Fluphenazine Hydrochloride: Package Insert and Label Information (Page 2 of 2)

Autonomic Nervous System:

Hypertension and fluctuations 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, has 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 central nervous system 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

Depending on severity and duration of symptoms, total daily dosage for adult psychotic patients may range initially from 2.5 mg to 10 mg and should be divided and given at 6 to 8 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 oral dose has been found to be approximately 2 to 3 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 mg 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 fluphenazine decanoate may be indicated (see package insert for fluphenazine decanoate for conversion information).

For geriatric patients, the suggested starting dose is 1 mg to 2.5 mg daily, adjusted according to the response of the patient.

HOW SUPPLIED

Fluphenazine Hydrochloride Tablets, USP are available as follows:

1 mg tablets are white, round, film-coated tablets debossed “LCI” on one side and “1788”
on the other side. They are supplied in bottles of 100 (NDC 0527-1788-01) and 500 (NDC 0527-1788-05).

2.5 mg tablets are blue, round, film-coated tablets debossed “LCI” on one side and “1789”
on the other side. They are supplied in bottles of 100 (NDC 0527-1789-01) and 500 (NDC 0527-1789-05).

5 mg tablets are dark pink, round, film-coated tablets debossed “LCI” on one side and “1790”
on the other side. They are supplied in bottles of 100 (NDC 0527-1790-01) and 500 (NDC 0527-1790-05).

10 mg tablets are orange, round, film-coated tablets debossed “LCI” on one side and “1791”
on the other side. They are supplied in bottles of 100 (NDC 0527-1791-01) and 500 (NDC 0527-1791-05).

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from light.

Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.

Distributed by:
Lannett Company, Inc.
Philadelphia, PA 19136

CIB70359D

Rev. 12/19

PRINCIPAL DISPLAY PANEL — 1 mg Tablets Bottle Label

NDC0527178801

Fluphenazine
HydrochlorideTablets, USP

1 mg

Rx Only

100 Tablets

Lannett

label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 2.5 mg Tablets Bottle Label

NDC 0527178901

Fluphenazine HydrochlorideTablets, USP

2.5 mg

Rx Only

100 Tablets

Lannett

label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mg Tablets Bottle Label

NDC 0527179001

Fluphenazine HydrochlorideTablets, USP

5 mg

Rx Only

100 Tablets

Lannett

label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg Tablets Bottle Label

NDC 0527179101

Fluphenazine HydrochlorideTablets, USP

10 mg

Rx Only

100 Tablets

Lannett

label
(click image for full-size original)

FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1788
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE) FLUPHENAZINE HYDROCHLORIDE 1 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
WATER
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code LCI;1788
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1788-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0527-1788-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089743 08/25/1988
FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1789
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE) FLUPHENAZINE HYDROCHLORIDE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
WATER
TITANIUM DIOXIDE
D&C RED NO. 27
FD&C BLUE NO. 2
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code LCI;1789
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1789-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0527-1789-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089743 08/25/1988
FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1790
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE) FLUPHENAZINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
WATER
TITANIUM DIOXIDE
D&C RED NO. 27
FD&C BLUE NO. 1
D&C RED NO. 30
D&C YELLOW NO. 10
Product Characteristics
Color PINK (Dark pink) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code LCI;1790
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1790-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0527-1790-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089743 08/25/1988
FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1791
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE) FLUPHENAZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYSORBATE 80
WATER
TITANIUM DIOXIDE
FD&C RED NO. 40
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code LCI;1791
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-1791-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:0527-1791-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089743 08/25/1988
Labeler — Lannett Company, Inc. (002277481)

Revised: 12/2019 Lannett Company, Inc.

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