HALOPERIDOL DECANOATE injection

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

HALOPERIDOL DECANOATE (UNII: AC20PJ4101) (HALOPERIDOL - UNII:J6292F8L3D)

متاح من:

Lifestar Pharma LLC

طريقة التعاطي:

INTRAMUSCULAR

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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: - 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 w

ملخص المنتج:

Haloperidol decanoate injection, 50 mg/mLis a clear colourless/pink to yellow amber (brown) solution for IM injection containing 50 mg haloperidol as 70.52 mg per mL haloperidol decanoate, USP in: NDC 70756-615-81              1 mL single-dose vial in individual carton. Discard unused portion. NDC 70756-615-33               1 mL single-dose vials packed in carton of 3's. Discard unused portion. NDC 70756-615-10               1 mL single-dose vials packed in carton of 10's. Discard unused portion. NDC 70756-624-85               5 mL multi-dose vial in individual carton. NDC 70756-624-10               5 mL multi-dose vials packed in carton of 10's. Haloperidol decanoate injection, 100 mg/mL is aclear colourless/pink to yellow amber (brown) solution for IM injection containing 100 mg haloperidol as 141.04 mg per mL haloperidol decanoate, USP in: NDC 70756-616-81            1 mL single-dose vial in individual carton. Discard unused portion. NDC 70756-616-05            1 mL single-dose vials packed in carton of 5's. Discard unused portion. NDC 70756-616-10             1 mL single-dose vials packed in carton of 10's. Discard unused portion NDC 70756-625-85             5 mL multi-dose vial in individual carton. NDC 70756-625-05             5 mL multi-dose vials packed in carton of 5's. NDC 70756-625-10             5 mL multi-dose vials packed in carton of 10's. Store at 20°C to 25°C (68°F to 77°F) excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Do not refrigerate or freeze. Protect from light. Keep out of reach of children. Manufactured for: Lifestar Pharma LLC 1200 MacArthur Blvd. Mahwah, NJ 07430 USA Made in India Revised: April 2023, V-05

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

HALOPERIDOL DECANOATE - HALOPERIDOL DECANOATE INJECTION
LIFESTAR PHARMA LLC
----------
RX ONLY
HALOPERIDOL DECANOATE INJECTION 50 MG/ML
HALOPERIDOL DECANOATE INJECTION 100 MG/ML
FOR INTRAMUSCULAR (IM) INJECTION ONLY
BOXED 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
INJECTION IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-
RELATED PSYCHOSIS (SEE WARNINGS).
DESCRIPTION
Haloperidol decanoate, USP is the decanoate ester of the
butyrophenone, haloperidol. 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, USP 4-(4-
Chlorophenyl)-1-[4-(4-fluorophenyl)-4-oxobutyl]-piperidin-4-yl
decanoate, is:
Haloperidol decanoate, USP is almost insoluble in water (0.01 mg/mL),
but is soluble in
most organic solvents.
Each mL of haloperidol decanoate injection, 50 mg/mL, for
intramuscular injection,