Fluphenazine Hydrochloride (Fluphenazine Hydrochloride)

Trade Name : Fluphenazine Hydrochloride

Pharmaceutical Associates, Inc.

SOLUTION, CONCENTRATE

Strength 5 mg/mL

FLUPHENAZINE HYDROCHLORIDE Phenothiazines [CS],Phenothiazine [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fluphenazine Hydrochloride (Fluphenazine Hydrochloride) which is also known as Fluphenazine Hydrochloride and Manufactured by Pharmaceutical Associates, Inc.. It is available in strength of 5 mg/mL per ml. Read more

Fluphenazine Hydrochloride (Fluphenazine Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rx Only
  • 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 Oral Solution USP (Concentrate) is not approved for the treatment of patients with dementia-related psychosis (n n n n ).n nn
  • Fluphenazine hydrochloride is a trifluoromethyl phenothiazine derivative intended for the management of schizophrenia. Each mL of Fluphenazine Hydrochloride Oral Solution USP (Concentrate), for oral administration, contains fluphenazine hydrochloride, 5 mg; alcohol, 14%. In addition, each mL contains the following inactive ingredients: glycerin, purified water, and sodium benzoate. Fluphenazine hydrochloride has the following structure:
  • 4-[3-[2-(Trifluoromethyl)phenothiazin-10-yl]propyl]-1-piperazineethanol dihydrochloride
  • Fluphenazine hydrochloride has activity at all levels of the central nervous system, as well as on multiple organ systems. The mechanism whereby its therapeutic action is exerted is unknown.
  • Fluphenazine hydrochloride is 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 is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may occur.
  • No data
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  • Depending on the severity and duration of symptoms, total daily dosage forn n n psychotic patients may range initially from 2.5 to 10 mg and should be divided and given at six- to eight- hour intervals.n nn
  • The smallest amount that will produce the desired results must be carefully determined for each individual, since optimal dosage levels of this potent drug may vary from patient to patient. In general, the oral dose has been found to be approximately two to three times the parenteral dose of fluphenazine. Treatment is best instituted with a low initial dosage, which may be increased, if necessary, until the desired clinical effects are achieved. Therapeutic effect is often achieved with doses under 20 mg daily. Patients remaining severely disturbed or inadequately controlled may require upward titration of dosage. Daily doses up to 40 mg may be necessary; controlled clinical studies have not been performed to demonstrate safety of prolonged administration of such doses.
  • When symptoms are controlled, dosage can generally be reduced gradually to daily maintenance doses of 1 to 5 mg, often given as a single daily dose. Continued treatment is needed to achieve maximum therapeutic benefits; further adjustments in dosage may be necessary during the course of therapy to meet the patient's requirements.
  • For psychotic patients who have been stabilized on a fixed daily dosage of orally administered Fluphenazine Hydrochloride dosage forms, conversion to the long-acting injectable Fluphenazine Decanoate may be indicated [see package insert for Fluphenazine Decanoate Injection for conversion information].
  • For n n n patients, the suggested starting dose is 1 to 2.5 mg daily, adjusted according to the response of the patient.n nn
  • When the Oral Concentrate dosage form is to be used, the desired dose (measured by a calibrated device only) should be added to at least 60 mL (2 fl oz) of a suitable diluent n n n to ensure palatability and stability. Suggested diluents include tomato or fruit juice, milk, and uncaffeinated soft drinks. The Oral Concentrate should not be mixed with beverages containing caffeine (coffee, cola), tannics (tea), or pectinates (apple juice) because of the potential incompatibility.n nn
  • Fluphenazine Hydrochloride Injection USP is useful when psychotic patients are unable or unwilling to take oral therapy.
  • Fluphenazine Hydrochloride Oral Solution USP (Concentrate), a colorless, unflavored concentrated liquid is available in the following oral dosage form:
  • NDC 0121-0653-04: 4 fl oz (120 mL) bottle with a 1 mL safety-cap dropper calibrated at 0.1 mL and in 0.2 mL increments. 5 mg fluphenazine hydrochloride per mL.
  • Store at 20u00b0 to 25u00b0 C (68u00b0 to 77u00b0 F) [See USP Controlled Room Temperature]. Avoid freezing. Protect from light. Keep tightly closed.
  • MANUFACTURED BY
  • Arrayn- Pharmaceutical n n n Associates, Inc.n n n
  • R02/17
  • 120 mL (4 fl oz) NDC 0121-0653-04n n n with calibrated droppern nn
  • Fluphenazinen n n Hydrochloriden n n Oral Solution USPn n n (Concentrate)n n n
  • 5 mg/mL
  • For oral use only
  • Rx ONLY
  • Arrayn- Pharmaceuticaln n n Associates, Inc.n n n

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