HALOPERIDOL injection

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

HALOPERIDOL LACTATE (UNII: 6387S86PK3) (HALOPERIDOL - UNII:J6292F8L3D)

থেকে পাওয়া:

Gland Pharma Limited

INN (আন্তর্জাতিক নাম):

HALOPERIDOL LACTATE

রচনা:

HALOPERIDOL 5 mg in 1 mL

প্রশাসন রুট:

INTRAMUSCULAR

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Haloperidol is indicated for the treatment of patients with schizophrenia. Haloperidol 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 ).

পণ্য সারাংশ:

Haloperidol Injection, USP equivalent to 5 mg/mL haloperidol (as the lactate) is supplied as follows: NDC 68083-117-01                1 mL (5 mg) Prefilled Syringe            10 Syringes per Carton Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light. Do not freeze. Keep out of reach of children.   Preservative Free.              Manufactured by:                                                             Gland Pharma Limited D.P.Pally, Dundigal Post, Hyderabad - 500 043, INDIA. Revised: December 2020

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

HALOPERIDOL - HALOPERIDOL INJECTION
GLAND PHARMA LIMITED
----------
HALOPERIDOL INJECTION USP
(FOR IMMEDIATE RELEASE)
PRESERVATIVE FREE
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. Each mL of Haloperidol Injection USP contains 5 mg
haloperidol (as the
lactate), Water for Injection USP q.s. and lactic acid USP for pH
adjustment between 3.0
to 3.6.
CLINICAL PHARMACOLOGY
Haloperidol is an antipsychotic. The mechanism of action of
haloperidol for the treatment
of schizophrenia is unclear. Howeve