Country: United States
Language: English
Source: NLM (National Library of Medicine)
perphenazine (UNII: FTA7XXY4EZ) (perphenazine - UNII:FTA7XXY4EZ)
Rebel Distributors Corp
perphenazine
perphenazine 4 mg
ORAL
PRESCRIPTION DRUG
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 tablets, 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 recommen
Perphenazine tablets, USP are round, unscored, film-coated white tablets available as: 4 mg: debossed GG 107 on one side and plain on the reverse side, supplied as: NDC 21695-414-60 blister of 60 tablets 8 mg: debossed GG 108 on one side and plain on the reverse side, supplied as: NDC 21695-415-60 blister of 60 tablets Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Dispense in a tight, light-resistant container.
Abbreviated New Drug Application
PERPHENAZINE- PERPHENAZINE TABLET, FILM COATED REBEL DISTRIBUTORS CORP ---------- PERPHENAZINE TABLETS, USP 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 PHARMACOLOGY PHARMACOKINETICS Following oral administration of perphenazine tablets, mean peak plasma perphenazine concentrations were observed between 1 to 3 hours. The plasma elimination half-life of perphenazine was independent of dose and ranged between 9 and 12 hours. In a study in which normal volunteers (n=12) received perphenazine 4 mg q8h for 5 days, steady-state concentrations of perphenazine were reached within 72 hours. Mean (%CV) C and C values for perphenazine and 7-hydroxyperphenazine at steady-state are listed below: PARAMETER PERPHENAZINE 7- HYDROXYPERPHENAZINE C (pg/mL) 984 (43) 509 (25) C (pg/mL) 442 (76) 350 (56) Peak 7-hydroxyperphenazine concentrations were observed between 2 to 4 hours with a terminal phase half-life ranging between 9.9 to 18.8 hours. Perphenazine is extensively metabolized in the liver to a number of metabolites by sulfoxidation, hydroxylation, dealkylation, and glucuronidation. The 21 26 3 max min max min pharmacokinetics of perphenazine covary with the hydroxylation of debrisoquine which is mediated by cytochrome P450 2D6 (CYP 2D6) and thus is subject to genetic polymorphism – i.e., 7% to 10% of Caucasians and a low percentage of Asians have little or no activity and are called “p Read the complete document