DRUGS & SUPPLEMENTS

Droperidol

Name: Droperidol drug & pharmaceuticals. Available Forms, Doses, Prices
Creator: sdrugs.com
Published: 2021-11-11T10:10:10+00:00

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Droperidol uses

Indications and usage
Contraindications
Warnings
Precautions
Adverse reactions
Overdosage
Dosage and administration
How supplied
References
Rl-0634
Droperidol reviews

INDICATIONS AND USAGE

Droperidol injection is indicated to reduce the incidenceof nausea and vomiting associated with surgical and diagnostic procedures.

CONTRAINDICATIONS

Droperidol is contraindicated in patients with known or suspectedQT prolongation (i.e., QTc interval greater than 440 msec for males or 450msec for females). This would include patients with congenital long QT syndrome.

Droperidolis contraindicated in patients with known hypersensitivity to the drug.

Droperidolis not recommended for any use other than for the treatment of perioperativenausea and vomiting in patients for whom other treatments are ineffectiveor inappropriate.

WARNINGS

Droperidol should be administered with extreme caution inthe presence of risk factors for development of prolonged QT syndrome, suchas: 1) clinically significant bradycardia (less than 50 bpm), 2) anyclinically significant cardiac disease, 3) treatment with Class I and ClassIII antiarrhythmics, 4) treatment with monoamine oxidase inhibitors (MAOI’s),5) concomitant treatment with other drug products known to prolong the QTinterval, and 6) electrolyte imbalance,in particular hypokalemia and hypomagnesemia, or concomitant treatment withdrugs (e.g., diuretics) that may cause electrolyte imbalance.

Effects on Cardiac Conduction:

Adose-dependent prolongation of the QT interval was observed within 10 minutesof Droperidol administration in a study of 40 patients without known cardiacdisease who underwent extracranial head and neck surgery. Significant QT prolongationwas observed at all three dose levels evaluated, with 0.1, 0.175, and 0.25mg/kg associated with prolongation of median QTc by 37, 44, and 59 msec,respectively.

Cases of QT prolongation and serious arrhythmias (e.g., torsade de pointes, ventricular arrhythmias, cardiac arrest, and death)have been observed during post-marketing treatment with Droperidol. Some caseshave occurred in patients with no known risk factors and at doses at or belowrecommended doses. There has been at least one case of nonfatal torsade depointes confirmed by rechallenge.

Based on these reports,all patients should undergo a 12-lead ECG prior to administration of droperidolto determine if a prolonged QT interval (i.e., QTc greater than 440 msec formales or 450 msec for females) is present. If there is a prolonged QT interval,droperidol should NOT be administered. For patients in whom the potential benefit of Droperidol treatment is feltto outweigh the risks of potentially serious arrhythmias, ECG monitoring shouldbe performed prior to treatment and continued for 2-3 hours after completingtreatment to monitor for arrhythmias.

FLUIDSAND OTHER COUNTERMEASURES TO MANAGE HYPOTENSION SHOULD BE READILY AVAILABLE.

As with other CNS depressant drugs, patientswho have received Droperidol should have appropriate surveillance.

Itis recommended that opioids, when required, initially be used in reduced doses.

Aswith other neuroleptic agents, very rare reports of neuroleptic malignantsyndrome (altered consciousness, muscle rigidity and autonomic instability)have occurred in patients who have received Droperidol.

Sinceit may be difficult to distinguish neuroleptic malignant syndrome from malignanthyperpyrexia in the perioperative period, prompt treatment with dantroleneshould be considered if increases in temperature, heart rate or carbon dioxideproduction occur.

PRECAUTIONS

General: The initial dose of Droperidol should be appropriately reduced in elderly, debilitated and other poor-risk patients. The effect of the initial dose should be considered in determining incremental doses.

Certain forms of conduction anesthesia, such as spinal anesthesia and some peridural anesthetics, can alter respiration by blocking intercostal nerves and can cause peripheral vasodilatation and hypotension because of sympathetic blockade. Through other mechanisms, Droperidol can also alter circulation. Therefore, when Droperidol is used to supplement these forms of anesthesia, the anesthetist should be familiar with the physiological alterations involved, and be prepared to manage them in the patients elected for these forms of anesthesia.

If hypotension occurs, the possibility of hypovolemia should be considered and managed with appropriate parenteral fluid therapy. Repositioning the patient to improve venous return to the heart should be considered when operative conditions permit. It should be noted that in spinal and peridural anesthesia, tilting the patient into a head-down position may result in a higher level of anesthesia than is desirable, as well as impair venous return to the heart. Care should be exercised in the moving and positioning of patients because of a possibility of orthostatic hypotension. If volume expansion with fluids plus these other countermeasures do not correct the hypotension, then the administration of pressor agents other than epinephrine should be considered. Epinephrine may paradoxically decrease the blood pressure in patients treated with Droperidol due to the alpha-adrenergic blocking action of Droperidol.

Since Droperidol may decrease pulmonary arterial pressure, this fact should be considered by those who conduct diagnostic or surgical procedures where interpretation of pulmonary arterial pressure measurements might determine final management of the patient.

Vital signs and ECG should be monitored routinely.

When the EEG is used for postoperative monitoring, it may be found that the EEG pattern returns to normal slowly.

Impaired Hepatic or Renal Function: Droperidol should be administered with caution to patients with liver and kidney dysfunction because of the importance of these organs in the metabolism and excretion of drugs.

Pheochromocytoma: In patients with diagnosed/ suspected pheochromocytoma, severe hypertension and tachycardia have been observed after the administration of Droperidol.

Drug Interactions:

Potentially ArrhythmogenicAgents: Any drug known to have the potential to prolong the QT intervalshould not be used together with Droperidol. Possible pharmacodynamic interactionscan occur between Droperidol and potentially arrhythmogenic agents such asclass I or III antiarrhythmics, antihistamines that prolong the QT interval,antimalarials, calcium channel blockers, neuroleptics that prolong the QTinterval, and antidepressants.

Caution should be usedwhen patients are taking concomitant drugs known to induce hypokalemia orhypomagnesemia as they may precipitate QT prolongation and interact with Droperidol. These would include diuretics, laxatives and supraphysiological use of steroidhormones with mineralocorticoid potential.

CNS Depressant Drugs: Other CNS depressantdrugs (e.g., barbiturates, tranquilizers, opioids and general anesthetics)have additive or potentiating effects with Droperidol. Following the administrationof Droperidol, the dose of other CNS depressant drugs should be reduced.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No carcinogenicity studies have been carried out with Droperidol. The micronucleus test in female rats revealed no mutagenic effects in single oral doses as high as 160 mg/kg. An oral study in rats (Segment I) revealed no impairment of fertility in either males or females at 0.63, 2.5 and 10 mg/kg doses (approximately 2, 9 and 36 times maximum recommended human I.V./I.M. dosage).

Pregnancy - Category C: Droperidol administered intravenously has been shown to cause a slight increase in mortality of the newborn rat at 4.4 times the upper human dose. At 44 times the upper human dose, mortality rate was comparable to that for control animals. Following intramuscular administration, increased mortality of the offspring at 1.8 times the upper human dose is attributed to CNS depression in the dams who neglected to remove placentae from their offspring. Droperidol has not been shown to be teratogenic in animals. There are no adequate and well-controlled studies in pregnant women. Droperidol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery: There are insufficient data to support the use of Droperidol in labor and delivery. Therefore, such use is not recommended.

Nursing Mothers: It is not known whether Droperidol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Droperidol is administered to a nursing mother.

Pediatric Use: The safety of Droperidol in children younger than two years of age has not been established.

ADVERSE REACTIONS

QT interval prolongation, torsade de pointes, cardiac arrest,and ventricular tachycardia have been reported in patients treated with Droperidol. Some of these cases were associated with death. Some cases occurred in patientswith no known risk factors, and some were associated with Droperidol dosesat or below recommended doses.

Physicians should bealert to palpitations, syncope, or other symptoms suggestive of episodes ofirregular cardiac rhythm in patients taking Droperidol and promptly evaluatesuch cases.

Themost common somatic adverse reactions reported to occur with Droperidol aremild to moderate hypotension and tachycardia, but these effects usually subsidewithout treatment. If hypotension occurs and is severe or persists, the possibilityof hypovolemia should be considered and managed with appropriate parenteralfluid therapy.

The most common behavioral adverse effectsof Droperidol include dysphoria, postoperative drowsiness, restlessness, hyperactivityand anxiety, which can either be the result of an inadequate dosage (lackof adequate treatment effect) or of an adverse drug reaction (part of thesymptom complex of akathisia).

Care should be takento search for extrapyramidal signs and symptoms (dystonia, akathisia, oculogyriccrisis) to differentiate these different clinical conditions. When extrapyramidalsymptoms are the cause, they can usually be controlled with anticholinergicagents.

Postoperative hallucinatory episodes (sometimesassociated with transient periods of mental depression) have also been reported.

Otherless common reported adverse reactions include anaphylaxis, dizziness, chillsand/or shivering, laryngospasm and bronchospasm.

Elevatedblood pressure, with or without pre-existing hypertension, has been reportedfollowing administration of Droperidol combined with fentanyl citrate or otherparenteral analgesics. This might be due to unexplained alterations in sympatheticactivity following large doses; however, it is also frequently attributedto anesthetic or surgical stimulation during light anesthesia.

OVERDOSAGE

Manifestations: The manifestationsof Droperidol overdosage are an extension of its pharmacologic actions andmay include QT prolongation and serious arrhythmias (e.g. torsade de pointes).

Treatment: In the presence of hypoventilation orapnea, oxygen should be administered and respiration should be assisted orcontrolled as indicated. A patent airway must be maintained; an oropharyngealairway or endotracheal tube might be indicated. The patient should be carefullyobserved for 24 hours; body warmth and adequate fluid intake should be maintained. If hypotension occurs and is severe or persists, the possibility of hypovolemiashould be considered and managed with appropriate parenteral fluid therapy..

If significant extrapyramidal reactionsoccur, in the context of an overdose, an anticholinergic should be administered.

Theintravenous Median Lethal Dose is 20 ― 43 mg/kg in mice; 30 mg/kg inrats; and 25 mg/kg in dogs and 11 ― 13 mg/kg in rabbits. Theintramuscular Median Lethal Dose of Droperidol is 195 mg/kg in mice; 104 ―110 mg/kg in rats; 97 mg/kg in rabbits and 200 mg/kg in guinea pigs.

DOSAGE AND ADMINISTRATION

Dosage should be individualized. Some of the factors to beconsidered in determining dose are age, body weight, physical status, underlyingpathological condition, use of other drugs, the type of anesthesia to be used,and the surgical procedure involved.

Vital signs andECG should be monitored routinely.

AdultDosage: The maximum recommended initial dose of Droperidol is 2.5mg I.M. or slow I.V. Additional 1.25 mg doses of Droperidol may be administeredto achieve the desired effect. However, additional doses should be administeredwith caution, and only if the potential benefit outweighs the potential risk.

Pediatric

Dosage: For children two to 12 yearsof age, the maximum recommended initial dose is 0.1 mg/kg, taking into accountthe patient’s age and other clinical factors. However, additional dosesshould be administered with caution, and only if the potential benefit outweighsthe potential risk.

Parenteral drug products should be inspectedvisually for particulate matter and discoloration prior to administration,whenever solution and container permit. If such abnormalities are observed,the drug should not be administered.

HOW SUPPLIED

Droperidol Injection, USP 2.5 mg/mL is supplied in 2 mL (5 mg) single-dose ampuls packaged in cartons of ten (List No. 1187).

Store at 20 to 25°C (68 to 77°F).

Protect from light.

REFERENCES

Saarnivaara L, Klemola UM, Lindgren L, et al. QT interval of the ECG, heart rate and arterial pressure using propofol, methohexital or midazolam for induction of anesthesia. Acta Anaesthesiol Scand 1990: 34: 276-81.
Schmeling WT, Warltier DC, McDonald DJ, et al. Prolongation of the QT interval by enflurane, isoflurane, and halothane in humans. Anesth Analg 1991:72:137-44.
Späth G. Torsade des pointe oder die andere Ursache des plötz-lichen Herztodes. Wien: Ueberreuter, 1998.
Riley DC, Schmeling WT, Al-Wathiqui MH, et al. Prolongation of the QT-interval by volatile anesthetics in chronically instrumented dogs. Anesth Analg 1988: 67: 741-9.
McConachie I, Keaveny JP, Healy TF, et al. Effects of anaesthesia on the QT-interval. Br J Anaesth 1989: 63: 558-60.
Lawrence KR, Nasraway SA. Conduction disturbances associated with administration of butyrophenone antipsychotics in the critically ill: a review of the literature. Pharmacotherapy 1997: 17(3): 531-7.
Lischke V, Behne M, Doelken P, et al. Droperidol causes a dose-dependent prolongation of the QT interval. Anesth Analg 1994: 79: 983-6.

Revised: October, 2004

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

RL-0634

Droperidol pharmaceutical active ingredients containing related brand and generic drugs:

Droperidol

Droperidol available forms, composition, doses:

	Price
Droperidol 2.5 mg/ml ampul	0.7 USD
Droperidol 2.5 mg/ml vial	2.04 USD
Inapsine 2.5 mg/ml ampul	4.59 USD
Injectable; Injection; Droperidol 0.5 mg / ml
Injectable; Injection; Droperidol 2.5 mg / ml

Droperidol destination | category:

Human:
Anxiolytics, sedatives and hypnotics

Droperidol Anatomical Therapeutic Chemical codes:

N01AX01 - Droperidol
N05AD08 - Droperidol

Droperidol pharmaceutical companies:

References

Dailymed."DROPERIDOL INJECTION, SOLUTION [HOSPIRA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
Dailymed."DROPERIDOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
"droperidol". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Droperidol?

Depending on the reaction of the Droperidol after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Droperidol not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Droperidol addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Droperidol, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Droperidol consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.