PERPHENAZINE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz Inc

INN (International Name):

PERPHENAZINE

Composition:

PERPHENAZINE 2 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Perphenazine tablets, USP are round, unscored, film-coated white tablets available as: 2 mg: debossed GG 18 on one side and plain on the reverse side, supplied as: NDC 0781-1046-01 bottles of 100 tablets NDC 0781-1046-10 bottles of 1000 tablets NDC 0781-1046-13 unit dose packages of 100 tablets 4 mg: debossed GG 107 on one side and plain on the reverse side, supplied as: NDC 0781-1047-01 bottles of 100 tablets NDC 0781-1047-05 bottles of 500 tablets NDC 0781-1047-13 unit dose packages of 100 tablets 8 mg: debossed GG 108 on one side and plain on the reverse side, supplied as: NDC 0781-1048-01 bottles of 100 tablets NDC 0781-1048-10 bottles of 1000 tablets NDC 0781-1048-13 unit dose packages of 100 tablets 16 mg: debossed GG 109 on one side and plain on the reverse side, supplied as: NDC 0781-1049-01 bottles of 100 tablets NDC 0781-1049-10 bottles of 1000 tablets NDC 0781-1049-13 unit dose packages of 100 tablets Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PERPHENAZINE- PERPHENAZINE TABLET, FILM COATED
SANDOZ INC
----------
PERPHENAZINE TABLETS, USP
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: lactose (monohydrate), hydroxypropyl cellulose,
hydroxypropyl methylcellulose,
magnesium stearate, microcrystalline cellulose, polyethylene glycol,
starch (corn), titanium dioxide, and
polysorbate 80. Its structural formula is:
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 PHARMAC