Country: United States
Language: English
Source: NLM (National Library of Medicine)
FLUPHENAZINE HYDROCHLORIDE (UNII: ZOU145W1XL) (FLUPHENAZINE - UNII:S79426A41Z)
NorthStar Rx LLC
ORAL
PRESCRIPTION DRUG
Fluphenazine hydrochloride tablets are indicated in the management of manifestations of psychotic disorders. Fluphenazine hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation. Phenothiazines are contraindicated in patients with suspected or established subcortical brain damage, in patients receiving large doses of hypnotics, and in comatose or severely depressed states. The presence of blood dyscrasia or liver damage precludes the use of fluphenazine hydrochloride. Fluphenazine hydrochloride tablets are contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.
Fluphenazine Hydrochloride Tablets, USP are available containing either 1 mg, 2.5 mg, 5 mg or 10 mg of fluphenazine hydrochloride, USP. Fluphenazine Hydrochloride Tablets USP, 1 mg are supplied as white to off-white colored, round shaped, film-coated tablets debossed with "D5" on one side and plain on other side. They are available as follows: Bottles of 100 with child-resistant closure: NDC 16714-002-01 Fluphenazine Hydrochloride Tablets USP, 2.5 mg are supplied as yellow colored, round shaped, film-coated tablets debossed with "E4" on one side and plain on other side. They are available as follows: Bottles of 100 with child-resistant closure: NDC 16714-003-01 Fluphenazine Hydrochloride Tablets USP, 5 mg are supplied as green colored, round shaped, film-coated tablets debossed with "E1" on one side and plain on other side. They are available as follows: Bottles of 100 with child-resistant closure: NDC 16714-004-01 Fluphenazine Hydrochloride Tablets USP, 10 mg are supplied as orange to light orange colored, round shaped, film-coated tablets debossed with "E2" on one side and plain on other side. They are available as follows: Bottles of 100 with child-resistant closure: NDC 16714-005-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Oral Solid Dosage Unit Ahmedabad 382213, INDIA Iss. 01-2021-00
Abbreviated New Drug Application
FLUPHENAZINE HYDROCHLORIDE- FLUPHENAZINE HYDROCHLORIDE TABLET, FILM COATED NORTHSTAR RX LLC ---------- FLUPHENAZINE HYDROCHLORIDE TABLETS, USP (1 MG, 2.5 MG, 5 MG AND 10 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. FLUPHENAZINE HYDROCHLORIDE IS NOT APPROVED FOR THE TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS (SEE WARNINGS). DESCRIPTION Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. Chemically it is 4-[3-[2-(Trifluoromethyl) phenothiazin-10- yl]propyl]-1-piperazineethanol dihydrochloride which may be represented by the following structural formula: Molecular Formula: C H F N OS.2HCl Molecular Weight: 510.44 g/mol. Fluphenazine hydrochloride, USP is a white or nearly white, crystalline powder. It is soluble in water, and practically insoluble in acetone, methylene chloride and in chloroform. Each tablet, for oral administration, contains 1 mg, 2 Read the complete document