Country: United States
Language: English
Source: NLM (National Library of Medicine)
Haloperidol (UNII: J6292F8L3D) (Haloperidol - UNII:J6292F8L3D)
TYA Pharmaceuticals
Haloperidol
Haloperidol 5 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
Haloperidol is indicated for use in the treatment of schizophrenia. Haloperidol is indicated for the control of tics and vocal utterances of Tourette's Disorder. Haloperidol is contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this drug or have Parkinson's disease.
NDC:64725-0911-1 in a BOX of 10 INJECTIONS Store Haloperidol Injection at controlled room temperature (15°–30°C, 59°–86°F). Protect from light. Do not freeze. Product of Belgium
New Drug Application Authorized Generic
HALOPERIDOL- HALOPERIDOL INJECTION TYA PHARMACEUTICALS ---------- HALOPERIDOL INJECTION (FOR IMMEDIATE RELEASE) WARNING INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH ANTIPSYCHOTIC DRUGS ARE AT AN INCREASED RISK OF DEATH. ANALYSES OF SEVENTEEN PLACEBO-CONTROLLED TRIALS (MODAL DURATION OF 10 WEEKS), LARGELY IN PATIENTS TAKING ATYPICAL ANTIPSYCHOTIC DRUGS, REVEALED A RISK OF DEATH IN DRUG-TREATED PATIENTS OF BETWEEN 1.6 TO 1.7 TIMES THE RISK OF DEATH IN PLACEBO-TREATED PATIENTS. OVER THE COURSE OF A TYPICAL 10-WEEK CONTROLLED TRIAL, THE RATE OF DEATH IN DRUG- TREATED PATIENTS WAS ABOUT 4.5%, COMPARED TO A RATE OF ABOUT 2.6% IN THE PLACEBO GROUP. ALTHOUGH THE CAUSES OF DEATH WERE VARIED, MOST OF THE DEATHS APPEARED TO BE EITHER CARDIOVASCULAR (E.G., HEART FAILURE, SUDDEN DEATH) OR INFECTIOUS (E.G., PNEUMONIA) IN NATURE. OBSERVATIONAL STUDIES SUGGEST THAT, SIMILAR TO ATYPICAL ANTIPSYCHOTIC DRUGS, TREATMENT WITH CONVENTIONAL ANTIPSYCHOTIC DRUGS MAY INCREASE MORTALITY. THE EXTENT TO WHICH THE FINDINGS OF INCREASED MORTALITY IN OBSERVATIONAL STUDIES MAY BE ATTRIBUTED TO THE ANTIPSYCHOTIC DRUG AS OPPOSED TO SOME CHARACTERISTIC(S) OF THE PATIENTS IS NOT CLEAR. HALOPERIDOL INJECTION IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS (SEE ). WARNINGS DESCRIPTION Haloperidol is the first of the butyrophenone series of major antipsychotics. The chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone and it has the following structural formula: Haloperidol is available as a sterile parenteral form for intramuscular injection. The injection provides 5 mg haloperidol (as the lactate) and lactic acid for pH adjustment between 3.0 – 3.6. ACTIONS The precise mechanism of action has not been clearly established. INDICATIONS Haloperidol is indicated for use in the treatment of schizophrenia. Haloperidol is indicated for the control of tics and vocal utterances of Tourette's Disorder. CO Read the complete document