pathological gambling, uncontrolled sexual urges, uncontrolled spending, binge or compulsive eating, and/or other intense urges. Patients with prior history of impulse control issues may be at increased risk. Dose reduction or discontinuation of therapy has been reported to reverse these behaviors in most, but not all, cases (Moore 2014).

• Neuroleptic malignant syndrome (NMS): Use of antipsychotics (including amisulpride) may be associated with NMS; monitor for mental status changes, fever, muscle rigidity, elevated CPK, and/or autonomic instability.

• Sleep apnea: Sleep apnea has been associated with antipsychotic use in patients with or without a history of sleep apnea or concomitant weight gain. Monitor patients with a history of or risk factors for sleep apnea or who are taking concomitant central nervous system depressants.

• Suicidal ideation: The possibility of a suicide attempt is inherent in psychotic illness; use with caution in high-risk patients during initiation of therapy. Prescriptions should be written for the smallest quantity consistent with good patient care.

• Weight gain: Significant weight gain has been observed with antipsychotic therapy; incidence varies with product. Amisulpride appears to have a relatively low profile with respect to weight gain compared to other atypical antipsychotics (Dent 2012). Monitor waist circumference and BMI.

Disease-related concerns:

• Dementia: 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 patients with Lewy body dementia or Parkinson disease dementia due to greater risk of adverse effects, increased sensitivity to extrapyramidal effects, and association with irreversible cognitive decompensation or death (APA [Reus 2016]). Amisulpride is not approved for the treatment of dementia-related psychosis.

• Diabetes: Use with caution in patients with diabetes (or diabetes risk factors) or other disorders of glucose regulation; monitor for worsening of glucose control.

• Hepatic impairment: Use with caution in patients with moderate or severe hepatic impairment; the impact of hepatic metabolism and hepato-biliary excretion has not been studied.

• Renal impairment: Use with caution in patients with renal impairment. Dosage adjustment is recommended. Some countries contraindicate use in patients with CrCl <10 mL/minute due to lack of data (consult local product labeling).

• Seizures: May increase risk of seizures; use caution in patients with a history of seizures.

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.

Special populations:

• Elderly: Use with caution due to risk of hypotension, sedation and/or extrapyramidal effects.

Other warnings/precautions:

• Discontinuation of therapy: When discontinuing antipsychotic therapy, gradual dose reduction is advised to avoid withdrawal symptoms (ie, insomnia, headache, and GI symptoms) unless discontinuation is due to significant adverse effects. The risk of withdrawal symptoms is highest following abrupt discontinuation of highly anticholinergic or dopaminergic antipsychotics (Cerovecki 2013). Additional factors such as duration of antipsychotic exposure, the indication for use, medication half-life, and risk for relapse should be considered. In schizophrenia, there is no reliable indicator to differentiate the minority who will not from the majority who will relapse with drug discontinuation. However, studies in which the medication of well-stabilized patients were discontinued indicate that 75% of patients relapse within 6 to 24 months. Indefinite maintenance antipsychotic medication is generally recommended, and especially for patients who have had multiple prior episodes or two episodes within 5 years (APA [Lehman 2004]).

• Withdrawal syndrome: Use caution when withdrawing therapy; decrease slowly and monitor for withdrawal symptoms. Abrupt cessation may cause (rarely) acute withdrawal symptoms (eg, nausea, vomiting, or insomnia) as well as the emergence of involuntary movement disorders (eg, dyskinesia, dystonia, akathisia).

Monitoring Parameters

Mental status; vital signs (as clinically indicated); blood pressure (baseline; repeat 3 months after antipsychotic initiation, then yearly); ECG (baseline; repeat as clinically indicated); 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); electrolytes, renal 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/hemoglobin A1c (baseline; repeat 3 months after starting antipsychotic, then yearly); 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 (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); ocular examination (yearly in patients >40 years; every 2 years in younger patients) (ADA 2004; Hasan 2012; Lehman 2004; Marder 2004).

Pregnancy Considerations

Amisulpride crosses the placenta.

Information related to the use of amisulpride in pregnancy is limited (Damkier 2018).

Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms) 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. Has been shown to cause hyperprolactinemia which may interfere with reproductive function; effective contraception should be considered in women of reproductive potential.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.