Adult Dosing

• Prevention of PONV: 5 mg as a single intravenous dose infused over 1 to 2 minutes at the time of induction of anesthesia.
• Treatment of PONV: 10 mg as a single intravenous dose infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure.

Pediatric Dosing

• Safety and effectiveness have not been established.

[Outline]

• Adult Dosing
• Pediatric Dosing

• Prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class.
• Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

• Known hypersensitivity to amisulpride.
• Severe renal impairment (eGFR < 30 mL/min/1.73 m²)

Renal Dose Adjustment

• eGFR less than 30 mL/min/1.73 m²: avoid use
• eGFR 30 mL/min/1.73 m² and above: No dosage adjustment is necessary.

Hepatic Dose Adjustment

• Hepatic impairment: Not defined.

Geriatric Dosing

• No overall differences in safety or effectiveness were observed.

See Supplemental Patient Information

• QT Prolongation: Occurs in a dose- and concentration-dependent prolongation of the QT interval.
• Avoid use in patients with congenital long QT syndrome and in patients taking droperidol.
• Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmias/cardiac conduction disorders; electrolyte abnormalities (e.g., hypokalemia or hypomagnesemia); congestive heart failure; and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval.

Interactions

• Dopamine agonists including levodopa, may reduce effectiveness; avoid concurrent use.
• Droperidol and other QT interval: causes dose- and concentration-dependent QT prolongation. To avoid potential additive effects, avoid using it in patients taking droperidol. ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval (e.g., ondansetron).

Supplemental Patient Information

• Instruct patients to contact their healthcare provider immediately if they perceive a change in their heart rate, if they feel lightheaded, or if they have a syncopal episode.
• Advise patients to report to their healthcare provider if they are taking drugs which prolong the QT interval.

Pregnancy Category:NR.

Breastfeeding: A lactating woman may consider interrupting breastfeeding pumping and discarding breast milk for 48 hours after the drug administration.

• Prevention of PONV:
• ENDO: increased blood prolactin
• METABOLIC: hypokalemia
• CV: procedural hypotension
• GI: abdominal distension
• MISC: chills

• Treatment of PONV:
• LOCAL: infusion site pain.

• Mechanism of Action: selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist.
• Absorption: Rapidly absorbed with absolute bioavailability
• Distribution: 127 to 144 L in surgical patients and 171 L in healthy subjects.
• Protein Binding: 25% to 30% in the concentration range from 37 to 1850 ng/mL.
• Metabolism/Excretion: No metabolites were detectable in plasma while four metabolites were identified in urine and feces. Each metabolite accounts for less than 7% of the dose. In vitro amisulpride is not metabolized by major cytochrome P450 enzymes. Urine 74% (58% unchanged), Feces 23% (20% unchanged);
• Half-life: 4-5 hrs.

US Trade Name(s)

• Barhemsys

US Availability

Barhemsys

• Injection: 5 mg/2 mL (2.5 mg/mL) or 10 mg/4 mL (2.5 mg/mL) in a single-dose vial.

[Outline]

Gastrointestinal

antiemetics

dopamine Antagonists