(floo fen' a zeen)
P / L : Contraindicated in pregnancy and lactation
|| See TERMINOLOGY & ABBREVIATIONS ||
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
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 is not approved for the treatment of patients with dementia-related psychosis.
|Indication(s) & Dosage||
|Administration||May be taken with or without food.
|Contraindications||Hypersensitivity; comatose or severely depressed states; blood dyscrasias; liver disease; bone marrow depression; phaeochromocytoma; suspected or established subcortical brain damage with or without hypothalamic damage; pregnancy (3rd trimester), lactation.|
|Special Precautions||Presence of convulsive disorders; hepatic, renal, cerebrovascular, resp and CV diseases; elderly or debilitated patients. May elevate prolactin levels which may persist after chronic admin. May exacerbate depression. Closed-angle glaucoma. History of jaundice, parkinsonism, DM, hypothyroidism, myasthenia gravis, paralytic ileus, prostatic hyperplasia or urinary retention. Regular eye examinations in patients receiving long term therapy. Avoid direct sunlight exposure.|
|Adverse Drug Reaction(s)||Tardive dyskinesia, sedation, mental confusion; hypotension; hyperprolactinaemia leading to galactorrhoea and amenorrhoea in women; loss of libido, impotence and sterility in males. Allergic reactions, cholestatic jaundice, corneal and lens deposits, skin pigmentation.
Potentially Fatal: Agranulocytosis; neuroleptic malignant syndrome.
|Drug Interactions||Reduces antihypertensive effects of guanethidine, methyldopa and clonidine. Lithium toxicity. Reduced bioavailability with antacids. Increased risk of arrhythmia when used with drugs that prolong QT interval. May cause electrolyte disturbance when used with diuretics.
Potentially Fatal: Additive CNS depressant effects with alcohol, barbiturates, hypnotics, sedatives, opiates and antihistamines. Please consult detailed drug interactions before prescribing.
|Pregnancy Category (FDA)||Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.|
|Storage||Intramuscular: Store at 15-30°C. Oral: Store at 15-30°C.|
|Pharmacology||Fluphenazine blocks postsynaptic dopamine D1 and D2 receptors in the mesolimbic system and decreases the release of hypothalamic and hypophyseal hormones. It reduces aggressiveness with disappearance of hallucinations and delusions.
Onset: 1-3 days.
Duration: 2-4 days.
Absorption: Absorbed as HCl from the GI tract (oral); slowly absorbed as decanoate and enantate (SC/IM).
Distribution: Crosses the placenta; enters breast milk. Protein-binding: 91-99%.
Excretion: Urine (as metabolites); 14.7 hr (elimination half-life).
|ATC Classification||N05AB02 - fluphenazine; Belongs to the class of phenothiazine antipsychotics with piperazine structure. Used in the management of psychosis.|
|Brand Name||Manufacturer/Marketer||Composition||Dosage Form||Pack Size & Price|
|Fenazine||Incepta Pharmaceuticals Limited||Fluphenazine Decanoate 25mg/ml||IM/SC Injection||1x5's:MRP 375 Tk|
|FLUPHENAZINE DECANOATE-Rotex||Rotex/City Overseas||Fluphenazine decanoate 25mg/1ml||Injection||1ml x10's, 10ml x1's: 960.00 TP, 700.00 TP|
Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as fluphenazine have an increased risk of death during treatment.
Fluphenazine is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking fluphenazine. For more information visit the FDA website: http://www.fda.gov/Drugs
Why is this medication prescribed?
Fluphenazine is an antipsychotic medication used to treat schizophrenia and psychotic symptoms such as hallucinations, delusions, and hostility.
This medication is sometimes prescribed for other uses; ask your doctor for more information.
How should this medicine be used?
Fluphenazine comes as a tablet or oral liquid (elixir and concentrate) to take by mouth. It is usually taken two or three times a day and may be taken with or without food. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand. Take fluphenazine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Fluphenazine oral liquid comes with a specially marked dropper for measuring the dose. Ask your pharmacist to show you how to use the dropper. Do not allow the liquid to touch your skin or clothing; it can cause skin irritation. Dilute the concentrate in water, Seven-Up, carbonated orange beverage, milk, or V-8, pineapple, apricot, prune, orange, tomato, or grapefruit juice just before taking it. Do not use beverages containing caffeine (coffee, tea, and cola) or apple juice.
Continue to take fluphenazine even if you feel well. Do not stop taking fluphenazine without talking to your doctor, especially if you have taken large doses for a long time. Your doctor probably will want to decrease your dose gradually. This drug must be taken regularly for a few weeks before its full effect is felt.
What special precautions should I follow?
Before taking fluphenazine,
- tell your doctor if you are allergic to fluphenazine or any other drugs.
- tell your doctor what prescription and nonprescription drugs you are taking or have taken within the last 2 weeks, especially antidepressants; antihistamines; bromocriptine; diet pills; lithium; medication for high blood pressure, seizures, Parkinson's disease, asthma, colds, or allergies; meperidine; methyldopa; muscle relaxants; propranolol; sedatives; sleeping pills; thyroid medications, tranquilizers; and vitamins.
- tell your doctor if you have or have ever had glaucoma, an enlarged prostate, difficulty urinating, seizures, an overactive thyroid gland, or liver, kidney, or heart disease.
- tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking fluphenazine, call your doctor. Fluphenazine may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking fluphenazine.
- you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
- remember that alcohol can add to the drowsiness caused by this drug.
- tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this drug.
What should I do if I forget a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Side effects from fluphenazine are common:
weakness or tiredness
excitement or anxiety
skin more sensitive to sunlight than usual
- changes in appetite or weight
Tell your doctor if any of these symptoms are severe or do not go away:
changes in sex drive or ability
If you experience any of the following symptoms, call your doctor immediately:
jaw, neck, and back muscle spasms
slow or difficult speech
persistent fine tremor or inability to sit still
fever, chills, sore throat, or flu-like symptoms
difficulty breathing or swallowing
severe skin rash
yellowing of the skin or eyes
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.
What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to this medicine.
Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Ref: MedlinePlus, U.S. National Library of Medicine.
This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.
|| See FDA approved Prescribing Information from Brand Manufacturer |||Manufacturer's|
|| Back to top ||
*Trademark name & prescribing information are the property of their respective Manufacturers.