fluphenazine

Therapeutic Classification: antipsychotics

Pharmacologic Classification: phenothiazines

BEERS REMS

Acute and chronic psychoses.

Alters the effects of dopamine in the CNS.
Has anticholinergic and alpha-adrenergic blocking activity.

Therapeutic effects:

Diminished signs and symptoms of psychoses.

Absorption: Well absorbed after PO/IM administration. Decanoate salt in sesame oil has delayed onset and prolonged action because of delayed release from oil vehicle and subsequent delayed release from fatty tissues.

Distribution: Widely distributed. Crosses the blood-brain barrier.

Protein Binding: ≥90%.

Metabolism/Excretion: Highly metabolized by the liver; undergo enterohepatic recirculation.

Half-Life: Fluphenazine hydrochloride: 33 hr; fluphenazine decanoate: 6.8–9.6 days.

(antipsychotic activity)

ROUTE	ONSET	PEAK	DURATION
PO hydrochloride	1 hr	unknown	6–8 hr
IM decanoate	24–72 hr	48–96 hr	≥4 wk

Contraindicated in:

Hypersensitivity;
Cross-sensitivity with other phenothiazines may exist;
Subcortical brain damage;
Severe CNS depression;
Coma;
Bone marrow depression;
Hepatic impairment;
Hypersensitivity to sesame oil (decanoate salt);
Some products contain alcohol or tartrazine and should be avoided in patients with known intolerance;
Concurrent use of drugs that prolong the QT interval;
Lactation: Lactation;
Pedi: Children <6 mo (safety not established).

Use Cautiously in:

Cardiovascular disease;
Parkinson's disease;
Angle-closure glaucoma;
Myasthenia gravis;
Prostatic hypertrophy;
Seizure disorders;
Patients at risk for falls;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Geri: Appears on Beers list. ↑ risk of stroke, cognitive decline, and mortality in older adults with dementia. Avoid use in older adults, except for schizophrenia.

CV: hypertension, hypotension, tachycardia

Derm: photosensitivity, pigment changes, rash

EENT: blurred vision, dry eyes

Endo: galactorrhea

GI: anorexia, constipation, hepatitis, dry mouth, ileus, nausea

GU: urinary retention

Hemat: AGRANULOCYTOSIS, leukopenia, thrombocytopenia

Metab: weight gain

Neuro: extrapyramidal reactions, NEUROLEPTIC MALIGNANT SYNDROME, sedation, tardive dyskinesia

Misc: allergic reactions

Drug-drug:

Concurrent use with QT interval prolonging drugs, including antiarrhythmics, pimozide, erythromycin, clarithromycin, fluoroquinolones, methadone, and tricyclic antidepressants may ↑ the risk for arrhythmias; concurrent use should be avoided.
Additive hypotension with antihypertensives.
Additive CNS depression with other CNS depressants, including alcohol, antidepressants, antihistamines, opioids, sedative/hypnotics, or general anesthetics.
Effects may be ↓ by phenobarbital.
May ↑ the risk of lithium toxicity.
Oral absorption may be ↓ by aluminum-containing antacids.
May ↓ anti-Parkinson activity of levodopa and bromocriptine.
May ↓ the vasopressor response to epinephrine and norepinephrine.
Effects may be ↑ by beta blockers, chlorpromazine, chloroquine, fluoxetine, paroxetine, quinidine, quinine, ritonavir, and ropinirole.
↑risk of anticholinergic effects with other agents having anticholinergic properties, including antihistamines, tricyclicantidepressants, disopyramide, or quinidine.
Metoclopramide may ↑ the risk of extrapyramidal reactions.

Fluphenazine Hydrochloride

PO (Adults ): 0.5–10 mg/day in divided doses every 6–8 hr (maximum dose = 40 mg/day).
PO Geriatric Patients or Debilitated Patients): 1–2.5 mg/day initially; ↑ dose every 4–7 days by 1–2.5 mg/day as needed (max dose = 20 mg/day).
IM (Adults ): 1.25–2.5 mg every 6–8 hr.

Fluphenazine Decanoate

IM (Adults ): 12.5–25 mg initially; may be repeated every 3 wk. Dose may be slowly ↑ as needed (not to exceed 100 mg/dose).

(Generic available)

Tablets: 1 mg; 2 mg; 2.5 mg; 5 mg; 10 mg
Elixirorange flavor: 2.5 mg/5 mL
Oral concentrate: 5 mg/mL
Solution for injection (decanoate): 25 mg/mL
Solution for injection (hydrochloride): 2.5 mg/mL

Assess mental status (orientation, mood, behavior) before and periodically during therapy.
Assess weight and body mass index initially and throughout therapy. Refer as appropriate for nutritional/weight and medical management.
Monitor BP (sitting, standing, lying), ECG, pulse, and respiratory rate before and frequently during the period of dose adjustment. May cause Q-wave and T-wave changes in ECG.
Observe carefully when administering oral medication to ensure that medication is actually taken and not hoarded.
Assess fluid intake and bowel function. Increased bulk and fluids in the diet help minimize constipation.
Monitor for onset of akathisia (restlessness or desire to keep moving) and extrapyramidal side effects (parkinsonian: difficulty speaking or swallowing, loss of balance control, pill rolling, mask-like face, shuffling gait, rigidity, tremors; dystonic: muscle spasms, twisting motions, twitching, inability to move eyes, weakness of arms or legs) every 2 mo during therapy and 8–12 wk after therapy has been discontinued. Reduction in dose or discontinuation of medication may be necessary. Benztropine or diphenhydramine may be used to control these symptoms.
Monitor for tardive dyskinesia (uncontrolled rhythmic movement of mouth, face, and extremities; lip smacking or puckering; puffing of cheeks; uncontrolled chewing; rapid or worm-like movements of tongue). Report immediately; may be irreversible.
Monitor for development of neuroleptic malignant syndrome (fever, respiratory distress, tachycardia, seizures, diaphoresis, arrhythmias, hypertension or hypotension, pallor, tiredness, severe muscle stiffness, loss of bladder control). Report immediately.
Monitor for symptoms related to hyperprolactinemia (menstrual abnormalities, galactorrhea, sexual dysfunction).
Assess for falls risk. Drowsiness, orthostatic hypotension, and motor and sensory instability increase risk. Institute prevention if indicated.

Lab Test Considerations:

Evaluate CBC, liver function tests, and ocular examinations periodically during therapy. May cause ↓ hematocrit, hemoglobin, leukocytes, granulocytes, and platelets. May cause ↑ bilirubin, AST, ALT, and alkaline phosphatase. Agranulocytosis may occur after 4–10 wk of therapy with recovery 1–2 wk after discontinuation. May recur if medication is restarted. Liver function abnormalities may require discontinuation of therapy.

Do not confuse fluphenazine with fluvoxamine.
Slight yellow to amber color does not alter potency.
- To prevent contact dermatitis, avoid getting liquid preparations on hands and wash hands thoroughly if spillage occurs.
- Injectable forms must be drawn up with a dry syringe and dry 21-gauge needle to prevent clouding of the solution.
PO: Dilute concentrate just before administration in 120–240 mL of water, milk, carbonated beverage, soup, or tomato or fruit juice. Do not mix with beverages containing caffeine (cola, coffee), tannics (tea), or pectinates (apple juice).
SC: Fluphenazine decanoate is dissolved in sesame oil for long duration of action. It may be administered SUBQ or IM. 12.5 mg of fluphenazine decanoate given every 3 wk is approximately equivalent to 10 mg/day orally of fluphenazine hydrochloride.
IM: IM dose of fluphenazine hydrochloride is usually 30–50% of oral dose. Because fluphenazine hydrochloride has a shorter duration of action, it is used initially to determine the patient’s response to the drug and to treat the acutely agitated patient.
- Administer deep IM, using a dry syringe and 21-gauge needle, into dorsal gluteal site. Instruct patient to remain recumbent for 30 min to prevent hypotension.
Syringe Compatibility:
- benztropine
- diphenhydramine
- hydroxyzine
Fluphenazine hydrochloride is compatible in syringe with.

Advise patient to take medication as directed and not to skip doses or double up on missed doses. If a dose is missed, take within 1 hr or skip dose and return to regular schedule if taking more than 1 dose/day; take as soon as possible unless almost time for next dose if taking 1 dose/day. Abrupt withdrawal may lead to gastritis, nausea, vomiting, dizziness, headache, tachycardia, and insomnia.
Inform patient of possibility of extrapyramidal symptoms and tardive dyskinesia. Caution patient to report these symptoms immediately to health care professional.
Advise patient to change positions slowly to minimize orthostatic hypotension. Protect from falls.
Medication may cause drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Caution patient to avoid taking alcohol or other CNS depressants concurrently with this medication.
Advise patient to use sunscreen and protective clothing when exposed to the sun. Exposed surfaces may develop a blue-gray pigmentation, which may fade after discontinuation of the medication. Extremes of temperature should also be avoided because this drug impairs body temperature regulation.
Advise patient that good oral hygiene, frequent rinsing of mouth with water, and sugarless gum or candy may help relieve dry mouth. Health care professional should be notified if dry mouth persists beyond 2 wk.
Instruct patient to notify health care professional promptly if sore throat, fever, unusual bleeding or bruising, rash, weakness, tremors, visual disturbances, dark-colored urine, or clay-colored stools occur.
Advise patient to notify health care professional of medication regimen before treatment or surgery.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Emphasize the importance of routine follow-up exams, including ocular exams, with long-term therapy.

Decrease in excitable, paranoiac, or withdrawn behavior.

NDC Code

0121- Pharmaceutical Associates, Inc.
- 0121-0653- Fluphenazine Hydrochloride
  - 0121-0653-04- 120 mL in 1 BOTTLE, DROPPER (0121-0653-04)

0121- Pharmaceutical Associates, Inc.
- 0121-0654- Fluphenazine Hydrochloride
  - 0121-0654-02- 60 mL in 1 BOTTLE (0121-0654-02)

0121- Pharmaceutical Associates, Inc.
- 0121-0654- Fluphenazine Hydrochloride
  - 0121-0654-16- 473 mL in 1 BOTTLE (0121-0654-16)

0378- Mylan Pharmaceuticals Inc.
- 0378-6004- Fluphenazine hydrochloride
  - 0378-6004-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6004-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-6004- Fluphenazine hydrochloride
  - 0378-6004-05- 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6004-05)

0378- Mylan Pharmaceuticals Inc.
- 0378-6009- Fluphenazine hydrochloride
  - 0378-6009-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6009-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-6009- Fluphenazine hydrochloride
  - 0378-6009-05- 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6009-05)

0378- Mylan Pharmaceuticals Inc.
- 0378-6074- Fluphenazine hydrochloride
  - 0378-6074-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6074-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-6074- Fluphenazine hydrochloride
  - 0378-6074-05- 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6074-05)

0378- Mylan Pharmaceuticals Inc.
- 0378-6097- Fluphenazine hydrochloride
  - 0378-6097-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6097-01)

0378- Mylan Pharmaceuticals Inc.
- 0378-6097- Fluphenazine hydrochloride
  - 0378-6097-05- 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6097-05)

0527- Lannett Company, Inc.
- 0527-1788- Fluphenazine Hydrochloride
  - 0527-1788-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1788-01)

0527- Lannett Company, Inc.
- 0527-1788- Fluphenazine Hydrochloride
  - 0527-1788-05- 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1788-05)

0527- Lannett Company, Inc.
- 0527-1789- Fluphenazine Hydrochloride
  - 0527-1789-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1789-01)

0527- Lannett Company, Inc.
- 0527-1789- Fluphenazine Hydrochloride
  - 0527-1789-05- 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1789-05)

0527- Lannett Company, Inc.
- 0527-1790- Fluphenazine Hydrochloride
  - 0527-1790-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1790-01)

0527- Lannett Company, Inc.
- 0527-1790- Fluphenazine Hydrochloride
  - 0527-1790-05- 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1790-05)

0527- Lannett Company, Inc.
- 0527-1791- Fluphenazine Hydrochloride
  - 0527-1791-01- 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1791-01)

0527- Lannett Company, Inc.
- 0527-1791- Fluphenazine Hydrochloride
  - 0527-1791-05- 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0527-1791-05)

17856- ATLANTIC BIOLOGICALS CORP.
- 17856-0654- Fluphenazine Hydrochloride
  - 17856-0654-1- 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0654-1) > 5 mL in 1 CUP, UNIT-DOSE

50090- A-S Medication Solutions
- 50090-3320- Fluphenazine Hydrochloride
  - 50090-3320-0- 60 mL in 1 BOTTLE (50090-3320-0)

51079- Mylan Institutional Inc.
- 51079-485- Fluphenazine hydrochloride
  - 51079-485-20- 100 BLISTER PACK in 1 CARTON (51079-485-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-485-01)

51079- Mylan Institutional Inc.
- 51079-486- Fluphenazine hydrochloride
  - 51079-486-20- 100 BLISTER PACK in 1 CARTON (51079-486-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-486-01)

51079- Mylan Institutional Inc.
- 51079-487- Fluphenazine hydrochloride
  - 51079-487-20- 100 BLISTER PACK in 1 CARTON (51079-487-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-487-01)

51079- Mylan Institutional Inc.
- 51079-488- Fluphenazine hydrochloride
  - 51079-488-20- 100 BLISTER PACK in 1 CARTON (51079-488-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-488-01)

63323- Fresenius Kabi USA, LLC
- 63323-281- Fluphenazine Hydrochloride
  - 63323-281-10- 1 VIAL in 1 BOX (63323-281-10) > 10 mL in 1 VIAL

70518- REMEDYREPACK INC.
- 70518-0318- Fluphenazine Hydrochloride
  - 70518-0318-0- 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0318-0)

70518- REMEDYREPACK INC.
- 70518-0318- Fluphenazine Hydrochloride
  - 70518-0318-1- 100 POUCH in 1 BOX (70518-0318-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-0318-2)

70518- REMEDYREPACK INC.
- 70518-0457- Fluphenazine hydrochloride
  - 70518-0457-0- 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0457-0)

70518- REMEDYREPACK INC.
- 70518-1496- Fluphenazine Hydrochloride
  - 70518-1496-0- 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1496-0)

70518- REMEDYREPACK INC.
- 70518-1496- Fluphenazine Hydrochloride
  - 70518-1496-1- 100 POUCH in 1 BOX (70518-1496-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-1496-2)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Code ⬆