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Barhemsys

Last reviewed on RxList: 1/22/2021
Barhemsys Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Barhemsys?

Barhemsys (amisulpride) is a dopamine-2 (D2) antagonist indicated in adults to prevent postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class, and to treat PONV in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

What Are Side Effects of Barhemsys?

Side effects of Barhemsys include:

Dosage for Barhemsys

The recommended dosage of Barhemsys to prevent postoperative nausea and vomiting (PONV), either alone or in combination with another antiemetic, is 5 mg as a single intravenous dose infused over 1 to 2 minutes at the time of induction of anesthesia. The recommended dosage of Barhemsys to treat PONV is 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.

Barhemsys In Children

Safety and effectiveness of Barhemsys in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Barhemsys?

Barhemsys may interact with other medicines such as:

  • dopamine agonists,
  • droperidol, and
  • drugs known to prolong the QT interval (e.g., ondansetron)

Tell your doctor all medications and supplements you use.

Barhemsys During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Barhemsys; it is unknown how it would affect a fetus. Barhemsys passes into breast milk. There are no reports of adverse effects on the breastfed child and no information on the effects of Barhemsys on milk production. A lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 48 hours after Barhemsys administration to minimize drug exposure to a breastfed infant.

Additional Information

Our Barhemsys (amisulpride) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Barhemsys Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

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

Common side effects may include:

  • low potassium;
  • feeling light-headed;
  • stomach bloating; or
  • pain where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Barhemsys (Amisulpride Injection, for Intravenous Use)

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Barhemsys Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to BARHEMSYS in 1,166 patients treated in placebo-controlled trials. 748 of these patients received a dose of 5 mg for prevention of PONV (of whom 572 received another antiemetic concomitantly) and 418 patients received 10 mg for treatment of PONV [see Clinical Studies]. The mean age of the population was 49 years (range 18 to 91 years), 87% female, 80% White/Caucasian, 9% Black, and 1% Asian.

Prevention Of PONV

Common adverse reactions reported in at least 2% of adult patients who received BARHEMSYS 5 mg and at a higher rate than placebo in Studies 1 and 2 for the prevention of PONV are shown in Table 1.

Table 1. Common Adverse Reactions* in Adult Patients in Studies 1 and 2 of BARHEMSYS for Prevention of PONV

BARHEMSYS 5 mgPlacebo
N=748N=741
Chills4%3%
Hypokalemia4%2%
Procedural hypotension3%2%
Abdominal distension2%1%
*Reported in at least 2% of patients treated with BARHEMSYS and at a higher rate than placebo

Serum prolactin concentrations were measured in Study 1 where 5% (9/176) of BARHEMSYS-treated patients vs 1% (1/166) of placebo-treated patients had increased blood prolactin reported as an adverse reaction. Serum prolactin concentrations increased from a mean of 10 ng/mL at baseline to 32 ng/mL after BARHEMSYS treatment in 112 females (upper limit of normal 29 ng/mL) and from 10 ng/mL to 19 ng/mL in 61 males (upper limit of normal 18 ng/mL). No clinical consequences due to elevated prolactin levels were reported.

Treatment Of PONV

The most common adverse reaction, reported in at least 2% of adult patients who received BARHEMSYS 10 mg (N=418) and at a higher rate than placebo (N=416), in clinical trials for the treatment of PONV (Studies 3 and 4) was infusion site pain (BARHEMSYS 6%; placebo 4%).

Postmarketing Experience

The following adverse reactions have been identified during postapproval chronic oral use of amisulpride outside of the United States (BARHEMSYS is not approved for oral dosing or chronic use). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Blood and lymphatic system disorders: agranulocytosis
  • Cardiac disorders: bradycardia, torsades de pointes, ventricular tachycardia, prolonged QT by electrocardiogram
  • General disorders: neuroleptic malignant syndrome
  • Immune system disorders: angioedema, hypersensitivity, urticaria
  • Hepatic disorders: increased hepatic enzymes
  • Nervous system disorders: agitation, anxiety, dystonia, extrapyramidal disorder, seizure
  • Psychiatric disorders: confusional state, insomnia, somnolence
  • Vascular disorders: hypotension

Read the entire FDA prescribing information for Barhemsys (Amisulpride Injection, for Intravenous Use)

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