Amisulpride

Amisulpride is a prescription medication used for the prevention and treatment of postoperative nausea and vomiting

• Amisulpride is available under the following different brand names: Barhemsys

Common side effects of Amisulpride include:

• increased blood prolactin concentrations,
• chills,
• low blood potassium (hypokalemia),
• procedural low blood pressure (hypotension),
• abdominal distension, and
• infusion site pain

Serious side effects of Amisulpride include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• sudden dizziness (like you might pass out);
• fast or pounding heartbeats, fluttering in the chest;
• shortness of breath; or
• low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in the chest, increased thirst or urination, numbness or tingling, muscle weakness, or limp feeling.

Rare side effects of Amisulpride include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution

• 2.5 mg/mL (2-mL or 4-mL, single-dose vial)

Postoperative Nausea & Vomiting

Adult dosage

• Prevention
  • 5 mg as a single IV dose at the time of anesthesia induction
• Treatment
  • 10 mg as a single IV dose in the event of nausea and/or vomiting postoperatively

Non-Hodgkin Lymphoma

Adult dosage

• Treatment
  • 10 mg as a single IV dose in the event of nausea and/or vomiting postoperatively

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Amisulpride has severe interactions with at least 26 other drugs.
• Amisulpride has serious interactions with at least 150 other drugs.
• Amisulpride has moderate interactions with at least 20 other drugs.
• Amisulpride has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Amisulpride?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Amisulpride?”

Cautions

• QT prolongation
  • May cause dose- and concentration-dependent prolongation of the QT interval
  • Avoid in patients with congenital long QT syndrome and in patients taking droperidol
  • ECG monitoring is recommended with preexisting arrhythmias/cardiac conduction disorders, electrolyte abnormalities (eg, hypokalemia, hypomagnesemia), congestive heart failure, and in patients taking other drugs (eg, ondansetron) or with other medical conditions known to prolong the QT interval
• Drug interactions overview
  • Amisulpride inhibits MATE1 and MATE2-K transporters
  • Amisulpride is a substrate for P-gp, BCRP, OCT1, MATE1, and MATE2-K
  • Dopamine agonists
    • Reciprocal antagonism of effects occurs between dopamine agonists (eg, levodopa)
    • Avoid use
• Drugs prolonging the QT interval
  • Amisulpride causes dose- and concentration-dependent QT prolongation
  • Avoid use with droperidol
  • ECG monitoring is recommended if coadministered with other drugs known to prolong QT interval (eg, ondansetron)

Pregnancy and Lactation

• Insufficient data available regarding use in pregnant women to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Infertility
  • In animal fertility studies, administration of repeated doses of amisulpride over a 10­-day period to female rats resulted in infertility that was reversible
• Lactation
  • Based on case reports in published literature, 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 (200-400 mg/day)
  • There are no reports of adverse effects on breastfed children and no information on the effects of amisulpride on milk production
  • May consider interrupting breastfeeding and pumping and discarding breast milk for 48 hr after administration to minimize drug exposure to a breastfed infant