Finished product reference
Amisulpride
Tablet · Oral · 400 mg
- List code
- 50727
- Pharmacologic class
- Dopamine-2 Receptor Antagonist
What it is and how it works
Mechanism of Action Amisulpride is a selective dopamine-2 (D 2 ) and dopamine-3 (D 3 ) receptor antagonist. D 2 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. Studies in multiple species indicate that D 3 receptors in the area postrema also play a role in emesis. Studies conducted in ferrets have shown that amisulpride inhibits emesis caused by apomorphine, with an estimated ED 50 of less than 1 mcg/kg, subcutaneously.
Mechanism class: Dopamine D2 Antagonists
Indications
® 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. BARHEMSYS is a dopamine-2 (D 2 ) antagonist 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.
Dosage and administration (summary)
The recommended dosage of BARHEMSYS: 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 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. See full prescribing information for preparation and administration instructions .
Contraindications
is contraindicated in patients with known hypersensitivity to amisulpride . Known hypersensitivity to amisulpride.
Warnings and precautions
Prolongation : Occurs in a dose- and concentration-dependent manner. Avoid use in patients with congenital long QT syndrome and in patients taking droperidol. 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.
Pregnancy
Pregnancy Risk Summary 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.
Storage and supply
Store vials at 20°C to 25°C (68°F to 77°F) . Protect from light. Administer BARHEMSYS within 12 hours after the vial is removed from the protective carton .
Source: Amisulpride (Barhemsys) — US FDA prescribing information, 2026-06-17, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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