Barhemsys
(Amisulpride)Dosage & Administration
The recommended dosage of BARHEMSYS:
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Barhemsys Prescribing Information
BARHEMSYS® 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.
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. ()
2.1 Recommended DosageThe recommended adult dosage of BARHEMSYS and infusion rate by indication is shown in the table below:
Indication Adult Dosage Regimen Prevention of PONV 5 mg as a single intravenous injection infused over 1 to 2 minutes at the time of induction of anesthesia [see Dosage and Administration (2.2)].Treatment of PONV 10 mg as a single intravenous injection infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure [see Dosage and Administration (2.2)]. - 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. ()
2.1 Recommended DosageThe recommended adult dosage of BARHEMSYS and infusion rate by indication is shown in the table below:
Indication Adult Dosage Regimen Prevention of PONV 5 mg as a single intravenous injection infused over 1 to 2 minutes at the time of induction of anesthesia [see Dosage and Administration (2.2)].Treatment of PONV 10 mg as a single intravenous injection infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure [see Dosage and Administration (2.2)]. - See full prescribing information for preparation and administration instructions. ()
2.2 Preparation and Administration- Dilution of BARHEMSYS is not required before administration. BARHEMSYS is chemically and physically compatible with Water for Injection, 5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringer's Solution (also known as Ringer's Lactate Solution, Compound Sodium Lactate Solution, and Hartmann's Solution), any of which may be used to flush an intravenous line before or after administration of BARHEMSYS.
- Protect from light. BARHEMSYS is subject to photodegradation. Administer BARHEMSYS within 12 hours of removal of the vial from the protective carton.
- Prior to administration, inspect the BARHEMSYS solution visually for particulate matter and discoloration. Discard if particulate matter or discoloration is observed.
Injection: 5 mg/2 mL (2.5 mg/mL) or 10 mg/4 mL (2.5 mg/mL) as a clear, colorless sterile solution in a single-dose vial.
8.2 LactationBased 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 to 400 mg/day). The estimated infant daily dose ranged from 5% to 11% of the maternal dose. There are ways to minimize drug exposure to a breastfed infant
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.
BARHEMSYS is contraindicated in patients with known hypersensitivity to amisulpride
6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post-approval 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
5.1 QT ProlongationBARHEMSYS causes dose- and concentration-dependent prolongation of the QT interval
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
7.2 Drugs Prolonging the QT IntervalBARHEMSYS causes dose- and concentration-dependent QT prolongation