Fluphenazine Hydrochloride (Page 3 of 3)

Autonomic Nervous System

Hypertension and fluctuation in blood pressure have been reported with fluphenazine hydrochloride.

Hypotension has rarely presented a problem with fluphenazine. However, patients with pheochromocytoma, cerebral vascular or renal insufficiency or a severe cardiac reserve deficiency such as mitral insufficiency appear to be particularly prone to hypotensive reactions with phenothiazine compounds, and should therefore be observed closely when the drug is administered. If severe hypotension should occur, supportive measures including the use of intravenous vasopressor drugs should be instituted immediately. Norepinephrine Bitartrate Injection is the most suitable drug for this purpose; epinephrine should not be used since phenothiazine derivatives have been found to reverse its action, resulting in a further lowering of blood pressure.

Autonomic reactions including nausea and loss of appetite, salivation, polyuria, perspiration, dry mouth, headache and constipation may occur. Autonomic effects can usually be controlled by reducing or temporarily discontinuing dosage.

In some patients, phenothiazine derivatives have caused blurred vision, glaucoma, bladder paralysis, fecal impaction, paralytic ileus, tachycardia or nasal congestion.

Metabolic and Endocrine

Weight change, peripheral edema, abnormal lactation, gynecomastia, menstrual irregularities, false results on pregnancy tests, impotency in men and increased libido in women have all been known to occur in some patients on phenothiazine therapy.

Allergic Reactions

Skin disorders such as itching, erythema, urticaria, seborrhea, photosensitivity, eczema and even exfoliative dermatitis have been reported with phenothiazine derivatives. The possibility of anaphylactoid reactions occurring in some patients should be borne in mind.

Hematologic

Routine blood counts are advisable during therapy since blood dyscrasias including leukopenia, agranulocytosis, thrombocytopenic or nonthrombocytopenic purpura, eosinophilia and pancytopenia have been observed with phenothiazine derivatives. Furthermore, if any soreness of the mouth, gums or throat, or any symptoms of upper respiratory infection occur and confirmatory leukocyte count indicates cellular depression, therapy should be discontinued and other appropriate measures instituted immediately.

Hepatic

Liver damage as manifested by cholestatic jaundice may be encountered, particularly during the first months of therapy; treatment should be discontinued if this occurs. An increase in cephalin flocculation, sometimes accompanied by alterations in other liver function tests, have been reported in patients receiving fluphenazine hydrochloride who have had no clinical evidence of liver damage.

Others

Sudden, unexpected and unexplained deaths have been reported in hospitalized psychotic patients receiving phenothiazines. Previous brain damage or seizures may be predisposing factors; high doses should be avoided in known seizure patients. Several patients have shown sudden flare-ups of psychotic behavior patterns shortly before death. Autopsy findings have usually revealed acute fulminating pneumonia or pneumonitis, aspiration of gastric contents or intramyocardial lesions.

Although this is not a general feature of fluphenazine, potentiation of CNS depressants (opiates, analgesics, antihistamines, barbiturates, alcohol) may occur.

The following adverse reactions have also occurred with phenothiazine derivatives; systemic lupus erythematosus-like syndrome; hypotension severe enough to cause fatal cardiac arrest; altered electrocardiographic and electroencephalographic tracings; altered cerebrospinal fluid proteins; cerebral edema; asthma, laryngeal edema and angioneurotic edema; with long-term use—skin pigmentation and lenticular and corneal opacities.

DOSAGE AND ADMINISTRATION

The average well tolerated starting dose for adult psychotic patients is 1.25 mg (0.5 mL) intramuscularly. Depending on the severity and duration of symptoms, initial total daily dosage may range from 2.5 to 10 mg and should be divided and given at six to eight hour intervals.

The smallest amount that will produce the desired results must be carefully determined for each individual, since optimal dosage levels of this potent drug vary from patient to patient. In general, the parenteral dose for fluphenazine has been found to be approximately 1/3 to 1/2 the oral dose. Treatment may be instituted with a low initial dosage, which may be increased, if necessary, until the desired clinical effects are achieved. Dosages exceeding 10 mg daily should be used with caution.

When symptoms are controlled, oral maintenance therapy can generally be instituted often with single daily doses. Continued treatment by the oral route, if possible, 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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED:

Product
No.
NDC
No.

28110
63323-281-10
Fluphenazine Hydrochloride Injection, USP 25 mg per 10 mL (2.5 mg per mL) flip-top vial packaged individually.

Solutions should be protected from exposure to light. Parenteral solutions may vary in color from essentially colorless to light amber. If a solution has become any darker than light amber or is discolored in any other way, it should not be used.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

PROTECT FROM LIGHT.

The container closure is not made with natural rubber latex.

logo
Lake Zurich, IL 60047

45846G
Revised: November 2016

PACKAGE LABEL — PRINCIPAL DISPLAY — Fluphenazine 10 mL Vial Label

Fluphenazine Hydrochloride Injection, USP
25 mg per 10 mL (2.5 mg per mL)

For intramuscular use only.
10 mL Multiple Dose Vial

Rx only

vial

PACKAGE LABEL — PRINCIPAL DISPLAY — Fluphenazine 10 mL Vial Carton Panel

Fluphenazine Hydrochloride Injection, USP
25 mg per 10 mL (2.5 mg per mL )

For intramuscular use only.
10 mL Multiple Dose Vial

Rx only

box
(click image for full-size original)
FLUPHENAZINE HYDROCHLORIDE
fluphenazine hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-281
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE) FLUPHENAZINE HYDROCHLORIDE 2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9 mg in 1 mL
METHYLPARABEN 1 mg in 1 mL
PROPYLPARABEN 0.1 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-281-10 1 VIAL in 1 BOX contains a VIAL
1 10 mL in 1 VIAL This package is contained within the BOX (63323-281-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089556 12/28/2010
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 023648251 manufacture (63323-281)

Revised: 12/2019 Fresenius Kabi USA, LLC

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