HALOPERIDOL DECANOATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Gland Pharma Limited

INN (International Name):

HALOPERIDOL DECANOATE

Composition:

HALOPERIDOL 50 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 with Lewy bodies (see WARNINGS, Neurological Adverse

Product summary:

Haloperidol decanoate injection is a clear colorless/pink to yellow amber oily liquid. Haloperidol decanoate injection, 50 mg haloperidol as 70.52 mg  per mL haloperidol decanoate is available as follows: Haloperidol decanoate injection, 100 mg haloperidol as 141.04 mg per mL haloperidol decanoate is available as follows:   * As haloperidol Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Do not refrigerate or freeze. PROTECT FROM LIGHT . Keep in carton until empty. Keep out of reach of children. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. Manufactured by: Gland Pharma Limited D.P.Pally, Dundigal Post, Hyderabad - 500 043, INDIA. Revised: April 2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HALOPERIDOL DECANOATE - HALOPERIDOL DECANOATE INJECTION
GLAND PHARMA LIMITED
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HALOPERIDOL DECANOATE INJECTION
(FOR INTRAMUSCULAR INJECTION ONLY)
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 DECANOATE
INJECTION IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-
RELATED PSYCHOSIS (SEE WARNINGS).
DESCRIPTION
Haloperidol decanoate 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:
Haloperidol decanoate 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,
contains 50 mg haloperidol (present as haloperidol decanoate 70.52 mg)
in