HALOPERIDOL DECANOATE injection

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Teva Parenteral Medicines, Inc.

INN (Tarptautinis Pavadinimas):

HALOPERIDOL DECANOATE

Sudėtis:

HALOPERIDOL 50 mg in 1 mL

Vartojimo būdas:

INTRAMUSCULAR

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Haloperidol decanoate injection 50 mg/mL and haloperidol decanoate injection 100 mg/mL are indicated for the treatment of schizophrenic patients 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 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.

Produkto santrauka:

0703-7011-03 50 mg/mL 1 mL fill in a 2 mL vial 0703-7021-03 100 mg/mL 1 mL fill in a 2 mL vial 0703-7013-01 50 mg/mL 5 mL multiple dose vial 0703-7023-01 100 mg/mL 5 mL multiple dose vial 2 mL vials are packaged 10 vials per shelf pack. 5 mL multiple dose vials are packaged in single unit cartons. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Do not refrigerate or freeze. Protect from light. Retain in carton until contents are used. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. F 1/2018

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

HALOPERIDOL DECANOATE- HALOPERIDOL DECANOATE INJECTION
TEVA PARENTERAL MEDICINES, INC.
----------
HALOPERIDOL DECANOATE INJECTION
RX ONLY
FOR INTRAMUSCULAR INJECTION 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
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,
4-(4-chlorophenyl)-1-[4-(4-fluorophenyl)-4-
oxobutyl]-4 piperidinyl decanoate is:
C
H ClFNO M.W. 530.11
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, contains 50 mg
haloperidol (present as
haloperidol decanoate, US