FDA Warns of Sudden Death Risk with IV Haloperidol (Haldol)Drug-maker Johnson haldol decanoate iv Johnson and the Haldop said there have been at least 28 dbol prices uk reports of QT prolongation and Torsades de Pointes "some with fatal outcome" when intravenous haloperidol was used off-label. The FDA said injectable haloperidol is only approved for intramuscular injections, but "there is haldol decanoate iv evidence that the intravenous administration of haloperidol is a relatively common off-label clinical practice. Moreover, the FDA alert reminded physicians that haloperidol was not approved for intravenous administration. One analysis identified case reports, which included 73 cases of Torsades de Pointes, including 11 fatalities. Eight of the 11 fatal cases involved decanoafe haloperidol, but the drug maker said that many of the cases identified in the analysis were "confounded by concomitant QT-prolonging drugs or medical conditions.
FDA Warns of Sudden Death Risk with IV Haloperidol (Haldol)
Oral to IV conversion approximate: Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QT-prolonging conditions including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome. As with all drugs used to treat schizophrenia, dosage should be individualized according to the needs and response of each patient.
Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control. To determine the initial dosage, consideration should be given to the patient's age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state.
Debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less HALDOL haloperidol. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels. Parenteral medication, administered intramuscularly in doses of 2 to 5 mg, is utilized for prompt control of the acutely agitated schizophrenic patient with moderately severe to very severe symptoms.
Depending on the response of the patient, subsequent doses may be given, administered as often as every hour, although 4 to 8 hour intervals may be satisfactory. Controlled trials to establish the safety and effectiveness of intramuscular administration in children have not been conducted.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If higher doses are given, ECG monitoring is recommended. Usual starting doses are 0. Switchover Procedure An oral form should supplant the injectable as soon as practicable. In the absence of bioavailability studies establishing bioequivalence between these two dosage forms the following guidelines for dosage are suggested.
For an initial approximation of the total daily dose required, the parenteral dose administered in the preceding 24 hours may be used. Since this dose is only an initial estimate, it is recommended that careful monitoring of clinical signs and symptoms, including clinical efficacy, sedation, and adverse effects, be carried out periodically for the first several days following the initiation of switchover.
In this way, dosage adjustments, either upward or downward, can be quickly accomplished. Depending on the patient's clinical status, the first oral dose should be given within 12—24 hours following the last parenteral dose. Medical Calculators - A thru Z. Lab Values - A thru Z. This site complies with the HONcode standard for trustworthy health information: The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment.