Fluphenazine Decanoate Full Prescribing Information
Brand Name: Prolixin, Permitil, Modecate
Generic Name: Pluphenazine Decanoate
Prolixin, Fluphenazine Decanoate, is an antipsychotic medication used to treat Schizophrenia. Uses, dosage, side effects.
Prolixin (Fluphenazine Decanoate) is a phenothiazine, an antipsychotic medication, used to treat emotional disorders such as schizophrenia. It may also be used to treat other conditions as determined by your doctor.
This medicine is usually administered as an injection at your doctor's office or a clinic. The onset of action generally appears between 24 to 72 hours after injection, and the effects of the drug on psychotic symptoms become significant within 48 to 96 hours. Amelioration of symptoms then continues for 1 to 8 weeks with an average duration of 3 to 4 weeks. There is considerable variation in the individual response of patients to this depot fluphenazine and its use for maintenance therapy requires careful supervision.
Fluphenazine Decanoate (Prolixin, Permitil, Modecate) is indicated for the treatment of schizophrenia.
Fluphenazine decanoate is not indicated for the management of severely agitated psychotic patients, psychoneurotic patients or geriatric patients with confusion and/or agitation.
Patients who have shown hypersensitivity to other phenothiazines, including fluphenazine, should not be given fluphenazine decanoate.
Phenothiazines should not be used in patients receiving large doses of hypnotics, due to the possibility of potentiation.
It is not intended for use in children under 12 years of age.
Severe adverse reactions requiring immediate medical attention may occur and are difficult to predict. Therefore, the evaluation of tolerance and response, and establishment of adequate maintenance therapy, require careful stabilization of each patient under continuous, close medical observation and supervision.
Interference with Cognitive or Motor Performance: Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to this medicine.
Do not become overheated in hot weather, during exercise, or other activities since heat stroke may occur while you are using this medicine.
This medicine may cause increased sensitivity to the sun. Avoid exposure to the sun or sunlamps until you know how you react to this medicine. Use a sunscreen or protective clothing if you must be outside for a prolonged period.
Pregnancy and Nursing
Safety during pregnancy has not been established. The drug should not be administered to women of childbearing potential, particularly during the first trimester, unless, in the opinion of the physician, the expected benefits outweigh the potential risks to the fetus.
Seizures: Phenothiazines should be used with caution in patients with a history of convulsive disorders since grand mal seizures have been known to occur.
Cardiac: Since hypotension and ECG changes suggestive of myocardial ischemia have been associated with the administration of phenothiazines, fluphenazine decanoate should be used with caution in patients with compensated cardiovascular or cerebrovascular disorders.
Before using this medicine, inform your doctor or pharmacist of all prescription and over-the-counter medicine that you are taking. This includes guanethidine and medicines used to treat depression and bladder or bowel spasms. Inform your doctor of any other medical conditions including depression, seizure disorders, allergies, pregnancy, or breast-feeding.
Use with other drugs: The effects of atropine or other drugs with similar action may be potentiated in patients receiving phenothiazines because of added anticholinergic effects. Paralytic ileus, even resulting in death, may occur especially in the elderly. Fluphenazine decanoate should be used cautiously in patients exposed to extreme heat or phosphorus insecticides.
Side effects that may go away during treatment, include drowsiness, dizziness, nasal congestion, blurred vision, dry mouth, or constipation. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience changes in vision; changes in breasts; changes in menstrual period; sore throat; inability to move eyes; muscle spasms of face, neck, or back; difficulty swallowing; mask-like face; tremors of hands; restlessness; tension in legs; shuffling walk or stiff arms or legs; puffing of cheeks; lip smacking or puckering; twitching or twisting movements; or weakness of arms or legs.
Signs and Symptoms
Symptoms of overdose may include restlessness, muscle spasms, tremors, twitching, deep sleep or loss of consciousness, and seizures.
Of the 354 cases of deliberate or accidental overdose involving fluvoxamine maleate reported, there were 19 deaths. Of the 19 deaths, 2 were in patients taking fluvoxamine maleate alone and the remaining 17 were in patients taking fluvoxamine maleate along with other drugs.
If you or someone you know may have used more than the recommended dose of this medicine, contact your local poison control center or emergency room immediately.
No further injections should be given until the patient shows signs of relapse and the dosage then should be decreased. An unobstructed airway should be established with maintenance of respiration as required. Severe hypotension calls for the immediate use of an i.v. vasopressor drug, such as levarterenol bitartrate USP. Extrapyramidal symptoms may be treated with antiparkinsonian agents.
- Follow the directions for using this medicine provided by your doctor.
- Store this medicine at room temperature, in a tightly-closed container, away from heat and light.
- If you miss a dose of this medicine and you are using it regularly, take it as soon as possible. If you are taking 1 dose at bedtime and do not remember until the next morning, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once.
- When using the solution form: mix your dose in water, juice, soup, or other liquid before taking.
Additional Information:: Do not share this medicine with others for whom it was not prescribed. Do not use this medicine for other health conditions. Keep this medicine out of the reach of children.
For oral dosage form (elixir, solution, or tablets):
Adults: At first, 2.5 to 10 milligrams (mg) a day, taken in smaller doses every six to eight hours during the day. Your doctor may increase your dose if needed. However, the dose is usually not more than 20 mg a day.
Children: 0.25 to 0.75 mg one to four times a day.
Elderly: 1 to 2.5 mg a day. Your doctor may increase your dose if needed.
Fluphenazine decanoate is given by injection.
The initial recommended dose is 2.5 mg to 12.5 mg. An initial dose of 12.5 mg is usually well tolerated. However, an initial test dose of 2.5 mg is recommended in patients: over the age of 50 or with disorders that predispose to undue reactions; whose individual or family history suggests a predisposition to extrapyramidal reactions; who have not previously received a long acting depot neuroleptic.
The onset of action generally appears between 24 to 72 hours after injection, and the effects of the drug on psychotic symptoms become significant within 48 to 96 hours.
Maintenance/Continuation Extended Treatment: Patients can usually be controlled with 25 mg or less, every 2 to 3 weeks. Although doses greater than 50 mg are usually not necessary, doses up to 100 mg have been used in some patients. If doses greater than 50 mg are necessary, the next dose and succeeding doses should be increased in increments of 12.5 mg. While the response to a single injection lasts usually 2 to 3 weeks, it may last for 4 weeks or more.
IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.
Each mL of injectable solution contains: Fluphenazine decanoate 25 mg in sesame oil with benzyl alcohol 1.5% as preservative. Vials of 5 mL.
Prolixin Tablets: Available in 1 mg, 2.5 mg, 5 mg, 10 mg.
Concentrate: Each mL of injectable solution contains: Fluphenazine decanoate 100 mg in sesame oil with benzyl alcohol 1.5% as preservative. Ampuls of 1 mL.
The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse. Last updated 3/03.
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