Sulmetic IV(Amisulpride)
Therapeutic Group: atypical antipsychotic
Presentation
SulmeticTM IV Injection: Each 2ml injectable solution contains Amisulpride BP 5 mg.
Description
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. Studies in multiple species indicate that D3 receptors in the postrema area also play a role in emesis. Studies have also shown that amisulpride inhibits emesis caused by apomorphine, with an estimated ED50 of less than 1 mcg/kg, subcutaneously, and inhibits cisplatin-induced emesis at 2 mg/kg and morphine-induced emesis at 3 to 6 mg/kg when given intravenously.
Indications
Sulmetic IV injection is indicated in adults for the following conditions:
1. Prevention of postoperative nausea and vomiting (PONV): Either alone or in combination with another antiemetic of a different class.
2. Treatment of postoperative nausea and vomiting (PONV): In patients who have received antiemetic prophylaxis of a different class or have not received prophylaxis.
Dosage & Administration
Prevention of postoperative nausea and vomiting (PONV):
5 mg as a single dose infused over 1 to 2 minutes at
the time of induction of anesthesia (intravenous).
Treatment of postoperative nausea and vomiting (PONV):
10 mg as a single dose infused over 1 to 2 minutes intravenously after a surgical procedure.
Side Effects
The most common adverse reactions (? 2%) are:
• Prevention of PONV: increased blood prolactin concentrations, chills, hypokalemia, procedural hypotension, and abdominal distension.
• Treatment of PONV: infusion site pain.
• Rare side effects: agranulocytosis, bradycardia, angioedema, urticaria, and hypotension.
Precautions
Amisulpride causes dose- and concentration-dependent prolongation of the QT interval. Avoid amisulpride in patients with congenital long QT syndrome and in patients taking droperidol. Electrocardiogram (ECG) monitoring is recommended in patients with pre-existing arrhythmia/cardiac conduction disorders; electrolyte abnormalities; congestive heart failure; and in patients taking other medicinal products (e.g., ondansetron) or with other medical conditions known to prolong the QT interval.
Use in Pregnancy & Lactation
Available data with Amisulpride use in pregnant women are insufficient to establish a drug associated risk.
Drug Interaction
• Dopamine Agonist: Avoid using levodopa with amisulpride.
• Drugs Prolonging the QT Interval To avoid potential additive effects, avoid the use of amisulpride in patients taking droperidol. ECG monitoring is recommended for patients taking other drugs known to prolong the QT interval (e.g., ondansetron).
Over Dose
Overdose data of Amisulpride injection is not available.
Storage
Do not store above 30 °C. Keep away from light and out of the reach of children.
Commercial Pack
Sulmetic TM IV Injection: Each box contains one vial of a 2 ml IV injection and a leaflet.
