Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D)
Mylan Institutional LLC
HALOPERIDOL DECANOATE
HALOPERIDOL 50 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
Haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy. Since the pharmacologic and clinical actions of haloperidol decanoate injection, 50 mg/mL and haloperidol decanoate injection, 100 mg/mL are attributed to haloperidol as the active medication, Contraindications, Warnings, and additional information are those of haloperidol, modified only to reflect the prolonged action. Haloperidol is contraindicated in patients with:
Haloperidol decanoate injection, 50 mg/mL contains 50 mg haloperidol as 70.52 mg per mL haloperidol decanoate, USP in: 5 mL multiple dose vials (NDC 67457-382-00) packaged in cartons of five - NDC 67457-382-58 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten - NDC 67457-410-13 Haloperidol decanoate injection, 100 mg/mL contains 100 mg haloperidol as 141.04 mg per mL haloperidol decanoate, USP in: 5 mL multiple dose vials (NDC 67457-381-00) packaged in cartons of five - NDC 67457-381-58 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five - NDC 67457-409-13 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Do not refrigerate or freeze. Protect from light. Retain vial in carton until contents are used.
Abbreviated New Drug Application
HALOPERIDOL DECANOATE- HALOPERIDOL DECANOATE INJECTION MYLAN INSTITUTIONAL LLC ---------- HALOPERIDOL DECANOATE INJECTION, 50 MG/ML HALOPERIDOL DECANOATE INJECTION, 100 MG/ML FOR INTRAMUSCULAR INJECTION ONLY RX ONLY 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 DECANOATE IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS (SEE WARNINGS). DESCRIPTION Haloperidol decanoate is the decanoate ester of the butyrophenone, haloperidol decanoate injection. It has a markedly extended duration of effect. It is available in sesame oil in sterile form for intramuscular (IM) injection. The structural formula of haloperidol decanoate, 4-(4-chlorophenyl)-1-[4-(4- fluorophenyl)-4-oxobutyl]-4 piperidinyl decanoate, is: Haloperidol decanoate, USP is a white or almost white powder. It very soluble in alcohol, in methanol and in methylene chloride, practically insoluble in water. Haloperidol decanoate injection is clea Olvassa el a teljes dokumentumot