PIMOZIDE tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

PIMOZIDE (UNII: 1HIZ4DL86F) (PIMOZIDE - UNII:1HIZ4DL86F)

제공처:

Par Pharmaceutical, Inc.

INN (International Name):

PIMOZIDE

구성:

PIMOZIDE 1 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Pimozide Tablets, USP is indicated for the suppression of motor and phonic tics in patients with Tourette’s Disorder who have failed to respond satisfactorily to standard treatment. Pimozide Tablets, USP is not intended as a treatment of first choice nor is it intended for the treatment of tics that are merely annoying or cosmetically troublesome. Pimozide Tablets, USP should be reserved for use in Tourette’s Disorder patients whose development and/or daily life function is severely compromised by the presence of motor and phonic tics. Evidence supporting approval of Pimozide Tablets, USP for use in Tourette’s Disorder was obtained in two controlled clinical investigations which enrolled patients between the ages of 8 and 53 years. Most subjects in the two trials were 12 or older. 1. Pimozide is contraindicated in the treatment of simple tics or tics other than those associated with Tourette’s Disorder. 2. Pimozide should not be used in patients taking drugs that may, themselves, cause motor and phonic tics (

제품 요약:

Pimozide Tablets USP, 1 mg is white to off white, uncoated round shaped tablets with debossed bisect separating "EP" and "320" on one side and other side has a single bisect. They are available in bottles of 100 (NDC 49884-347-01). Pimozide Tablets USP, 2 mg is white to off white, uncoated oval shaped tablets with debossed bisect separating "EP" and "321" on one side and other side has a single bisect. They are available in bottles of 100 (NDC 49884-348-01). Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Pharmacist : Dispense in a tight, light-resistant container as defined in the official compendium with a child-resistant closure as required. Rx Only Dist. by: Par Pharmaceutical Chestnut Ridge, NY 10977 U.S.A. Mfg. by: Par Formulations Private Limited, 9/215, Pudupakkam, Kelambakkam - 603 103. Made in India Mfg.Lic.No.: TN00002121 OS347-01-74-02 Revised: 03/2017

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

PIMOZIDE- PIMOZIDE TABLET
PAR PHARMACEUTICAL, INC.
----------
PIMOZIDE TABLETS, USP
DESCRIPTION
Pimozide is an orally active antipsychotic agent of the
diphenyl-butylpiperidine series. The structural
formula of pimozide, 1-[1-[4,4-bis(4-fluorophenyl)
butyl]-4piperidinyl]-1,3-dihydro-2H-
benzimidazole-2-one is:
The solubility of pimozide in water is less than 0.01 mg/mL; it is
slightly soluble in most organic
solvents.
Each white Pimozide tablet contains either 1 mg or 2 mg of pimozide
and the following inactive
ingredients: calcium stearate, microcrystalline cellulose, lactose
anhydrous and corn starch.
CLINICAL PHARMACOLOGY
PHARMACODYNAMIC ACTIONS
Pimozide tablets, USP is an orally active antipsychotic drug product
which shares with other
antipsychotics the ability to blockade dopaminergic receptors on
neurons in the central nervous system.
Although its exact mode of action has not been established, the
ability of pimozide to suppress motor
and phonic tics in Tourette’s Disorder is thought to be a function
of its dopaminergic blocking activity.
However, receptor blockade is often accompanied by a series of
secondary alterations in central
dopamine metabolism and function which may contribute to both
pimozide’s therapeutic and untoward
effects. In addition, pimozide tablets, USP in common with other
antipsychotic drugs, has various
effects on other central nervous system receptor systems which are not
fully characterized.
METABOLISM AND PHARMACOKINETICS
More than 50% of a dose of pimozide is absorbed after oral
administration. Based on the
pharmacokinetic and metabolic profile, pimozide appears to undergo
significant first pass metabolism.
Peak serum levels occur generally six to eight hours (range 4 to 12
hours) after dosing.
Pimozide is extensively metabolized, primarily by N-dealkylation in
the liver. This metabolism is
catalyzed mainly by the cytochrome P450 3A4 (CYP 3A4) enzymatic system
and to a lesser extent, by
cytochrome P450 1A2 (CYP 1A2) and cytochrome P450 2D6 (CYP 2D6). Two
major metabolites have