Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
haloperidol lactate (UNII: 6387S86PK3) (haloperidol - UNII:J6292F8L3D)
Sagent Pharmaceuticals
haloperidol lactate
haloperidol 5 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
Haloperidol Injection, USP is indicated for the treatment of patients with schizophrenia. Haloperidol injection is contraindicated in patients with: - Severe toxic central nervous system depression or comatose states from any cause. - Hypersensitivity to this drug – hypersensitivity reactions have included anaphylactic reaction and angioedema (see WARNINGS, Hypersensitivity Reactions and ADVERSE REACTIONS ). - Parkinson's disease (see WARNINGS, Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodies ). - Dementia with Lewy bodies (see WARNINGS, Neurological Adverse Reactions in Patients with Parkinson's Disease or Dementia with Lewy Bodies ).
Haloperidol Injection, USP (For Immediate Release) 5 mg per mL (as the lactate) is supplied in single-dose vials (preservative-free) and multi-dose vials as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not freeze. Protect from light. Retain in carton until time of use. *Discard unused portion. Keep out of reach of children. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in Canada ©2020 Sagent Pharmaceuticals, Inc. Revised: December 2020 SAGENT Pharmaceuticals ®
Abbreviated New Drug Application
HALOPERIDOL- HALOPERIDOL LACTATE INJECTION, SOLUTION SAGENT PHARMACEUTICALS ---------- HALOPERIDOL INJECTION, USP (FOR IMMEDIATE RELEASE) (FOR INTRAMUSCULAR USE) SAGENT 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 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 Injection, USP is available as a sterile parenteral form for intramuscular injection in a 1 mL single-dose vial, each mL containing 5 mg haloperidol (as the lactate) and lactic acid for pH adjustment between 3.0 to 3.8. Haloperidol Injection, USP is also available as a sterile parenteral form for intramuscular injection in a 10 mL multi-dose vial, each mL containing Læs hele dokumentet