Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

FLUPHENAZINE CONCENTRATE - ORAL

(flew-FEN-uh-zeen)

COMMON BRAND NAME(S): Prolixin

Uses

This medication is used to treat symptoms of certain types of mental or emotional conditions.

How To Use

Take with food or milk if stomach upset occurs unless directed otherwise by your doctor. Measure carefully and dilute (mix) with 4 ounces (120ml) or more of water, milk, juice or non-caffeinated carbonated drink. Do not dilute with coffee, tea, colas or apple juice as the drug may lose its effectiveness. Take immediately after diluting. Do not dilute drug for later use. Avoid skin contact with the drug to prevent rash. This medication must be taken as prescribed. Do not stop taking this drug suddenly without consulting your doctor. Some conditions may worsen if the medication is suddenly stopped. It may take up to two weeks for the full benefit of this medication to take effect.

Side Effects

Constipation, drowsiness, vision changes, or dry mouth may occur. If any of these effects persist or worsen, notify your doctor. Unlikely to occur but report promptly: restlessness, muscle stiffness, weakness, difficulty speaking, loss of balance, mask- like facial expression, trembling or shaking, dizziness, lip smacking or other uncontrollable movements, difficulty urinating, skin rash/discoloration. Very unlikely to occur but report promptly: sore throat, unusual bleeding or bruising, stomach pain, yellowing of eyes or skin, dark urine, hot dry skin, vomiting. Though very unlikely to occur, notify your doctor immediately if you experience any of the following effects: severe muscle stiffness, confusion, fever, seizures, irregular/fast heartbeat, increased sweating, prolonged/painful erection. In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history especially: very high or very low blood pressure, liver or heart disease, Reye's syndrome, alcohol or drug dependencies, nervous system problems, blood disorders, any allergies (especially any drug allergies). Use caution performing tasks that require alertness, such as driving or using machinery. Use of alcohol can cause extreme drowsiness. Avoid alcohol use. This medication may increase sensitivity to sunlight. Avoid prolonged sun exposure and wear a sunscreen and protective clothing when you are exposed to the sun. This medication can reduce sweating making you more susceptible to heat stroke. Avoid strenuous work or exercise in hot weather. This drug is not intended for use in children under 12 years of age. Fluphenazine is not recommended for use during pregnancy. Consult your doctor before using this drug. Certain drugs closely related to fluphenazine (a phenothiazine) are excreted into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Drug Interactions

Tell your doctor or pharmacist of all prescription and nonprescription drugs you may use, especially: other anti-depressant/anti-anxiety drugs, sparfloxacin, grepafloxacin, guanethidine, guanadrel, metrizamide, cabergoline, lithium. Tell your doctor if you are taking drugs that cause drowsiness such as: medicine for sleep, sedatives, tranquilizers, anti- anxiety drugs (e.g., diazepam), narcotic pain relievers (e.g., codeine), anti-seizure drugs (e.g., carbamazepine), muscle relaxants, antihistamines that cause drowsiness (e.g., diphenhydramine). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of these products. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include restlessness, muscle spasms, tremors, twitching, deep sleep or loss of consciousness, and seizures.

Notes

It is important you be monitored. Keep all doctor appointments. Do not share this medication with others.

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 away from sunlight and moisture. Do not store in the bathroom. Do not freeze. Keep tightly closed.

Medical Alert

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).