There may be a slightly increased risk of serious, possibly fatal side effects (such as heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.Who should not take Prolixin Decanoate injection?
This medication is a long-acting form of fluphenazine that is used to treat certain mental/mood problems (chronic schizophrenia). Fluphenazine decanoate is usually used in patients who have benefited from regular doses of short-acting forms of fluphenazine and who may benefit from long-term (maintenance) treatment with less frequent dosing. Fluphenazine belongs to a class of medications called phenothiazines and is also referred to as a neuroleptic. It works by affecting the balance of natural chemicals (neurotransmitters) in the brain.
This product does not work right away. It may take 1-3 days to notice an effect from this drug, and up to 4 days to experience the full effect. For severe agitation or other symptoms, use a short-acting medication as directed by your doctor.
This medication is not recommended for use in children under 12 years of age. Also, it should not be used to manage behavioral problems in patients with mental retardation.
This medication is given by injection into a muscle (intramuscularly-IM) or beneath the skin (subcutaneously-subQ) by a nurse or doctor. This medication is usually injected every 4-6 weeks, or as directed by your doctor. If you are giving yourself this medication, learn how to prepare and inject this medication. If any of the information is unclear, consult your doctor or pharmacist.
This medication is usually pale yellow in color. If the liquid becomes any darker than pale yellow, is discolored in any other way, or if particles appear in the liquid, do not use the liquid.
Wash and dry your hands thoroughly before measuring and injecting the drug. Clean the injection site with rubbing alcohol. Avoid getting the medication on your skin because allergic reactions (contact dermatitis) may occur.
Learn how to store and discard needles and medical supplies safely. Never reuse syringes or needles. Consult your pharmacist for more details.
Use this medication regularly in order to get the most benefit from it. Dosage is based on your medical condition, past use of other drugs for your condition, and response to therapy. The dose should not be greater than 100 milligrams.
Inform your doctor if your condition does not improve or worsens.
Drowsiness, lethargy, dizziness, nausea, loss of appetite, sweating, dry mouth, blurred vision, headache, constipation, and pain/redness at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: feelings of restlessness, mask-like facial expression, greatly increased saliva, tremors, unusual mental/mood changes (such as depression, worsening of psychosis), confusion, unusual dreams, frequent urination or difficulty urinating, vision problems, weight change, swelling of the feet/ankles, fainting, skin discoloration, butterfly-shaped facial rash, joint pain, seizures.
In rare instances, this medication may increase your level of a certain hormone (prolactin). For females, this rare increase in prolactin may result in unwanted breast milk, missing/stopped menstrual periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.
Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.
Fluphenazine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual/uncontrolled movements (especially of the face, mouth, tongue, arms, or legs).
This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.
This drug may rarely cause serious blood problems (such as agranulocytosis, leukopenia) or liver problems. Get medical help right away if you notice any of the following rare but very serious side effects: signs of infection (such as fever, persistent sore throat), easy bruising/bleeding, severe stomach/abdominal pain, yellowing of the eyes/skin.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using fluphenazine decanoate, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (such as chlorpromazine, perphenazine); or if you have any other allergies. This product may contain inactive ingredients (such as sesame oil, benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain damage, nervous system problems (such as CNS depression, cerebrovascular insufficiency, brain tumors, encephalitis, encephalopathy), blood problems (such as leukopenia, thrombocytopenia, agranulocytosis), liver problems, breast cancer, eye problems (such as glaucoma), heart problems (such as very high or very low blood pressure, mitral valve insufficiency), kidney problems, certain types of tumors (pheochromocytoma), seizures, exposure to phosphorus insecticides, chronic breathing problems (such as asthma, emphysema, frequent infections), low blood calcium, enlarged prostate, drug or alcohol dependency, Reye's syndrome, dehydration.
Before having surgery or any diagnostic testing, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.
This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.
Avoid being exposed to very cold temperatures (such as swimming in cold water). Severe lowering of your body temperature may occur.
Children may be more sensitive to the side effects of this drug, especially the side effect of uncontrolled movements. This is especially true if the child is sick (such as has chickenpox, measles, stomach flu).
Older adults may be more sensitive to the side effects of this drug, especially to facial or muscle twitching, muscle spasms/stiffness, uncontrolled movements (tardive dyskinesia), drowsiness, confusion, and possible effects on blood pressure. Drowsiness and confusion can increase the risk of falling. Elderly patients may also experience more pain from the injection.
During pregnancy, this medication should be used only when clearly needed. Liver problems or birth defects may occur in infants exposed to this type of medication in the womb. Tell the doctor right away if you notice yellowing of the eyes/skin or dark urine in your infant. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.
Since untreated mental/mood problems (such as schizophrenia) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.
It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.
Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergics (e.g., atropine), dopamine agonists (e.g., cabergoline, levodopa, pergolide), guanadrel, guanethidine, lithium.
Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with fluphenazine decanoate, such as isoniazid (INH), theophylline, or tramadol, among others. Consult your doctor or pharmacist for more details.
Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: antihistamines that cause drowsiness (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., carbamazepine), medicine for sleep (e.g., zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), other psychiatric medicines (e.g., other phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), tranquilizers.
Check the labels on all your medicines (e.g., cold-and-cough products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.
This drug may interfere with certain laboratory tests (pregnancy test, phenylketonuria test, some urine tests). Make sure laboratory personnel and your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: loss of consciousness, seizures, fast/irregular heartbeat, or slow/shallow breathing.
Do not share this medication with others.
Laboratory and/or medical tests (e.g., liver function, kidney function, complete blood counts, eye exams, AIMS test) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss an injection, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.
Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Avoid freezing. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised March 2015. Copyright(c) 2015 First Databank, Inc.
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