PERPHENAZINE tablet

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

PERPHENAZINE (UNII: FTA7XXY4EZ) (PERPHENAZINE - UNII:FTA7XXY4EZ)

Boleh didapati daripada:

Chartwell RX, LLC

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Perphenazine is indicated for use in the treatment of schizophrenia and for the control of severe nausea and vomiting in adults. Perphenazine has not been shown effective for the management of behavioral complications in patients with mental retardation. Perphenazine products are contraindicated in comatose or greatly obtunded patients and in patients receiving large doses of central nervous system depressants (barbiturates, alcohol, narcotics, analgesics, or antihistamines); in the presence of existing blood dyscrasias, bone marrow depression, or liver damage; and in patients who have shown hypersensitivity to perphenazine products, their components, or related compounds. Perphenazine products are also contraindicated in patients with suspected or established subcortical brain damage, with or without hypothalamic damage, since a hyperthermic reaction with temperatures in excess of 104°F may occur in such patients, sometimes not until 14 to 16 hours after drug administration. Total body ice-packing is recomme

Ringkasan produk:

4 mg : White to off-white, round, film coated tablets, debossed with "AC393" on one side and plain on other side, supplied as: Bottle of 90 tablets         NDC 62135-799-90 Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71785 Rev.11/2023

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

PERPHENAZINE- PERPHENAZINE TABLET
CHARTWELL RX, LLC
----------
PERPHENAZINE TABLETS, USP 4 MG
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. PERPHENAZINE IS NOT
APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS
(SEE WARNINGS).
DESCRIPTION
Perphenazine
(4-[3-(2-chlorophenothiazin-10-yl)propyl]-1-piperazineethanol), a
piperazinyl phenothiazine, having the chemical formula, C
H
CIN
OS. It is available
as oral tablets containing 2 mg, 4 mg, 8 mg, and 16 mg of
perphenazine.
Inactive ingredients: hydroxypropyl cellulose, hypromellose, lactose
monohydrate,
magnesium stearate, microcrystalline cellulose, pregelatinized starch,
polyethylene
glycol, polysorbate 80 and titanium dioxide. Its structural formula
is:
21
26
3
ACTIONS:
Perphenazine has actions at all levels of the central nervous system,
particularly the
hypothalamus. However, the site and mechanism of action of therapeutic
effect are not
known.
CLINICAL P