fluphenazine decanoate

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. Some of the benefits of continued use of this medication include reduced episodes of hallucinations, delusions, or bizarre behaviors that occur in patients with schizophrenia. This product does not work immediately. 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.

If you miss an injection, contact your doctor or pharmacist immediately to establish a new dosing schedule.

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.

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, pergolide), guanadrel, guanethidine, lithium, sibutramine. Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with fluphenazine decanoate, such as isoniazid (INH), theophylline, bupropion, 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.

Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (USA), or 1-800-668-1507 (Canada).

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.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: loss of consciousness, seizures, fast/irregular heartbeat, or slow/shallow breathing.

Before using fluphenazine decanoate, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (e.g., 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. This medication should not be given to patients who are unconscious. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: brain damage, severe nervous system problems (severe CNS depression). Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., leukopenia, thrombocytopenia, agranulocytosis), liver problems, breast cancer, eye problems (e.g., glaucoma), heart problems (e.g., 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 (e.g., asthma, emphysema, frequent infections), low blood calcium, enlarged prostate, drug or alcohol dependency, Reye's syndrome, other nervous system problems (e.g., cerebrovascular insufficiency, brain tumors, encephalitis, encephalopathy), dehydration. Before having surgery or any diagnostic testing, tell your doctor or dentist that you are taking fluphenazine decanoate. 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. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. 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. The medication can reduce sweating, making you more susceptible to heat stroke. Avoid strenuous work or exercise in hot weather. Avoid being exposed to very cold temperatures (e.g., swimming in cold water). Severe lowering of your body temperature may occur. Caution is advised when using this drug in children because they may be more sensitive to its effects, especially the side effect of uncontrolled movements. This is especially true if the child is sick (e.g., has chickenpox, measles, stomach flu). Caution is advised when using this drug in the elderly, because they may be more sensitive to its effects, especially to facial or muscle twitching, muscle spasms/stiffness, uncontrolled movements (tardive dyskinesia) and possible effects on blood pressure. Elderly patients may also experience more pain from the injection. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It should not be used during the first three months of pregnancy. Liver problems, birth defects, or side effects involving involuntary muscle movements may occur in infants exposed to this type of medication in the womb. Tell your doctor immediately if you notice yellowing of the eyes/skin, dark urine, unusual muscle movements, or muscle stiffness in your infant. Based on information for similar drugs, fluphenazine may pass into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

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.

Drowsiness, lethargy, dizziness, nausea, loss of appetite, sweating, dry mouth, blurred vision, headache, constipation, or pain/redness at the injection site may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. 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 immediately if any of these unlikely but serious side effects occur: feelings of restlessness, mask-like facial expression, greatly increased saliva, tremors, unusual mental/mood changes (e.g., depression, worsening of psychosis), confusion, unusual dreams, frequent urination or difficulty urinating, vision problems, weight change, swelling of the feet/ankles, fainting, skin discoloration. Tell your doctor immediately if any of these rare but very serious side effects occur: butterfly-shaped facial rash, joint/muscle 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 immediately. For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, 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 immediately if you develop any unusual/uncontrolled movements (especially of the face, mouth, tongue, arms, or legs). This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop the following: fever, muscle stiffness, severe confusion, increased sweating, fast or irregular heartbeat. This drug may infrequently cause serious blood problems (e.g., agranulocytosis, leukopenia) or liver problems. Seek immediate medical attention if you notice any of the following rare but very serious side effects: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, severe stomach/abdominal pain, dark urine, yellowing of the eyes/skin. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

There may be a slightly increased risk of serious, possibly fatal side effects (e.g., pneumonia, heart failure) when this medication is used in 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.