See Supplemental Patient Information
- Fluphenazine is not approved for treatment of dementia-related psychosis [US Black Box Warning]
- Elderly patients with dementia-related psychosis receiving antipsychotics are at an increased risk of death [US Black Box Warning]
- Elderly patients, especially women receiving this drug may develop tardive dyskinesia, a condition characterized by potentially irreversible, involuntary, dyskinetic movements
- To reduce the occurrence of tardive dyskinesia, use the smallest dose and the shortest possible duration of treatment producing satisfactory clinical response
- Potentially fatal neuroleptic malignant syndrome (NMS), characterized by hyperpyrexia, muscle rigidity, altered mental status and autonomic instability, has been reported with fluphenazine use. If NMS is observed, discontinue therapy and initiate appropriate treatment
- Exposure to fluphenazine during pregnancy may cause extrapyramidal and withdrawal symptoms in neonates. Use of fluphenazine in pregnancy is advised only if potential benefit to the mother outweighs the risk to the fetus
- Use with caution in patients with cholestatic jaundice, dermatoses or allergic reactions to phenothiazines due to the possibility of cross-sensitivity
- Monitor patients treated with large doses of fluphenazine who are undergoing surgery due to the risk of developing hypotension
- Prolonged use of fluphenazine may cause liver damage, pigmentary retinopathy, lenticular/corneal deposits, and irreversible dyskinesia
- Increase in serum prolactin levels, manifested by galactorrhea, amenorrhea, gynecomastia, and impotence, has been reported with the use of fluphenazine
- Hematological abnormalities like leukopenia, neutropenia and agranulocytosis have been reported in clinical trial and postmarketing experience with fluphenazine
- Patients with preexisting low WBC and a history of drug-induced leukopenia/neutropenia are at higher risk of such hematological abnormalities. Monitor CBC regularly during the first few months of therapy; if there is a decline in WBC, discontinue the drug
- Fluphenazine may potentiate the effects of atropine in certain patients due to added anticholinergic effects
- Although psychical or psychological dependence is not seen with fluphenazine, abrupt discontinuation may cause withdrawal symptoms such as gastritis, nausea and vomiting, dizziness, and tremulousness
- Regularly monitor renal and hepatic function during prolonged therapy. If BUN levels are abnormal, discontinue the drug
- Physicians should be alert to the possibility of silent pneumonias occurring in patients treated with fluphenazine
Cautions: Use cautiously in
- Exposure to extreme heat
- Exposure to organophosphates
- History of convulsive disorders
- Mitral insufficiency
- Cardiovascular diseases
- Pheochromocytoma
- Severe hypotension
- Parkinson disease
- Myasthenia gravis
- History of glaucoma
- Pulmonary disease
- Elderly patients
- Obstructive GI disease
Supplemental Patient Information
- Advise patients to avoid performing tasks that require mental alertness like driving or operating machinery, as the drug may impair mental and physical abilities
- Instruct patients to avoid drinking alcohol during therapy
Pregnancy Category:C
Breastfeeding: Safety unknown. An alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 22 June 2011).
