Amisulpride
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What is Amisulpride?[edit | edit source]
- Amisulpride (Barhemsys) is a dopamine-2 (D2) antagonist.
What are the uses of this medicine?[edit | edit source]
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?[edit | edit source]
- 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 ?[edit | edit source]
- This medicine cannot be used in patients with:
- known hypersensitivity to amisulpride.
What drug interactions can this medicine cause?[edit | edit source]
- 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?[edit | edit source]
- It was approved for use in the United States in 2020.
How should this medicine be used?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
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?[edit | edit source]
- 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?[edit | edit source]
- Safety and effectiveness in pediatric patients have not been established.
What should I know about storage and disposal of this medication?[edit | edit source]
- 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.
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