FLUPHENAZINE DECANOATE PACKAGE INSERT PDF

More Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Prolixin Decanoate Fluphenazine Decanoate Injection may be given intramuscularly or subcutaneously. A dry syringe and needle of at least 21 gauge should be used. Use of a wet needle or syringe may cause the solution to become cloudy.

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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.

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. 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. 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.

If they continue or are bothersome, check with your doctor. Overdose Signs and Symptoms Symptoms of overdose may include restlessness, muscle spasms, tremors, twitching, deep sleep or loss of consciousness, and seizures. Of the 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. Treatment 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. Extrapyramidal symptoms may be treated with antiparkinsonian agents.

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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. Over the course of a typical week controlled trial, the rate of death in drug-treated patients was about 4. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular e. 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 patient is not clear. It is a highly potent behavior modifier with a markedly extended duration of effect.

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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. Over the course of a typical week controlled trial, the rate of death in drug-treated patients was about 4. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular e. 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.

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Fluphenazine Decanoate Full Prescribing Information

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. 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.

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