Country: United States
Language: English
Source: NLM (National Library of Medicine)
HALOPERIDOL LACTATE (UNII: 6387S86PK3) (HALOPERIDOL - UNII:J6292F8L3D)
Cardinal Health
INTRAMUSCULAR
PRESCRIPTION DRUG
Haloperidol Injection, USP is indicated for use in the treatment of schizophrenia. Haloperidol Injection, USP is indicated for the control of tics and vocal utterances of Tourette's Disorder. Haloperidol Injection 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.
Haloperidol Injection, USP, equivalent to 5 mg/mL haloperidol (as the lactate), is supplied as follows: Overbagged with 5 vials per bag, NDC 55154-7478-5 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light . Do not freeze . To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: West-Ward Pharmaceuticals Eatontown, NJ 07724 USA Distributed by: Cardinal Health Dublin, OH 43017 L55235350419 Revised June 2018 PIN425-WES/7
Abbreviated New Drug Application
HALOPERIDOL- HALOPERIDOL LACTATE INJECTION CARDINAL HEALTH ---------- HALOPERIDOL INJECTION USP (FOR IMMEDIATE RELEASE) 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: M.F. =C H ClFNO M.W.=375.86 Haloperidol Injection, USP is available as a sterile parenteral form for intramuscular injection. Each mL of Haloperidol Injection, USP contains 5 mg haloperidol (as the lactate) with 1.8 mg methylparaben and 0.2 mg propylparaben per mL, and lactic acid for pH adjustment between 3.0 to 3.8. CLINICAL PHARMACOLOGY The precise mechanism of action has not been clearly established. INDICATIONS AND Read the complete document