Amisulpride

What is Amisulpride?

• Amisulpride (Barhemsys) is a dopamine-2 (D2) antagonist.

What are the uses of this medicine?

This medicine is indicated in adults for:

• 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.

How does this medicine work?

• Amisulpride is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist.
• D2 receptors are located in the chemoreceptor trigger zone (CTZ) and respond to the dopamine released from the nerve endings.
• Activation of CTZ relays stimuli to the vomiting center which is involved in emesis.
• Amisulpride has no appreciable affinity for any other receptor types apart from low affinities for 5-HT2B and 5-HT7 receptors.

Who Should Not Use this medicine ?

• This medicine cannot be used in patients with:
• known hypersensitivity to amisulpride.

What drug interactions can this medicine cause?

• Avoid using levodopa withBarhemsys.
• Avoid use ofBarhemsys in patients taking droperidol .ECG monitoring is recommended in patients taking other drugs known to prolong the QT interval (e.g., ondansetron).

Is this medicine FDA approved?

• It was approved for use in the United States in 2020.

How should this medicine be used?

Recommended Dosage Prevention of PONV, either alone or in combination with another antiemetic: 5 mg as a single intravenous dose infused over 1 to 2 minutes at the time of induction of anesthesia. Treatment of postoperative nausea and vomiting (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.

Administration

• Dilution ofBarhemsys is not required before administration.
• BARHEMSYS is chemically and physically compatible with Water for Injection, 5% Dextrose Injection and 0.9% Sodium Chloride Injection, which may be used to flush an intravenous line before or after administration ofBarhemsys.
• Protect from light.
• BARHEMSYS is subject to photodegradation.
• AdministerBarhemsys within 12 hours of removal of the vial from the protective carton.
• Prior to administration, inspect theBarhemsys solution visually for particulate matter and discoloration.
• Discard if particulate matter or discoloration is observed.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

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

This medicine is available in fallowing brand namesː BARHEMSYS

What side effects can this medication cause?

The most common side effects of this medicine include: Prevention of PONV:

• increased blood prolactin concentrations
• chills
• hypokalemia
• procedural hypotension
• abdominal distension

Treatment of PONV:

• infusion site pain

What special precautions should I follow?

• BARHEMSYS causes dose- and concentration-dependent prolongation of the QT interval. The recommended dosage is 5 or 10 mg as a single intravenous dose infused over 1 to 2 minutes .
• 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.

What to do in case of emergency/overdose?

Doses of oral amisulpride (BARHEMSYS is not approved for oral dosing) above 1200 mg/day have been associated with adverse reactions as fallows:

• cardiovascular adverse reactions (e.g., prolongation of the QT interval, torsades de pointes, bradycardia and hypotension)
• neuropsychiatric adverse reactions (e.g., sedation, coma, seizures, and dystonic and extrapyramidal reactions).

Management for overdosage: There is no specific antidote for amisulpride overdose.

• Management includes cardiac monitoring and treatment of severe extrapyramidal symptoms.
• Since amisulpride is weakly dialyzed, hemodialysis should not be used to eliminate the drug.

Can this medicine be used in 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.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What should I know about storage and disposal of this medication?

• Store vials at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].
• Protect from light.
• AdministerBarhemsys within 12 hours after the vial is removed from the protective carton.

• Dailymed label info on Amisulpride
• FDA Amisulpride

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