Amisure Injection
Amisulpride IV
5mg/2ml
Acme Laboratories Ltd.
| Pack size | 5's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 60.00 AED |
Indications
Amisure Injection is used for:
Postoperative Nausea & Vomiting
Adult Dose
Postoperative Nausea & Vomiting
Prevention
Indicated for prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class
5 mg as a single IV dose n infused over 1 to 2 minutes at the time of induction of anesthesia
Treatment
Indicated for treatment of PONV in adults who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis
10 mg as a single IV dose infused over 1 to 2 minutes in the event of nausea and/or vomiting after a surgical procedure
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
Mild-to-severe: No dosage adjustment is necessary
Pharmacokinetics changes following a single 5-mg or 10-mg IV dose are not considered to be clinically meaningful
Administration
IV Administration
Dilution not required
Infuse over 1-2 min
May flush IV line before or after administration with sterile water for injection, D5W, or 0.9% NaCl
Contra Indications
Hypersensitivity
Precautions
QT prolongation
May causes dose- and concentration-dependent prolongation of the QT interval
Avoid in patients with congenital long QT syndrome and in patients taking droperidol
ECG monitoring 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
Pregnancy-Lactation
Pregnancy
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 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
Interactions
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)
Potentially Fatal: Reciprocal antagonism between levodopa and neuroleptics.
Contraindicated (27)
aripiprazole
asenapine
brexpiprazole
cariprazine
chlorpromazine
clozapine
dronedarone
droperidol
fluphenazine
haloperidol
iloperidone
loxapine
loxapine inhaled
lumateperone
lurasidone
olanzapine
paliperidone
perphenazine
pimozide
prochlorperazine
quetiapine
risperidone
thalidomide
thioridazine
thiothixene
trifluoperazine
ziprasidone
Adverse Effects
Side effects of Amisulpride IV :
1-10%
Prevention of PONV
Increased blood prolactin (5%)
Chills (4%)
Hypokalemia (4%)
Procedural hypotension (3%)
Abdominal distension (2%)
Treatment of PONV
Infusion site pain (6%)
Mechanism of Action
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
Note
Amisure 5mg/2ml Injection manufactured by Acme Laboratories Ltd.. Its generic name is Amisulpride IV. Amisure is availble in Bangladesh.
Farmaco BD drug index information on Amisure Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.