Amisulpride is a parenteral antiemetic medication that is a dopamine-2 (D2) and dopamine-3 (D3) antagonist. It is used intravenously for the prevention and treatment of postoperative nausea and vomiting (PONV). For the prevention of PONV, it may be used either alone or in combination with an antiemetic of a different class. Two randomized, double-blind, placebo-controlled trials were conducted in adult patients for the prevention of PONV. In a trial of patients who received amisulpride 5 mg IV alone at the time of anesthesia induction, amisulpride was significantly more effective than placebo at treating patients (44% amisulpride vs. 33% placebo). In a PONV prevention trial in patients who received 5 mg of amisulpride IV or placebo in combination with another antiemetic, efficacy was better in the amisulpride treatment group (58% amisulpride vs. 47% placebo). For the treatment of PONV, amisulpride may be used in patients who have received antiemetic prophylaxis with an agent of a different class or in those who have not received prophylaxis. Two randomized, double-blind, placebo-controlled trials were conducted in adult patients for the treatment of PONV. During these clinical trials, amisulpride 10 mg IV was significantly more effective than placebo at treating PONV in patients who had failed an antiemetic in a different class (42% amisulpride vs. 29% placebo) and in treating PONV in patients who had received no prior prophylaxis (31% amisulpride vs. 22% placebo). Amisulpride can cause dose- and concentration-related prolongation of the QT interval, and cardiac monitoring is recommended for certain patients.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Injectable Administration
-For intravenous use only.
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Amisulpride injection solution is clear and colorless.
Intravenous Administration
Direct IV injection
-Administer IV over 1 to 2 minutes.
-Dilution is not required before administration.
-When flushing the IV line before or after administration, the following are compatible IV solutions: Sterile Water for Injection, 5% Dextrose Injection, and 0.9% Sodium Chloride Injection.
-Storage: Store unopened vials at 20 to 25 degrees C (68 to 77 degrees F). Protect from light. Vials are single-use only. Amisulpride is subject to photodegradation and must be administered within 12 hours of removal of the vial from the protective carton.
The most common adverse reaction, reported in at least 2% of adult patients who received amisulpride 10 mg (n = 418) and at a higher rate than placebo during clinical trials for the treatment of PONV, was an injection site reaction described as infusion site pain (amisulpride 6%; placebo 4%).
During clinical trials for PONV prophylaxis, procedural hypotension was reported in 3% of patients receiving amisulpride injection vs. 2% placebo. Dose- and concentration-dependent QT prolongation has been reported with amisulpride use. In healthy Caucasian and Japanese patients (n = 40), the maximum mean difference in QTcF from placebo after baseline-correction was 5 (7.1) milliseconds after a 2-minute IV infusion of 5 mg amisulpride and 23.4 (25.5) milliseconds after an 8-minute IV infusion of 40 mg amisulpride. Based on the exposure-response relationship, a 1-minute IV infusion of 10 mg amisulpride has a maximum mean difference in QTcF predicted of 13.4 (15.1) milliseconds. Bradycardia, torsade de pointes (TdP), ventricular tachycardia, hypotension, and QT prolongation by electrocardiogram (ECG) have been reported postmarketing during postapproval chronic oral use of amisulpride outside of the United States.
During clinical trials for PONV prophylaxis, chills were reported in 4% of adult patients receiving amisulpride vs. 3% placebo. Abdominal distension was reported in 2% of patients receiving amisulpride vs. 1% placebo.
During a clinical trial of amisulpride 5 mg IV as a single dose for PONV prophylaxis, prolactin concentrations were measured. Increased serum prolactin concentrations were reported in 5% of amisulpride-treated patients vs. 1% of those receiving placebo. Serum prolactin concentrations increased from a mean of 10 ng/mL at baseline to 32 ng/mL after amisulpride treatment in 112 female patients (upper limit of normal 29 ng/mL) and from 10 ng/mL to 19 ng/mL in 61 males (upper limit of normal 18 ng/mL). No clinical consequences due to hyperprolactinemia were reported.
Nervous system disorders such as agitation, anxiety, dystonic reaction, extrapyramidal disorder (e.g., dyskinesia, tremor), and seizures have been reported with chronic oral use of amisulpride during postmarketing surveillance outside of the United States. Psychiatric disorders such as confusion, insomnia, drowsiness, and somnolence have been reported postmarketing during postapproval chronic oral use of amisulpride outside of the United States.
Angioedema, urticaria, and other hypersensitivity reactions have been reported postmarketing during postapproval chronic oral use of amisulpride outside of the United States.
During clinical trials for PONV prophylaxis, hypokalemia was reported in 4% of patients receiving amisulpride vs. 2% placebo. Agranulocytosis and elevated hepatic enzymes have been reported postmarketing during postapproval chronic oral use of amisulpride outside of the United States.
Neuroleptic malignant syndrome has been reported postmarketing during postapproval chronic oral use of amisulpride outside of the United States.
Amisulpride is contraindicated in patients with a history of hypersensitivity to amisulpride. Hypersensitivity reactions, angioedema, and urticaria have been reported during postmarketing surveillance.
Amisulpride increases the risk of developing QT prolongation in a dose and concentration-dependent manner, which can lead to abnormal and potentially fatal heart rhythms, including torsade de pointes. Avoid amisulpride in patients with congenital long QT syndrome and in patients taking droperidol. Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing cardiac disease such as cardiac arrhythmias/cardiac conduction disorders or congestive heart failure, patients predisposed to electrolyte imbalance (e.g., hypokalemia or hypomagnesemia), with other conditions that may prolong the QT interval, or in patients taking other medications known to prolong the QT interval (e.g., ondansetron). Use amisulpride with caution in patients with conditions that may increase the risk of QT prolongation including congenital long QT syndrome, bradycardia, AV block, heart failure, stress-related cardiomyopathy, myocardial infarction, stroke, hypomagnesemia, hypokalemia, hypocalcemia, or in patients receiving medications known to prolong the QT interval or cause electrolyte imbalances. Females, people 65 years and older, patients with sleep deprivation, pheochromocytoma, sickle cell disease, hypothyroidism, hyperparathyroidism, hypothermia, systemic inflammation (e.g., human immunodeficiency virus (HIV) infection, fever, and some autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus (SLE), and celiac disease) and patients undergoing apheresis procedures (e.g., plasmapheresis [plasma exchange], cytapheresis) may also be at increased risk for QT prolongation. Instruct patients who receive amisulpride to contact their healthcare provider immediately if they perceive a change in their heart rate, if they feel lightheaded, or if they have syncope.
Avoid the use of amisulpride in patients with severe renal impairment (eGFR less than 30 mL/minute/1.73 m2) and renal failure, due to possible accumulation and toxicity. Amisulpride is substantially excreted by the kidneys and is only weakly dialyzed.
There are no adequate data regarding amisulpride use during human pregnancy. Available data with amisulpride use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. No adverse developmental effects were reported during animal reproduction studies with oral administration of amisulpride in rats and rabbits during the period of organogenesis at exposures about 43 and 645 times, respectively, the exposure delivered by the highest recommended dose of 10 mg.
Amisulpride is distributed into human breast milk. There are no reports of adverse effects on the breastfed infant, however, a lactating woman may consider interrupting breast-feeding and pumping and discarding breast milk for 48 hours after amisulpride administration to minimize drug exposure to the infant. Based on case reports, amisulpride is present in human milk at concentrations that are 11- to 20-fold higher than human plasma in patients taking multiple oral doses of amisulpride (200 to 400 mg/day) with the estimated infant daily dose ranging from 5% to 11% of the maternal dose. There is no information on milk production, however, based on the pharmacological action of amisulpride, a dopamine-2 (D2) receptor antagonist, an increase in serum prolactin may result in a reversible increase in maternal milk production. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for amisulpride and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.
Amisulpride injection is given in single doses and is unlikely to affect fertility during this limited use. When amisulpride is given repeatedly, it may affect female fertility. In animal fertility studies, the administration of repeated doses of amisulpride over a 10-day period to female rats resulted in infertility that was reversible.
No overall differences in safety or effectiveness were observed between geriatric patients and younger adult patients during clinical trials of amisulpride injection for the prevention or treatment of post-operative nausea/vomiting (PONV). However, greater sensitivity of some older individuals cannot be ruled out. Amisulpride is known to be substantially excreted by the kidneys, and the risk of adverse reactions to amisulpride may be greater in elderly patients with impaired renal function. The older adult may be more likely to have risk factors that may predispose to QT prolongation.
For the treatment of post-operative nausea/vomiting (PONV) in patients who have or have not received antiemetic prophylaxis with an agent of a different class:
Intravenous dosage:
Adults: 10 mg IV as a single dose infused over 1 to 2 minutes when PONV presents after a surgical procedure.
For post-operative nausea/vomiting (PONV) prophylaxis, either alone or in combination with an antiemetic agent of a different class:
Intravenous dosage:
Adults: 5 mg IV as a single dose infused over 1 to 2 minutes at the time of induction of anesthesia.
Maximum Dosage Limits:
-Adults
10 mg/dose IV.
-Geriatric
10 mg/dose IV.
-Adolescents
Safety and efficacy have not been established.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
No dosage adjustments are needed.
Patients with Renal Impairment Dosing
eGFR 30 mL/minute/1.73 m2 or more: No dosage adjustment needed.
eGFR less than 30 mL/minute/1.73 m2: Avoid use.
*non-FDA-approved indication
Adagrasib: (Major) Concomitant use of adagrasib and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Alfuzosin: (Major) Monitor the ECG in patients taking amisulpride with alfuzosin due to the risk of additive QT prolongation. Amisulpride causes dose- and concentration- dependent QT prolongation.
Amiodarone: (Major) Concomitant use of amiodarone and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. Due to the extremely long half-life of amiodarone, a drug interaction is possible for days to weeks after drug discontinuation.
Amoxicillin; Clarithromycin; Omeprazole: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with clarithromycin. Amisulpride causes dose- and concentration- dependent QT prolongation. Clarithromycin is associated with an established risk for QT prolongation and TdP.
Anagrelide: (Major) Do not use anagrelide with other drugs that prolong the QT interval, such as amisulpride. Torsade de pointes (TdP) and ventricular tachycardia have been reported with anagrelide. In addition, dose-related increases in mean QTc and heart rate were observed in healthy subjects. Amisulpride causes dose- and concentration- dependent QT prolongation.
Apomorphine: (Major) Use apomorphine and amisulpride together with caution due to the risk of additive QT prolongation. Monitor ECGs for QT prolongation when amisulpride is administered with apomorphine. Amisulpride causes dose- and concentration- dependent QT prolongation. Dose-related QTc prolongation is associated with therapeutic apomorphine exposure.
Aripiprazole: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with aripiprazole. Amisulpride causes dose- and concentration- dependent QT prolongation. QT prolongation has occurred during therapeutic use of aripiprazole and following overdose.
Arsenic Trioxide: (Major) Avoid coadministration of amisulpride and arsenic trioxide due to the potential for additive QT prolongation and torsade de pointes (TdP); discontinue or select an alternative drug that does not prolong the QT interval prior to starting arsenic trioxide therapy. Monitor ECG frequently if coadministration is required. Amisulpride causes dose- and concentration- dependent QT prolongation. QT interval prolongation, TdP, and complete atrioventricular block have been reported with arsenic trioxide use.
Artemether; Lumefantrine: (Major) Avoid coadministration of amisulpride and artemether; lumefantrine due to the potential for additive QT prolongation. Monitor ECG for QT prolongation if coadministration is required. Amisulpride causes dose- and concentration- dependent QT prolongation. Artemether; lumefantrine is associated with QT interval prolongation.
Asenapine: (Major) Avoid coadministration of amisulpride and asenapine due to the potential for additive QT prolongation. Asenapine has been associated with QT prolongation. Amisulpride causes dose- and concentration- dependent QT prolongation.
Atomoxetine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with atomoxetine. QT prolongation and torsade de pointes have been reported in patients receiving clofazimine in combination with QT prolonging medications. Amisulpride causes dose- and concentration- dependent QT prolongation.
Azithromycin: (Major) Avoid coadministration of azithromycin with amisulpride due to the increased risk of QT prolongation. If use together is necessary, obtain an ECG at baseline to assess initial QT interval and determine frequency of subsequent ECG monitoring, avoid any non-essential QT prolonging drugs, and correct electrolyte imbalances. QT prolongation and torsade de pointes (TdP) have been spontaneously reported during azithromycin postmarketing surveillance. Amisulpride causes dose- and concentration- dependent QT prolongation.
Bedaquiline: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with bedaquiline. Discontinue bedaquiline if evidence of serious ventricular arrhythmia or QTcF interval greater than 500 ms. Bedaquiline prolongs the QT interval. Amisulpride causes dose- and concentration- dependent QT prolongation.
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline: (Major) Concomitant use of metronidazole and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Bismuth Subsalicylate; Metronidazole; Tetracycline: (Major) Concomitant use of metronidazole and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Buprenorphine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with buprenorphine. Amisulpride causes dose- and concentration- dependent QT prolongation. Buprenorphine has been associated with QT prolongation and has a possible risk of TdP. FDA-approved labeling for some buprenorphine products recommend avoiding use with Class 1A and Class III antiarrhythmic medications while other labels recommend avoiding use with any drug that has the potential to prolong the QT interval.
Buprenorphine; Naloxone: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with buprenorphine. Amisulpride causes dose- and concentration- dependent QT prolongation. Buprenorphine has been associated with QT prolongation and has a possible risk of TdP. FDA-approved labeling for some buprenorphine products recommend avoiding use with Class 1A and Class III antiarrhythmic medications while other labels recommend avoiding use with any drug that has the potential to prolong the QT interval.
Cabotegravir; Rilpivirine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with rilpivirine. Amisulpride causes dose- and concentration- dependent QT prolongation. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation; caution is advised when administering rilpivirine with other drugs that may prolong the QT or PR interval.
Carbidopa; Levodopa: (Major) Avoid using these drugs together. Amisulpride is a central dopamine antagonist and can antagonize the actions of dopamine agonists such as levodopa. Amisulpride is generally used perioperatively to prevent and treat postoperative nausea and vomiting. Prior to general anesthesia, levodopa may be continued as long as the patient is permitted to take oral medication. If levodopa-based therapy is interrupted temporarily, the usual daily dosage may be reinstituted or titrated upward to the normal dosage as soon as the patient is able to take oral medications.
Carbidopa; Levodopa; Entacapone: (Major) Avoid using these drugs together. Amisulpride is a central dopamine antagonist and can antagonize the actions of dopamine agonists such as levodopa. Amisulpride is generally used perioperatively to prevent and treat postoperative nausea and vomiting. Prior to general anesthesia, levodopa may be continued as long as the patient is permitted to take oral medication. If levodopa-based therapy is interrupted temporarily, the usual daily dosage may be reinstituted or titrated upward to the normal dosage as soon as the patient is able to take oral medications.
Ceritinib: (Major) Avoid coadministration of ceritinib with amisulpride if possible due to the risk of QT prolongation. If concomitant use is unavoidable, monitor ECGs and periodically monitor electrolytes; an interruption of ceritinib therapy, dose reduction, or discontinuation of therapy may be necessary if QT prolongation occurs. Ceritinib causes concentration- dependent QT prolongation. Amisulpride causes dose- and concentration-dependent QT prolongation.
Chloroquine: (Major) Avoid coadministration of chloroquine with amisulpride due to the increased risk of QT prolongation. If use together is necessary, obtain an ECG at baseline to assess initial QT interval and determine frequency of subsequent ECG monitoring, avoid any non-essential QT prolonging drugs, and correct electrolyte imbalances. Chloroquine is associated with an increased risk of QT prolongation and torsade de pointes (TdP); the risk of QT prolongation is increased with higher chloroquine doses. Amisulpride causes dose- and concentration-dependent QT prolongation.
Chlorpromazine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with chlorpromazine. Amisulpride causes dose- and concentration- dependent QT prolongation. Chlorpromazine, a phenothiazine, is associated with an established risk of QT prolongation and TdP.
Ciprofloxacin: (Major) Concomitant use of ciprofloxacin and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Cisapride: (Contraindicated) Coadministration of cisapride with amisulpride is contraindicated due to the risk of additive QT prolongation and torsade de pointes (TdP). QT prolongation and ventricular arrhythmias, including TdP and death, have been reported with cisapride. Amisulpride causes dose- and concentration- dependent QT prolongation.
Citalopram: (Major) Avoid coadministration of amisulpride and citalopram due to the potential for additive QT prolongation. Monitor ECG for QT prolongation if coadministration is required. Amisulpride causes dose- and concentration- dependent QT prolongation. Citalopram causes dose-dependent QT interval prolongation.
Clarithromycin: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with clarithromycin. Amisulpride causes dose- and concentration- dependent QT prolongation. Clarithromycin is associated with an established risk for QT prolongation and TdP.
Clofazimine: (Major) Concomitant use of clofazimine and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Clozapine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with clozapine. Amisulpride causes dose- and concentration- dependent QT prolongation. Treatment with clozapine has been associated with QT prolongation, TdP, cardiac arrest, and sudden death.
Codeine; Phenylephrine; Promethazine: (Major) Concomitant use of promethazine and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Codeine; Promethazine: (Major) Concomitant use of promethazine and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Crizotinib: (Major) Avoid coadministration of crizotinib with amisulpride due to the risk of QT prolongation. If concomitant use is unavoidable, monitor ECGs for QT prolongation and monitor electrolytes. An interruption of therapy, dose reduction, or discontinuation of therapy may be necessary for crizotinib if QT prolongation occurs. Crizotinib can cause concentration-dependent QT prolongation. Amisulpride causes dose- and concentration- dependent QT prolongation.
Dasatinib: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with dasatinib. Amisulpride causes dose- and concentration- dependent QT prolongation. In vitro studies have shown that dasatinib has the potential to prolong the QT interval.
Degarelix: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with degarelix. Amisulpride causes dose- and concentration- dependent QT prolongation. Androgen deprivation therapy (i.e., degarelix) may also prolong the QT/QTc interval.
Desflurane: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with halogenated anesthetics. Amisulpride causes dose- and concentration- dependent QT prolongation. Halogenated anesthetics can prolong the QT interval.
Deutetrabenazine: (Major) Monitor the ECG in patients taking amisulpride with deutetrabenazine due to the risk of additive QT prolongation. Amisulpride causes dose- and concentration-dependent QT prolongation. Deutetrabenazine may prolong the QT interval, but the degree of QT prolongation is not clinically significant when deutetrabenazine is administered within the recommended dosage range.
Dexmedetomidine: (Major) Concomitant use of dexmedetomidine and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Dextromethorphan; Quinidine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with quinidine. Quinidine administration is associated with QT prolongation and torsade de pointes (TdP). Amisulpride causes dose- and concentration- dependent QT prolongation.
Disopyramide: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with disopyramide. Amisulpride causes dose- and concentration- dependent QT prolongation. Disopyramide administration is associated with QT prolongation and TdP.
Dofetilide: (Major) Coadministration of dofetilide and amisulpride is not recommended as concurrent use may increase the risk of QT prolongation. Monitor ECGs for QT prolongation if concomitant use is unavoidable. Dofetilide, a Class III antiarrhythmic agent, is associated with a well-established risk of QT prolongation and torsade de pointes (TdP). Amisulpride causes dose- and concentration- dependent QT prolongation.
Dolasetron: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with dolasetron. Amisulpride causes dose- and concentration- dependent QT prolongation. Dolasetron has been associated with a dose-dependent prolongation in the QT, PR, and QRS intervals on an electrocardiogram.
Dolutegravir; Rilpivirine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with rilpivirine. Amisulpride causes dose- and concentration- dependent QT prolongation. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation; caution is advised when administering rilpivirine with other drugs that may prolong the QT or PR interval.
Donepezil: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with donepezil. Amisulpride causes dose- and concentration- dependent QT prolongation. Case reports indicate that QT prolongation and TdP can occur during donepezil therapy.
Donepezil; Memantine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with donepezil. Amisulpride causes dose- and concentration- dependent QT prolongation. Case reports indicate that QT prolongation and TdP can occur during donepezil therapy.
Dronedarone: (Contraindicated) Coadministration of dronedarone with amisulpride is contraindicated due to the risk of additive QT prolongation and torsade de pointes (TdP). Dronedarone administration is associated with a dose-related increase in the QTc interval. The increase in QTc is approximately 10 milliseconds at doses of 400 mg twice daily (the FDA-approved dose) and up to 25 milliseconds at doses of 1600 mg twice daily. Amisulpride causes dose- and concentration- dependent QT prolongation.
Droperidol: (Major) To avoid potential additive effects, avoid use of amisulpride in patients taking droperidol. Both drugs are dopamine antagonists. Droperidol administration is associated with an established risk for QT prolongation and torsade de pointes (TdP). Any drug known to have the potential to prolong the QT interval should not be used together with droperidol. Possible pharmacodynamic interactions can occur between droperidol and neuroleptics that prolong the QT interval, Amisulpride has neuroleptic activity and causes dose- and concentration-dependent QT prolongation.
Efavirenz: (Major) Avoid coadministration of efavirenz and amisulpride due to the risk of QT prolongation and torsade de pointes (TdP). QT prolongation has been observed with use of efavirenz. Although data are limited, the manufacturer of efavirenz recommends an alternative antiretroviral be considered for patients receiving medications with a known risk for TdP. Amisulpride causes dose- and concentration- dependent QT prolongation.
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate: (Major) Avoid coadministration of efavirenz and amisulpride due to the risk of QT prolongation and torsade de pointes (TdP). QT prolongation has been observed with use of efavirenz. Although data are limited, the manufacturer of efavirenz recommends an alternative antiretroviral be considered for patients receiving medications with a known risk for TdP. Amisulpride causes dose- and concentration- dependent QT prolongation.
Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate: (Major) Avoid coadministration of efavirenz and amisulpride due to the risk of QT prolongation and torsade de pointes (TdP). QT prolongation has been observed with use of efavirenz. Although data are limited, the manufacturer of efavirenz recommends an alternative antiretroviral be considered for patients receiving medications with a known risk for TdP. Amisulpride causes dose- and concentration- dependent QT prolongation.
Eliglustat: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with eliglustat. Amisulpride causes dose- and concentration- dependent QT prolongation. Eliglustat is predicted to cause PR, QRS, and/or QT prolongation at significantly elevated plasma concentrations.
Emtricitabine; Rilpivirine; Tenofovir alafenamide: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with rilpivirine. Amisulpride causes dose- and concentration- dependent QT prolongation. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation; caution is advised when administering rilpivirine with other drugs that may prolong the QT or PR interval.
Emtricitabine; Rilpivirine; Tenofovir Disoproxil Fumarate: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with rilpivirine. Amisulpride causes dose- and concentration- dependent QT prolongation. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation; caution is advised when administering rilpivirine with other drugs that may prolong the QT or PR interval.
Encorafenib: (Major) Avoid coadministration of encorafenib and amisulpride due to QT prolongation. If concurrent use cannot be avoided, monitor ECGs for QT prolongation and monitor electrolytes; correct hypokalemia and hypomagnesemia prior to treatment. Encorafenib has been associated with dose-dependent QT prolongation. Amisulpride causes dose- and concentration- dependent QT prolongation.
Entrectinib: (Major) Avoid coadministration of entrectinib with amisulpride due to the risk of QT prolongation. If concomitant use is unavoidable, monitor ECGs. Entrectinib has been associated with QT prolongation. Amisulpride causes dose- and concentration -dependent QT prolongation.
Eribulin: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with eribulin. Amisulpride causes dose- and concentration- dependent QT prolongation. Eribulin has been associated with QT prolongation.
Erythromycin: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with erythromycin. Amisulpride causes dose- and concentration- dependent QT prolongation. Erythromycin is associated with QT prolongation and TdP.
Escitalopram: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with escitalopram. Amisulpride causes dose- and concentration- dependent QT prolongation. Escitalopram has been associated with a risk of QT prolongation and TdP.
Etrasimod: (Major) Concomitant use of etrasimod and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. Etrasimod has a limited effect on the QT/QTc interval at therapeutic doses but may cause bradycardia and atrioventricular conduction delays which may increase the risk for TdP in patients with a prolonged QT/QTc interval.
Fexinidazole: (Major) Concomitant use of fexinidazole and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Fingolimod: (Major) Monitor ECG continuously overnight in a medical facility after the first fingolimod dose if amisulpride is coadministered due to the potential for additive QT prolongation. Amisulpride causes dose- and concentration- dependent QT prolongation. Fingolimod initiation results in decreased heart rate and may prolong the QT interval. Fingolimod has not been studied in patients treated with drugs that prolong the QT interval, but drugs that prolong the QT interval have been associated with cases of TdP in patients with bradycardia.
Flecainide: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with flecainide. Amisulpride causes dose- and concentration- dependent QT prolongation. Flecainide is a Class IC antiarrhythmic associated with a possible risk for QT prolongation and/or TdP; flecainide increases the QT interval, but largely due to prolongation of the QRS interval. Although causality for TdP has not been established for flecainide, patients receiving concurrent drugs that have the potential for QT prolongation may have an increased risk of developing proarrhythmias.
Fluconazole: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with fluconazole. Amisulpride causes dose- and concentration- dependent QT prolongation. Fluconazole has been associated with QT prolongation and rare cases of TdP.
Fluoxetine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with fluoxetine. Amisulpride causes dose- and concentration- dependent QT prolongation. QT prolongation and TdP have been reported in patients treated with fluoxetine.
Fluphenazine: (Minor) Monitor ECGs for QT prolongation when amisulpride is administered with fluphenazine. Amisulpride causes dose- and concentration- dependent QT prolongation. Fluphenazine is associated with a possible risk for QT prolongation.
Fluvoxamine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with fluvoxamine. Amisulpride causes dose- and concentration- dependent QT prolongation. QT prolongation and TdP have been reported during fluvoxamine postmarketing use.
Foscarnet: (Major) Avoid coadministration of amisulpride and foscarnet due to the potential for additive QT prolongation and torsade de pointes (TdP). Amisulpride causes dose- and concentration- dependent QT prolongation. Both QT prolongation and TdP have been reported during postmarketing use of foscarnet.
Fostemsavir: (Major) Monitor the ECG in patients taking amisulpride with fostemsavir due to the risk of additive QT prolongation. Amisulpride causes dose- and concentration-dependent QT prolongation. Supratherapeutic doses of fostemsavir (2,400 mg twice daily, four times the recommended daily dose) have been shown to cause QT prolongation. Fostemsavir causes dose-dependent QT prolongation.
Gemifloxacin: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with gemifloxacin. Amisulpride causes dose- and concentration- dependent QT prolongation. Gemifloxacin may prolong the QT interval in some patients. The maximal change in the QTc interval occurs approximately 5 to 10 hours following oral administration of gemifloxacin. The likelihood of QTc prolongation may increase with increasing dose of the drug; therefore, the recommended dose should not be exceeded especially in patients with renal or hepatic impairment where the Cmax and AUC are slightly higher.
Gemtuzumab Ozogamicin: (Major) Monitor ECG and electrolytes if amisulpride is coadministered with gemtuzumab due to the potential for additive QT prolongation. Amisulpride causes dose- and concentration- dependent QT prolongation. Although QT interval prolongation has not been reported with gemtuzumab, it has been reported with other drugs that contain calicheamicin.
Gilteritinib: (Major) Use caution and monitor electrocardiograms (ECGs) for evidence of QT prolongation if concurrent use of gilteritinib and amisulpride is necessary. Gilteritinib has been associated with QT prolongation. Amisulpride causes dose- and concentration- dependent QT prolongation.
Glasdegib: (Major) Avoid coadministration of glasdegib with amisulpride due to the potential for additive QT prolongation. If coadministration cannot be avoided, monitor patients for increased risk of QT prolongation with increased frequency of ECG monitoring. Amisulpride causes dose- and concentration- dependent QT prolongation. Glasdegib therapy may result in QT prolongation and ventricular arrhythmias including ventricular fibrillation and ventricular tachycardia.
Goserelin: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with goserelin. Amisulpride causes dose- and concentration- dependent QT prolongation. Androgen deprivation therapy (i.e., goserelin) may also prolong the QT/QTc interval.
Granisetron: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with granisetron. Amisulpride causes dose- and concentration- dependent QT prolongation. Granisetron has been associated with QT prolongation.
Halogenated Anesthetics: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with halogenated anesthetics. Amisulpride causes dose- and concentration- dependent QT prolongation. Halogenated anesthetics can prolong the QT interval.
Haloperidol: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with haloperidol. Amisulpride causes dose- and concentration- dependent QT prolongation. QT prolongation and TdP have been observed during haloperidol treatment. Excessive doses (particularly in the overdose setting) or IV administration of haloperidol may be associated with a higher risk of QT prolongation.
Histrelin: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with histrelin. Amisulpride causes dose- and concentration- dependent QT prolongation. Androgen deprivation therapy (i.e., histrelin) may also prolong the QT/QTc interval.
Hydroxychloroquine: (Major) Avoid coadministration of amisulpride and hydroxychloroquine due to the risk of increased QT prolongation. If use together is necessary, obtain an ECG at baseline to assess initial QT interval and determine frequency of subsequent ECG monitoring, avoid any non-essential QT prolonging drugs, and correct electrolyte imbalances. Hydroxychloroquine prolongs the QT interval. Amisulpride causes dose- and concentration-dependent QT prolongation.
Hydroxyzine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with hydroxyzine. Amisulpride causes dose- and concentration- dependent QT prolongation. Postmarketing data indicate that hydroxyzine causes QT prolongation and TdP.
Ibutilide: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with ibutilide. Amisulpride causes dose- and concentration- dependent QT prolongation. Ibutilide administration can cause QT prolongation and TdP; proarrhythmic events should be anticipated. The potential for proarrhythmic events with ibutilide increases with the coadministration of other drugs that prolong the QT interval.
Iloperidone: (Major) Avoid coadministration of amisulpride and iloperidone due to the potential for additive QT prolongation. Amisulpride causes dose- and concentration- dependent QT prolongation. Iloperidone has been associated with QT prolongation.
Inotuzumab Ozogamicin: (Major) Avoid coadministration of inotuzumab with amisulpride due to the potential for additive QT prolongation and torsade de pointes (TdP). If coadministration is unavoidable, obtain ECGs and prior to the start of treatment and periodically during treatment. Amisulpride causes dose- and concentration- dependent QT prolongation. Inotuzumab has been associated with QT interval prolongation.
Isoflurane: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with halogenated anesthetics. Amisulpride causes dose- and concentration- dependent QT prolongation. Halogenated anesthetics can prolong the QT interval.
Itraconazole: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with itraconazole. Amisulpride causes dose- and concentration- dependent QT prolongation. Itraconazole has been associated with prolongation of the QT interval.
Ivosidenib: (Major) Avoid coadministration of ivosidenib with amisulpride due to an increased risk of QT prolongation. If concomitant use is unavoidable, monitor ECGs for QTc prolongation and monitor electrolytes; correct any electrolyte abnormalities as clinically appropriate. An interruption of therapy and dose reduction of ivosidenib may be necessary if QT prolongation occurs. Prolongation of the QTc interval and ventricular arrhythmias have been reported in patients treated with ivosidenib. Amisulpride causes dose- and concentration- dependent QT prolongation.
Ketoconazole: (Contraindicated) Avoid concomitant use of ketoconazole and amisulpride due to an increased risk for torsade de pointes (TdP) and QT/QTc prolongation.
Lansoprazole; Amoxicillin; Clarithromycin: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with clarithromycin. Amisulpride causes dose- and concentration- dependent QT prolongation. Clarithromycin is associated with an established risk for QT prolongation and TdP.
Lapatinib: (Major) Monitor ECGs for QT prolongation and monitor electrolytes if coadministration of lapatinib with amisulpride is necessary; correct electrolyte abnormalities prior to treatment. Lapatinib has been associated with concentration-dependent QT prolongation; ventricular arrhythmias and torsade de pointes (TdP) have been reported in postmarketing experience with lapatinib. Amisulpride causes dose- and concentration- dependent QT prolongation.
Lefamulin: (Major) Avoid coadministration of lefamulin with amisulpride as concurrent use may increase the risk of QT prolongation. If coadministration cannot be avoided, ECG monitoring is recommended during treatment. Lefamulin has a concentration dependent QTc prolongation effect. The pharmacodynamic interaction potential to prolong the QT interval of the electrocardiogram between lefamulin and other drugs that effect cardiac conduction is unknown. Amisulpride causes dose- and concentration- dependent QT prolongation.
Lenvatinib: (Major) Avoid coadministration of lenvatinib with amisulpride due to the risk of QT prolongation. Prolongation of the QT interval has been reported with lenvatinib therapy. Amisulpride causes dose- and concentration- dependent QT prolongation.
Leuprolide: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with leuprolide. Amisulpride causes dose- and concentration- dependent QT prolongation. Androgen deprivation therapy (i.e., leuprolide) may also prolong the QT/QTc interval.
Leuprolide; Norethindrone: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with leuprolide. Amisulpride causes dose- and concentration- dependent QT prolongation. Androgen deprivation therapy (i.e., leuprolide) may also prolong the QT/QTc interval.
Levodopa: (Major) Avoid using these drugs together. Amisulpride is a central dopamine antagonist and can antagonize the actions of dopamine agonists such as levodopa. Amisulpride is generally used perioperatively to prevent and treat postoperative nausea and vomiting. Prior to general anesthesia, levodopa may be continued as long as the patient is permitted to take oral medication. If levodopa-based therapy is interrupted temporarily, the usual daily dosage may be reinstituted or titrated upward to the normal dosage as soon as the patient is able to take oral medications.
Levofloxacin: (Major) Concomitant use of levofloxacin and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Levoketoconazole: (Contraindicated) Avoid concomitant use of ketoconazole and amisulpride due to an increased risk for torsade de pointes (TdP) and QT/QTc prolongation.
Lithium: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with lithium. Amisulpride causes dose- and concentration- dependent QT prolongation. Lithium has been associated with QT prolongation.
Lofexidine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with lofexidine. Amisulpride causes dose- and concentration- dependent QT prolongation. Lofexidine prolongs the QT interval.
Loperamide: (Major) Concomitant use of loperamide and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Loperamide; Simethicone: (Major) Concomitant use of loperamide and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Lopinavir; Ritonavir: (Major) Avoid coadministration of lopinavir with amisulpride due to the potential for additive QT prolongation. If use together is necessary, obtain a baseline ECG to assess initial QT interval and determine frequency of subsequent ECG monitoring, avoid any non-essential QT prolonging drugs, and correct electrolyte imbalances. Lopinavir is associated with QT prolongation. Amisulpride causes dose- and concentration-dependent QT prolongation.
Macimorelin: (Major) Avoid concurrent administration of macimorelin with drugs that prolong the QT interval, such as amisulpride. Use of these drugs together may increase the risk of developing torsade de pointes-type ventricular tachycardia. Sufficient washout time of drugs that are known to prolong the QT interval prior to administration of macimorelin is recommended. Treatment with macimorelin has been associated with an increase in the corrected QT (QTc) interval. Amisulpride causes dose- and concentration- dependent QT prolongation.
Maprotiline: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with maprotiline. Amisulpride causes dose- and concentration- dependent QT prolongation. Maprotiline has been reported to prolong the QT interval, particularly in overdose or with higher-dose prescription therapy (elevated serum concentrations). Cases of long QT syndrome and TdP tachycardia have been described with maprotiline use, but rarely occur when the drug is used alone in normal prescribed doses and in the absence of other known risk factors for QT prolongation. Limited data are available regarding the safety of maprotiline in combination with other QT-prolonging drugs.
Mefloquine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with mefloquine. Amisulpride causes dose- and concentration- dependent QT prolongation. There is evidence that the use of halofantrine after mefloquine causes a significant lengthening of the QTc interval. Mefloquine alone has not been reported to cause QT prolongation. However, due to the lack of clinical data, mefloquine should be used with caution in patients receiving drugs that prolong the QT interval.
Methadone: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with methadone. Amisulpride causes dose- and concentration- dependent QT prolongation. Methadone is considered to be associated with an increased risk for QT prolongation and TdP, especially at higher doses (more than 200 mg/day but averaging approximately 400 mg/day in adult patients). Most cases involve patients being treated for pain with large, multiple daily doses of methadone, although cases have been reported in patients receiving doses commonly used for maintenance treatment of opioid addiction.
Metronidazole: (Major) Concomitant use of metronidazole and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Midostaurin: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with midostaurin. Amisulpride causes dose- and concentration- dependent QT prolongation. QT prolongation was reported in patients who received midostaurin in clinical trials.
Mifepristone: (Major) Concomitant use of amisulpride and mifepristone increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Mirtazapine: (Major) Concomitant use of amisulpride and mirtazapine increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Mobocertinib: (Major) Concomitant use of mobocertinib and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Moxifloxacin: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with moxifloxacin. Amisulpride causes dose- and concentration- dependent QT prolongation. Quinolones have been associated with a risk of QT prolongation and TdP. Although extremely rare, torsade de pointes has been reported during postmarketing surveillance of moxifloxacin. These reports generally involved patients with concurrent medical conditions or concomitant medications that may have been contributory.
Nilotinib: (Major) Avoid the concomitant use of nilotinib and amisulpride; significant prolongation of the QT interval may occur. Sudden death and QT prolongation have been reported in patients who received nilotinib therapy. Amisulpride causes dose- and concentration- dependent QT prolongation.
Ofloxacin: (Major) Concomitant use of ofloxacin and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Olanzapine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with olanzapine. Amisulpride causes dose- and concentration- dependent QT prolongation. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval.
Olanzapine; Fluoxetine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with fluoxetine. Amisulpride causes dose- and concentration- dependent QT prolongation. QT prolongation and TdP have been reported in patients treated with fluoxetine. (Major) Monitor ECGs for QT prolongation when amisulpride is administered with olanzapine. Amisulpride causes dose- and concentration- dependent QT prolongation. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval.
Olanzapine; Samidorphan: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with olanzapine. Amisulpride causes dose- and concentration- dependent QT prolongation. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval.
Ondansetron: (Major) Concomitant use of ondansetron and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. Do not exceed 16 mg of IV ondansetron in a single dose; the degree of QT prolongation associated with ondansetron significantly increases above this dose.
Osilodrostat: (Major) Monitor ECGs in patients receiving osilodrostat with amisulpride. Osilodrostat is associated with dose-dependent QT prolongation. Amisulpride causes dose- and concentration- dependent QT prolongation.
Osimertinib: (Major) Avoid coadministration of amisulpride with osimertinib due to the risk of QT prolongation and torsade de pointes (TdP). If concomitant use is unavoidable, periodically monitor ECGs for QT prolongation and monitor electrolytes; an interruption of osimertinib therapy with dose reduction or discontinuation may be necessary if QT prolongation occurs. Concentration-dependent QTc prolongation occurred during clinical trials of osimertinib. Amisulpride causes dose- and concentration- dependent QT prolongation.
Oxaliplatin: (Major) Monitor ECG and electrolytes if amisulpride is coadministered with oxaliplatin due to the potential for additive QT prolongation and torsade de pointes (TdP). Correct electrolyte abnormalities prior to administration of oxaliplatin. Amisulpride causes dose- and concentration- dependent QT prolongation. QT prolongation and ventricular arrhythmias including fatal TdP have been reported with oxaliplatin use in postmarketing experience.
Ozanimod: (Major) In general, do not initiate ozanimod in patients taking amisulpride due to the risk of additive bradycardia, QT prolongation, and torsade de pointes (TdP). If treatment initiation is considered, monitor ECGs. Ozanimod initiation may result in a transient decrease in heart rate and atrioventricular conduction delays. Ozanimod has not been studied in patients taking concurrent QT prolonging drugs; however, QT prolonging drugs have been associated with TdP in patients with bradycardia. Amisulpride causes dose- and concentration-dependent QT prolongation.
Pacritinib: (Major) Concomitant use of pacritinib and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Paliperidone: (Major) Avoid coadministration of amisulpride and paliperidone due to the potential for additive QT prolongation. Monitor ECG if coadministration is necessary. Amisulpride causes dose- and concentration- dependent QT prolongation. Paliperidone has been associated with QT prolongation; TdP and ventricular fibrillation have been reported in the setting of overdose.
Panobinostat: (Major) Coadministration of amisulpride and panobinostat is not recommended due to the potential for additive QT prolongation. Amisulpride causes dose- and concentration- dependent QT prolongation. Panobinostat can cause QT prolongation.
Pasireotide: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with pasireotide. Amisulpride causes dose- and concentration- dependent QT prolongation. QT prolongation has occurred with pasireotide at therapeutic and supra-therapeutic doses.
Pazopanib: (Major) Coadministration of amisulpride and pazopanib is not recommended due to the risk of additive QT prolongation and torsade de pointes (TdP). Amisulpride causes dose- and concentration- dependent QT prolongation. Pazopanib is associated with QT interval prolongation.
Pentamidine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with pentamidine. Amisulpride causes dose- and concentration- dependent QT prolongation. Systemic pentamidine has been associated with QT prolongation.
Perphenazine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with perphenazine. Amisulpride causes dose- and concentration- dependent QT prolongation. Perphenazine is associated with a possible risk for QT prolongation.
Perphenazine; Amitriptyline: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with perphenazine. Amisulpride causes dose- and concentration- dependent QT prolongation. Perphenazine is associated with a possible risk for QT prolongation.
Pimavanserin: (Major) Avoid coadministration of amisulpride and pimavanserin due to the potential for additive QT prolongation. Amisulpride causes dose- and concentration- dependent QT prolongation. Pimavanserin may cause QT prolongation.
Pimozide: (Contraindicated) Coadministration of pimozide with amisulpride is contraindicated due to the risk of additive QT prolongation and torsade de pointes (TdP). Pimozide is associated with a well-established risk of QT prolongation and TdP. Amisulpride causes dose- and concentration- dependent QT prolongation.
Pitolisant: (Major) Avoid coadministration of pitolisant with amisulpride as concurrent use may increase the risk of QT prolongation. If concomitant therapy is unavoidable, monitor ECGs. Amisulpride causes dose- and concentration- dependent QT prolongation.
Ponesimod: (Major) In general, do not initiate ponesimod in patients taking amisulpride due to the risk of additive bradycardia, QT prolongation, and torsade de pointes (TdP). If treatment initiation is considered, seek advice from a cardiologist. Ponesimod initiation may result in a transient decrease in heart rate and atrioventricular conduction delays. Ponesimod has not been studied in patients taking concurrent QT prolonging drugs; however, QT prolonging drugs have been associated with TdP in patients with bradycardia. Amisulpride causes dose- and concentration-dependent QT prolongation.
Posaconazole: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with posaconazole. Amisulpride causes dose- and concentration- dependent QT prolongation. Posaconazole has been associated with prolongation of the QT interval as well as rare cases of TdP.
Primaquine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with primaquine. Amisulpride causes dose- and concentration- dependent QT prolongation. Primaquine has the potential to prolong the QT interval.
Procainamide: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with procainamide. Amisulpride causes dose- and concentration- dependent QT prolongation. Procainamide is associated with a well-established risk of QT prolongation and TdP.
Prochlorperazine: (Minor) Monitor ECGs for QT prolongation when amisulpride is administered with prochlorperazine. Amisulpride causes dose- and concentration- dependent QT prolongation. Prochlorperazine is associated with a possible risk for QT prolongation.
Promethazine: (Major) Concomitant use of promethazine and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Promethazine; Dextromethorphan: (Major) Concomitant use of promethazine and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Promethazine; Phenylephrine: (Major) Concomitant use of promethazine and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Propafenone: (Major) Concomitant use of propafenone and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Quetiapine: (Major) Concomitant use of quetiapine and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Quinidine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with quinidine. Quinidine administration is associated with QT prolongation and torsade de pointes (TdP). Amisulpride causes dose- and concentration- dependent QT prolongation.
Quinine: (Major) Avoid coadministration of amisulpride and quinine due to the potential for additive QT prolongation and torsade de pointes (TdP). Amisulpride causes dose- and concentration- dependent QT prolongation. Quinine has been associated with QT prolongation and rare cases of TdP.
Quizartinib: (Major) Concomitant use of quizartinib and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Ranolazine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with ranolazine. Amisulpride causes dose- and concentration- dependent QT prolongation. Ranolazine is associated with dose- and plasma concentration-related increases in the QTc interval.
Relugolix: (Major) Monitor the ECG in patients taking amisulpride with relugolix due to the risk of additive QT prolongation. Amisulpride causes dose- and concentration-dependent QT prolongation. Androgen deprivation therapy (i.e., relugolix) may also prolong the QT/QTc interval.
Relugolix; Estradiol; Norethindrone acetate: (Major) Monitor the ECG in patients taking amisulpride with relugolix due to the risk of additive QT prolongation. Amisulpride causes dose- and concentration-dependent QT prolongation. Androgen deprivation therapy (i.e., relugolix) may also prolong the QT/QTc interval.
Rilpivirine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with rilpivirine. Amisulpride causes dose- and concentration- dependent QT prolongation. Supratherapeutic doses of rilpivirine (75 to 300 mg/day) have caused QT prolongation; caution is advised when administering rilpivirine with other drugs that may prolong the QT or PR interval.
Risperidone: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with risperidone. Amisulpride causes dose- and concentration- dependent QT prolongation. Risperidone has been associated with a possible risk for QT prolongation and/or TdP. Reports of QT prolongation and TdP during risperidone therapy are noted by the manufacturer, primarily in the overdosage setting.
Romidepsin: (Major) Monitor ECG and electrolytes if amisulpride is coadministered with romidepsin due to the potential for additive QT prolongation. Amisulpride causes dose- and concentration- dependent QT prolongation. Romidepsin has been reported to prolong the QT interval.
Saquinavir: (Major) Avoid coadministration of amisulpride and saquinavir boosted with ritonavir due to the potential for additive QT prolongation and torsade de pointes (TdP). Monitor ECG at baseline and during therapy if coadministration cannot be avoided. Amisulpride causes dose- and concentration- dependent QT prolongation. Saquinavir boosted with ritonavir increases the QT interval in a dose-dependent fashion, which may increase the risk for serious arrhythmias such as TdP.
Selpercatinib: (Major) Monitor ECGs more frequently for QT prolongation if coadministration of amisulpride with selpercatinib is necessary due to the risk of additive QT prolongation. Concentration-dependent QT prolongation has been observed with selpercatinib therapy. Amisulpride causes dose- and concentration-dependent QT prolongation.
Sertraline: (Major) Concomitant use of sertraline and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary. The degree of QT prolongation associated with sertraline is not clinically significant when administered within the recommended dosage range; QT prolongation has been described at 2 times the maximum recommended dose.
Sevoflurane: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with halogenated anesthetics. Amisulpride causes dose- and concentration- dependent QT prolongation. Halogenated anesthetics can prolong the QT interval.
Siponimod: (Major) In general, do not initiate treatment with siponimod in patients receiving amisulpride due to the potential for QT prolongation. Consult a cardiologist regarding appropriate monitoring if siponimod use is required. Siponimod therapy prolonged the QT interval at recommended doses in a clinical study. Amisulpride causes dose- and concentration- dependent QT prolongation.
Sodium Stibogluconate: (Major) Concomitant use of sodium stibogluconate and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Solifenacin: (Moderate) Monitor ECGs for QT prolongation when amisulpride is administered with solifenacin. Amisulpride causes dose- and concentration- dependent QT prolongation. Solifenacin has been associated with dose-dependent prolongation of the QT interval. TdP has been reported with postmarketing use, although causality was not determined.
Sorafenib: (Major) Avoid coadministration of sorafenib with amisulpride due to the risk of additive QT prolongation. If concomitant use is unavoidable, monitor electrocardiograms and correct electrolyte abnormalities. An interruption or discontinuation of sorafenib therapy may be necessary if QT prolongation occurs. Sorafenib is associated with QTc prolongation. Amisulpride also causes dose- and concentration-dependent QT prolongation.
Sotalol: (Major) Concomitant use of sotalol and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Sunitinib: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with sunitinib. Amisulpride causes dose- and concentration- dependent QT prolongation. Sunitinib can prolong the QT interval.
Tacrolimus: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with tacrolimus. Amisulpride causes dose- and concentration- dependent QT prolongation. Tacrolimus causes QT prolongation.
Tamoxifen: (Major) Concomitant use of tamoxifen and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Telavancin: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with telavancin. Amisulpride causes dose- and concentration- dependent QT prolongation. Telavancin has been associated with QT prolongation.
Tetrabenazine: (Major) Avoid coadministration of amisulpride with tetrabenazine due to the potential for additive QT prolongation. Amisulpride causes dose- and concentration- dependent QT prolongation. Tetrabenazine causes a small increase in the corrected QT interval (QTc).
Thioridazine: (Contraindicated) Coadministration of thioridazine with amisulpride is contraindicated due to the risk of additive QT prolongation and torsade de pointes (TdP). Thioridazine is associated with a well-established risk of QT prolongation and TdP. Amisulpride causes dose- and concentration- dependent QT prolongation.
Tolterodine: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with tolterodine. Amisulpride causes dose- and concentration- dependent QT prolongation. Tolterodine has been associated with dose-dependent prolongation of the QT interval, especially in poor CYP2D6 metabolizers.
Toremifene: (Major) Avoid coadministration of amisulpride with toremifene due to the risk of additive QT prolongation. If concomitant use is unavoidable, closely monitor ECGs for QT prolongation and monitor electrolytes. Toremifene has been shown to prolong the QTc interval in a dose- and concentration-related manner. Amisulpride causes dose- and concentration- dependent QT prolongation.
Trazodone: (Major) Concomitant use of trazodone and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Triclabendazole: (Major) Concomitant use of triclabendazole and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Trifluoperazine: (Moderate) Monitor ECGs for QT prolongation when amisulpride is administered with trifluoperazine. Amisulpride causes dose- and concentration- dependent QT prolongation. Trifluoperazine is associated with a possible risk for QT prolongation.
Triptorelin: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with triptorelin. Amisulpride causes dose- and concentration- dependent QT prolongation. Androgen deprivation therapy (i.e., triptorelin) may also prolong the QT/QTc interval.
Vandetanib: (Major) Avoid coadministration of vandetanib with amisulpride due to an increased risk of QT prolongation and torsade de pointes (TdP). If concomitant use is unavoidable, monitor ECGs for QT prolongation and monitor electrolytes; correct hypocalcemia, hypomagnesemia, and/or hypomagnesemia prior to vandetanib administration. An interruption of vandetanib therapy or dose reduction may be necessary for QT prolongation. Vandetanib can prolong the QT interval in a concentration-dependent manner; TdP and sudden death have been reported in patients receiving vandetanib. Amisulpride causes dose- and concentration- dependent QT prolongation.
Vardenafil: (Major) Concomitant use of vardenafil and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Vemurafenib: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with vemurafenib. Amisulpride causes dose- and concentration- dependent QT prolongation. Vemurafenib has been associated with QT prolongation and TdP.
Venlafaxine: (Major) Concomitant use of venlafaxine and amisulpride increases the risk of QT/QTc prolongation and torsade de pointes (TdP). Avoid concomitant use if possible, especially in patients with additional risk factors for TdP. Consider taking steps to minimize the risk for QT/QTc interval prolongation and TdP, such as electrolyte monitoring and repletion and ECG monitoring, if concomitant use is necessary.
Voclosporin: (Major) Monitor the ECG in patients taking amisulpride with voclosporin due to the risk of additive QT prolongation. Amisulpride causes dose- and concentration-dependent QT prolongation. Voclosporin has been associated with QT prolongation at supratherapeutic doses.
Vonoprazan; Amoxicillin; Clarithromycin: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with clarithromycin. Amisulpride causes dose- and concentration- dependent QT prolongation. Clarithromycin is associated with an established risk for QT prolongation and TdP.
Vorinostat: (Major) Monitor ECGs for QT prolongation when amisulpride is administered with vorinostat. Amisulpride causes dose- and concentration- dependent QT prolongation. Vorinostat therapy is associated with a risk of QT prolongation.
Ziprasidone: (Major) Avoid coadministration of amisulpride with ziprasidone due to the potential for additive QT prolongation and torsade de pointes (TdP). Amisulpride causes dose- and concentration- dependent QT prolongation. Clinical trial data indicate that ziprasidone causes QT prolongation; there are postmarketing reports of TdP in patients with multiple confounding factors.
Amisulpride blocks dopaminergic receptors, specifically, dopamine-2 (D2) and dopamine-3 (D3). D2 receptors are located in the chemoreceptor trigger zone (CTZ) and respond to the dopamine released from the nerve endings. CTZ activation relays stimuli to the vomiting center which is involved in emesis. Animal studies indicate that D3 receptors in the area postrema also play a role in emesis. Studies in ferrets have found that amisulpride antagonizes the actions of apomorphine, a known central dopamine agonist, with an estimated ED50 of less than 1 mcg/kg, subcutaneously; the drug also inhibits cisplatin-induced emesis at 2 mg/kg and morphine-induced emesis at 3 to 6 mg/kg, when given intravenously. Amisulpride has no appreciable affinity for any other receptor types, other than low affinities for 5-HT2B and 5-HT7 receptors.
Amisulpride is administered intravenously. It is approximately 25% to 30% bound to plasma protein in the concentration range from 37 to 180 ng/mL; circulating drug also distributes into erythrocytes. Animal data indicate amisulpride distributes into breast milk. The mean Vd and CL are estimated to be 127 to 144 L and 20.6 L/hour, respectively, in surgical patients compared to 171 L and 24.1 L/hour, respectively, in healthy patients. Amisulpride is primarily eliminated by the kidney. Renal clearance is estimated to be 20.5 L/hour (342 mL/minute) in healthy patients suggesting that amisulpride undergoes active renal secretion. After IV administration, 74% of the administered dose is recovered in the urine (58% unchanged amisulpride) and 23% in the feces (20% unchanged amisulpride). The mean elimination half-life in adults is approximately 4 to 5 hours.
Affected cytochrome P450 (CYP450) isoenzymes and drug transporters: MATE1, MATE2-K, P-glycoprotein (P-gp), BCRP, OCT1
Amisulpride inhibits multidrug and toxin extrusion (MATE) transporters MATE1 and MATE2-K. Amisulpride is a substrate for P-gp, BCRP, OCT1, MATE1, and MATE2-K. The hepatic CY450 system is not involved in the metabolism of amisulpride, and amisulpride does not inhibit any CYP450 substrates. Amisulpride does not inhibit P-gp, BCRP, OCT1, OCT2, OAT1, OAT3, OATP1B1, OATP1B3 at therapeutic concentrations. The drug is not a substrate for OATP1B1, OATP1B3, OAT1, OAT3, or OCT2.
-Route-Specific Pharmacokinetics
Intravenous Route
After intravenous administration, the peak plasma concentration (Cmax) is achieved at the end of the infusion period and decreases to about 50% of the peak value within approximately 15 minutes. Systemic exposure (AUC) increases proportionately across the dose range of 5 mg to 40 mg IV. After a 5 mg dose, the Cmax and AUC were 161 ng/mL and 260 ng x hour/mL, respectively, for patients receiving PONV prophylaxis. After a 5 mg dose, the Cmax and AUC were 127 ng/mL and 204 ng x hour/mL, respectively, for patients receiving PONV treatment. After a 10 mg dose, the Cmax and AUC were 285 ng/mL and 401 ng x hour/mL, respectively, for patients receiving PONV treatment.
-Special Populations
Hepatic Impairment
Amisulpride is not significantly metabolized. Urinary and fecal metabolites each account for less than 7% of the dose and were not detectable in plasma.
Renal Impairment
Amsulpride is substantially eliminated by the kidney and studies indicate active renal secretion. In surgical patients with mild or moderate renal impairment (eGFR 30 to 89 mL/minute/1.73 m2), the Cmax of amisulpride was not significantly different and the AUC increased about 1.3-fold compared to patients with normal renal function. The pharmacokinetics of amisulpride in patients with severe renal impairment (eGFR less than 30 mL/minute/1.73 m2) have not been adequately studied in clinical trials.
Pediatrics
Pharmacokinetic data for amisulpride injection are not available for pediatric patients.
Geriatric
No clinically significant effect on the pharmacokinetics of amisulpride was observed based on age alone.
Gender Differences
No clinically significant effect on the pharmacokinetics of amisulpride was observed based on sex.
Ethnic Differences
No clinically significant effect on the pharmacokinetics of amisulpride was observed based on race.