FLUPHENAZINE

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.

Drowsiness, lethargy, dizziness, nausea, loss of appetite, sweating, dry mouth, blurred vision, headache, and constipation 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.

Tell your doctor right away if you have any serious side effects, including:

• feelings of restlessness,
• mask-like facial expression,
• greatly increased salivation,
• 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,

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.

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 immediately 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 infrequently 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.

Before taking fluphenazine, 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, 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.

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 infrequently 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.

Interactions

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 immediately. Symptoms of overdose may include: loss of consciousness, seizures, fast/irregular heartbeat, or slow/shallow breathing.

Notes

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.

Missed Dose

If you miss a dose and take 1 dose daily: take as soon as remembered unless it is almost time for the next dose. In that case, skip the missed dose and resume your usual schedule. If you take more than 1 dose daily: take as soon as possible if it is within an hour or so of the missed dose. If not remembered within an hour, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze. Keep tightly closed. 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.

Brands

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