DORAVIT Solution for Injection

Droperidol

1.25 mg/ml

HIKMA ITALIA SPA

Pack size	10 Ampoule (2 ml)
Dispensing mode
Source
Agent
Retail Price	18.82 AED

Indications

DORAVIT Solution for Injection is used for: Nausea, vomiting

Adult Dose

Intravenous Treatment and prophylaxis of postoperative nausea and vomiting Adult: 0.625-1.25 mg 30 min prior to anticipated end of surgery, repeat 6 hrly, as necessary. Hepatic impairment: 0.625 mg 30 min prior to anticipated end of surgery, repeat 6 hrly, as necessary. Prophylaxis of nausea and vomiting associated with postoperative patient controlled analgesia (PCA) Adult: 15-50 mcg per mg of morphine. Max: 5 mg daily.

Child Dose

Intravenous Treatment and prophylaxis of postoperative nausea and vomiting Child: 2-18 yr 10-50 mcg/kg (Max: 1.25 mg) 30 min prior to anticipated end of surgery, repeat 6 hrly, as necessary.

Renal Dose

Renal impairment: 0.625 mg 30 min prior to anticipated end of surgery, repeat 6 hrly, as necessary.

Administration

IV/IM Administration Administered IM or slow IV (2-5 min) IV infusion has been used in high-risk pts

Contra Indications

Severe depression, Parkinson's disease, coma, phaeochromocytoma, hypokalaemia, hypomagnesaemia, bradycardia (<55 heartbeats/min), known or suspected QT prolongation (QTc >440 millisecond in male and >450 millisecond in female). Concomitant use w/ class IA/III antiarrhythmics, macrolides, fluoroquinolones, antihistamines, certain antipsychotics, antimalarials, cisapride, domperidone, methadone, pentamidine, metoclopramide and other neuroleptics.

Precautions

Patient w/ epilepsy, risk factors for cardiac arrhythmia (e.g. history of serious ventricular arrhythmia, 2nd- or 3rd-degree AV block, sinus node dysfunction, CHF, ischaemic heart disease and left ventricular hypertrophy), glaucoma, COPD, resp failure, prolactin-dependent tumours (e.g. breast cancer), risk factors for electrolyte imbalance, history of alcohol abuse. Renal and hepatic impairment. Elderly, childn. Pregnancy and lactation. Patient CounsellingThis drug may cause drowsiness, if affected, do not drive or operate machinery. Avoid exposure to direct sunlight. Monitoring Parameters Perform ECG monitoring at baseline and continue for 2-3 hr after admin. Monitor vital signs, serum Mg and K, mental status, abnormal involuntary movement scale (AIMS). Observe for dystonia, extrapyramidal side effects and temp changes.

Pregnancy-Lactation

Pregnancy Category: C Lactation: distributed into breast milk; avoid

Interactions

May induce electrolyte imbalance when used w/ K-wasting diuretics, laxatives and glucocorticoids. May potentiate the sedative effect of barbiturates, benzodiazepines, morphine derivatives. May cause orthostatic hypotension w/ antihypertensive agents. May inhibit the action of dopamine agonists (e.g. bromocriptine, lisuride, levodopa). Prolonged effects w/ CYP1A2 (e.g. ciprofloxacin) and CYP3A4 (e.g. ketoconazole) inhibitors.

Adverse Effects

Side effects of Droperidol : >10% Restlessness Anxiety Extrapyramidal Symptoms Dystonic reactions Pseudoparkinsonian signs and symptoms Tardive dyskinesia Seizure Altered central temperature regulation Sedation Drowsiness Prolonged QT interval (dose dependent) Swelling of breasts Weight gain Constipation 1-10% Hallucinations Persistent tardive dyskinesia Akathisia Orthostatic hypotension Tachycardia ECG: abnormal T waves Hypertension Nausea Vomiting Dysuria

Mechanism of Action

Droperidol blocks dopamine in the chemoreceptor trigger zone in the area postrema. It produces mild α-adrenergic blockade, peripheral vasodilation and reduction of the pressor effect of epinephrine resulting in hypotension and decreased peripheral resistance. It may also reduce pulmonary artery pressure.

Note

DORAVIT 1.25 mg/ml Solution for Injection manufactured by HIKMA ITALIA SPA. Its generic name is Droperidol. DORAVIT is availble in Saudi Arabia. Farmaco SA drug index information on DORAVIT Solution for Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.